The Food and Drug Administration is trying to issue an emergency use authorization for the Pfizer/BioNTech COVID-19 vaccine Friday evening, a source familiar with the process told USA TODAY.
White House Chief of Staff Mark Meadows on Friday told the head of the FDA to submit his resignation if the agency does not authorize the vaccine by day’s end, according to multiple reports, first revealed by The Washington Post.
Commissioner Stephen Hahn, however, said the reports presented an « untrue representation of the phone call with the Chief of Staff » and that the FDA « was encouraged to continue working expeditiously. »
If the FDA authorizes a vaccine Friday, mass vaccinations could begin within days in hundreds of thousands of frontline heath care workers and nursing home residents, a potential turning point in the country’s bitter battle against the virus. The vaccine authorization process is taking place as U.S. death toll from the novel coronavirus moves closer to 300,000.
More news to know today:
- There’s been a delay in the vaccine being developed by Sanofi and GlaxoSmithKline. The companies said that study results found older patients failed to demonstrate a sufficient immune response against the virus.
- As many as 300,000 COVID-19 cases across the U.S. and world can be traced back to a two-day conference in Boston held in February, a study published Thursday suggests.
- The nation topped 292,000 total deaths from COVID-19 on Thursday, several hundred more than the number of battlefield deaths in World War II, according to the U.S. Department of Veterans Affairs. The U.S. surpassed 3,000 deaths in a single day for the first time on Wednesday, a count higher than the 9/11 terrorist attacks.
- In one small Kansas town, officials resisted a mask mandate. Now, its residents — along with other rural areas reluctant to impose precautionary measures — are paying the price, as COVID-19 rates skyrocket with an intensity not seen in urban counties.
- New York City will shut down indoor dining starting Monday due to an uptick in « infection rates, » Gov. Andrew Cuomo said.
📰 What we’re reading: He could’ve gone home to family for Thanksgiving and is glad he didn’t: A reporter recounts what it was like to call his mom about his positive COVID-19 test amid a holiday gathering.
📈 Today’s numbers: The U.S. has reported nearly 15.7 million cases and more than 293,000 deaths, according to Johns Hopkins University data. The global totals: 70million cases and more than 1.5 million deaths.
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Reports of White House threatening FDA chief’s job could undercut agency’s credibility, scientists worry
The push from the White House on the FDA comes as the agency has already faced tremendous pressure over the past months to both approve COVID-19 drugs that it was less than convinced of and to speed the vaccine approval process. Despite some early stumbles, the FDA has worked to hold firm on its timeline to following the science rather than succumbing to politics.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in August that he would quit if he were under political pressure to speed a vaccine to market before it was ready.
By all accounts, the FDA had been ready to issue the Emergency Use Authorization by Saturday or Sunday, so the effort from Trump is not likely to make an enormous different. Scientists worry what it could do is undercut faith in the agency’s process and the COVID-19 vaccine itself, already fragile due to early and misinformation.
« If the story is accurate, then indeed I am concerned that it will undermine public confidence in the science-based process of authorization by the FDA and recommendation by the CDC’s Advisory Committee on Immunization practices, » said L.J. Tan, chief strategy officer for the Immunization Action Coalition, a nonprofit that works with the CDC to distribute information about vaccines.
The FDA is clearly trying to do a thorough review in very difficult circumstances, said Gillian Woollett, a senior vice president and expert on FDA guidance and regulatory issues at the health care consulting firm Avalere Health.
« Commissioner Hahn should know that his efforts to keep FDA focused on the scientific and data-driven basis for their decisions is greatly appreciated by many; this will vastly increase the public confidence in the vaccine when it becomes available. »
– Elizabeth Weise
Biden calls for leadership in ‘teeth’ of COVID-19 crisis
President-elect Joe Biden led off his announcement of administration appointees Friday with warnings about « a grim milestone » in the COVID-19 crisis and sought to promote confidence in the vaccines federal regulators are considering for approval.
« This is serious business, » Biden said. « We’re in the teeth of a crisis right now. »
Biden said that President Donald Trump should be offering more leadership now to provide a national strategy for dealing with the virus and to prepare more for distributing vaccines.
« This nation needs presidential leadership right now, » Biden said. « We can wish this away, but we have to face it head on. »
– Bart Jansen and John Fritze
FDA authorization of Pfizer COVID-19 vaccine expected Friday evening
A person familiar with the FDA approval process told USA TODAY on Friday afternoon that the agency was working to ready its authorization for Friday evening. Authorization had been expected Saturday morning. The news was first reported by the New York Times.
President Donald Trump sent an angry tweet berating the agency for not moving faster at 4:11 a.m. Friday. « While my pushing the money drenched but heavily bureaucratic @US_FDA saved five years in the approval of NUMEROUS great new vaccines, it is still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!! »
The FDA will stop short of fully approving either the Pfizer vaccine or one developed with similar technology by Moderna, which is expected to cleared for use next week. Although it has received all the standard short-term safety and effectiveness data, the vaccines have not been tested for the two years typical of an approved vaccine – so it is not yet clear how long protection will last.
A meeting of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention had been scheduled to vote on vaccine allocation on Sunday. During a discussion meeting Friday, CDC’s Amanda Cohen said if FDA issued the Pfizer authorization by 10 a.m. Saturday, the vote would be moved up to that day.
ACIP committee recommendations are signed off on by the director of CDC.
Reimbursement for vaccines from federal and private medical programs is only available to ACIP-recommended vaccines, so its vote is a key part of the distribution process.
– Elizabeth Weise
Florida’s DeSantis lashes out at former data scientist Rebekah Jones
“Just because you’re a darling of some corners of the fever swamps, that does not exempt you from following the law,” DeSantis said during an appearance in Tampa.
The video of law enforcement’s arrival at the Tallahassee home of Rebekah Jones has gone viral and the former health department data scientist has denied allegations that she accessed a state emergency alert system to urge former co-workers to speak out about the DeSantis administration’s handling of the coronavirus.
DeSantis said Friday that what Jones is accused of doing is “clearly a felony offense.” Jones, who has not been charged, was fired from the Department of Health in May. Jones said she was let go by the agency for refusing to falsify data on COVID-19.
– John Kennedy, Sarasota Herald-Tribune
Indoor dining to close in New York City, Cuomo says
New York Gov. Andrew Cuomo revealed new details Friday on the state’s plan to combat the coronavirus this winter, with updated restrictions for communities in « red » and « orange » zones expected to take effect Monday.
Among the changes is that gyms and salons will be able to remain open in orange zones, with capacity at 25% and weekly staff testing. Indoor dining will be closed in New York City, while decision on potential new restrictions on indoor dining for other communities statewide will be made on Monday, Cuomo said.
– David Robinson and Jon Campbell, New York State Team
US borders with Canada, Mexico to stay closed through at least Jan. 21
As expected, U.S. border closures will be extending into the New Year.
Due to the rise in coronavirus cases, the land borders with Canada and Mexico will remain closed through Jan. 21, Chad Wolf, acting secretary of the U.S. Department of Homeland Security announced on Friday.
The borders have been closed since March, with DHS issuing month-to-month extensions. He added that nonessential travel restrictions will be reevaluated « as this administration continues to make great progress on a vaccine for COVID. »
– Jenna Ryu
Kentucky snow leopard becomes first ever to test positive for coronavirus
A 5-year-old female snow leopard at the Louisville Zoo has tested positive for SARS-CoV-2, the virus that causes COVID-19 in humans. This is the first confirmed case of SARS-CoV-2 infection in a snow leopard, according to the Louisville Zoo.
The zoo announced the positive test of the snow leopard, NeeCee, Friday morning and said it is awaiting results of its other two male snow leopards — Kimti and Meru.
All the cats have « very mild symptoms, » according to a news release, as the Louisville Zoo continues to monitor their conditions closely. All cats are expected to recover, and no other animals are showing symptoms.
– Ben Tobin, Louisville Courier Journal
Arizona hospital fires ER doctor for talking about ‘unprecedented’ COVID-19 severity
Dr. Cleavon Gilman, a well-known emergency-medicine physician who moved with his two children from New York, has been asked not to return to his work at Yuma Regional Medical Center near the U.S.-Mexico border after he posted on social media about the severity of the pandemic in Arizona, according to him and his staffing agency.
It started Nov. 22 when Gilma tweeted, « Just got to work and was notified there are no more ICU beds in the state of Arizona. » His tweet received more than 81,000 likes and 30,000 retweets.
Gilman was scheduled the following three days but the « hospital did not permit » him to come in, he said. But the hospital said in a statement late Thursday night that « there has been a misunderstanding » and Gilman is scheduled to work this weekend. « News to me, » Gilman tweeted.
« What I don’t understand about this is I have been advocating for Arizona, » Gilman told The Arizona Republic, part of the USA TODAY Network. « I did all of this because we are seeing an unprecedented number of cases. This is my third surge — I know how this ends. »
– Jamie Landers, Arizona Republic
Dr. Fauci, medical workers named TIME’s Guardians of the Year
Dr. Anthony Fauci and frontline medical workers were named TIME Magazine’s Guardians of the Year — an honor bestowed as America grapples with some of the darkest days of the pandemic yet.
The honor comes days after Fauci and health care workers were jointly named as a finalist for TIME’s Person of the Year, going up against President-elect Joe Biden and Vice President-elect Kamala Harris, who were also jointly nominated, and President Donald Trump.
“With steadfast integrity, Fauci nudged, elided and gently corrected a President used to operating in a reality of his own construction, buoyed by the fervent repetition of lies,” the magazine wrote of America’s leading infectious diseases expert.
The magazine also interviewed health workers worldwide — home aides, nurses, doctors and EMTs, among others — who sacrificed their emotional and physical well-being for the greater good.
Delay in Sanofi and GSK’s vaccine after older people fail to show immune response
Sanofi and GlaxoSmithKline (GSK) announced Friday a delay in their COVID-19 vaccine program after study results found older patients failed to demonstrate a sufficient immune response against the virus.
“The results of the study are not as we hoped,” Roger Connor, president of GSK Vaccines, said in the press release. “Our aim now is to work closely with our partner Sanofi to develop this vaccine, with an improved antigen formulation, for it to make a meaningful contribution to prevention COVID-19.”
French company Sanofi and U.K.-based GSK said a Phase 2b study with the improved vaccine will start in February 2021 and will be available to the public by the end of next year pending its success.
The U.S. government paid up to $2.1 billion to test and produce 100 million doses under Operation Warp Speed. The majority of the $2.1 billion will go to Sanofi, which made the vaccine candidate. GSK made a booster that improves how the body responds to it. Read more here.
– Adrianna Rodriguez
HHS Secretary Azar says Pfizer vaccine will get FDA authorization
Health and Human Services Secretary Alex Azar said on ABC’s “Good Morning America” the U.S. Food and Drug Administration will grant emergency use authorization to Pfizer COVID-19 vaccine and expects Americans could start getting vaccinated as soon as next week.
« We could see people getting vaccinated Monday, Tuesday of next week, » Azar said.
The news comes a day after the independent Vaccines and Related Products Advisory Committee voted in an eight-hour public hearing Thursday to recommend authorizing the vaccine made by Pfizer and its partner BioNTech called BNT162b2.
Other countries have already approved the vaccine, including Canada and the United Kingdom, with the latter already rolling out the first doses and vaccinating its population.
The FDA’s thorough review has prompted some backlash from President Donald Trump, who called the agency “a big, old slow turtle,” in a tweet Friday morning.
“Get the dam vaccines out NOW, Dr. Hahn… stop playing games and start saving lives!!!” he tweeted.
– Adrianna Rodriguez
Stark numbers show COVID’s vice-like grip on the US
The United States has now reported more deaths from COVID-19 than combat deaths in World War II. Johns Hopkins University shows 291,929 coronavirus deaths, several hundred more than the U.S. Department of Veterans Affairs says were lost in battle in World War II. South Dakota on Thursday became the second state to have 1 of every 10 of its people test positive, Johns Hopkins University data shows. North Dakota hit that mark on Thanksgiving.
The place with the most cases per person is Crowley County, Colorado, where about 22.7 percent of the people have tested positive, Johns Hopkins University says. Most of those cases came in a month. Additionally, a county in Hawaii became the United States’ final county to have a resident test positive for COVID-19, the Maui News reported Thursday. In the last month, the U.S. has seen more deaths from COVID-19 (51,518) than battle deaths from Vietnam (47,434).
– Mike Stucka
Leaked reports: Feds secretly pulled toy police from ports amid COVID
The federal safety inspectors who protect kids from dangerous and deadly toys were not standing guard for nearly six months while this year’s holiday gifts entered the U.S. by the shipload due to the threat of COVID-19. Princess palaces and playhouses, water guns and tricycles landed on store shelves and front doorsteps without the usual security checks for lead, chemicals or choking hazards.
The Consumer Product Safety Commission pulled its inspectors from ports around the country in mid-March because of the threat of COVID-19. Leaders of the federal agency made the decision in private, without a warning to consumers or full disclosure to Congress, then continued the shutdown at the ports and a government testing laboratory until September, USA TODAY has found. That included spring and summer months that were their inspectors’ busiest last year. Read more.
– Letitia Stein and Brett Murphy
Key committee endorses Pfizer vaccine for FDA authorization
A committee of leading U.S. vaccine scientists recommended Thursday that the Food and Drug Administration authorize the first COVID-19 vaccine for Americans. The endorsement paves the way for a final decision by the FDA.
Mass vaccinations may begin within days in thousands of frontline heath care workers and nursing homes residents.
After a day-long public hearing, the independent Vaccines and Related Biological Products Advisory Committee voted 17 to 4, with 1 abstention, to recommend the vaccine made by Pfizer and its partner BioNTech called BNT162b2. The FDA is expected to clear the vaccine for emergency use as early as Friday. Once it authorized, it will begin shipping to all 50 states.
– Elizabeth Weise and Karen Weintraub
Will the vaccine be required? Any side effects? USA TODAY answers questions
- Yes, it is safe. The approval process for vaccines is stringent and heavily reviewed. The FDA on Tuesday released a 53-page report summarizing data from Pfizer/BioNTech’s COVID-19 candidate vaccine trial.
- What are potential side effects? All three vaccine makers have reported mild to moderate reactions, including pain at injection site, fatigue and sore muscles and joints. Doctors say this is normal.
- The vaccine itself will be free, but health care providers can charge a fee for administering it, which can be paid for by insurance or a government relief fund.
- The vaccines require two doses, and they must be from the same manufacturer, as the composition and timing of vaccines differ.
- It is not known if you can still get sick or spread the virus to others after you’ve been vaccinated. However, the vaccines are at least 95% effective. It’s not known yet how long the vaccination lasts.
- The vaccines weren’t tested on children, so school-age kids won’t be getting vaccinated at first. But college students are eligible, and colleges are debating whether they will, or when they will, be required.
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Boston Biogen conference was likely superspreader, study says
The Biogen conference, held Feb. 26-27, is responsible for roughly 1.6% of all U.S. cases since the start of the pandemic, researchers estimated.
The study says that the conference is an example of what happens when the virus spreads unchecked, as the outbreak likely created « major outbreaks among individuals experiencing homelessness, spread[ing] throughout the Boston area including to other higher risk communities, and were exported to other domestic and international sites. »
COVID-19 resources from USA TODAY
Contributing: The Associated Press
