(DEc 3, 2020)
Pfizer chairman Albert Bourla told Dateline host Lester Holt that the pharmaceutical company was “not certain” if the vaccine prevented the coronavirus from being transmitted, saying, “This is something that needs to be examined.”
Archiv: medicine / drugs / vaccines
. @EU_Commission and Member States expressed deep dissatisfaction with this. We insisted on a precise delivery schedule on the basis of which Member States should be planning their vaccination programs, subject to the granting of a contitional marketing authorisation. /2
The @EU_Commission will continue to insist with @AstraZeneca on measures to increase predictability and stability of deliveries, and acceleration of the distribution of doses/3.
COVID-19: AstraZeneca to ‚cut COVID-19 vaccine delivery to EU by 60%‘
The company was expected to deliver around 80 million doses to the 27 EU countries by the end of March, an EU official told the agency.
However, it now expects that to be cut to 31 million doses due to „production problems“ at a vaccine factory in Belgium run by its partner Novasep.
Pfizer Will Ship Fewer Vaccine Vials to Account for ‘Extra’ Doses
After the surprise discovery of an extra dose in every vial, Pfizer executives successfully lobbied the F.D.A. to change the vaccine’s formal authorization language. The company charges by the dose.
Slow vaccine rollout could make lockdown last PAST Easter as Priti Patel blames AstraZeneca and Pfizer for causing ’supply issues‘ by ‚upgrading their factories‘ – even though ’21m doses are already in UK‘ and Scotland is ’sitting on 400k‘
Priti Patel today blamed AstraZeneca and Pfizer for an alarming slowdown in the UK’s vaccine rollout – amid warnings the target of giving jabs to the 14million most vulnerable people by mid-February is now ‚very tight‘.
The Home Secretary pointed the finger at the firms after the daily rate fell for a third consecutive day, saying ‚upgrades‘ at factories and ‚reconfiguring‘ of supply chains were causing delays.
Derbyshire health chiefs warn that vaccines alone will not mean an end to restrictions
“We don’t know yet whether an individual can, although not becoming ill from the virus because they have been vaccinated, still catch it and spread it on to others.
Vaccinated Brits told not to hug kids amid fears millions will ignore Covid rules once they have jab
Asked whether people who had received the jab could hug their children, Janet Lord, director of Birmingham University’s Institute of Inflammation and Ageing, said: “I would certainly advise not to do that at the moment because as you probably know with the vaccines they take several weeks before they are maximally effective.“
The COVID Vaccine May Not Protect You From This One Thing, Experts Warn
(05.12.2020)
In order to halt the spread of coronavirus completely, a vaccine would need to produce antibodies that stop the virus from replicating. „To prevent asymptomatic infection and transmission, you need what’s called sterilizing immunity,“ Greg Poland, MD, director of the Mayo Clinic’s Vaccine Research Group, explained to USA Today. While it’s possible that one or more of the vaccines could produce sterilizing immunity, it currently remains unproven.
Covid-19 vaccination associated with adverse drug reactions in elderly people who are frail
(15.01.2021)
The reports suggest that common adverse reactions to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some frail patients, says Sigurd Hortemo, chief physician at the Norwegian Medicines Agency.
The large studies on Comirnaty (BioNTec/Pfizer) did not include patients with unstable or acute illness – and included few participants over 85 years of age.
BIG news: Citing post-vaccination deaths, Norway now says “very frail” people should NOT receive the #Covid vaccine. Norway reports 23 post-vaccine deaths (out of only 25,000 shots). After examining 13, it says “side effects from the mRNA vaccines… may have led to deaths.”
(15.01.2021)
Protection versus immunity: the great vaccination debate
That issue had been quietly bubbling away for months as animal and human trial data pointed to difficulties in making vaccines that achieve „sterilising immunity“ – total immunity from infection, versus immunity from getting seriously ill.
Concerns circulated among scientists and doctors on social media.
Those who have received Covid jab to be offered ‚vaccine passport‘ in new trial
The news comes depsite the Vaccines Minister, Nadhim Zahawi, ruling out immunity passports back in December, a week after suggesting it was something ministers were considering, saying: “We are not looking at immunity passports at all.”
Matt Hancock also denied plans to implement passporting last week, telling the Spectator: „It’s not an area that we’re looking at.“
Even if you’ve had your #COVID19 vaccine, it’s important that you continue to follow national restrictions. We don’t yet know if the vaccine prevents transmission – you could potentially still carry and transmit the virus to other vulnerable people, even if you are protected
Doctor’s Death After Covid Vaccine Is Being Investigated
Shortly after receiving the vaccine, Dr. Michael developed an extremely serious form of a condition known as acute immune thrombocytopenia, which prevented his blood from clotting properly.
In a statement, Pfizer, the maker of the vaccine, said it was “actively investigating” the case, “but we don’t believe at this time that there is any direct connection to the vaccine.”
How well does the Oxford vaccine work? What we know so far
(30.12.2020)
And while there are some early signs the Oxford/AstraZeneca vaccine might not only prevent people becoming seriously ill with Covid but also prevent asymptomatic infections, more data is needed to confirm such protection.
The data supports the investigation of intranasal delivery of COVID-19 vaccines. With the roll-out of COVID-19 vaccines worldwide, it will be crucial to investigate whether the vaccines provide sterilizing immunity…
Once you and your friends are vaccinated, can you quit social distancing?
How long it takes for various countries to reach herd immunity will depend in part on how fast they can access vaccines and what share of their populations are willing to get the shot. But as mentioned above, there’s another crucial factor.
“It’s really going to come down to what we learn over the next few months about how well the vaccine prevents infection and transmission,” Murray said, adding that she doesn’t expect we’ll have an answer to that until March at the earliest.
China’s Kangtai starts mid-stage trial of its COVID-19 vaccine candidate
(29.10.2020)
Apart from developing its own vaccine, Kangtai also has a deal to make and supply mainland China with the vaccine candidate developed by AstraZeneca and researchers at the University of Oxford.
AstraZ did not apply for approval until now. EMA cannot approve what they do not get.
(…)
Good news! @AstraZeneca has applied to @EMA_News to have its vaccine authorised in the EU. @EMA_News will assess the vaccine’s safety & efficacy.
Once the vaccine receives a positive scientific opinion, we will work full speed to authorise its use in Europe.
Ireland. Just had a 16 Billion Euro COVID bill, that it gets 1.5 back from. Waits patiently for the EMA to approve its vaccines. No sign of the EMA approving Oxford any time soon. 2009 – gets another Lisbon ref, whilst being threatened with perdition. „Independence“
EU land news. EMA who sign off vaccine has not even began to look at the AZ Oxford vaccine while its own curevac vaccine is still months away from approval. The eu failed to buy needles & its vaccine distributions hit a brick wall yesterday (accept holland They not yet started)
Good article in The Economist trying to explain why the vaccination campaigns across Europe are so very slow and why this ‚risks extending the pandemic for months.‘
Covid-19: UK begins immunisation drive of second vaccine, Mexico okays Oxford-AstraZeneca candidate
2. Mexico has approved the Oxford-AstraZeneca vaccine, its government announced on Monday, joining the UK, Argentina and India in giving a nod to the shot.
Argentina and El Salvador approve AstraZeneca/Oxford Covid-vaccine
(31.12.2020)
Argentina has approved the coronavirus vaccine developed by Oxford University and the pharmaceutical company AstraZeneca, making it the second country after Britain to do so.
Matt Hancock blames Covid spread on public as government under pressure for new lockdown
Health secretary Matt Hancock has said that Boris Johnson’s tier system is “no longer strong enough” to deal with the new more virulent variant of coronavirus.
Operation Hope begins: Half a MILLION Covid-19 jabs will be made available to vulnerable people this week in UK’s biggest EVER mass vaccination drive as health bosses ramp up efforts to beat the pandemic
Elderly and infirm people in Oxford, London, Brighton, Morecambe in Lancashire and Nuneaton in Warwickshire are due to be first to receive the jab.
A total of 530,000 doses will be made available at 540 GP vaccination sites and 101 hospitals this week.
The NHS has ordered 100million doses which it is hoped will free the country from Covid-19.
First of 530,000 Oxford/AstraZeneca jabs to be rolled out today in Britain’s war on coronavirus
Hospitals at six NHS trusts across London, Brighton, Oxford, Morecambe and Nuneaton will be the first to give the vaccine.
It will reach more than 500 GP surgeries and community centres by the end of the week — with PM Boris Johnson saying “we are going as fast as we can”.
Amazing 7,750 volunteers sign up to The Sun’s Jabs Army appeal in first 48 hours
The Sun joined forces with the NHS and the Royal Voluntary Service to urge readers to volunteer as stewards at the pop-up vaccination centres across the UK. It launched on New Year’s Day.
According to the latest figures, 7,744 have signed up to help, with most of those crediting The Sun.
Catherine Johnstone CBE, chief exec of the Royal Voluntary Service, said: “The response from Sun readers has been incredible.
COVID-19: Chief medical officer Chris Whitty warns coronavirus vaccine shortages will last months
(01.01.2021)
„At the moment it doesn’t look good – a hole is appearing because there’s a lack of other approved vaccines and we have to fill the gap with our own vaccine,“ BioNTech CEO Ugur Sahin told news weekly Spiegel.
Global partnership COVAX secures two billion COVID-19 vaccine doses
(19.12.2020)
UNITED NATIONS: Global vaccine partnership COVAX has lined up almost two billion doses of existing and candidate COVID-19 vaccines for use worldwide, including 200 million doses of the AstraZeneca/Oxford vaccine through an agreement between the Vaccine Alliance Gavi, the Serum Institute of India and the Bill and Melinda Gates Foundation.
Boris Johnson hails Oxford vaccine as a ‚triumph for British science‘ and says he is ‚confident this is the year we will defeat coronavirus‘
The initial supplies of Oxford-AstraZeneca vaccine have been produced by a company called Halix in the Netherlands.
Once produced in bulk, the vaccine goes to a plant in Wrexham, run by an Indian company called Wockhardt, where it is decanted into vials in a process known as ‚fill and finish‘. The plant can bottle at least 150,000 doses a day.
First Oxford Covid vaccine doses arrive at UK hospitals with 530,000 jabs to be rolled out from Monday
While the Oxford vaccine uses a harmless, weakened version of a common virus in chimpanzees, the Pfizer jab is known as a messenger vaccine (MRNA), using a genetic code rather than a weakened form of the virus.
And experts have urged patients not to mix and match the two.
EU bureaucracy is accused of ‚costing lives‘ after European regulators said they cannot approve the Oxford vaccine before February
(31.12.2020)
Mr Wathion told Belgian newspaper Het Nieuwsblad the EMA was ‘in the dark’ about what kind of data was being used for Britain to approve the use of the Oxford vaccine.
The EU has already bought 400million doses of the jab while awaiting regulatory approval.
Why no jab? Australia lags behind in race for vaccine
Despite assurances by Health Minister Greg Hunt that the progression of the vaccine was well under way, the Australian Government is unlikely to start immunising health workers and the elderly until at least March.
AstraZeneca vaccine could get approval in Australia by late January
(31.12.2020)
The Australian government could grant final approval for the AstraZeneca/Oxford vaccine by late January, according to AstraZeneca Australia.
A spokesperson for the company told SBS World News that the federal government has indicated the vaccine could get final approval by January 31, with a roll out in March.
Wrexham factory to produce millions of doses of the Oxford/AstraZeneca vaccine
(30.12.2020)
The Wrexham plant is able to produce around 300 million doses of the vaccine each year, and has been producing 150,000 phials a day for months in readiness to roll out the vaccine across the UK.
The CP Pharmaceuticals lab will carry out the „fill and finish“ stage of the manufacturing process. This involves dispensing the vaccine into vials ready for it to be sent out across the country.
The 18-month agreement with parent company Wockhardt was announced back in August.
Oxford Covid-19 vaccine Covishield gets emergency use approval in India
An expert panel on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on Friday granted emergency use authorisation for the Oxford Covid-19 vaccine Covishield, being manufactured by Serum Institute of India, sources said on Friday.
COVID-19: Chief medical officer Chris Whitty warns coronavirus vaccine shortages will last months
„At the moment it doesn’t look good – a hole is appearing because there’s a lack of other approved vaccines and we have to fill the gap with our own vaccine,“ BioNTech CEO Ugur Sahin told news weekly Spiegel.
EU still holds out on granting approval to Oxford-AstraZeneca’s COVID-19 vaccine
„Additional scientific information on issues related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation (CMA) and this has been requested from the company,“ the EMA said in a statement. „Further information from the ongoing clinical trials is also expected from January.“
The Amsterdam-based agency earlier told AFP that it had not yet received any formal marketing authorisation and that it had set no timetable for approving the vaccine.
PROFESSOR ANGUS DALGLEISH: The Oxford AstraZeneca coronavirus vaccine is as close to a miracle as medicine ever gets
Everyone can see what a serious emergency this is. We have to act. Bin the bureaucracy, and get this miracle vaccine to work right now.
How well does the Oxford vaccine work? What we know so far
And while there are some early signs the Oxford/AstraZeneca vaccine might not only prevent people becoming seriously ill with Covid but also prevent asymptomatic infections, more data is needed to confirm such protection.
Will the Vaccine End the Pandemic? This Question Must Be Answered First
One key to these successes is that these vaccines provide sterilizing immunity — recipients are not infected by the viruses that cause the diseases and don’t pass it on. When a sufficiently large percentage of the population is immunized, it reaches herd immunity: the pathogen can’t find enough new hosts to keep propagating, and outbreaks peter out.
U.K. Authorizes Covid-19 Vaccine From Oxford and AstraZeneca
A decision is further off in the United States, where the Food and Drug Administration is waiting for data from a separate clinical trial. The study was halted in September and delayed for nearly seven weeks — much longer than in other countries — as regulators investigated whether an illness in a participant in Britain was related to the vaccine. American regulators ultimately allowed the trial to proceed.
It is truly fantastic news – and a triumph for British science – that the @UniofOxford /@AstraZeneca vaccine has been approved for use. We will now move to vaccinate as many people as quickly as possible.
AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine
(30.04.2020)
The collaboration aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford. Under the agreement, AstraZeneca would be responsible for development and worldwide manufacturing and distribution of the vaccine.
AstraZeneca’s Covid-19 vaccine may have to wait for EU’s approval
The EMA’s deputy executive director Noel Wathion told Belgian newspaper Het Nieuwsblad that the pharmaceutical company “has not even filed an application” with the European drug regulators yet.
He further said that EMA “did not even have enough to warrant a conditional marketing license.”
Australia locks in coronavirus vaccine deal to produce Oxford University-AstraZeneca candidate if approved
(18 August 2020)
Amid rising pressure to lock in supply of a coronavirus vaccine, the Government has signed an agreement with UK-based drug company AstraZeneca to secure the potential COVID-19 vaccine developed by Oxford University, if its trials prove successful.
AstraZeneca/Oxford COVID-19 vaccine approved in Britain
Australia has secured 53.8 million doses of the Oxford vaccine, most of which could be manufactured locally by CSL. The federal government has also ordered 10 million doses of the Pfizer vaccine, which will all have to be imported.
Federal Health Minister Greg Hunt said on Monday he expects Australia to be „fully vaccinated“ against coronavirus by October next year.
COVID-19: UK approves use of AstraZeneca-Oxford vaccine, all eyes on India now
The approval by UK government is a good news for India because as per sources, the government was waiting for this approval and it is expected that Indian regulators would call SEC meet soon and reconsider the data and approve AstraZeneca vaccine for its use in India.
Oxford University/AstraZeneca vaccine authorised by UK medicines regulator
The Government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise Oxford University/AstraZeneca’s Covid-19 vaccine for use.
Covid-19: Oxford-AstraZeneca coronavirus vaccine approved for use in UK
The Oxford-AstraZeneca vaccine has been approved for use in the UK, with the first doses due to be given on Monday amid rising coronavirus cases.
What’s the update on the Oxford vaccine Mr Hancock
Fantastic to see Margaret Keenan receive her second dose of the @Pfizer /@BioNTech_Group #coronavirus vaccine
Covid: Millions more braced for tougher rules in England
Government sources have indicated an announcement later will see more areas move into tier four – „stay at home“.
Health Secretary Matt Hancock is due to detail the changes – which could be introduced within days – in the House of Commons after 14:30 GMT.
Still no Oxford vaccine emergency approval. Unbelievable.
(23.12.2020)
How many willing to bet that this case is part of pharma wars to sabotage Oxford vaccine?
(28.11.2020)
Coronavirus latest news: One million vaccinations a week will not bring pandemic under control, warns Sage expert
Sir Jeremy Farrar, the director of the Wellcome Trust who advises Number 10’s advisory panel Scientific Advisory Group for Emergencies (Sage) said: „We’re not going to be free of this pandemic by February, this is now a human endemic infection.
No herd immunity through vaccine programme before summer, Sage scientist warns
Calum Semple, professor of outbreak medicine at the University of Liverpool and a member of the Scientific Advisory Group for Emergencies (Sage), described the Oxford/AstraZeneca vaccine as a “game changer” if it is approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the coming days.
But he told BBC Breakfast…
Oxford coronavirus vaccine: 10,000 medics and volunteers recruited to administer jab
The Oxford/AstraZeneca jab could be approved early next week by the independent Medicines and Healthcare products Regulatory Agency (MHRA), after the final cut of data was submitted by the Government last Monday.
Still no Oxford vaccine emergency approval. Unbelievable.
(23.12.2020)
Britain could be free of Covid restrictions by February after ministers pinpointed the 15million people to vaccinate to end the cycle of lockdowns, with Oxford’s jab due to be approved Monday and rolled out within a week
Government sources say that between 12 million and 15 million people have been identified as likely to require hospital treatment if they contract coronavirus, or be at risk of dying from it. Once this group has received the vaccine – which some officials hope could be achieved by the end of February – then the NHS would no longer be at risk of being overwhelmed if the virus spread through the greater population. That would remove the main argument for shutting the economy at a stroke.
A source said: ‚The path to liberation is finally becoming clear.‘
‚THE BEST OF BRITISH‘: Oxford Covid vaccine expected to be approved MONDAY as huge efforts ‘pay off’
„We have seen the best of British at every stage, from our world-leading scientists working around the clock to carry out vital research, to builders and engineers constructing new facilities.
“Manufacturers are boosting their capabilities and hundreds of thousands of people in every corner of the UK are taking part in clinical trials — developing, finding and preparing for a vaccine has involved us all.
“It has and continues to be a truly UK-wide effort and one which showcases what a fantastic nation we are.”
How many willing to bet that this case is part of pharma wars to sabotage Oxford vaccine?
(28.11.2020)
Can I ask why the Oxford vaccine approval is taking so long? It only took 23 days for Pfizers, we are nearly at day 30 and still no sign of approval!
(21.12.2020)
Millions to receive Oxford coronavirus vaccine from Jan 4
The Government is aiming for two million people to receive their first dose of either the Oxford vaccine or the Pfizer jab within a fortnight as part of a major ramping up of the inoculation programme.
5 Questions Fauci and FDA Need to Answer on Pfizer and Moderna COVID Vaccines
1. Why didn’t the FDA’s Center for Biological Evaluation and Research require Moderna and Pfizer-BioNTech to conduct immunogenicity testing on their COVID-19 vaccines for anti-drug antibodies as recommended in the agencies’ own guidelines for drug development during clinical trials?
(…)
2. Why does the FDA seem surprised by the recent reports of life-threatening anaphylactic reactions after the agency approved emergency use of two mRNA COVID-19 vaccines that contain polyethylene glycol?
(…)
3. Why did FDA officials not acknowledge the valid and scientifically supported concerns regarding the use of PEG in COVID-19 vaccines when CHD first notified them in September?
(…)
4. Why did the FDA abandon its regulatory authority to the pharmaceutical companies developing COVID-19 vaccines?
(…)
5. Will FDA and NIAID now require mRNA vaccine manufacturers to conduct assessments of the immunogenicity of the pegylated lipid nanoparticles used in their COVID-19 vaccines, and will they also consider pre-screening of all mRNA vaccine recipients for the presence and titers of anti-PEG antibodies?
This Israeli Election Season Will Feature Vaccines, Generals and Political Cannibalism
Netanyahu will flaunt COVID vaccines and peace, Kahol Lavan might fall into oblivion and the Joint List is facing a split as Israel gears up for its fourth election in two years.
Oxford vaccine: How did they make it so quickly?
(23.11.2020)
Scientists took a common cold virus that infected chimpanzees and engineered it to become the building block of a vaccine against almost anything.
Before Covid, 330 people had been given ChAdOx1 based-vaccines for diseases ranging from flu to Zika virus, and prostate cancer to the tropical disease chikungunya.
The virus from chimps is genetically modified so it cannot cause an infection in people. It can then be modified again to contain the genetic blueprints for whatever you want to train the immune system to attack.
Boris Johnson’s future as Prime Minister rests on the Oxford vaccine being approved
The hope in Downing Street is that the Oxford vaccine will get the green light by the end of the year. This would allow the Prime Minister to start laying out plans for restrictions to be lifted.
India likely to approve AstraZeneca vaccine by next week
India is likely to approve Oxford/AstraZeneca’s coronavirus vaccine for emergency use by next week after its local manufacturer submitted additional data sought by authorities, two sources with knowledge of the matter told Reuters on Tuesday.
How the Oxford-AstraZeneca Vaccine Works
The Oxford-AstraZeneca team used a modified version of a chimpanzee adenovirus, known as ChAdOx1. It can enter cells, but it can’t replicate inside them. (…)
The Oxford-AstraZeneca vaccine for Covid-19 is more rugged than the mRNA vaccines from Pfizer and Moderna. DNA is not as fragile as RNA, and the adenovirus’s tough protein coat helps protect the genetic material inside. As a result, the Oxford vaccine doesn’t have to stay frozen.
Oxford vaccine still under review, says UK medicine agency
But Whitehall sources said that while they hoped the vaccine would be available that week, it was by no means certain, and the authorisation could be delayed until the beginning of January.
The delay has caused frustration in Whitehall and the NHS, with the vaccine taking much longer to meet approval than the Pfizer vaccine, which was rolled out in the UK last week.
FDA investigating allergic reactions to Pfizer vaccine reported in multiple states
“We are working hand in hand with the Centers for Disease Control and Prevention (CDC), and we’ve actually been working closely with our United Kingdom colleagues, who of course reported the allergic reaction. I think we’ll be looking at all the data we can from each of these reactions to sort out exactly what happened, and we’ll also be looking to try to understand which component of the vaccine might be helping to produce them,” Marks said.
Third Alaskan health care worker has allergic reaction to Covid-19 vaccine
For the third time in three days, an Alaska health care worker had an allergic reaction after receiving a dose of the new Pfizer Covid-19 vaccine.
Nurse Fainting After COVID Vaccine Not Due to Shot Ingredients, Doctor Says
The nurse told reporters she has a condition that often causes her to faint when she experiences pain. As a result, Dover said she was not surprised that she had fainted after receiving the vaccine.
Nurse faints at press conference after getting COVID-19 vaccine
(17.12.2020)
About 17 minutes after receiving the Pfizer-made vaccine against COVID-19, she started feeling dizzy, apologized and fell over before she was caught by doctors standing behind her.
“It just hit me all of a sudden, I could feel it coming on. I felt a little disoriented, but I feel fine now, and the pain in my arm is gone,” Ms. Dover said.
FDA says Pfizer’s COVID-19 vaccine vials may hold extra ‚obtainable‘ doses, adding to US supply
Pharmacists must throw away any extra amount of the vaccine if it does not consist of the 0.3 mL needed for a full dose, Pfizer said. The remaining amount „must never“ be combined with the vaccine from another vial.
The Pfizer vaccine, green-lighted by the FDA on Dec. 11, was developed in less than a year, a fraction of the time it would usually take as researchers worldwide frantically sought an antidote to a virus discovered in China in December 2019.
2 Alaska Health Workers Got Emergency Treatment After Receiving Pfizer’s Vaccine
One of the workers, who did not have a history of allergies, remained in the hospital on Wednesday night. Some reactions to the vaccine were also reported last week in Britain.
Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—let’s be cautious and first see the full data
(26.11.2020)
Let’s put this in perspective. First, a relative risk reduction is being reported, not absolute risk reduction, which appears to be less than 1%. Second, these results refer to the trials’ primary endpoint of covid-19 of essentially any severity, and importantly not the vaccine’s ability to save lives, nor the ability to prevent infection, nor the efficacy in important subgroups (e.g. frail elderly). Those still remain unknown.
What is sterilizing immunity and do we need it for the coronavirus?
(08.06.2020)
Neutralizing antibodies prevent the virus from replicating.
How a Covid-19 Vaccine Could End Up Helping the Virus Spread
(11.11.2020)
A vaccine that protects against symptoms of Covid-19 could contribute to the spread of the disease if — and this is still just an if — the people who get vaccinated remain capable of carrying and transmitting the virus. That’s a risk that’s gotten little attention amid the deserved jubilation over a Nov. 9 report from Pfizer Inc. and BioNTech SE that their vaccine candidate appears to be highly effective.
Scientist behind Oxford vaccine urges FDA not to delay data review
Professor Adrian Hill, part of the team behind the Oxford-AstraZeneca Covid-19 vaccine, says he hopes the FDA will review the available data in January, because waiting for the trial’s end next year would be “too late.”
It took AstraZeneca researchers 1 month to get vaccine trial data to FDA, source tells CNN
(14.10.2020)
The source said the root of the delay is that the participant was in the United Kingdom, and the European Medicines Agency and the FDA store data differently.
„They had to convert data from one format to another format. It’s like taking stuff off a PC and putting it onto an Apple. They had to spend a lot of hours to get what they wanted,“ the source said.
Blunders Eroded U.S. Confidence in Early Vaccine Front-Runner
AstraZeneca was in part to blame for the delay, said the people with knowledge of the F.D.A. talks. The company was slow to provide the F.D.A. with all the data that regulators wanted to review before allowing the trial to start up again.
In late October, after 47 days, the F.D.A. cleared the U.S. trial to restart.
It was now even further behind the late-stage trials that Pfizer and Moderna had begun in the United States about a month before AstraZeneca’s trial started.
Covid-19: F.D.A. Clears Pfizer Vaccine and Millions of Doses Will Be Shipped Right Away
The authorization is a historic turning point in a pandemic that has taken more than 290,000 lives in the United States. With the decision, the United States becomes the sixth country — in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico — to clear the vaccine. Other authorizations, including by the European Union, are expected within weeks.
Israel said considering restrictions on those who refuse COVID vaccine
Under the proposal being considered, those who refuse to be inoculated will only be allowed to fly, attend certain events, dine at restaurants or frequent cultural venues by providing a recent negative result from a coronavirus test, according to Channel 12 news, which quoted unnamed senior officials.
Health officials were also reportedly considering barring medical personnel who refuse vaccination from working in coronavirus wards or intensive care units.
Warning after two NHS workers have allergic reaction to Pfizer/BioNTech Covid vaccine
They developed symptoms of “anaphylactoid reaction” shortly after receiving the vaccine, but both recovered after the appropriate treatment.
After the incident, the Medicines and Healthcare products Regulatory Agency (MHRA) told NHS trusts that anyone who has a history of “significant” allergic reactions – including to medicines, food or vaccines – should not currently receive the vaccine.
First peer-reviewed results of phase 3 human trials of Oxford coronavirus vaccine demonstrate efficacy
. These data indicate that the low dose / standard dose vaccine may provide a protection against asymptomatic infection, but stress that these data are at an early phase, with too high a level of uncertainty to be certain that this vaccine will protect against asymptomatic infection.
Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial
ChAdOx1 nCoV-19 appears to be better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a boost dose.
Oxford confirms its Covid vaccine is 70% effective and safe – but scientists warn regulators face ‚dilemma‘ in approving jab to be given as 1.5 doses (which they accidentally found is 90% protective)
The MHRA has been considering whether to approve the vaccine since November 27 and is expected to reach a decision before the end of the year.
There’s NO evidence that Covid candidate vaccines prevent infection, prevent/reduce transmission, reduce hosps or reduce mortality. Nor are clinical trials designed to determine these endpoints. Longterm efficacy/safety also unknowns All we know—may reduce “common cold symptoms”
Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—let’s be cautious and first see the full data
(26.11.2020)
Let’s put this in perspective. First, a relative risk reduction is being reported, not absolute risk reduction, which appears to be less than 1%. Second, these results refer to the trials’ primary endpoint of covid-19 of essentially any severity, and importantly not the vaccine’s ability to save lives, nor the ability to prevent infection, nor the efficacy in important subgroups (e.g. frail elderly). Those still remain unknown. Third, these results reflect a time point relatively soon after vaccination, and we know nothing about vaccine performance at 3, 6, or 12 months, so cannot compare these efficacy numbers against other vaccines like influenza vaccines (which are judged over a season). Fourth, children, adolescents, and immunocompromised individuals were largely excluded from the trials, so we still lack any data on these important populations.
I previously argued that the trials are studying the wrong endpoint, and for an urgent need to correct course and study more important endpoints like prevention of severe disease and transmission in high risk people. Yet, despite the existence of regulatory mechanisms for ensuring vaccine access while keeping the authorization bar high (which would allow placebo-controlled trials to continue long enough to answer the important question), it’s hard to avoid the impression that sponsors are claiming victory and wrapping up their trials (Pfizer has already sent trial participants a letter discussing “crossing over” from placebo to vaccine), and the FDA will now be under enormous pressure to rapidly authorize the vaccines.
Vaccination cards will be issued to everyone getting Covid-19 vaccine, health officials say
(02.12.2020)
„Everyone will be issued a written card that they can put in their wallet that will tell them what they had and when their next dose is due,“ Moore said. „Let’s do the simple, easy thing first. Everyone’s going to get that.“
‚Immunity Cards‘ To Be Issued To All Americans; Enable CDC To Track COVID-19 Vaxx Status In Database
On Wednesday the Department of Defense released the first images of a COVID-19 vaccination record card as well as vaccination kits, according to CNN.
„Everyone will be issued a written card that they can put in their wallet that will tell them what they had and when their next dose is due,“ says Dr. Kelly Moore, associate director of the Immunization Action Coalition.
No10 stops short of ruling out Covid ‚immunity passports‘ despite saying it is ’not something the PM wants‘ – as Wales raises fears of spot checks at pubs and shops by bringing in ID-style cards for people who get vaccine
– Pfizer vaccines licensed by UK regulator and will be distributed from next week
– Wales says people will be issued with ID-style cards to show they have had jab
– Fears that pubs and shops could demand proof of vaccine before allowing entry
Challenges in Assessing the Efficacy of COVID-19 Vaccines
Determining whether a vaccine can protect against severe disease and death from COVID-19 may not be possible in phase 3 clinical trials and will often require long-term, ongoing studies after widespread deployment of a vaccine.
To ensure ongoing evaluation of vaccine safety, well-supported pharmacovigilance studies after licensure will be necessary.
Pfizer chairman: We’re not sure if someone can transmit virus after vaccination
Pfizer chairman Albert Bourla told Dateline host Lester Holt that the pharmaceutical company was “not certain” if the vaccine prevented the coronavirus from being transmitted, saying, “This is something that needs to be examined.”
Oxford vaccine professor Sarah Gilbert on working as the world watches
Sarah Gilbert was at home at the start of the year when she received her first inkling of the perplexing new disease that within months would make her one of the best-known scientists on the planet………..
Why is the Pfizer vaccine so difficult to transport? Light, temperatures above -70C and movement ALL speed up the chemical reactions that destroy fragile mRNA — meaning care homes have been sidelined
The approval of Pfizer/BioNTech’s coronavirus vaccine on Wednesday was hailed as the light at the end of the lockdown tunnel that could finally revert Britain back to pre-pandemic normality.
But the breakthrough jab — shown to be 95 per cent effective at blocking Covid-19 infection — has thrown up a series of logistical hurdles that make getting the vaccine to those who need it most challenging, including care homes.
Oxford AstraZeneca Covid vaccine: everything we know so far
(23.11.2020)
No mRNA vaccine has ever been approved by regulators, but the Oxford approach has been used in vaccines given safely to thousands of people of all ages for diseases ranging from TB and malaria to Mers (another coronavirus) and Ebola, for which it is now being used in Uganda and the Democratic Republic of the Congo. Oxford opted for the chimp virus because it has the potential to generate a strong immune response and, since it cannot grow in humans, it should be safe.
Two other frontrunner vaccines, from BioNTech (developed with Pfizer) and Moderna (developed with the US National Institute of Allergy and Infectious Diseases), perform well, according to interim results from phase 3 human trials, achieving more than 90% efficacy. These are based on technology that is new to the vaccine field. Both use genetic material called mRNA, or messenger RNA, which tells human cells how to make coronavirus spike proteins.
How many willing to bet that this case is part of pharma wars to sabotage Oxford vaccine?
(28.11.2020)
UK authorizes Pfizer coronavirus vaccine for emergency use
The Medicines and Healthcare Products Regulatory Agency, which licenses drugs in the U.K., recommended the vaccine could be used after it reviewed the results of clinical trials that showed the vaccine was 95% effective overall — and that it also offered significant protection for older people, among those most at risk of dying from the disease.
AstraZeneca CEO blames trial delays, not manufacturing, for COVID-19 vaccine delivery shortfall
In fact, AZ has already produced a bulk vaccine that’s kept at freezing temperatures.
Delivery timetable for Oxford/AstraZeneca vaccine slips, UK official says
UK Vaccine Taskforce Chair Kate Bingham said that the vaccine was being made in bulk first, known as „drug substance“, but could not yet be put into vials until more was known on the timing of late-stage trial data.
„We’ve not yet put them into vials because as soon as you put them into vials you start the clock for the… shelf life, or how quickly you have to use the vaccine,“ she told lawmakers.
‚I’m so thrilled that you’ve cracked it!‘: Prince William congratulates Oxford scientists via Zoom as their Covid vaccine is proved to be 90 per cent effective
– The Duke of Cambridge hailed the team’s ‚amazing achievement‘ this morning
– Three Oxford professors told how the vaccine is based on decades of research
– It emerged this month that William caught coronavirus in April but didn’t reveal it
AstraZeneca to seek FDA authorization for vaccine based on foreign trial data
The company halted its U.S. trial in early September over safety concerns, after a trial participant reported neurological problems. The study resumed earlier this month after FDA concluded that no evidence linked the volunteer’s symptoms to the shot.
AstraZeneca shares slip after analyst says vaccine will struggle to get green light in US – live updates
SVB Leerink analyst Geoffrey Porges said the treatment may never gain approval from US regulator the FDA, and said Astra had highlighted results from a “relatively small” number of patients.
Oxford AstraZeneca Covid vaccine: everything we know so far
No mRNA vaccine has ever been approved by regulators, but the Oxford approach has been used in vaccines given safely to thousands of people of all ages for diseases ranging from TB and malaria to Mers (another coronavirus) and Ebola, for which it is now being used in Uganda and the Democratic Republic of the Congo. Oxford opted for the chimp virus because it has the potential to generate a strong immune response and, since it cannot grow in humans, it should be safe.
Two other frontrunner vaccines, from BioNTech (developed with Pfizer) and Moderna (developed with the US National Institute of Allergy and Infectious Diseases), perform well, according to interim results from phase 3 human trials, achieving more than 90% efficacy. These are based on technology that is new to the vaccine field. Both use genetic material called mRNA, or messenger RNA, which tells human cells how to make coronavirus spike proteins.
Oxford University breakthrough on global COVID-19 vaccine
he University of Oxford, in collaboration with AstraZeneca plc, today announces interim trial data from its Phase III trials that show its candidate coronavirus vaccine, ChAdOx1 nCoV-2019, is effective at preventing COVID-19 (SARS-CoV-2) and offers a high level of protection.
UK’s Covid-19 Oxford AstraZeneca vaccine on course to be ready by end of 2020
The UK has ordered 100 million doses of the Oxford AstraZeneca vaccine – enough for the entire population
Top Scots academic warns ministers not to prioritise Pfizer vaccine
The vaccine, which is thought to be effective against Covid-19 in nine out of 10 people, could be ready for distribution by next month but it needs to be stored at -80C for it to work.
This ‚ultra-cold‘ state is part of the logistical challenge facing the country, particularly if the vaccine is manufactured overseas.
The professor, from the university’s Centre for Sustainable Road Freight, explained that it may make more sense to prioritise the AstraZenica Oxford vaccine which can be made in the UK.
So the Pfizer vaccine is expected to be up to seven times more expensive than the Oxford one, reports the Times.
Welcome to profit first, morals later America.
Oxford v Pfizer: how costs and logistics could still see Oxford’s vaccine win out
Matt Hancock has warned the mass distribution would be a “colossal exercise” involving not just the NHS but the Armed Forces.
The Health Secretary acknowledged there was “enormous complexity” in administering the Pfizer vaccine.
Vaccine taskforce chief may benefit from £49m UK investment
She is expected to leave her post at the end of the year, according to a government source who said her contract ran until January 2021 and she had always intended to leave at that point.
Huge thanks to Kate Bingham and the Vaccine Taskforce for all their fantastic work in securing 40 million doses of the @pfizer & @BioNTech_Group vaccine and over 300 million doses of other promising vaccine candidates.
Oxford vaccine is not mRNA based its DNA based. This is prolly the best description right now:
This vaccine needs to be kept at below -80 ^C because it uses mRNA. Not suitable for most clinics and GP practices. My money is still on Oxford to produce a more effective and ergonomic one.
Oxford-AstraZeneca COVID-19 vaccine production begins in Australia
The Sydney Morning Herald reported that it will take CSL about 50 days to completely process the vaccine. According to the newspaper, the company has separate contracts with AstraZeneca and the Australian government for the production of the vaccine.
The AstraZeneca vaccine still needs to be approved by Australia’s Therapeutic Goods Administration (TGA). Phase three clinical trials of the vaccine are expected to wrap up by the end of this year.
The tube that could change the world: First vial of COVID-19 vaccine ’starting material‘ after Australian breakthrough – with millions to be made from tomorrow
Biotechnology giant CSL announced they would start producing the AstraZeneca AZD1222 coronavirus vaccine at its factory in Melbourne this week.
About 30million doses will be manufactured as part of a first-of-its-kind agreement with the Australian government, with the company hoping to release them in the first half of 2021 pending clinical trials and approval.
The jab, which was produced at the University of Oxford, is seen as the leading candidate across the globe and is in final-stage trials.
The Oxford Vaccine
The University of Oxford’s Jenner Institute and Oxford Vaccine Group have been at the forefront of scientific endeavour to develop vaccines for diseases of major global importance for more than 30 years.
Their ChAdOx1 trials are currently assessing whether the vaccine will be effective in combatting COVID-19.
Coronavirus Vaccine Update: India shifts focus on indigenous vaccine as AstraZeneca deliveries run late
India seems to have shifted focus on its indigenous novel coronavirus vaccine soon after AstraZeneca said earlier this week that it was holding back deliveries of its Covid-19 vaccine.
Thank you to all of our brilliant scientists at @UniOfOxford , @AstraZeneca & across the UK who are working tirelessly to find a vaccine and to all those who have volunteered to take part in a clinical trial. This government – and the whole country – are backing you 100%
(06.11.2020)
COVID vaccine deliveries on ice as AstraZeneca awaits trial data
(05.11.2020)
A summer dip in UK coronavirus infections has pushed back test results for AstraZenca’s potential COVID-19 vaccine, leading the drugmaker to delay deliveries of shots to the UK government.
Britain starts accelerated review for AstraZeneca’s potential COVID-19 vaccine
Work began on the Oxford vaccine in January. Called AZD1222 or ChAdOx1 nCoV-19, the viral vector vaccine is made from a weakened version of a common cold virus that causes infections in chimpanzees.
German Pfizer vaccine could be ready before Oxford-AstraZeneca injection and be given to Brits before Christmas
Ms Bingham was appointed chair of the UK’s Vaccine Taskforce for Covid-19 in May and reports directly to the Prime Minister on the progress of a coronavirus vaccine, which experts say is key to controlling the pandemic.
The taskforce, which Ms Bingham says was the ‚brainchild of Sir Patrick Vallance‘ — Number 10’s chief scientific adviser, is at the forefront of putting plans in place to get the UK population vaccinated.
University Hospitals and CWRU join global study of AstraZeneca’s COVID-19 vaccine
AstraZeneca paused its trial in early September to review safety data because a British trial participant developed a neurological condition.
Last week, the Food and Drug Administration authorized the resumption of the company’s U.S. trials after reviewing global safety data. The trial had already resumed in other countries.
Astrazeneca Scores $286.9M US Army Contract For Covid Vaccine
Astrazeneca Pharmaceuticals (AZN) has been awarded a $286.9 milllion firm-fixed-price contract for the delivery of 200 million doses of AZD1222 vaccine for COVID- 19.
Bids were solicited via the internet with one received, the US Department of Defense revealed.
EU warns not enough COVID vaccines for all in Europe until 2022
(27.10.2020)
The EU has so far secured doses of the potential vaccines being developed by AstraZeneca, Sanofi and Johnson & Johnson. It has also said it is in talks with …
Germany to include Israel in EU deal for vaccine, citing ‘special relationship’
(14.10.2020)
Berlin’s foreign minister reportedly tells Gabi Ashkenazi that Israel will get AstraZeneca COVID-19 inoculation when it is sold to European countries
European Commission say that AstraZeneca has sold its jab at about $3 to $4 a dose in deals with the EU
Astra-Oxford Vaccine Stays Near Front of Line Despite U.S. Delay
A seven-week halt to a U.S. trial of the Covid vaccine developed by AstraZeneca Plc and the University of Oxford bumped it from pole position in the race for a protective shot, but it’s still in the leading pack.
AstraZeneca says its coronavirus vaccine triggers immune response among adults
“It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” an AstraZeneca spokesman told CNBC via email.
“The results further build the body of evidence for the safety and immunogenicity of AZD1222,” the spokesman said, referring to the technical name of the Oxford-AstraZeneca vaccine.
It took AstraZeneca researchers 1 month to get vaccine trial data to FDA, source tells CNN
(14.10.2020)
The source said the root of the delay is that the participant was in the United Kingdom, and the European Medicines Agency and the FDA store data differently.
„They had to convert data from one format to another format. It’s like taking stuff off a PC and putting it onto an Apple. They had to spend a lot of hours to get what they wanted,“ the source said.
As AstraZeneca’s Covid-19 vaccine trial remains on hold in U.S., participants waiting on a second dose are in limbo
(06.10.2020)
Still, such participants occupy an unusual position in a trial shutdown that is being closely watched as a potential indicator of the prospects of a frontrunner in the race to develop a vaccine to curb the devastation of the Covid-19 pandemic.
For the participant who spoke with STAT — and others in his same position who can’t currently get their booster shot — the trial halt has become a waiting game. “Now, we’re waiting as the lab rats in the corner,” said the participant, who requested anonymity because he was worried he could face consequences if study investigators found out he had spoken to the press.
AstraZeneca, J&J resuming US tests of COVID-19 vaccines
The two coronavirus vaccines are among several candidates in final-stage testing, the last step before seeking regulatory approval.
The drugmakers said they got the go-ahead Friday from the Food and Drug Administration to restart tests in the U.S.
Oxford COVID-19 vaccine follows its programmed genetic instructions, independent analysis finds
The AstraZeneca Oxford COVID-19 vaccine (ChAdOx1 nCoV-19 and also known as AZD1222) now undergoing Phase III clinical trials, has already undergone rigorous testing to ensure the highest standards of quality and safety. Now a team at Bristol University has used recently developed techniques to further validate that the vaccine accurately follows the genetic instructions programmed into it by the Oxford team. This novel analysis provides even greater clarity and detail about how the vaccine successfully provokes a strong immune response.
Five US military facilities are among the locations selected for final coronavirus vaccine trials
The military medical facilities chosen in Texas, California and the Washington D.C. area were among dozens of locations across the country selected to participate in Phase III testing of drug maker AstraZeneca’s AZD1222, one of four vaccine candidates undergoing testing. In Phase III, thousands of volunteers are given the potential vaccines to study its effectiveness and safety, according to the National Centers for Disease Control and Prevention.
In change of tack, EU leaves door open to COVID vaccines purchase through WHO
The move could allow EU governments to secure vaccines from companies that are not negotiating with Brussels, such as U.S. firms Merck, Inovio and Novavax. They are all in talks with the WHO scheme, dubbed COVAX, but have so far not been reported to be involved in negotiations with the EU Commission.
Some Russian teachers fear back-to-school shots of ‚Sputnik V‘ COVID vaccine
“I am afraid of taking the risk of an untested vaccine,” said Dmitry Kazakov, a history teacher who signed the Uchitel petition and is wary even though his bosses have not asked him to have the jab. “Sometimes you get an offer you cannot reject.”
Big Pharma’s Covid-19 Profiteers
How the race to develop treatments and a vaccine will create a historic windfall for the industry — and everyone else will pay the price
Forbidden Op-Ed: The Sputnik Vaccine as a Lifesaving Global Partnership
The use of two vectors is the unique technology, developed by the Gamaleya Center scientists, which differentiates the Russian vaccine from other adenoviral vector-based vaccines under development around the world. Vaccines based on adenoviral vectors also have clear advantages over other technologies such as mRNA vaccines.
Prospective mRNA vaccines, undergoing clinical trials in the United States and other countries, do not use vectors for delivery and represent an RNA molecule with coronavirus protein code wrapped in a lipid membrane. This technology is promising but its side effects, especially an impact on fertility, have not yet been studied in depth. No mRNA vaccine has yet received regulatory approval in the world.
Russia wealth fund head: Sputnik V vaccine could be delivered by November or December
„We were just fortunate that the coronavirus was very close to MERS, so we pretty much had a ready-to-go vaccine on MERS, studied for two years on MERS (and) slightly modified to be the coronavirus vaccine, and that is the real story, no politics … Russia has always been at the forefront of vaccine research,“ Kirill Dmitriev, CEO of Russia’s sovereign wealth fund RDIF, which is backing the vaccine, told CNBC.
The World Health Organisation states that no vaccine or treatment for MERS is currently available, but says that there are several in development.
AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries
July 30, 2020
AstraZeneca has been granted protection from future product liability claims related to its COVID-19 vaccine hopeful by most of the countries with which it has struck supply agreements, a senior executive told Reuters.
Mexican president orders creation of state-run medicine agency
“This means breaking up the monopoly of companies that had control in Mexico. They sold medications that were expensive, of poor quality and there were often shortages,” said President Andres Manuel Lopez Obrador at a regular news conference.
EU buys 30,000 doses of remdesivir to treat severe Covid-19 cases
Remdesivir is the first drug that received EU approval for coronavirus treatment.
U.K. Orders 90 Million Vaccine Doses from Pfizer and Valneva
“It’s the right thing to be doing to be at the absolute front of the queue to make sure we’re in a position to get those vaccines first when they become available,” Education Secretary Gavin Williamson told the BBC during the government’s media round on Monday.
Oxford coronavirus vaccine is safe and induces immune reaction, findings suggest
Initial trials on 1,077 British adults found that the vaccine induced strong antibody and T-cell responses, which may improve further after a booster jab, as reported by the Telegraph.
There were found to be no serious adverse events, and minor side effects could be controlled by paracetamol, two papers in The Lancet reported.
Coronavirus: ‚There may never be a COVID-19 vaccine‘
The chair of the UK Vaccine Taskforce says there may never be a vaccine for coronavirus.
Kate Bingham told Kay Burley @Breakfast if a vaccine was found, it may not prevent people from getting the virus but will reduce symptoms.
Scientists from the Wuhan virus lab have ‚defected‘ to the West, reveals senior Trump ally Steve Bannon – as FBI gathers evidence that coronavirus pandemic was caused by an accidental leak
He said: ‘The thing was built with French help, so don’t think that there aren’t some monitoring devices in there. I think what you are going to find out is that these guys were doing experiments which they weren’t fully authorised [for] or knew what they were doing and that somehow, either through an inadvertent mistake, or on a lab technician, one of these things got out.
‘It’s not that hard for these viruses to get out. That is why these labs are so dangerous.
‘You essentially had a biological Chernobyl in Wuhan, but the centre of gravity, the Ground Zero, was round the Wuhan lab, in terms of the casualty rates. And like Chernobyl, you also had the cover-up – the state apparatus reports to itself and just protects itself.’
Why the Bill Gates global health empire promises more empire and less public health
Behind a veil of corporate media PR, the Gates Foundation has served as a vehicle for Western capital while exploiting the Global South as a human laboratory. The coronavirus pandemic is likely to intensify this disturbing agenda.
Big Price, Modest COVID-19 Drug
(29.06.2020)
Congressman Doggett has been seeking information from both Secretary Azar and Gilead on remdesivir pricing for almost two months. Neither disclosed the huge taxpayer expenditure that the Trump Administration is making today to purchase remdesivir supplies through September. Copies of related correspondence are available upon request.
Remdesivir Priced At More Than $3,100 For A Course Of Treatment
(29.06.2020)
Rep. Lloyd Doggett, D-Texas, called the price „outrageous.“
„Without a taxpayer investment of $99 million, this drug would have been abandoned. It would be on the scrap heap of failures,“ he tells NPR. „So it’s the taxpayer who’s really taking the risk here and ought to get the reward of the angel investors that taxpayers are.“
Public Citizen, a nonprofit consumer advocacy group, echoed his remarks with a similar sentiment.
Hydroxychloroquine Knocked Again: WHO Shuts Down Trials For It, HIV Drug As Coronavirus Treatments
According to Reuters, the WHO is also leading a trial into whether remdesivir, Gilead’s antiviral treatment, can be used for Covid-19 infections.
Study finds hydroxychloroquine may have boosted survival, but other researchers have doubts
(03.06.2020)
The US Food and Drug Administration withdrew its emergency use authorization for the drug earlier this month and trials around the world, including trials sponsored by the World Health Organization and the National Institutes of Health, were halted.
A surprising new study found that the controversial antimalarial drug hydroxychloroquine helped Covid-19 patients better survive in the hospital.
(03.07.2020)
Why Gilead Sciences Shares Rose 18.4% in the First Half
Early into the health crisis, Gilead began testing remdesivir as a possible treatment for the illness caused by the novel coronavirus. The antiviral initially had been studied in other coronaviruses — severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). More recently, remdesivir entered clinical trials for COVID-19, and as promising data emerged, the U.S. Food and Drug Administration granted the drug Emergency Use Authorization.
UN recruits an army of social media coronavirus “misinformation” correctors
The fight against COVID-19 misinformation will be “long-term, without a clear end in sight,” according to Fleming.
WHO expert says anti-malaria drug to be stopped from Solidarity Trial in fighting COVID-19
„Based on the analysis and on the review of the published evidence, the executive group of the Solidarity / recovery trial has … after the deliberation … concluded that hydroxychloroquine arm will be stopped from the Solidarity Trial,“ Ana Maria Henao Restrepo, Medical Officer, Department of Immunization Vaccines and Biologicals at WHO said on Wednesday at a press conference in Geneva.
WHO welcomes preliminary results about dexamethasone use in treating critically ill COVID-19 patients
Dexamethasone is a steroid that has been used since the 1960s to reduce inflammation in a range of conditions, including inflammatory disorders and certain cancers. It has been listed on the WHO Model List of Essential Medicines since 1977 in multiple formulations, and is currently off-patent and affordably available in most countries.
Dexamethasone: Coronavirus breakthrough as £5 steroid dexamethasone could have saved lives of 5,000 who died in UK claims Professor Martin Landray
The RECOVERY trial (which stands for ‘Randomised Evaluation of COVid-19 thERapY’) was funded by UKRI as part of the UKRI/DHSC/NIHR COVID-19 rapid research response.
The drug, which is currently used to treat ulcerative colitis, arthritis and some types of cancer, was found to have reduced the number of deaths of patients on ventilators and patients requiring oxygen by a third and by a fifth respectively.
The Mount Vernon Police Tapes: In Secretly Recorded Phone Calls, Officers Say Innocent People Were Framed
Bovell’s first batch of recordings landed in the lap of Thomas Drake, an investigator for the Westchester County District Attorney’s office, on February 19, 2019, according to a text message he sent Bovell. On March 4, 2019, Drake texted Bovell saying that he had listened to some of them. The whistleblower recalls being hopeful.
“I gave them that information, and I thought this is it. Something big, positive will happen,” Bovell said.
But nine months later, at a meeting with Bovell and his attorney, Joseph Murray, at the DA’s office, Drake told them that the probe had not moved forward because they had been expecting Bovell to send more recordings, according to both men.
Bovell gave them more recordings in February of this year, and they say they haven’t heard anything since.
Flu Misinformation and Coronavirus Fears: My Letter to Dr. Sanjay Gupta
9. CNN assertion: Sanjay, I’ve watched your video assuring the public that getting the flu shot cannot increase one’s chances of getting the flu.
Fact: While that assertion has some meager support from a very small number of studies, the overwhelming weight of published science suggests that getting an annual flu shot can actually increase your risk of both flu and flu-like illnesses.
Only about 7 percent to 15 percent of what are called “influenza-like illnesses” are actually caused by influenza viruses. Many studies suggest the flu vaccine increases vulnerability to both flu infections and the remaining 85% -93% of non-flu respiratory infections.
A 2011 study of healthy Australian children published in the Pediatric Infectious Disease Journal found that seasonal flu shots increase the risk of flu by 73% and doubled the risk of non-flu respiratory infections.
Similarly, another 2012 randomized controlled trial published in Clinical Infectious Diseases found that influenza-vaccinated children had no significantly lessened risk from influenza and also a higher risk of infection from non-influenza viruses.
Furthermore, the flu vaccine depletes capacity to fight off future flu infections. In April 2010, a study (by Skowronek, et al) published in the journal PLoS Medicine reported the “unexpected” finding from four epidemiologic studies in Canada that receipt of the influenza vaccine for the 2008 – 2009 season, while apparently effective in reducing the risk of illness due to the seasonal flu, was associated with an increased risk of illness due to the pandemic influenza A (H1N1) “swine flu” virus during the spring and summer of 2009. The scientists suggested that this finding could be due to the difference in the way the vaccine affects the immune system compared with natural infection.
GLOBAL VACCINATION SUMMIT: PANEL MEMBER BIOGRAPHIES ROUNDTABLE 1: „In Vaccines we trust: Stepping up action to increase vaccine confidence”
(12.09.2019)
JASON HIRSCH, Public Policy Manager,
Jason Hirsch joined Facebook’s Public Policy team in October 2018, where he focuses on development of policies to help guide Facebook’s approach to content distribution and moderation. Within that role, Mr. Hirsch heads up Facebook’s Health Integrity Policy efforts, including leading the development of Facebook’s multi-faceted approach to combatting misinformation about vaccinations.
ROADMAP FOR THE IMPLEMENTATION OF ACTIONS BY THE EUROPEAN COMMISSION BASED ON THE COMMISSION COMMUNICATION AND THE COUNCIL RECOMMENDATION ON STRENGTHENING COOPERATION AGAINST VACCINE PREVENTABLE DISEASE
(March 2019)
Examine the feasibility of developing a common vaccination card/passport for EU citizens (that takes into account potentially different national vaccination schedules and), that is compatible with electronic immunisation information systems and recognised for use across borders, without duplicating work at nati
Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial
(29.04.2020)
Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23 [95% CI 0·87–1·75]). Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95–2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.
Leaked data on Gilead’s remdesivir suggest drug didn’t help patients with COVID-19
(23.04.2020)
According to STAT’s screenshot, 14% of the 158 patients treated with remdesivir died 28 days after treatment, compared to 13% of the 79 who were on placebo. Notably, investigators in China stopped giving remdesivir due to side effects in 18 patients versus in just four who received placebo.
Fauci Calls Early Data From Gilead Virus-drug Trial ‘Good News’
Anthony Fauci, the head of National Institute of Allergy and Infectious Diseases, which is conducting the study, said at a White House meeting with President Donald Trump and Louisiana Gov. John Bel Edwards that the trial showed a significant positive effect in treating the virus.
WHO and UN launch drive to accelerate vaccine development
As the deaths caused by the coronavirus passed 190,000 at the global level and the number of cases crossed the 2.7 million threshold (Johns Hopkins University data updated Friday), a „historic collaboration“ was launched to accelerate the arrival of a vaccine.
Secretary-General’s remarks at the launch of the Statement of Commitment and Call for Support for the Global Collaboration to Accelerate the Development, Production and Equitable Access to New COVID-19 Tools [as delivered]
This launch brings together world leaders, the private sector, scientific and humanitarian actors and other partners to promote health, keep the world safe and advance the public good.
Human health is the quintessential global public good.
And today, we face a global public enemy like no other.
$8-billion effort aims to speed development of coronavirus vaccines and treatments
Friday’s launch event was co-hosted by French President Emmanuel Macron, European Commission President Ursula von der Leyen and philanthropists Bill and Melinda Gates.
Leaders from South Africa, Rwanda, Germany, Great Britain, Spain, Italy, Malaysia, Saudi Arabia, Finland and Costa Rica joined the call to pledge their commitment to work with and support the ACT Accelerator.
Representatives from the United States and China were noticeably absent.
Global collaboration to accelerate new COVID-19 health technologies
The launch of the new collaboration is being co-hosted by WHO Director-General Dr Tedros Adhanom Ghebreyesus, Emmanuel Macron, President of the French Republic, Ursula von der Leyen, President of the European Commission, and the Bill and Melinda Gates Foundation.
The virtual event will include senior United Nations, government and public health and industry leaders from around the world.
World leaders call for global collaboration in COVID-19 fight
World leaders have joined the World Health Organisation in calling for global collaboration to accelerate the development and equitable access to new COVID-19 tools, including vaccines.
Study of malaria drug on VA virus patients shows no benefit, more deaths
There were more deaths among those patients who were given the drug, hydroxychloroquine, than patients who received standard care, researchers found.
Gates’ Globalist Vaccine Agenda: A Win-Win for Pharma and Mandatory Vaccination
Vaccines, for Bill Gates, are a strategic philanthropy that feed his many vaccine-related businesses (including Microsoft’s ambition to control a global vaccination ID enterprise) and give him dictatorial control of global health policy.
Next they’ll be doing this if you don’t take the vaccine
Gates fordert Impfstoff-Finanzierung von G-20
Viele Länder hätten CEPI in den vergangenen zwei Wochen Unterstützung zukommen lassen, „doch benötigt die Koalition für ihre Arbeit mindestens zwei Milliarden Dollar“, so Gates. Die Gates-Stiftung hatte CEPI gemeinsam mit der Wellcome-Stiftung und mehreren Regierungen gegründet.
The first patient tests new drug against COVID-19
(06.04.2020)
The Japanese drug camostat mesylate has now arrived in Denmark and the first patient at Aarhus University Hospital is now testing the effect of the drug against COVID-19.
Just one week ago, researchers at Aarhus University Hospital and Aarhus University received DKK 5 million from the Lundbeck Foundation to test if a new Japanese drug against heartburn – camostat mesylate – is useful to treat the new coronavirus (COVID-19).
Lockdowns can’t end until Covid-19 vaccine found, study says
“While these control measures appear to have reduced the number of infections to very low levels, without herd immunity against Covid-19, cases could easily resurge as businesses, factory operations, and schools gradually resume and increase social mixing, particularly given the increasing risk of imported cases from overseas as Covid-19 continues to spread globally,” says Prof Joseph T Wu from the University of Hong Kong, who co-led the research.
Chloroquine May Fight Covid-19—and Silicon Valley’s Into It
A blockchain investor named James Todaro tweeted that an 85-year-old malaria drug called chloroquine was a potential treatment and preventative against the disease caused by the new coronavirus. Todaro linked to a Google doc he’d cowritten, explaining the idea.
Japanese flu drug ‚clearly effective‘ in treating coronavirus, says China
(18.03.2020)
Zhang Xinmin, an official at China’s science and technology ministry, said favipiravir, developed by a subsidiary of Fujifilm, had produced encouraging outcomes in clinical trials in Wuhan and Shenzhen involving 340 patients.
“It has a high degree of safety and is clearly effective in treatment,” Zhang told reporters on Tuesday.
Patients who were given the medicine in Shenzhen turned negative for the virus after a median of four days after becoming positive, compared with a median of 11 days for those who were not treated with the drug, public broadcaster NHK said.
Ebola Drug From Japan May Emerge Among Key Candidates
(August 7, 2014)
Favipiravir is in the final stages of human studies in the U.S. as a treatment for flu. A Phase II study in the U.S. using 10 grams of the drug showed the medicine reduced flu symptoms against a placebo. The U.S. phase III study of the treatment for flu is scheduled to be completed around March 2015, the company said last month.
The U.S. Department of Defense funded the trials to improve the country’s response capability and protect the military from flu pandemics, its BioDefense Therapeutics unit said in an October statement.
Israel among the first countries to receive new Japanese coronavirus drug
(today)
Katz praised the work of Jerusalem’s diplomatic mission in Tokyo, the Foreign Affairs Ministry and the Health Ministry for „having successfully brought this groundbreaking research to Israel.“
Cuomo: Use of antimalarial drug in New York hospitals ‚anecdotally‘ positive
“There has been anecdotal evidence that it is promising; that’s why we’re going ahead,” he added, noting that some patients have a pre-existing condition or medication regimen that prevents them from taking it.
An increase in the supply from the federal government, Cuomo added, would allow New York to lift the 14-day restriction.
Trump aide Peter Navarro says ’second opinion‘ needed on Fauci’s view of anti-malaria drug
(06.03.2020)
Peter Navarro, the top trade and manufacturing aide to the president who is coordinating the use of the Defense Production Act for the White House, told CNN’s John Berman Monday that he believes a „second opinion“ is needed about hydroxychloroquine as a treatment.
„I let (Fauci) speak for himself, John, but I would have two words for you: second opinion,“ Navarro said. „Doctors disagree about things all the time.“
Trump touts hydroxychloroquine as a cure for Covid-19. Don’t believe the hype
(06.03.2020)
Trump has been repeatedly contradicted by public health experts including his own top infectious diseases adviser, Dr Anthony Fauci, who has warned that there is only “anecdotal evidence” that the drugs could be helpful.
Social Security advocate says pharmaceutical companies ‚looking at a pandemic as a massive profit potential‘
Lawson discussed how drugmaker Gilead Sciences asked the Food and Drug administration last week to give it the rare „orphan“ status for remdesivir, the company’s experimental coronavirus treatment.
Germany hopes Bayer malaria drug could treat COVID-19
In an interview with Bild newspaper (link in German), federal health minister Jens Spahn said that there “are early indications that certain medications seem to help,” and that there were ongoing studies in Germany into what drugs could potentially work in treating coronavirus, “including with this old malaria drug.”
He added that more studies are needed as all drugs have side effects. However, he expects an effective drug to treat COVID-19 to come on the market much earlier than a vaccine.
My good news contribution for today: Researchers in Denmark are starting to test a promising drug in #covid19 patients, barely a month after research appeared showing the drug could stop the virus in cell culture.
KroganLab Camostat mesylate binds to a protein on human cells called TMPRSS2. And SARS-CoV-2 needs this protein to efficiently enter human cells: The spike protein on top of the virus attaches to the ACE2 receptor on human cells. And then TMPRSS2 needs to make a cut in the spike.
Denmark will start a clinical trial of a drug named camostat mesylate tomorrow—barely 1 month after a Cell paper showed the compound can prevent the novel coronavirus, SARS-CoV-2, from entering human cells…
Coronavirus | Germany says low death rate is due to widespread testing
(26.03.2020)
“The reason why Germany has so few deaths compared to the number of infected people can be explained by the fact that we carry out an extremely large number of laboratory diagnostic tests,” said Mr. Drosten, who heads the Institute of Virology at Berlin’s Charite University Hospital.
The Trumpian French Doctor Behind the Chloroquine Hype
(30.03.2020)
The founder and director of Institut Hospitalo-Universitaire, or IHU, in Marseille, the 68-year-old Raoult has compiled a sometimes dazzling, sometimes disturbing career that could have been scripted by Marcel Pagnol or Honoré de Balzac. Born in Senegal, Raoult defied his father, who was serving there as a military doctor, and quit high school in his junior year. Signing up with the French merchant marine, the young Raoult spent the next two years at sea.
Column: The suspect science behind Trump’s chloroquine claims
(01.04.2020)
Chloroquine is dangerous when not taken under a doctor’s rigorous supervision, and its shortage can cause life-threatening consequences for lupus patients and serious health effects for rheumatoid or inflammatory arthritis patients.
The bottom line is that evidence for chloroquine’s effectiveness in COVID-19 is unsubstantiated. It derives heavily from the work of a controversial French expert in infectious diseases, Didier Raoult,
Jens Spahn reserved huge amounts Chloroquine against Corona at the German pharma giant Bayer. Bayer also assured the US a big amount of it
(20.03.2020)
BILL GATES: A new kind of terrorism could wipe out 30 million people in less than a year — and we are not prepared
(18. Februar 2017)
When I decided 20 years ago to make global health the focus of my philanthropic work, I didn’t imagine that I’d be speaking at a conference on international security policy. But I’m speaking here at the Munich Security Conference because I believe our worlds are more tightly linked than most people realize.
Event 201: Bill Gates & World Economic Forum Simulated Coronavirus Outbreak 6 Weeks Before First Case in Wuhan
(27.01.2020)
Event 201 is a pandemic tabletop exercise hosted by The Johns Hopkins Center for Health Security in partnership with the World Economic Forum and the Bill and Melinda Gates Foundation on October 18, 2019, in New York, NY. The exercise illustrated the pandemic preparedness efforts needed to diminish the large-scale economic and societal consequences of a severe pandemic. Drawing from actual events, Event 201 identifies important policy issues and preparedness challenges that could be solved with sufficient political will and attention. These issues were designed in a narrative to engage and educate the participants and the audience.
Does a Japanese medication for heartburn work on corona patients?
At the moment, the researchers are waiting for the actual drug to arrive from Japan.
Coronavirus Round-Up: Eight more deaths in Denmark
Researchers at the University of Aarhus are assessing an already established drug that could prevent the coronavirus from spreading into the human lungs and perhaps slow down the pandemic. Camostat mesylate was developed several years ago for the treatment of heartburn and pancreatitis in Japan, where it was approved by the Japanese Medicines Agency. A trial is planned to test it on 180 coronavirus patients across Denmark as early as next week.
There Is A Drug Already Used In Japan Which May Treat COVID-19, Says New Study
(03.03.2020)
“We knew from our previous work that camostat mesylate was active against other coronaviruses, including SARS-CoV. Therefore, we tested whether it is also active against SARS-CoV-2,” said Stefan Pöhlmann, PhD, Professor in the same institute in Göttingen. “Our study shows that camostat mesylate blocks infection of cells with SARS-CoV-2-like particles and with authentic, patient-derived SARS-CoV-2. Moreover, camostat mesylate inhibited infection of important target cells – human lung epithelial cells,” he added.
The novel coronavirus 2019 (2019-nCoV) uses the SARS-coronavirus receptor ACE2 and the cellular protease TMPRSS2 for entry into target cells
(31.01.2020)
Here, we demonstrate that 2019-nCoV-S uses the SARS-coronavirus receptor, ACE2, for entry and the cellular protease TMPRSS2 for 2019-nCoV-S priming. A TMPRSS2 inhibitor blocked entry and might constitute a treatment option. Finally, we show that the serum form a convalescent SARS patient neutralized 2019-nCoV-S-driven entry. Our results reveal important commonalities between 2019-nCoV and SARS-coronavirus infection, which might translate into similar transmissibility and disease pathogenesis. Moreover, they identify a target for antiviral intervention.
(…)
The present study suggests that 2019-nCoV spread might also depend on TMPRSS2 activity and it is noteworthy that the serine protease inhibitor camostat mesylate blocks TMPRSS2 activity (24, 26) and has been approved in Japan for human use, although for an unrelated indication. This compound or related ones should be considered for treatment of 2019-nCoV infected patients.