Month: December 2020

Mexico approved the emergency use of a coronavirus vaccine late Friday, bringing to six the number of countries that are inoculating or plan to inoculate with shots produced by U.S. drugmaker Pfizer and Germany’s BioNTech.Britain, Bahrain, Canada, Saudi Arabia and the United States have also approved the vaccine.Mexican Assistant Health Secretary and epidemiologist Hugo Lopez-Gatell called the vaccine approval “a reason for hope.” Reuters reports Mexico signed an agreement with Pfizer to acquire 34 million doses of the vaccine, with the first batch expected later this month.Mexico has recorded 1.2 million COVID-19 cases and 113,000 deaths, according to Johns Hopkins University.The vaccine’s approval by the U.S. Food and Drug Administration Friday came as the United States topped 295,000 fatalities from COVID-19, the world’s highest death toll, according to Johns Hopkins University, which calculates the United States has had 15.8 million of the world’s more than 71 million COVID infections.Hospitalizations are at record levels in America’s most populous state, California. Los Angeles County reported its highest-ever daily number for new COVID-19 cases at more than 12,000 earlier this week. A public health official said the county is “on a very dangerous track to seeing unprecedented and catastrophic suffering and death … if we can’t stop the surge.”Meanwhile, the World Health Organization and the International Federation of Red Cross and Red Crescent Societies signed an agreement, the Emergency Medical Team (EMT) Initiative, on Friday to strengthen the delivery of emergency medical and health services during humanitarian crises.“We are very committed to working …

Trump Hails Approved Coronavirus Vaccine as ‘Medical Miracle’

U.S. President Donald Trump late Friday hailed what he termed “a medical miracle” – the immediate but extremely limited availability of a coronavirus vaccine less than a year after the first cases of COVID-19 were reported in the United States.In a video message posted on Twitter, Trump said the first doses of the Pfizer-BioNTech vaccine the U.S. Food and Drug Administration approved for emergency use will be administered “within 24 hours” and will be “free [of charge] for all Americans.”The president said the vaccine “will save millions of lives and soon end the pandemic once and for all.” The assertion contradicted health officials who note that it will be months before many Americans can be inoculated and that eradication of COVID-19 is far from assured.There was no immediate reaction from President-elect Joe Biden, who earlier this week promised that 100 million vaccine doses would be administered in the first 100 days of his administration. Biden will be sworn in Jan. 20.The top Democrat in Congress, House Speaker Nancy Pelosi, said “Americans should have full confidence in this vaccine knowing that it has been reviewed and recommended by the independent experts of the FDA’s advisory panel.”In a statement, Pelosi urged federal action to accelerate vaccine manufacturing, adding, “We must ensure that the vaccine will be free and distributed in a fair and equitable manner to as many Americans as possible as soon as possible.”Health and Human Services Secretary Alex Azar, meanwhile, said millions of vaccine doses are being shipped but that, …

Brazil Nears 180,000 Deaths in Second Coronavirus Wave

Brazil, which is second to the U.S. in deaths from COVID-19 and third in the world in positive cases, is approaching 180,000 deaths as it suffers through its second wave of the disease caused by the coronavirus.In the past day, more than 53,000 cases and 770 deaths have been reported, according to the Johns Hopkins Coronavirus Resource Center. Since the start of the pandemic, Brazil has recorded more than 6.7 million cases.Brazil, with a population of 212 million, is entering its summer, when beaches fill with weekend crowds.”The situation is likely to worsen with the summer, because people will move around more, without any control, most of the restriction measures having already been lifted,” Christovam Barcellos, a researcher at the Fiocruz institute, told AFP.The coronavirus crisis in the U.S. continued to intensify Friday, as more than 2,700 people died of COVID-19, according to Johns Hopkins data, down from the record toll of 3,124 set Wednesday. The country’s deaths now stand at more than 292,000, the most in the world.The U.S. Food and Drug Administration authorized Friday the emergency use of a vaccine produced by U.S. drugmaker Pfizer and Germany’s BioNTech.An FDA advisory panel voted to recommend approval of the vaccine late Thursday.And the U.S. purchased 100 million more doses of another vaccine, one by Moderna. Friday’s agreement brings the number of Moderna doses to 200 million, enough shots for 100 million people. Both the Pfizer and Moderna vaccines require two shots.”Securing another 100 million doses from Moderna by June 2021 …

US Allows Emergency COVID-19 Vaccine in Bid to End Pandemic

The U.S. gave the final go-ahead Friday to the nation’s first COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed nearly 300,000 Americans, according to a person familiar with the decision but not authorized to discuss it publicly.Shots for health workers and nursing home residents are expected to begin in the coming days after the Food and Drug Administration authorized an emergency rollout of what promises to be a strongly protective vaccine from Pfizer Inc. and its German partner BioNTech.Initial doses are scarce and will be rationed as the U.S. joins Britain and several other countries in scrambling to vaccinate as many people as possible ahead of winter. It will take months of work to tamp down the coronavirus that has surged to catastrophic levels in recent weeks and already claimed 1.5 million lives globally.While the FDA decision came only after public review of data from a huge, ongoing study, it has also been dogged by intense political pressure from the Trump administration, which has accused the agency of being too slow and even threatened to remove FDA chief Stephen Hahn if a ruling did not come Friday.The move sets off what will be the largest vaccination campaign in U.S. history — but it also has global ramifications because it’s a role model to many other countries facing the same decision.The world desperately needs multiple vaccines for enough to go around, and the Pfizer-BioNTech shot is the first based on rigorous scientific …

White House Threatens FDA Chief’s Job Over Vaccine Approval

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 …

US On Verge of Launching COVID Vaccinations

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 …

WHO Seeks Global Access to Approved Coronavirus Vaccines

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 …

Scotland Reduces COVID-19 Isolation Time

Scotland’s first minister, Nicola Sturgeon, announced Friday that beginning Monday, the self-isolation period after contact with confirmed COVID-19 carriers will be shortened from 14 to 10 days in the nation. At her COVID-19 news briefing in Edinburgh, Sturgeon also said that the four-day reduction in the self-isolation period would apply to travelers returning from high-risk countries. She said the new policy was based on recommendations from Britain’s Scientific Advisory Group for Emergencies (SAGE). She said the chief medical officers in all four British jurisdictions – Britain, Scotland, Wales and Northern Ireland – have agreed to the reduction. In an interview with the Associated Press, British Deputy Chief Medical Officer Jenny Harries said the new policy was based on studies conducted by the SAGE and a separate advisory group on emerging respiratory virus threats. Harries said those studies found people were least likely to transmit COVID-19 at the end of their infection. She said reducing the self-isolation period would allow a “reasonable balance” between managing the risk to the public and intruding on people’s lives. Sturgeon reported 1,001 new cases of COVID-19 over the past 24-hour period. It was the first time in about two weeks that the daily rate was over 1,000. But that number was the result of nearly 25,000 test results, reflecting a positivity rate of less than five percent — which is considered a good sign. The first minister also announced that non-essential shops across much of western Scotland — including Glasgow — have reopened for …

‘A New Beginning’: Relief, Hope as Britain Begins Mass Coronavirus

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 …

Australia Abandons COVID-19 Vaccine Trials After False Positive HIV Results

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 …

Americans May Get First Vaccines This Weekend

A US government advisory panel on Thursday recommended emergency use of the Pfizer-BioNTech coronavirus vaccine, which meant Americans could begin being vaccinated as soon as this weekend. Earlier this week, the country recorded its highest death toll from COVID-19, with more than 3,100 deaths in a single day. White House correspondent Patsy Widakuswara has the story. Producer: Kim Weeks …

When and Which COVID-19 Vaccines Are Likely to be Available in Asia

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 …

US Panel Recommends Approval of First COVID-19 Vaccine 

After nine hours of deliberation Thursday, a special panel of the U.S. Food and Drug Administration endorsed for emergency use a coronavirus vaccine developed by U.S. pharmaceutical giant Pfizer and Germany’s BioNTech.The decision came as the United States recorded a one-day record of deaths from the coronavirus, with more than 3,100 lives lost Wednesday.As of Thursday evening, the U.S. had recorded 15.5 million cases and more than 291,000 deaths, according to Johns Hopkins University data.Pharmacy supervisor Kevin Weissman wears a thick glove as he opens the door of a special freezer that will hold the Pfizer vaccine at LAC USC Medical Center, during the outbreak of the coronavirus disease, in Los Angeles, California, Dec. 10. 2020.Of the 22 people on the special panel of the Food and Drug Administration (FDA), 17 voted yes, four voted no and one abstained on the question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer/BioNTech COVID-19 vaccine outweigh its risks for use in individuals 16 years of age and older?”The four panelists who dissented largely expressed concern about giving the vaccine to 16- and 17-year-olds. Teens younger than 18 were represented in small numbers in studies for the vaccine, and during the hours of deliberations, some scientists worried the effects on this age group weren’t known well enough.The vaccine was approved after hours of deliberation on topics including allergic reactions to the vaccine recorded in Britain this week.Documents created by Pfizer for the meeting with the Food and Drug …

At-Home Test Kits: New Tools to Close the COVID-19 Testing Gap

Getting a COVID test can mean long lines and delayed results. Matt Dibble looks into recent breakthroughs that may have more of us performing a test at home. Camera: Matt Dibble Producer: Matt Dibble …

Accepting Nobel Peace Prize, UN World Food Program Warns Of ‘Hunger Pandemic’

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 …

FDA Panel Recommends Approval of First COVID-19 Vaccine

After nine hours of deliberation Thursday, a special panel of the U.S. Food and Drug Administration approved for emergency use a coronavirus vaccine developed by U.S. pharmaceutical giant Pfizer and Germany’s BioNTech. The decision was made as the U.S. continues to confirm record numbers of coronavirus cases. As of Thursday evening, the U.S. had recorded 15.5 million cases and more than 291,000 deaths, according to Johns Hopkins University data. Of the 22 people on the special panel of the Food and Drug Administration (FDA), 17 voted yes, four voted no and one abstained on the question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer/BioNTech COVID-19 vaccine outweigh its risks for use in individuals 16 years of age and older?” With the recommendation of the emergency use authorization by the Vaccines and Related Biological Products Advisory Committee, the FDA will likely give its final consent as early as Friday or Saturday. The U.S. government will immediately ship 6.4 million doses of the vaccine across the country, 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 less than 44,000 doses. A Pentagon spokesman 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 was held …

‘Vaccine Nationalism’ Leaves World’s Poorest Nations Unable to Secure COVID-19 Vaccine, UN Chief Says

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 …

NASA Introduces New Crop of Lunar Astronauts

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. …

US Nearing Approval of First COVID-19 Vaccine

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 …

SpaceX Starship Makes Highest Test Flight, Crashes on Landing