White House chief of staff Mark Meadows on Friday pressed Food and Drug Administration chief Stephen Hahn to grant an emergency use authorization for Pfizer’s coronavirus vaccine by the end of the day or face possible firing, two administration officials said.The vaccine produced by Pfizer Inc. and its German partner BioNTech won a critical endorsement Thursday from an FDA panel of outside advisers, and signoff from the agency — which is expected within days — is the next step needed to get the shots to the public.The FDA is not required to follow the guidance of its advisory committees, but often does.Meadows spoke to Hahn by telephone on Friday, according to a senior administration official who was familiar with the conversation but was not authorized to discuss private conversations.Hahn disputed characterizations of his conversation with Meadows.US On Verge of Launching COVID VaccinationsFDA advisory panel voted to recommend approval of vaccine late Thursday The chief of staff also told Hahn his job was in jeopardy if the emergency use authorization was not issued before Saturday, said a second administration official familiar with the conversation.Hahn signaled that he would tell regulators to allow the vaccine to be issued on an emergency basis, the official said.President Donald Trump has been pressing for quick approval for the vaccine and tweeted directly at Hahn earlier Friday, complaining that FDA “is still a big, old, slow turtle.” Trump has publicly bashed the pace of the FDA’s vaccine review process.”Get the dam vaccines out NOW, Dr. Hahn,” Trump tweeted Friday. “Stop playing games and start saving lives.”Hahn issued a statement later Friday.”This is an untrue representation of the phone call with the chief of staff,” Hahn said in the statement. “The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”The FDA said earlier Friday that it “will rapidly work” to grant emergency use of the vaccine. 
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The World Health Organization (WHO) says action and money are needed to ensure coronavirus vaccines are available around the world as Western nations approve them.
During Friday’s COVID-19 briefing at WHO headquarters in Geneva, Director-General Tedros Adhanom Ghebreyesus applauded the fact Britain was already vaccinating its citizens and that Canada, the United states and others would not be far behind. He said to have safe and effective vaccines for a virus that was completely unknown a year ago is an “astounding scientific achievement.”
The WHO chief noted it would be an even greater achievement to ensure all countries have equal access to those vaccines. Tedros said the U.N. agency has worked hard over the past year to secure political commitments from world leaders for equal access to vaccines and he said he wants to see those commitments translated into action.  
He said the WHO needs $4.3 billion to procure vaccines for the world’s neediest countries and urged donors to help fill a funding gap.  
The director-general said the organization is working with its partners to ensure developing countries have infrastructure in place to deliver vaccines to their populations. Through its COVAX vaccine cooperative and the 189 countries participating, Tedros said the WHO has secured nearly a billion doses of three potential vaccines.  Americans Await Final Approval of First COVID-19 Vaccine as Deaths Reach Record HighUS Food and Drug Administration widely expected to authorize emergency use after special panel votes to recommend approval   But Tedros said closing the funding gap is crucial to ensuring the entire world is protected.
“We have all seen images of people being vaccinated against COVID-19. We want to see these same images all over the world, and that will be a true sign of solidarity,” he said Friday.
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The United States could be hours away from starting its COVID-19 vaccination program. The U.S. Food and Drug Administration reportedly could authorize on Friday or Saturday the emergency use of a COVID-19 vaccine produced by U.S. drug maker Pfizer and Germany’s BioNTech. An FDA advisory panel voted to recommend approval of the vaccine late Thursday. With the U.S. on the verge of its inoculation program, human rights group Amnesty International’s director of economic and social justice issued a warning.  Steve Cockburn told The New York Times, “Rich countries have clear human rights obligations not only to refrain from actions that could harm access to vaccines elsewhere, but also to cooperate and provide assistance to countries that need it.”Food and Drug Administration building is shown Dec. 10, 2020 in Silver Spring, Md.The Johns Hopkins University Coronavirus Resource Center said early Friday there are 69.7 million worldwide COVID-19 infections, with 1.6 million deaths. The U.S. continues to lead the world in the number of cases with 15.6 million infections, followed by India with 9.7 million and Brazil with 6.7 million. Robert Redfield, the director of the U.S. Centers for Disease Control and Prevention, said for the next two or three months, the virus in the U.S. could kill as many people every day who died during the September 11, 2001, terrorist attack on the U.S. or the Pearl Harbor attack of December 7, 1941. A health care worker at LAC USC Medical Center swabs a person at a drive-through testing center during the coronavirus outbreak, in Los Angeles, California, Dec. 10, 2020.The daily U.S. death toll passed the 3,000 mark for the first time on Wednesday.Elsewhere, Australia has abandoned a massive order for a locally produced COVID-19 vaccine after it was discovered that the vaccine was producing false positive HIV results during a trial. 
And Germany’s interior minister says his country needs to go into a lockdown now to stop the spread of COVID-19. Horst Seehofer told Der Spiegel magazine, “The only chance to regain control of the situation is a lockdown, but this must happen immediately. If we wait until Christmas, we’ll have to struggle with high numbers for months.” 
 
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British health officials are warning that people with a “significant history” of allergic reactions should not receive the new coronavirus vaccine that was rolled out in a mass vaccination program Tuesday, pending investigation of two adverse reactions.  Britian is the first western country to begin the mass vaccinations, as Henry Ridgwell reports from London.Camera: Henry Ridgwell
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Clinical trials of a COVID-19 vaccine being developed by Australia’s University of Queensland in partnership with biotech company CSL have been abandoned after participants returned false positive HIV test results. The treatment was a key part of Australia’s response to the pandemic, and the government had signed a deal to buy 51 million doses.Vaccines typically take years of painstaking research to develop, but COVID-19 has sent scientists around the world racing to find an effective treatment.The Australian government was no different, but it has announced the sudden termination of clinical trials of a vaccine being developed at the University of Queensland.A small component of the experimental drug was derived from the human immunodeficiency virus, also known as HIV. It is used to give the vaccine stability, helping it to recognize and then neutralize the coronavirus. Some participants recorded false positive HIV test results. Researchers have stressed that the treatments are harmless and do not expose patients to the risk of disease.Biotech giant CSL, which has worked alongside the university team in Queensland, has insisted the vaccine had a “strong safety profile.”Phase one clinical trials involving 216 people began in July. Phases two and three have been canceled.The University of Queensland vaccine was one of four potential coronavirus treatments secured by the Australian government for potential use next year, including the Oxford University-AstraZeneca drug.“At no stage we believed all four of those vaccines would likely get through that process,” said Australian Prime Minister Scott Morrison. “If that had occurred that would have been truly extraordinary based on the process of vaccine development not only in this country but anywhere else. So, that is why we spread our risk. The advice we have received is that the University of Queensland vaccine will not be able to proceed based on the scientific advice and that will no longer feature as part of Australia’s vaccine plan.”Morrison said the decision to end the trial should give “Australians great assurance that we are proceeding carefully” toward a COVID-19 vaccine.But some experts fear it could damage public confidence in the inoculation program.The government has said Australia’s vaccine agreements will be enough to cover the entire population of 25 million people, even if one or two candidates proved unsuccessful.Australia has recorded 28,000 coronavirus cases since the pandemic began, and 908 people have died, according to Johns Hopkins University data.
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Trial data from Pfizer Inc with partner BioNTech SE, Moderna Inc and AstraZeneca Plc has shown their experimental vaccines are effective in preventing novel coronavirus infection.While regulatory processes are underway, few Asian countries expect to receive significant amounts of the vaccines initially. Here are estimated distribution time lines, supply deals announced and clinical trials being held in the region.AustraliaThe country has secured around 140 million doses: 53.8 million from AstraZeneca, 51 million from Novavax Inc, 10 million from Pfizer, and 25.5 million from distribution program COVAX.It expects delivery of 3.8 million doses of AstraZeneca’s vaccine in January and February next year and plans to begin inoculations in March.ChinaChina has not announced supply deals with Western drug makers, which instead have partnered with private companies in the country.AstraZeneca’s vaccine may be approved in China by mid-2021 and its Chinese partner Shenzhen Kangtai Biological Products Co Ltd plans annual production capacity of at least 100 million doses by the end of this year.For the Pfizer/BioNTech vaccine, a unit of Shanghai Fosun Pharmaceutical Group Co Ltd plans a Phase II trial.Tibet Rhodiola Pharmaceutical Holding Co is bringing in Russian vaccine candidate Sputnik V and plans early and mid-stage trials in China.China has also approved three vaccine candidates developed by Sinovac Biotech Ltd and state-owned China National Pharmaceutical Group (Sinopharm) for emergency use, and Sinopharm hopes its two candidates will get conditional approval for general use this year.JapanJapan has deals to buy 120 million doses from Pfizer/BioNTech in the first half of next year and 120 million from AstraZeneca – the first 30 million of which will be shipped by March 2021 – and 250 million from Novavax.It is also in talks with Johnson & Johnson and has a deal with Shionogi & Co Ltd.Experts said vaccine makers would need to conduct at least Phase I and II trials in Japan before seeking approval for use.South KoreaThe country has deals to buy 20 million doses each from AstraZeneca, Pfizer and Moderna and another 4 million doses from Johnson & Johnson’s Janssen, enough to cover up to 34 million people.It will procure additional doses for 10 million people through COVAX.Inoculation is likely to start in the second quarter of next year to allow time to observe possible side effects.IndiaThe head of the Serum Institute of India, which makes the AstraZeneca vaccine, said on Nov. 23 the positive late-state trial result of the candidate will allow it to seek emergency use approval by year-end, before securing approval for full introduction by February or March.India also expects a government-backed vaccine to be launched as early as February. It is also conducting a late-stage trial of Sputnik V.TaiwanTaiwan aims to secure around 15 million doses initially, both via the COVAX scheme and by direct purchases from manufacturers, and may buy an additional 15 million doses.The government has said it hopes to begin vaccinations in the first quarter next year.MalaysiaThe Southeast Asian nation has agreed to buy 12.8 million doses of the Pfizer vaccine, becoming the first country in the region to announce a deal with the U.S. drug maker after some expressed reservations over the need for the ultra-cold storage that the vaccine requires.Pfizer will deliver the first batch of 1 million doses in the first quarter of next year.The PhilippinesThe archipelago announced a deal on Nov. 27 for 2.6 million doses of the AstraZeneca vaccine and is discussing a possible 1 million more, covering about 1% of a population of 108 million people.It is also seeking 20 million to 50 million doses from Sinovac and is in talks with others, including Pfizer.Vaccine makers can seek approval from Philippine regulators even if no clinical trial is conducted in the country.IndonesiaSoutheast Asia’s most populous country has secured 125.5 million doses from Sinovac, 30 million from Novavax, is in talks with AstraZeneca and Pfizer to buy 50 million doses each, and expects to get 16 million from COVAX.Indonesia is testing Sinovac’s vaccine and preparing mass vaccination for medical staff and other frontline workers to start as soon as late January.VietnamA government official said COVAX vaccines would cover only 20% of the population and the country is likely to have a chance to secure separate deals soon, as demand is very high.BangladeshBangladesh signed a deal with India’s Serum Institute to buy 30 million doses of the AstraZeneca vaccine.It also expects to receive 68 million doses from global vaccine alliance GAVI at a subsidized rate, a senior health ministry official said.
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The United Nations’ World Food Program was awarded the 2020 Nobel Peace Prize in a virtual ceremony Thursday. As Henry Ridgwell reports, the head of the organization warned that hundreds of millions of people are facing starvation around the world, exacerbated by the coronavirus pandemic. 
Camera: Henry Ridgwell   Produced by: Mary Cieslak 
 
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United Nations Secretary-General Antonio Guterres says “vaccine nationalism” is on the rise as wealthier nations line up to buy millions of doses of potential COVID-19 vaccines at the expense of much poorer nations.During a virtual meeting Wednesday with African Union Commission Chairman Moussa Faki Mahamat, Guterres called for contributions of $4.2 billion over the next two months for the COVID-19 Vaccines Global Access Facility, or COVAX, the joint project between the World Health Organization, the Coalition for Epidemic Preparedness Innovations and Gavi, The Vaccine Alliance, an organization founded by Bill and Melinda Gates to vaccinate children in the world’s poorest countries.     FILE – Canada’s Prime Minister Justin Trudeau attends a news conference in Ottawa, Ontario, Canada, Dec. 7, 2020.Canada approves vaccine
Canada’s national health agency, Health Canada, announced Wednesday it has approved Pfizer-BioNTech’s COVID-19 vaccine, and Canadians will start receiving it as early as next week. Pfizer/BioNTech COVID-19 Vaccine Nears Approval for Emergency Use in USFDA publishes documents online confirming vaccine’s effectivenessIn a statement, Health Canada said that it completed a full independent review of the data on the vaccine’s safety and effectiveness, after receiving the company’s submission October 9. In its statement, the agency said, “Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place.” On Monday, Prime Minister Justin Trudeau said that the first doses of the Pfizer vaccine will arrive at 14 Canadian distribution centers next week, with more than 200,000 doses due before the end of the year. Canada has ordered a total of 6 million doses from Pfizer. Canada becomes the third nation, after Britain and Bahrain, to approve the drug for use.The push to approve and purchase the new vaccines comes as many nations are experiencing a mounting toll of new COVID-19 infections and fatalities on a daily basis. The United States, which leads the world with nearly 290,000 deaths out of more than 15.3 million total cases, set a grim milestone Wednesday with more than 3,000 coronavirus deaths, the highest single-day total in the nearly yearlong pandemic.  US sets new record
The U.S. has also averaged well over 200,000 new cases a day over the past seven days, another record-setting figure.  Japan’s health ministry posted 2,810 new COVID-19 cases on Wednesday, it’s highest one-day record since the start of the outbreak, including 555 people across the country diagnosed with serious coronavirus symptoms.  Germany’s national disease control and prevention agency, the Robert Koch Institute, posted 23,679 new coronavirus cases over a 24 hour period on Thursday, it’s highest one-day total.  Thursday’s figure includes 440 deaths, one day after posting 590 fatalities, its highest number of COVID-19 deaths in a single day.The worldwide coronavirus death toll remains at more than 1.5 million people out of more than 68.9 million total infections, according to Johns Hopkins Coronavirus Resource Center.
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NASA on Wednesday formally introduced 18 astronauts who will take part in the U.S. space agency’s new manned lunar program.Nine men and nine women are the first group of astronauts assigned to the Artemis program, half of whom have already flown into space. Two of the Artemis astronauts, Victor Glover and Kate Rubins, are currently serving on the International Space Station as part of the first full-fledged crew to fly aboard the privately owned SpaceX Crew Dragon.The Artemis astronauts also include Christina Koch and Jessica Meir, who conducted the world’s first all-female spacewalk last year at the ISS.Vice President Mike Pence, who led the introduction ceremony at NASA’s Kennedy Space Center in Florida, hailed the Artemis astronauts as “the future of American space exploration – and that future is bright.”The first Artemis mission, tentatively scheduled for next year, will be an unmanned test flight of NASA’s powerful new Space Launch System and its deep space Orion capsule, which is designed to transport humans to the Moon and Mars.  If NASA achieves its goal of landing the first Artemis crew on the moon in 2024, it will be the first manned lunar mission since the end of the legendary Apollo program in 1972.
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After more than 15.3 million total infections, the United States is on the verge of obtaining a safe and effective COVID-19 vaccine.A special panel of the Food and Drug Administration will meet Thursday morning to consider whether to grant emergency use authorization to the new vaccine developed by U.S.-based pharmaceutical giant Pfizer and Germany’s BioNTech.If the Vaccines and Related Biological Products Advisory Committee recommends the emergency authorization as expected, the FDA will likely give its final consent as early as Friday or Saturday. The federal government will immediately ship 6.4 million doses of the vaccine across the United States, with front-line health care workers receiving top priority for the first inoculations.The U.S. military will also prioritize its health care workers for its initial allocation of the Pfizer/BioNTech vaccine, which will be just under 44,000 doses.  A Pentagon spokesperson told reporters Wednesday that the military will start inoculations “within a day or two” after the FDA approves the emergency use authorization. The vaccinations will be voluntary at first, but could become mandatory once the vaccine is fully licensed.Thursday’s meeting is being held a day after the United States recorded more than 3,000 COVID-19 deaths in a single day for the first time in the nearly yearlong pandemic.The Pfizer/BioNTech vaccine has jumped to the front of the line in the global effort to develop a vaccine against the novel coronavirus that causes COVID-19. Britain became the first Western nation to begin mass inoculations of the drug on Tuesday, just days after the government’s medical regulatory agency approved the drug.
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