The United States is awaiting the authorization of the first COVID-19 vaccine after the Food and Drug Administration gave its strongest indication yet that it would give an emergency use authorization for the Pfizer-BioNTech vaccine Friday evening.
The FDA Commissioner Stephen Hahn said the agency would “rapidly work toward finalization and issuance of an emergency use authorization,” adding that “the agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.”
Meanwhile, the White House is increasing pressure on Hahn to authorize the Pfizer vaccine by the end of the day or submit his letter of resignation. He called the reports “an untrue representation of the phone call with the Chief of Staff [Mark Meadows].”
“The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request,” Hahn said. “FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”
The FDA vaccine advisory panel recommended that Pfizer’s coronavirus vaccine be authorized for public use after a full day of debates and question-and-answer sessions about the clinical trial results.
That prompted Health and Human Services Secretary Alex Azar to tell ABC News on Friday, “We will work with Pfizer to get that shipped out, and so, we could see people getting vaccinated Monday, Tuesday of next week.”
Dr. Anthony Fauci, the government’s top infectious disease expert, told the New York Times Friday that he plans to get the coronavirus vaccine publicly in the public space so that “people can see me getting vaccinated,” as soon as “the vaccine becomes available to me.”
To date, nearly 15.8 million infections and more than 294,000 deaths due to COVID-19 have been confirmed in the U.S. Current case totals are undercounts, given the fact that many infections go undetected and undiagnosed.
New York Gov. Andrew Cuomo announced a temporary ban on indoor dining in New York City starting Monday in an attempt to fend off a second wave of coronavirus cases. New York City is the former coronavirus epicenter that slowed down community spread in late spring and began to reopen. Hospitalizations across the five boroughs surpassed the 200-patient threshold for the first time since May, New York City Mayor Bill de Blasio said Monday. City health officials reported 205 new hospitalizations across the five boroughs on Thursday, as well as an average 5.35% test positivity rate.
“As COVID-19 indicators continue to rise, it’s time to shut down indoor dining. This is painful. So many restaurants are struggling. But we can’t allow this virus to reassert itself in our city,” de Blasio said, adding, “I fully support Gov. Cuomo’s decision.”
Roughly 300,000 coronavirus cases can be traced back to a two-day meeting of international Biogen executives in the Boston Marriott Long Wharf hotel in February, according to a report published Thursday in the journal Science. Nearly 100 people associated with the event tested positive, and attendees brought the virus back to 29 states, Australia, Slovakia, and Sweden. Public health experts used genetic code to track down how those cases spread once attendees returned home and found those infections spread rapidly and widely.
The federal government procured an additional 100 million doses of the Moderna vaccine if it receives authorization from the FDA, bringing the total to 200 million doses at the ready. Of the first 100 million doses, 20 million will be shipped out by the end of December, and the balance will be delivered in the first quarter of 2021. The additional 100 million doses will be delivered in the second quarter of 2021.
A laboratory error has forced Sanofi and GlaxoSmithKline to delay the push of its coronavirus vaccine from the first half of 2021 into the second half of the year, the Wall Street Journal reported Friday. Volunteers were accidentally given lower doses than intended in initial clinical trials due to an inadequate formulation.
“It’s a sad setback,” said Thomas Triomphe, Sanofi’s executive vice president for vaccines. “We prefer to take a step back, let the science work, and come back with a product that is very efficacious in addition to being safe. … You don’t want to do compromises there.”
Leaders in the food, restaurant, aviation, and utility industries are calling on state and federal officials to prioritize their workers for the vaccine, arguing their employees are vital to keeping the economy running, the Wall Street Journal reported. While the Centers for Disease Control and Prevention recommends that states prioritize nursing home residents and healthcare workers, followed by essential workers and people with serious health conditions, state leaders have the final say.
