China and the US have reached a long-stalled agreement on the year-long audit dispute for listed companies, based on the principles of equality and reciprocity and abiding by each other’s laws, the Chinese securities regulator announced on Friday, marking a significant breakthrough in bilateral auditing cooperation that partially helps to clear delisting clouds hanging over 280 Chinese companies listed in the US.
Perennial American Russophobes from opposite sides of the political spectrum, Sen. Richard Blumenthal and Sen. Lindsey Graham, are now agitating members of Congress to include Russia in Washington’s list of ‘state sponsors of terrorism,’ which presently includes North Korea, Iran, Cuba and Syria.
At least 12 people were killed when al Qaeda-linked militants attacked a hotel in Somalia’s capital Mogadishu, seizing hostages who authorities were still battling to free 24 hours later, an intelligence officer said on Saturday.
(May 18, 2022)
A senior U.S. defense official has confirmed to Fox News on Monday that President Joe Biden has authorized the deployment of hundreds of Special Operations troops inside Somalia.
The decision comes alongside approval of a Pentagon request for standing authority to target about a dozen suspected leaders of the al-Shabab terrorist group that operates inside the east African country’s borders, the official said.
The firm only acquired its first commercial manufacturing plant in March 2021, located in Boston, MA and purchased from Sanofi, followed shortly thereafter by the acquisition of another separate plant located in Mississauga, Ontario, Canada. Makeovers were announced for the plants, but little is publicly known about their progress. Prior to the acquisitions, the company had been subleasing a Bay area facility in Fremont, California. Reporters were puzzled at the time as to why a company with roughly 700 employees at the time had acquired a total of 599,00 square feet of manufacturing space after having only emerged from stealth less than 6 months prior.
In April 2021, National Resilience acquired Ology Bioservices Inc., which had received a $37 million contract from the US military the previous November to develop an advanced anti-COVID-19 monoclonal antibody treatment. This acquisition also provided National Resilience with its first Biosafety Level 3 (BSL-3) laboratory and the ability to manufacture cell and gene therapies, live viral vaccines and vectors and oncolytic viruses.
Despite being in the earliest stages of developing its “revolutionary” manufacturing capabilities, National Resilience entered into a partnership with the Government of Canada in July of last year.
“When we form the government, I will promote the Deportation Law, which will deport anyone who acts against the State of Israel or IDF soldiers,” Ben-Gvir said in the interview. “Those who throw stones and Molotov cocktails at soldiers will be deported from here. Those who work against the state like [Joint List MK] Ofer Cassif will be deported. Maybe to Europe. They need working hands there.”
However, he said, the same law would not apply to Jews.
Itamar Ben-Gvir, Otzma Yehudit party head hoping to be part of Israel’s next government, declared he would support a deportation policy for anyone who works ‚against the state of Israel,‘ specifically mentioning Joint List lawmakers
Under both 127e and 1202, the use of proxy forces must support “authorized” U.S. military operations. The Defense Department has cited two sources of authority for engaging in combat through and with 127e proxies: the 2001 Authorization for Use of Military Force, or AUMF—the authority for the United States’s endless “war on terror”—and the president’s constitutional prerogative to engage in “self-defense,” defined expansively by executive branch lawyers.
The Defense Department could cite similar authorities for the use of 1202 proxies. Although no AUMF was designed to counter Iran, North Korea, Russia, or China, the executive branch believes it has the authority to engage these countries militarily.
– Russia and Ukraine sent defence and infrastructure ministers to Istanbul, Turkey
– They signed the landmark deal alongside U.N. gen sec and Turkish president
– The accord opens the way to significant volumes of vital commercial food exports from three key Ukrainian ports – Odesa, Chernomorsk and Yuzhny
– Russia had been blockading the ports, preventing essential grain from leaving
– The deal, seen by many as the first breakthrough in the conflict, comes after almost six months of war
Ukraine and Russia, two neighboring countries in war since February, have signed two historic deals with Türkiye and the U.N. for the creation of a secure food corridor through the Black Sea under a comprehensive plan, dubbed the Black Sea Initiative, that would prevent a major global food crisis.
Ukraine and Russia signed two memorandums of understanding with Türkiye and the U.N. on July 22 to begin exporting their grains and other food products.
According to Buccino, the fuel tankers simulated refueling two US F-15s and four Israeli F-16s. The timing of the refueling exercise was coincidental, Buccino said.
“There is no direct US military involvement in that exercise,” Buccino said, referring to “Chariots of Fire.”
Pentagon spokesman Maj. Rob Lodewick also denied that the Department of Defense was “directly participating” in the exercise, according to the report.
“A small number of personnel from across US Central Command are observing portions of the exercise,” Lodewick added.
According to the unsourced report, the US Air Force will serve as a complementary force, with refueling planes drilling with Israeli fighter jets as they simulate entering Iranian territory and carrying out repeated strikes.
The unprecedented Israel- US aerial collaboration in a drill simulating a strike on Iran’s nuclear facilities is seen as a potential message to Iran amid long-stalled negotiations in Vienna over a return to the 2015 nuclear deal, a possibility Israel has repeatedly voiced its objection to, warning it would lead to “a more violent, more volatile Middle East.”
Gantz is slated to meet with his American counterpart, Lloyd Austin, on Thursday at the Pentagon in Washington. Meanwhile, Michael Kurilla, head of the United States Central Command (CENTCOM), arrived in Israel on Tuesday for his first official visit.
BREAKING: Gaetz calls out „progressives“ for not opposing American hostility in Somalia
Together, the decisions by Mr. Biden, described by the officials on the condition of anonymity, will revive an open-ended American counterterrorism operation that has amounted to a slow-burn war through three administrations. The move stands in contrast to his decision last year to pull American forces from Afghanistan, saying that “it is time to end the forever war.”
As you may have heard, during the confirmation process, I had the distinct honor of having 95 personal meetings with 97 sitting senators. (Laughter.) And we had substantive and engaging conversations about my approach to judging and about the role of judges in the constitutional system we all love.
As a brief aside, I will note that these are subjects about which I care deeply. I have dedicated my career to public service because I love this country and our Constitution and the rights that make us free.
Should the Security Council consider that measures provided for in Article 41 would be inadequate or have proved to be inadequate, it may take such action by air, sea, or land forces as may be necessary to maintain or restore international peace and security. Such action may include demonstrations, blockade, and other operations by air, sea, or land forces of members of the Renewed United Nations, when peaceful solutions to the conflict, leading to freedom, personal responsibility, self-determination, increased prosperity and further implemenations of fundamental rights and freedoms for the population of the territory are simultaneously proposed or put into effect.
This was not a politician convening his team for discussions, this was a supreme leader marshalling his minions and ensuring collective responsibility for a decision that, at minimum, will change the security architecture in Europe, and may well lead to a horrific war that consumes Ukraine.
Putin appeared genuinely angry and passionate in his speech, which he almost certainly wrote himself.
– Vladimir Putin will recognise Ukraine’s eastern regions as independent and sign a degree to that effect shortly
– Move would pave the way for Russian troops to roll in, on basis of ‚defending‘ them against Ukrainian ‚threats‘
– Mr Johnson said Putin’s decision to recognise the two separatist Ukrainian republics was an ‚ill omen‘ and a ‚dark sign‘ that things are moving in the wrong direction
– Putin spoke after an hours-long meeting of Russia’s security council, with aides laying out the case for war
– Having spent days staging what are widely thought to be false flag attacks and blaming them on Kiev, Kremlin officials presented them as ‚evidence‘ that ethnic Russians are at risk of ‚genocide‘ and must be protected
– All eyes will now turn to Ukraine’s border regions, where Russian tanks have been spotted in ‚battle formation‘
The Kremlin announced Monday that Moscow will recognize the independence of two breakaway regions in eastern Ukraine, a move that Russia could use to justify an attack in those areas.
Pfizer and its German partner, BioNTech, on Tuesday asked the Food and Drug Administration to authorize a booster dose of its coronavirus vaccine for people 18 and older.
The FDA could clear the request by the end of the month, according to health officials who spoke on the condition of anonymity because they were not authorized to discuss the issue.
Despite Jackson repeatedly notifying Ventavia of the problems, the company reportedly took no corrective action. This prompted Jackson to send a complaint by email to the US Food and Drug Administration (FDA) – the country’s top regulatory body – in September 2020. But less than 24 hours later, Ventavia fired her in an apparent reprisal.
In a further surprise, the FDA did not follow up on Jackson’s complaint either.
In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1
But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day.
In 1977, following revelations of U.S. lethal targeting operations and ensuing Church (Senate) and the Pike (House) Committee hearings, President Gerald Ford issued Executive Order 11,905. The order prohibited Executive Branch personnel from engaging in, or conspiring to engage in, political assassination. Subsequent administrations continued the ban. Four years later, President Regan issued Executive Order 12,333, which, as amended, remains in effect today. It contains the same prohibition, although it limits application to individuals “acting on behalf of” the U.S. government.
Following Mr Putin’s comments on supplies, gas prices dropped to about 257p a therm later on Wednesday.
Deputy prime minister Alexander Novak urged German regulators to quickly certify the Nord Stream 2 pipeline to help.
1.CDC, FDA, NIH are spreading misinfo on vax vs. early treatment: Early treatment is being deliberately sabotaged
2.The data is clear: all the “experts” are wrong about vax safety
3.Our medical freedoms are being stripped away
4.Nobody prominent will challenge my conclusions with a better analysis even with large $ incentives
5.Debates → Government-driven censorship and intimidation
6.CDC and FDA won’t engage or investigate fraud.
7.Medical recommendations are now being driven by the White House
8.Vaccines don’t offer an all-cause morbidity or mortality benefit
9.Geert Vanden Bossche was right: vaccinate mid-pandemic → disaster
Kirsch, an entrepreneur with a background in banking technology who is funding research into COVID-19 treatments unrelated to vaccines, claimed in the meeting that “the vaccines kill more people than they save.”
To support his argument, Kirsch referenced data from the Vaccine Adverse Event Reporting System, a CDC- and FDA-run database of unverified reports of adverse events that occur after receiving a vaccine. The VAERS system does not determine whether a vaccine caused the events that are reported.
Over several hours of discussion, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on safety of extra doses.
And they complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.
(June 24, 2021)
Pfizer and Moderna vaccine fact sheets will soon feature a label from the Food and Drug Administration (FDA) warning of a heart inflammation risk in adolescents and young adults after a Centers for Disease Control and Prevention (CDC) safety panel determined there is a „likely association“ between the vaccines and cases of myocarditis and pericarditis in younger vaccine recipients, according to an analysis presented by the panel Wednesday.
The CDC says the findings do not change the basic recommendation that all people 12 and older should be vaccinated …
August 23, 2021
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Late Friday, The Wall Street Journal and The New York Times reported that the FDA could approve the vaccine, which up until now has been distributed on an emergency basis, as early as Monday but could possibly go past that if regulators need more time to review data.
The conditions were reported in patients who took the mRNA vaccines made by either Moderna or BioNTech-Pfizer.
Pfizer stock fell 3%.
The latest mandate came Monday, when Defense Secretary Lloyd Austin announced he would move to make the vaccine mandatory for troops by mid-September but would act “immediately” if it received full approval before then.
Anthony Fauci, the government’s top infectious diseases expert, added to the chorus on Sunday, when he expressed hope that the approval would move quickly.
DoD officials have made several calls to key lawmakers in recent days to gauge support for the mandate, according to a congressional source and a senior administration official familiar with the talks.
The Pentagon on Monday said that it will seek U.S. President Joe Biden’s approval by mid-September to require 1.3 million military members to get vaccinated against COVID-19, anticipating full regulatory clearance for a vaccine by then.
The FDA has only granted emergency-use approval of the Pfizer, Moderna and Johnson & Johnson vaccines, but the agency is expected to soon give full approval to Pfizer.
Israel’s defense exports, including the sale of offensive cyber technologies to foreign countries, and the policy that governs them is beyond the jurisdiction of Israeli courts, the Supreme Court ruled Sunday. The court’s justices refused to hear a petition filed by human right activists against the director of Israel’s Defense Ministry and Cellebrite, the digital forensics company, for the sale of phone-hacking tech to Russia.
The Israeli interministerial team „will conduct its checks, and we will be sure to look into the findings and see if we need to fix things here,“ Ben Barak said.
DECA is within Israel’s Defense Ministry and oversees NSO exports.
Israeli Minister of Defense Benny Gantz spoke at the same conference and said Israel was „studying“ reports about the alleged use of the Pegasus software in violation of the terms of its export license.
“We approve the export of cyber products only to governments and only for lawful use in order to prevent crime and terrorism. Countries who purchase those systems must adhere to the conditions of use,“ Gantz said.
(31 March 2020)
Earlier in the day, in a series of tweets, Bennett had floated the idea of giving the Israel Defense Forces’ elite Unit 8200, along with NSO, access to highly personal data of Israeli citizens that had been collected by the Shin Bet security service and Health Ministry as part of an already contentious mass surveillance program.
After 12 years of Benjamin Netanyahu’s tenure as prime minister, in which human rights activists and Knesset members were smeared as supporters of terrorism, critical journalists deemed enemies of the people and left-wing voters as traitors, why would the Israeli public, which had grown accustomed to view dissident voices as enemies, care about what happens to journalists in Azerbaijan, India or Hungary?
According to Zarif Biden has agreed to annul these executive order:
13781, 13902, 13876 (Khamenei and his office), 13846 (partially), 13754, 13590, 13622, 13645, 13628
According to Zarif the Biden administration has agreed to suspend these laws:
National Defense Authorization Act (NDAA) of 2012
Iran Threat Reduction and Syria Human Rights Act (TRA)
Iran Freedom and Counter-Proliferation Act, (IFCA)
Iran Sanctions Act (ISA)
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
On Friday, June 25, the United Nations accused Israel of blatantly violating international law and called on it to halt the illegal expansions in settlements. According to Al-Ittihad, Antonio Guterres, UN Secretary-General and Tor Wennesland, UN Mideast envoy, cited Security Council resolution 2334 from December 2016 that declared the occupation’s settlements as having “no legal validity.”
“I again underscore, in no uncertain terms, that Israeli settlements constitute a flagrant violation of United Nations resolutions and international law,” Wennesland said. “They are a major obstacle to the achievement of a two-state solution and a just, long lasting and comprehensive peace. The advancement of all settlement activity must cease immediately.
– EMA does not recognise the Covishield AstraZeneca vaccine produced in India
– This could cause issue for vaccinated Britons eagerly hoping to travel abroad
– Still a theoretical issue as so few European nations are on the ‚green‘ travel list
The EU’s passport scheme does not recognise batches of AstraZeneca that were made in India and given out in the UK.
The EU Digital Covid Certificate will allow people to travel safely across Europe by acting as a Covid passport.
Ebrahim Raisi, the frontrunner, is particularly controversial. Head of the country’s powerful judiciary, he led the crackdown on anti-government protesters in 2019, and he tolerates zero dissent. If elected, he would become the first Iranian president to take office with U.S.-imposed sanctions already listing him personally: He was sanctioned by the U.S. government over his involvement in a mass-execution of political prisoners almost three decades ago.
By the morning of March 23, officials at the National Institute of Allergy and Infectious Diseases released a letter from its data and safety monitoring board that’s been examining the AstraZeneca trial, Andrew Joseph reports for STAT News. The letter stated that AstraZeneca had used outdated data to reach its efficacy number. The move was unprecedented; usually, monitoring boards keep their correspondence with companies private.
“We just felt we could not remain silent. Because if we did remain silent, we could be understandably accused of covering something up. And we definitely didn’t want to be in that position,” says Anthony Fauci, director of the NIAID, to STAT News. “In my mind, it’s an unforced error by the company.”
With huge global public health implications, Handelsblatt’s story rapidly became international news—and was rapidly rebuffed. Calls for the underlying data filled social media. An AstraZeneca spokesperson described the reported figure as “completely incorrect.”
The controversy came at a moment of intense finger pointing between the European Commission and AstraZeneca over unfulfilled vaccine shipments, and in the week that the European Medicines Agency (EMA) was expected to decide whether to recommend authorisation.
„We continue to call for Covid-19 vaccine developers to submit their dossiers to WHO for review at the same time as they submit them to regulators in high-income countries,“ he said.
A WHO statement said it had approved the vaccine as produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.
The level of coronavirus infections is still high and the number of hospitalisations higher than they were during the first peak, Chris Whitty said.
However, the PM cannot ignore 63 of his own MPs. He knows how strongly they feel about lockdown easing. Some 53 Tories voted against his tiered system in December. He will probably want to renew some of the current restrictions when they expire on 31 March.
Drawing on the Civil Contingencies Act, measures would also need Parliamentary approval before coming into effect (unless too urgent – in which case validity would be provisional) and they would expire after no more than 30 days unless renewed, so that in the event of another pandemic, restrictions could not be imposed for months on end without proper scrutiny.
Prof Andy Pollard, of the University of Oxford, said the lack of data is understandable. “In our trials, the older adults were recruited later and, because they were recruited later there has been less time for cases to occur, and, older adults are known to be more cautious in the pandemic, meaning the ‘attack rate’ is lower,” he said.
AstraZeneca has stressed that older adults were recruited later because the team wanted to be sure the vaccine was safe before administering it to older age groups.
AstraZeneca’s vaccine has not been granted approval yet for general use in the European Union, but the bloc’s medicines regulator EMA is poised to authorise it on Friday.
The German panel, STIKO did not detail the data from clinical trials on the vaccine on older people, but two prominent German media outlets had reported that the efficacy on above-65s was below 10 per cent.
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.
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.
Health Minister Zweli Mkhize announced on Friday that the South African Health Products Regulatory Authority (SAHPRA) has granted approval to the SII, which is producing the vaccine in collaboration with the University of Oxford and AstraZeneca, to supply the drug to the country.
Senators voted 84-10 to confirm Haines, who appears to be the only Cabinet official Biden will get confirmed on the first day of his administration.
The coronavirus vaccine developed by AstraZeneca and Oxford University is not likely to be authorized for use in the U.S. until April, a top Trump administration health official said Wednesday.
“We project, if everything goes well, that the readout and emergency use authorization may be granted somewhere early in the month of April,” Moncef Slaoui, the chief science adviser for the administration’s Operation Warp Speed, told reporters.
Once the vaccine receives a positive scientific opinion, we will work full speed to authorise its use in Europe.
President Trump acknowledged the end of his first term as president early Thursday morning saying there would be an „orderly transition of power“ on Jan. 20 minutes after Congress formally certified the Electoral College votes in favor of President-elect Joe Biden.
Chaos erupted inside the U.S. Capitol as of pro-Trump demonstrators charged the building and eventually made their way past multiple layers of barriers and inside.
Both the House and Senate recessed in response to the breach, and Vice President Mike Pence, who was in the Senate, was whisked away. Lawmakers and staff were ordered to seek shelter and remain away from doors and windows.
Speaking in the US Senate following an objection to the counting of Arizona’s electoral votes, Majority Leader Mitch McConnell (R-KY) warned about Congress overruling the voters saying it would „damage our Republic forever.“
Congress convenes Wednesday at 1 p.m. for a joint session to record the Electoral College votes from November’s presidential election.
Follow along with our live coverage.
This is a live, uninterrupted feed of the House floor, where a joint session of Congress is meeting on Jan. 6 to certify President-elect Joe Biden’s win.
For live coverage and analysis of the full process, watch here:
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 has approved the coronavirus vaccine developed by Oxford University and the pharmaceutical company AstraZeneca, making it the second country after Britain to do so.
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.
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.
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.
„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.
Her Majesty’s approval paves the way for the deal to take effect at 11pm on Thursday when the current Brexit transition period, during which the UK has continued to follow EU rules, ends.
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.
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.
“As President, I have told Congress that I want far less wasteful spending and more money going to the American people in the form of $2,000 checks per adult and $600 per child,” Trump said in a statement.
“On Monday the House will vote to increase payments to individuals from $600 to $2,000,” he added. “Therefore, a family of four would receive $5,200.”
The Covid-19 relief legislation was passed by Congress on Monday and was flown to Mar-a-Lago on Thursday to await Trump’s signature. But after sitting on the sidelines during the negotiations, Trump emerged with an eleventh-hour complaint that a separate provision in the deal, which the President’s own White House helped broker, would only provide up to $600 in direct payments. Trump wanted to send out $2,000 checks.
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.”
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?
Morell has no place in a Biden-Harris administration. His nomination would send a chilling message to torture survivors and other victims of grave injustice that the United States government, including the Biden administration, does not uphold its own stated principles. Senator Ron Wyden (D-OR) from the Senate Intelligence Committee has said about Morell: “No torture apologist can be confirmed as CIA director. It’s a nonstarter.” We agree and urge the President-elect not to nominate Morell.
We also oppose Avril Haines, another toture apologist, as Director of National Intelligence. Since she has already been nominated, we ask Senators to oppose her confirmation.
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.
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.
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.”
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.
The new tiers system for England came into force at midnight after the Commons approved it by 291 to 78 – but the healthy majority masked a disaster for Mr Johnson as a swathe of his own MPs abandoned him.
Scores of Tories joined the biggest uprising of this Parliament despite Mr Johnson personally waiting in the division lobbies and urging them to stick with the government, and he only secured victory because Sir Keir stopped short of opposing the measures.
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.
Fifteen countries have formed the world’s largest trading bloc, covering nearly a third of the global economy.
The Regional Comprehensive Economic Partnership (RCEP) is made up of 10 Southeast Asian countries, as well as South Korea, China, Japan, Australia and New Zealand.
A damning report published on Tuesday said the Covert Human Intelligence Sources (Criminal Conduct) Bill should not be introduced in its current form.
Parliament’s Joint Committee on Human Rights said the proposed law “raises the abhorrent possibility of serious crimes such as rape, murder or torture being carried out under an authorisation”.
Zohar allgedly threatened Mendelblit in October, saying that if the attorney general did not resign from his position and drop the three pending corruption indictments against Prime Minister Benjamin Netanyahu, incriminating recordings of Mendelblit would be leaked to the public.
The police interrogation of Zohar was authorized by the state prosecutor’s office.
This article has listed a number of terrible consequences that war engenders. However, I want to conclude on a positive note. 19 years of persistent war has taught the United States a vivid lesson about the power of hope. After all, what else would keep men and women fighting for an entire generation? They don’t do it for medals of valor, nor for glory. Rather, there is a hope inside of them for a better future.
I really believe in the power of hope! As a career warrior, I got up, put on my equipment and went out to face our enemies on many different battlefields because I had hope for a greater future. –a greater future for my children and a greater future for my country.
German Foreign Minister Heiko Maas said it was a ‚great honor‘ to host the high-level summit
Hosted by President Trump at the White House Tuesday, the United Arab Emirates and Bahrain became the third and fourth Arab nations to move toward normalizing relations with Israel.
Netanyahu’s main coalition partners, Defense Minister Benny and Foreign Minister Gabi Ashkenazi, were shunned from the trip
Riyadh is systematically building a nuclear infrastructure that it could easily flip from civilian to military purposes. A Saudi Arabia whose strategic interests align with the U.S. and Israel today may be a very different country down the line
And third, Benjamin Netanyahu has utilized the paralysis and confusion he has imposed on Israel’s body politic over the past two years to dismantle the checks and balances that stand in the way of his efforts to avoid criminal trial. It is one of many battles in the total war that Netanyahu is waging against the very foundations of Israeli democracy, which, in his distress and incessant self-victimization, he has come to despise.
In addition, the German Chancellor said at the press conference that the EU will also strengthen its cooperation with China in third countries, for example, the cooperation between the two sides in African countries.
Merkel said that the EU and China should also hold conversations on topics where they have different views. „We want to continue the conversation and set an example for multilateralism with fair framework conditions,“ said Merkel.
LONDON: Britain’s prince Charles on Saturday led the UK’s commemoration of the 75th anniversary of Victory over Japan (VJ) Day – the day World War II ended with Japan’s surrender in 1945.
The cities to be locked down include the economic powerhouse of Casablanca as well as Tangier, Marrakech, Fez and Meknes.
Powers like these have been deployed sparingly: A few days after the Sept. 11 attacks, a proclamation declaring a national emergency, followed by an executive order days later, invoked some presidential powers, including the use of National Guard and U.S. military forces.
What little we know about these secret powers comes from the Brennan Center for Justice at the New York University Law School, but we believe they may include suspension of habeas corpus, surveillance, home intrusion, arrest without a judicial warrant, collective if not mass arrests and more; some could violate constitutional protections.
The president portrayed the nation’s cities as out of control. “Look at what’s going on — all run by Democrats, all run by very liberal Democrats. All run, really, by radical left,” Mr. Trump said. He added: “If Biden got in, that would be true for the country. The whole country would go to hell. And we’re not going to let it go to hell.”
Democrats said the president was the one out of control.
Heavily armed federal officers without name tags have carried out nightly attacks on antiracist demonstrations in Portland, Oregon, and snatched people off the streets into unmarked vans, sparking widespread outrage. “What we’ve seen is a continuous escalation in violence against our protesters,” says Lilith Sinclair, an Afro-Indigenous local organizer in Portland. They note the federal violence follows many years of “severe police brutality” from local police. “It’s left the people of Portland not only worried about their safety, but, even more so, justified in the fight that we’re engaged in.”
The U.S. attorney for the District of Oregon has called for an investigation into the conduct of federal officers deployed to protests in Portland, calling their behavior “unlawful.” Local officials are also mounting legal challenges to remove the agents from city streets. Juan Chavez, project director and attorney at the Oregon Justice Resource Center, says it’s a terrifying situation for Portland residents who face “these camouflaged goon squads” who often refuse to identify themselves or their agencies. “They just appear in the middle of the night next to people who are in and around downtown who then get corralled into these vehicles, not told where or who’s picking them up,” he says.
Democrat Congresswoman Jim Clyburn compared federal law enforcement to Nazi Germany Gestapo, when he appeared on CNN on 7/20/2020.
“The Department of Justice (DOJ) and the Department of Homeland Security (DHS) appear to have increasingly abused emergency authorities to justify the use of force against Americans exercising their right to peaceful assembly,” wrote House Judiciary Committee Chairman Jerrold Nadler (D-N.Y.), Homeland Security Committee Chairman Bennie Thompson (D-Miss.) and Oversight and Reform Committee Chairwoman Carolyn Maloney (D-N.Y.).
Food and Drug Administration (FDA) Commissioner Stephen Hahn declined on Sunday to confirm or deny whether President Trump’s claim that 99 percent of COVID-19 cases are “harmless.”
First published on April 8, 2020
Timeline from September 2019 – April 2020
Speaker Nancy Pelosi (D-Calif.) on Thursday demanded that President Trump provide a list of the agencies involved in deploying law enforcement officers around Washington, D.C., in response to the crowds of demonstrators protesting police brutality.
Some officers policing protests in the city in recent days have been seen without any identifying labels on their uniforms, raising questions about which law enforcement agencies they represent.
They were dressed in mixed riot gear, with helmets and face masks, shields and guns loaded with crowd control agents.
Likewise, a group of humanitarian organizations said that the government’s measure is „null“ and called on the Prosecutor’s Office to promote an investigation against executive officials for the alleged „alteration of the constitutional order.“
The Wisconsin Supreme Court has overturned the state’s stay-at-home order, ruling it „unlawful“ and „unenforceable“ in a high-profile win for the state’s Republican-led Legislature.
In a 4-3 decision Wednesday, the court ruled that Democratic Gov. Tony Evers‘ administration overstepped its authority when the state Department of Health Services extended the order to May 26.
Raucous protests erupted around California this week as demonstrators demanded that Gov. Gavin Newson’s stay-at-home order be lifted.
“My conscience will not allow me to arrest someone who is trying to make a living,” Schuster told the paper. “I don’t believe it is a crime to try and make a living.”
“I don’t think, for the most part, people want to be defying (the order),” Schuster also said. “They’re trying to do what’s best for their families.”
Gov. Gavin Newsom on Friday faced the most intense pressure yet to lift restrictions on daily life, with a series of raucous protests around the state, a legal tussle with Orange County over closing its beaches and a rural Northern California county that defied his stay-at-home order and opened up for business.
Modoc County moved Friday to reopen hair salons, churches, restaurants and the county’s only movie theater. There haven’t been any confirmed cases of COVID-19 among 9,000 residents, but the reopening came with strict social distancing limits.
The debate over how soon to ease restrictions and start opening California has pitted local and state officials against one another in one of the states hit hardest by the coronavirus outbreak. It comes as other states such as Georgia and Texas are moving faster to open up their economies.
– Legislative—including budget and veto—authority
Wolf has not said whether he will sign the measure but has said he will consider it.
President Trump has moved from stating that he alone can fix it to telling America’s governors that they need to “call your own shots” when it comes to reopening their economies during the nation’s worst health crisis in 100 years.
That’s our top takeaway from Trump’s announcement Thursday on federal guidelines to reopen the country “that put the onus on governors of making decisions about their states‘ economies,” per NBC News.
The guidelines released by the president effectively mean that any restoration of American society will take place on a patchwork basis.
Trump, by way of a signing statement, noted that his administration would quite simply override a provision in the nearly 900-page stimulus bill that would require the country’s newest inspector general–just created and tasked with overseeing the disbursement of the stimulus funds–to report to Congress any time the administration stonewalled about where or how those funds were being spent.
President Donald Trump has issued a signing statement declaring that he can block a watchdog from telling Congress when information is withheld about payouts to businesses in the massive new $2 trillion economic relief law.
Democrats fought hard for provisions in the measure to ensure …
The passage did not come without drama: House lawmakers were forced to scramble back to Washington Friday over concerns a conservative lawmaker objecting to the legislation, Rep. Thomas Massie (R-Ky.), would force a roll call vote.
TWO KOREAS TO SIGN MILITARY AGREEMENT TO CARRY OUT PANMUNJOM DECLARATION
In a ceremony on the sidelines of the 51st ASEAN Foreign Ministers’ Meeting in Singapore on Thursday, Iran officially joined the Treaty of Amity and Cooperation in Southeast Asia.
Iranian Foreign Minister Mohammad Javad Zarif attended the event.
The Association of Southeast Asian Nations (ASEAN) ratified Iran’s membership in the Treaty of Amity and Cooperation in Southeast Asia (TAC) on Thursday, the media reported. In a ceremony on the sidelines of the 51st Asean Foreign Ministers‘ Meeting in Singapore, Iran officially joined the TAC treaty in the presence of Foreign Minister Mohammad Javad Zarif, Tasnim news agency reported.
Most American adults say that the meeting between President Donald Trump and North Korean Leader Kim Jong Un was a good idea, according to a Monmouth poll released Thursday.
The seven-in-10 who say it’s a good idea is up from 63% in late April, including 93% of Republicans, 74% of independents, and 49% of Democrats. Only 20% say it was a bad idea.
Following his historic meeting with North Korean leader Kim Jong Un, President Trump’s approval ratings are now at one of the highest points of his presidency.
(8.12.2017) First, what is the source of the additional $794 billion in the Army’s Fund Balance? This adjustment represents more than six times appropriated spending. Second, do these transfers represent a flow of funds to the Army beyond those authorized by Congress? Third, were these funds authorized and if so when and by whom? Fourth, what is the source of these funds?
Administration and congressional officials said the hawkish Mr. Bolton is not expected to defer to the defense secretary; already, neoconservative members of the Republican foreign policy establishment have started to air concerns that Mr. Mattis is ceding strategic territory to Iran and Russia in Syria.
Mr. Mattis is widely viewed by global leaders as the strongest and perhaps most credible voice on foreign policy in an administration that has been rocked by firings and resignations among senior presidential advisers.
Use of chemical weapons is horrific. But our Constitution does not allow @POTUS to attack a country–which has not attacked the US–without Congressional approval.