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The Delta variant is more transmissible than the viruses that cause MERS, SARS, Ebola, the common cold, the seasonal flu and smallpox, and it is as contagious as chickenpox, according to the document, a copy of which was obtained by The New York Times.
The immediate next step for the agency is to “acknowledge the war has changed,” the document said. Its contents were first reported by The Washington Post on Thursday evening.
Gentlemen. I very deeply appreciate the honour which you have conferred upon me in awarding the Nobel Prize for 1923 to me and Professor J.J.R. Macleod. I am fully aware of the responsibility which rests upon me to deliver an address in which certain aspects of the work on insulin may be placed before you. This I propose to do today and I regret that an earlier opportunity has not been afforded me of satisfying this obligation.
(26.07.2021)
President Joe Biden will announce on Thursday a requirement that all federal employees and contractors be vaccinated against Covid-19, or be required to submit to regular testing and mitigation requirements, according to a source with direct knowledge of the matter.
(27.07.2021)
Unvaccinated Americans were the talking point of the day on Monday with a slew of figures slamming those who have chosen not to take the coronavirus jabs, assigning blame to them for America ‘going backwards’, likening them to murderers, and suggesting that they are to blame for more deadly variants of the virus emerging.
(23.07.2021)
The US government is buying an additional 200m doses of the BioNTech/Pfizer Covid-19 vaccine, expanding its total order to 500m, as officials prepare for the next phase of vaccinations, including children under 12 and potential booster shots.
Doses of the messenger RNA shots — to be delivered between October and April next year — will either be the current formulation or one that has been adapted to coronavirus variants
Protesters marched in the cities of Paris, Marseille, Lyon, Lille and elsewhere, and some argued that the government was encroaching on their ability to choose whether they wanted to get the vaccine, Reuters noted.
(15.07.2021)
The ultimate goal of T cell-based vaccination strategies is the induction of long-term immunological protection via effector memory T cells1. Adenovirus (Ad) vector-based vaccines using the backbone of human Ads have been shown in clinical studies
to be highly immunogenic with induction of specific antibody and/or T cell responses to viral or cancer antigens. However, pre-existing anti-Ad antibodies in vaccinated individuals reduces immunogenicity and efficacy of vaccines based on human Ads, which led to the development of non-human vectors based on chimpanzee viruses. Chimeric Ad vectors have been shown to induce long-lived T cell responses against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and to generate polyfunctional central and effector memory T cells against hepatitis C
virus.
(…)
Results
Targeting of human fibroblasts by Ad vectors. Human Ads were first described as cytopathogenic agents isolated from human adenoid tonsils28. Here, we used sliced tissue cultures from human
palatine tonsils to assess the cellular tropism of green fluorescent protein (GFP)-expressing Ad vectors (Extended Data Fig. 1a). Both HuAd5-GFP and chimpanzee (Ch)AdOx1-GFP vectors readily transduced cells in the tissue slides, with PDPN+CD45− cells most
frequently expressing the GFP transgene (Fig. 1a,b). Next, we compared side-by-side the susceptibility to infection with recombinant Ad vectors of short-term cultured tonsillar stromal cells (TSCs) and peripheral blood mononuclear cells (PBMCs). Both ChAdOx1-GFP (Fig. 1c,d) and HuAd5-GFP (Fig. 1e,f ) efficiently transduced TSCs following an incubation of 3 h, while the transduction rate of PBMCs remained low. Even at the high multiplicity of infection (MOI) of 1,000 particles per cells, less than 2% of the hematopoietic cells were GFP-positive.
(15.07.2021)
Scientists from Oxford and Switzerland, writing in journal Nature, say T-cell protection is a “key feature” of adenovirus vaccines like the Oxford and J&J jabs.
Researcher Prof Burkhard Ludewig, of Cantonal Hospital in Switzerland, said: „The T-cells that come from these cellular training camps appear to have a very high level of ‘fitness’.
“Adenoviruses have co-evolved with humans over a very long time, and learned a lot about the human immune system in the process.
HHS officials had a briefing from Pfizer on Monday regarding their latest, preliminary data on vaccinations and will continue to discuss when and if booster shots will be needed in the future, the spokesperson said.
Pfizer said it planned to publish “more definitive data” in a peer-reviewed journal.
Dr Soumya Swaminathan, the chief WHO scientist, said: “At this point … there is no scientific evidence to suggest that boosters are definitely needed.”
Swaminathan said the WHO would make recommendations on booster shots “based on the science and data, not on individual companies declaring that the vaccines should now be administered as a booster dose”.
Consequentially, from July 1st onwards, only persons who have taken these EMA-approved vaccines can travel freely within the EU region. Any other vaccine, such as WHO-approved Covishield, manufactured by Serum Institute of India under license from Oxford-AstraZeneca, is not recognized by EMA. However, the EU has clarified that the “Green pass” is not a precondition to travel. Nevertheless, people vaccinated with Covishield in India and other countries where New Delhi has exported its vaccines, such as Nepal, Bangladesh, Kenya, Mauritania and other African countries, might face specific issues while travelling within the EU
(23 November 2020)
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. This target is known is an antigen.
ChAdOx1 is in essence a sophisticated, microscopic postman. All the scientists have to do is change the package.
„We drop it in and off we go,“ said Prof Gilbert.
(10.06.2021)
Although the new vaccine variants shows considerable promise, Prof Gilbert said there was no guarantee it would be mass-produced since existing jabs are proving effective against new strains – so it may make more sense to carry on producing those rather than manufacturing different ones.
Vaccines minister Nadhim Zahawi insists 31 July target for offering doses to all adults will be hit despite ‘tight’ supplies of Pfizer
The European Union cemented its support for Pfizer-BioNTech and its novel COVID-19 vaccine technology Saturday by agreeing to a massive contract extension for a potential 1.8 billion doses through 2023.
EU Commission President Ursula von der Leyen said her office has approved a contract for a guaranteed 900 million doses with the same amount of doses as a future option.
German chancellor says waiver would have serious implications for production worldwide
The Biden administration „believes strongly in intellectual property protections,“ Tai said in a statement, but the White House will back the waiver given the „extraordinary circumstances of the COVID-19 pandemic.“ The administration has faced pressure to support the measure, which is aimed at increasing vaccinations around the world — especially in countries experiencing a surge in infections, like India — without having to rely solely on exports.
(23.04.2021)
As Bourla said in an interview with Channel 12 News last month, Bourla was impressed with Netanyahu’s “obsessiveness” with purchasing the vaccines. The Yisrael HaYom report added that Bourla was also impressed by Netanyahu’s insistence on having the lawyers from both sides joining in on the conversations in order to prevent any legal deterrents to the deal.
No results found.
Read more on „Deutsche Welle“
And government sources have told the paper they hope to roughly double the UK’s original order of 40 million jabs.
If negotiations are successful, the extra stock could be used for those in their twenties, who are to be offered an alternative to the AstraZeneca jab amid blood clot fears.
The European Union has approached India in a bid to buy 10million doses of the AstraZeneca jab from its Serum Institute, as the bloc desperately scrambles to procure more vaccine supplies.
Britain has already blamed India’s export ban for delaying the shipment of five million doses to the UK and restricting the country’s vaccine drive to mainly administering second doses to the over-50s in April.
Levy, the ministry’s director general, points to Europe’s potential ban on exporting the vaccine beyond the continent, particularly to countries such as Israel, where vaccination levels are high. If Israel signs the new contracts, it might be protected against such export bans. The ministry is also hastening Israel to sign contracts prior to the completion of clinical trials of the vaccine on children, before stiff international competition sets in.
UK prime minister Boris Johnson has sent an envoy to India to secure millions of doses of the AstraZeneca (AZN.L) COVID-19 vaccine.
Lord Eddie Lister, the PM’s Conservative peer, and international adviser David Quarrey, met with India’s foreign secretary Harsh Shringla in New Delhi on Monday.
(26.03.2021)
The prime minister’s full remarks, which first appeared in the Sun newspaper, were reported to be: „The reason we have the vaccine success is because of capitalism, because of greed, my friends.“
Wales Office Minister David TC Davies, who attended the meeting, said Mr Johnson „made it absolutely clear it was a joke – a reference to the film Wall Street“.
Britain negotiated a better contract to secure vaccine supplies with AstraZeneca that trumps the EU’s agreement with the company, the health secretary has said.
EU leaders will today discuss European Commission proposals for export bans if there are new supply shortages this spring amid a dispute over who gets a stock of four million doses made by AstraZeneca’s Dutch factory.
The PM is appealing to other leaders in a bid to resolve the crisis without a clash, and he spoke with continental heavyweights Angela Merkel and Emmanuel Macron last night to try and persuade them to soften their stance. He has also sent Lord Lister, a government ally, to India to ease tensions over the delay to a batch of five million UK-bound doses of the same vaccine.
(31.01.2021)
First, the parties.
The agreement is between the European Commission, acting on behalf of European Union member states, and AstraZeneca AB, incorporated in Sweden.
That this is the AstraZeneca entity that is party to the agreement may be significant, for (all other things being equal) only that entity will be bound by obligations on AstraZeneca in the agreement – and not any other AstraZeneca entity.
Ms von der Leyen said Brussels had the right to ban the export of vaccines to the UK. But according to a UK Government official, such a move would be illegal.
The source told the Daily Mail: “The reality is our contract with AstraZeneca is rock-solid and better than the EU’s.
“And we’re only getting what we helped to develop and paid for.”
The nation’s top infectious diseases doctor Anthony Fauci on Thursday clashed with Sen. Rand Paul (R-Ky.) over the need for people to continue wearing masks once they’ve already been infected with or vaccinated against COVID-19.
And data from the Medicines and Healthcare products Regulatory Agency (MHRA) regulator in the UK show more people have reported blood clots after having Pfizer’s vaccine than the Oxford one — even though Pfizer’s jab has not been suspended anywhere.
Up to February 28 there were 38 reports from approximately 11.5million doses of Pfizer’s jab, compared to 30 from 9.7m AstraZeneca doses. However, neither figure – the equivalent of one blood clot seen in every 367,000 jabs – is thought to be higher than the risk expected in the general population.
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Bourla further noted that studies on the risk of the vaccine are also underway on pregnant women and younger children.
(today)
Israel:
Total Cases: 812,823
New Cases: +1,331
Total Deaths: 5,955
New Deaths: +5
Total Recovered: 770,156
Active Cases: 36,712
Serious, Critical: 645
Newly Infected vs. Newly Recovered in Israel
Findings not yet peer-reviewed, interaction of vaccine with B1351 variant unclear due to limited data
(01.03.2021)
(08.03.2021)
Israel has administered over 8.7 million doses of the Pfizer vaccine to its population of 9.3 million. Over 3.7 million Israelis — more than 40% — have received both of the doses required for maximum immunity.
(07.02.2021)
While Israel races ahead on putting shots in arms, the country is also seeing a spike in cases, with almost 74 out of every 100,000 Israelis testing positive for the virus, compared to about 40 out of every 100,000 Americans. On Thursday, the death toll in Israel crossed 5,000.
When asked about the seemingly contradictory puzzle, Galia Rahav, the head of the infectious-disease unit at Tel Aviv’s Sheba Medical Center, sighed, chuckled, and said: “This is Israel. We have to be extreme in everything.”
(04.02.2021)
INFECTIONS are rising in Israel despite a third of the population having already received the first dose of the Covid-19 vaccine
Israeli medical students and students in other health-care professions will be banned from participating in clinical training at hospitals and clinics unless they have been vaccinated against the coronavirus, the Israeli Medical School Deans Forum announced on Sunday.
Unvaccinated students will also be prohibited from doing rounds in hospitals.
The party believed that the COVID vaccination rollout would highlight all of Prime Minister Benjamin Netanyahu’s advantages: an international leader with vision, connections and strategy who resolved the coronavirus crisis before any other country. Last week Netanyahu tried a new message – only he can bring in another 36 million vaccine doses and establish a vaccine factory here. But according to Likud polling, this message did not sink in; it has raised hackles and is going to be shelved.
The CEO of Pfizer, the manufacturer of the main coronavirus vaccine used in Israel, has delayed his planned visit to Israel following warnings that Prime Minister Benjamin Netanyahu may exploit Albert Bourla’s visit for his campaign ahead of Israel’s March 23 election.
(04.03.2021)
“Netanyahu looked very carefully at what happened in the United States and he saw that Trump lost his presidency because of the COVID issue,” Hasson told Reuters. “So he thinks it’s going to help him, this matter (of vaccines).”
In an interview last week on NBC, Bourla said: “I believe Israel has become the world’s lab right now, because they are using only our vaccine … and they vaccinated a very big part of their population, so we can study both economy and health indices.”
„Europe is no more, no less than the world leader in vaccine production today. More than 75 per cent of vaccines worldwide are produced in Europe. Nevertheless, there is a crucial lack of supply,“ he said, adding the UK, Canada, Israel and the US are not facing the same shortages.
According to new results, a single dose of the Oxford-AstraZeneca vaccine prevents two-thirds of Covid transmissions, raising hopes for the easing of restrictions by Easter.
The data, released on Feb 2, also revealed that the first jab prevents 100 per cent of hospitalisations after 22 days once an immune response has had time to develop.
(10.02.2021)
AstraZeneca subcontracted the plant — previously owned by Novasep — to produce the drug substance of its vaccine. Volanti would not say how many doses the plant was contracted to provide. He said the plant sends its drug substance to an Italian company to be put into vials and packaged for distribution.
AstraZeneca declined to comment on Thermo Fisher’s remarks, according to Reuters.
(09.02.2021)
AstraZeneca has said it could take between six and nine months to produce Covid-19 vaccines that are effective against new variants of the coronavirus, and begin administering them to the public.
Both companies plan to invest in capacity expansion at IDT Biologika’s production site in Dessau, Germany to build up to five 2,000-litre bioreactors capable of making tens of millions of doses per month of AstraZeneca’s COVID-19 vaccine.
It expects to have a vaccine designed to address the variant discovered in South Africa ready by autumn.
Production BioNTech has said it can produce a fresh vaccine within six weeks of a decision being made. But the Oxford/AstraZeneca team, which uses more traditional viral vector technology, says that while it can make a new formulation in days, it takes much longer to produce
The study from South Africa suggested that two doses of the AstraZeneca vaccine provided „substantially reduced“ protection against mild to moderate Covid-19 disease from the new virus variant first identified there, known as B.1.351.
The study has not yet been peer reviewed or published in full, so many unknowns remain. What we do know is that it included a relatively small number of volunteers who were predominantly young and healthy and therefore not likely to suffer from severe Covid-19 disease.
But hopes the world-beating vaccine roll-out will mean lockdown curbs can be significantly eased any time soon were shot down today by Mr Hancock, who unveiled the latest suite of border curbs and warned they could last until the Autumn when booster vaccines will be available.
Evidence suggests the Oxford University vaccine – the main weapon in Britain’s arsenal to combat the virus – does not stop people falling ill with the South African variant, which is feared to be spreading in the community already.
(20.01.2021)
“This lineage exhibits complete escape from three classes of therapeutically relevant monoclonal antibodies,” the team of scientists from three South African universities working with the National Institute for Communicable Diseases (NICD) wrote in a paper in bioRxiv, a website that publishes scientific research prior to its being peer-reviewed and submitted to journals.
Professor Gilbert earlier told the BBC’s Andrew Marr Show that her team currently has ‚a version with the South African spike sequence in the works‘ with hopes it will be ready to administer by the autumn.
‚It’s not quite ready to vaccinate people with yet, but, as all of the developers are using platform technologies, these are ways of making a vaccine that are very quick to adapt,‘ she added.
“Unfortunately, viruses mutate. Sometimes this is by accident. But often the reason is that the virus wants to become more adept to infect the host.”
This, Madhi explained, was what had happened with the South African variant as well as another variant that was first identified in the United Kingdom.
(05.02.2021)
In recent weeks, scientists have sounded the alarm about new variants of the coronavirus that carry a handful of tiny mutations, some of which seem to make vaccines less effective.
But it is not just these small genetic changes that are raising concerns. The novel coronavirus has a propensity to mix large chunks of its genome when it makes copies of itself. Unlike small mutations, which are like typos in the sequence, a phenomenon called recombination resembles a major copy-and-paste error in which the second half of a sentence is completely overwritten with a slightly different version.
As of Jan. 29, about 35 million people in the U.S. had received one or both doses of a COVID vaccine. So far, only the Pfizer and Moderna vaccines have been granted Emergency Use Authorization in the U.S. by the U.S. Food and Drug Administration (FDA). By the FDA’s own definition, the vaccines are still considered experimental until fully licensed.
According to the latest data, 453 of the 501 reported deaths were in the U.S. Fifty-three percent of those who died were male, 43% were female, the remaining death reports did not include the gender of the deceased. The average age of those who died was 77, the youngest reported death was of a 23-year-old. The Pfizer vaccine was taken by 59% of those who died, while the Moderna vaccine was taken by 41%.
(05.02.2021)
A statement released Friday from State Health Commissioner M. Norman Oliver confirmed the death occurred within hours of the woman receiving the vaccine, although it did not state the day of her death.
(27.01.2021)
‘Never been so excited to get a shot before. I am now fully vaccinated after receiving my 2nd Pfizer dose’ on Facebook on January 5. The 60 year-old uploaded a photo of his arm with a Band-Aid on it, as well as a snap of his vaccination card. But just hours later Zook suffered an upset stomach at work, and began struggling to breathe.
(20.01.2021)
The deaths were all among elderly care home residents aged 75 and over with pre-existing conditions. France’s health minister has said studies will be carried out to determine if there is a link to the vaccine or it is just ‚bad timing‘
(15.01.2021)
According to the medical expert, the deceased were aged from 79 to 93, all with antecedent diseases. The time between vaccination and death ranged from several hours to four days.
(04.01.2021)
According to WTKR, Drene Keyes, a gifted singer and grandmother of six, was vaccinated with the first dose of the Pfizer vaccine in the town of Warsaw shortly before she found herself unable to breathe as she began vomiting. It was after this that fluid filled her lungs and she died.
Keyes suffered from obesity, diabetes, and sleep apnea, but was still eligible for the vaccine.
Pfizer and Moderna, which produce the vaccines used in Israel, have said their shots appear to be slightly less effective in preventing the so-called South African strain of the virus, though the companies say they remain quite potent.
(07.02.2021)
Staff and outside experts attribute the health of these people in the face of their COVID-19 infections primarily to the Pfizer and Moderna vaccines. Nearly 80% of the people who live and work in the facility have received at least one of the shots in the two-shot series.
“I am aware that alone a country can be a speedboat, while the EU is more like a tanker,” Von der Leyen said. “Before concluding a contract with a pharmaceutical company, the 27 member states had five full days to say whether they agreed or not.
“This naturally delays the process. Indeed, we must constantly put pressure on ourselves so that each step of the decision-making process is as fast and efficient as possible.
“But I am absolutely convinced that the European approach is the right one. On these vaccines, we worked faster than usual.
‚Every vaccine is welcome in the European Union,‘ Merkel said in an interview with German broadcaster ARD. ‚Today we have read good data for the Russian vaccine too‘.
Merkel also told ARD she had recently spoken to Russian President Vladimir Putin about the vaccine, which has been found to 91.6 per cent effective in trial results.
A batch of Sputnik V arrived in Hungary today, making it the first country to adopt the once-controversial jab.
The Oxford AstraZeneca vaccine will not be recommended for over-65s in France or Sweden, the countries‘ health ministries announced today.
It comes after Germany advised against administering the jab to those over 65 and Emmanuel Macron claimed it was ‚almost ineffective‘ for the age bracket.
Continental objections to the jab last week came amid a furious row between the Bloc and AstraZeneca over lagging supply, which has seen newly-unshackled Brexit Britain storm ahead in its immunisation roll-out.
Below are the responses in full from European Commission president Ursula von der Leyen to questions posed by Irish Times Europe Correspondent Naomi O’Leary.
The current COVID-19 pandemic, caused by the SARS-CoV-2 virus, represents a major threat to health. The COVID-19 Genomics UK (COG-UK) consortium has been created to deliver large-scale and rapid whole-genome virus sequencing to local NHS centres and the UK government.
COG-UK is made up of an innovative partnership of NHS organisations, the four Public Health Agencies of the UK, the Wellcome Sanger Institute and over twelve academic partners providing sequencing and analysis capacity.
There’s good evidence that the shots made by Pfizer Inc.-BioNTech SE and Moderna Inc. are very effective — as much as 95% — at preventing recipients from developing Covid-19 itself. However, data haven’t been released on their ability to prevent people from developing asymptomatic infections or transmitting the virus to others. The gold standard in vaccinology is to stop infection as well as disease, providing so-called sterilizing immunity.
Speaking ahead of an emergency summit with vaccine manufacturers to tackle the country’s sluggish rollout, Jens Spahn said that if a vaccine “can be considered safe and effective, regardless of what country it has been produced in, then it could help”.
As game-changing as the Pfizer vaccine (and Moderna’s equally effective mRNA-1273 vaccine) may be in affording protection against the COVID-19 illness, the results do not reflect complete „sterilizing immunity.“
This is the type of immunity that completely prevents a disease-causing pathogen like COVID-19 from establishing an infection. Sterilizing immunity differs from effective immunity in that the latter can prevent illness but still lead to asymptomatic infection.
Rep. Stephen Lynch (D-MA) announced late Friday that he had tested positive for COVID-19 more than a week after receiving his second dose of the Pfizer coronavirus vaccine.
A government source said the Taoiseach had not been given any advance warning of the EU decision to invoke the article in the protocol.
The source said the article may have been inadvertently triggered by “someone who did not understand the political implications” of the decision.
Some EU officials are understood to be livid about the move, which they see as ruining the work they’ve done since the Brexit vote in 2016.
In a steep escalation of the EU’s fight to secure vaccine supplies, Brussels had said it would trigger clauses in the Northern Irish Protocol in the EU-UK withdrawal agreement to control shots moving across the open Border between the State and the North. It said this plan aimed to prevent the movement of vaccines onwards into the rest of the UK via a Northern Ireland “backdoor”, while preserving the capacity to allow shipments into the North.
It comes after the bloc invoked part of the Northern Ireland Protocol in an attempt to stop vaccines made in the EU from getting into the UK through the back door.
The protocol, which is part of the Brexit deal, allows goods from the EU to be exported to Northern Ireland without checks.
However the EU triggered Article 16 of the protocol tonight to slap temporary export controls on vaccines sent to Northern Ireland.
Following the renewed request from the European Commission on 27 January 2021, pharmaceutical company AstraZeneca has agreed to publish the redacted contract signed between the two parties on 27 August 2020.
The Commission welcomes the company’s commitment towards more transparency in its participation in the rollout of the EU Vaccines Strategy.
The meeting comes as a row escalates over the supply of its coronavirus vaccine. #sabcnews
AstraZeneca says it has not pulled out of talks with the EU on vaccine deliveries, plans meeting later Wednesday.
The cancellation follows an explosive interview with AstraZeneca CEO Pascal Soriot on Tuesday night, in which he insisted the company didn’t have a contractual obligation but rather a „best effort“ to supply the EU with its vaccine.
Instead of the meeting, the company will respond in writing to Health Commissioner Stella Kyriakides‘ demand for more information, the Commission official said. AstraZeneca did not immediately confirm this plan.
The Oxford/AstraZeneca vaccine has advantages that make it an attractive possibility. It can be stored at normal refrigeration temperatures, and its price is low relative to its competitors. Public health experts have long targeted it as ideal for use in lower and moderate-income countries because of these features.
The problem is that its U.S. Phase III trial was delayed because of an adverse event investigation in the fall, and the data from the international trials used by the U.K. government are difficult to interpret due to unplanned modifications to dosing levels.
The government is seeking 100 million doses from Pfizer/BioNTech and 100 million from Moderna, an order that would be made available over the summer. They would be in addition to the 400 million combined doses the companies had already committed to provide the U.S., Biden said. He said he expects to be able to confirm the purchase soon.
Pfizer will supply the US with 200 million doses of its coronavirus vaccine two months sooner than expected, according to the firm’s chief executive.
A University of Oxford spokesperson said clinical trials showed similar immune responses in younger and older adults, a good safety profile and high efficacy in younger adults. “There is no basis for the claims of very low efficacy of the Oxford/AstraZeneca vaccine which have been circulating in the media,” they said.
While it is true that there was less data from older adults involved in the trials, the team say early figures were promising: “Preliminary efficacy data in older adults supports the importance of this vaccine for use in this population,” they said.
Handelsblatt was still running the original story today with the headline: ‚Setback to coronavirus vaccine: AstraZeneca vaccine appears to hardly work on seniors‘.
A subheading noted that Germany’s health minister Jens Spahn had been ‚circumspect‘ about the claim, without mentioning the ministry’s subsequent denial.
Gregor Waschinski, one of the journalists behind the story, stood by it on Monday night and said it was confirmed by ‚multiple sources familiar with the German vaccination policy‘.
The reports emerged in Handelsblatt, a respected financial daily, and the mass-circulation Bild, quoting sources within Germany’s governing coalition.
EXCLUSIVE-ASTRAZENECA HAS PROPOSED TO THE EU TO BRING FORWARD START OF SUPPLIES OF ITS COVID-19 VACCINE TO FEB 7 FROM FEB 15 – EU SOURCES
The European Commission has warned it will impose controls on vaccines that could affect the UK’s supply of the Pfizer/BioNTech coronavirus vaccine, which is shipped from its manufacturing base in Belgium.
But vaccines minister Nadhim Zahawi told Sky News on Tuesday: “I’m confident that the Pfizer vaccine will be delivered.
EU countries learnt late last week that deliveries of the vaccine from AstraZeneca, which is expected to be approved on Friday, would be some 60% lower in the first quarter than initially indicated.
There have also been reduced deliveries of a vaccine jointly produced by Pfizer and BioNTech.
The health ministry insisted the claims made in German media last night were based on confused analysis of a study into the effectiveness of the AstraZeneca jab.
Another Westminster official said: “The efficacy claims circulating in the German media are unsubstantiated and incorrect.”
Speaking to Politico, a third added: “After this, support for Brexit will be at about 90 percent.”
The claims in the German media were made on the same day a row broke out between the European Union and AstraZeneca over supplies of the vaccine to the continent.
(15.06.2020)
Novasep brings to AstraZeneca more than 20 years of expertise in viral vector production. Novasep’s investment strategy in the large-scale production of biopharmaceutical products for immunotherapy and gene therapy enables Novasep to support the alliance for the production of the vaccine active substance in Europe.
The production operations will be carried out at Novasep’s Belgian site in Seneffe. Furthermore, the biopharmaceutical ecosystem in the region allows Novasep to rapidly mobilize the additional human resources needed to achieve this project.
(December 2020)
Most of the UK’s supply of the vaccine is being produced at Pfizer’s facilities in Puurs, Belgium.
Some does are also being made at BioNTech’s sites in Germany.
Meanwhile, there is another row raging after two German newspapers claimed the EU’s regulator could refuse to give the Oxford/AstraZeneca jab full approval, with officials anonymously briefing its efficacy for pensioners was just eight per cent.
However, the claim was branded ‚absolutely incorrect‘ and ‚unsubstantiated‘ by the pharmaceutical company – and No10 sources told MailOnline it was ‚rubbish‘. One Whitehall source told Playbook it was the kind of tactics ‚you expect from the Russians‘.
Good evening.
You know that AstraZeneca’s vaccine is currently in the final stages of the approval process with the European Medicines Agency.
If all requirements are met, the European Medicines Agency could recommend market authorisation by the end of this week.
But there is a problem on the supply side.
Last Friday, the company AstraZeneca surprisingly informed the Commission and the European Union Member States that it intends to supply considerably fewer doses in the coming weeks than agreed and announced.
This new schedule is not acceptable to the European Union.
n a sign of the EU’s frustration – after Pfizer also announced a temporary slowdown in vaccine supplies earlier in January – EU health commissioner Stella Kyriakides proposed forcing drug makers to register in advance their Covid-19 vaccine exports, so the bloc can keep track of what they are doing.
(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.”
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.
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.
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.
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.
“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.
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.“
(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.
(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.
(15.01.2021)
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.
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.“
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.”
(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.
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.
(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.
(…)
Once the vaccine receives a positive scientific opinion, we will work full speed to authorise its use in Europe.
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.
(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.
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.
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.
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”.
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.
(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.
(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.
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.
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.
(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.
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.
(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.
(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.
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.
„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.
„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.
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.
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.
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.
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.
(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.
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.”
(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.
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.
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.
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.
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.
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.
(23.12.2020)
(28.11.2020)
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.
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…
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.
(23.12.2020)
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.‘
„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.”
(28.11.2020)
(21.12.2020)
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.
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?
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.
(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.
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 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.
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.
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.
“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.
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.
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.
(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.
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.
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.
(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.
(08.06.2020)
Neutralizing antibodies prevent the virus from replicating.
(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.
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.”
(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.
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.
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.
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.
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.
. 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.
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.
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.
(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.
(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.“