UPDATE: The FDA gave its blessing for emergency use of the Pfizer coronavirus vaccine late Friday night.
The FDA’s emergency use authorization will now kick-start the federal government’s distribution of the potentially lifesaving doses to 64 states, territories and major cities across the nation.
In addition, U.S. federal government will continue to monitor occurrences of Bell’s palsy — a partial paralysis in the face — among people who receive Pfizer’s Covid-19 vaccine after four cases were reported among trial participants, though the vaccine doesn’t appear to cause the condition. Also, Pfizer warns of an allergic reaction, anaphylactic shock, in some recipients.
The government plans to distribute 2.9 million doses of the vaccine within 24 hours, followed by an additional 2.9 million doses 21 days later for patients to get their second shot, Gen.
Gustave Perna, who oversees logistics for President Donald Trump’s vaccine program Operation Warp Speed, said Wednesday. Pfizer’s vaccine requires two doses administered three weeks apart.
The number of Americans who have died of the coronavirus has just surpassed the U.S. death toll in World War Two killing close to 300,000 Americans.
Health and Human Services Secretary Alex Azar said Friday morning that the FDA intends to go ahead with emergency use authorization for the Pfizer BioNTech vaccine.
An F-D-A panel approved the COVID-19 vaccine last night for emergency use and now we wait for the final decision by the FDA on the inoculation.
Meanwhile, millions of doses just waiting to be shipped. The most vulnerable and healthcare workers will be the first to receive the vaccine.
Hollywood’s Memorial Regional hospital in Broward expects to get 20-thousand doses in the next few weeks.
Pfizer vaccine will be given to Americans in 'next couple of days', says Alex Azar https://t.co/P2Nm1iKsJ6
— Newsweek (@Newsweek) December 11, 2020
Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committee’s recommendation. The F-D-A is likely to approve the coronavirus vaccine Saturday.
“This is a light at the end of the long tunnel of this pandemic,” declared Dr. Sally Goza, president of the American Academy of Pediatrics.
In a 17-4 vote with one abstention, the government advisers concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and teenagers 16 and over.
That endorsement came despite questions about allergic reactions in two people who received the vaccine earlier this week when Britain became the first country to begin dispensing the Pfizer-BioNTech shot.
Meanwhile, President Trump is pushing the F-D-A to approve the Pfizer and BioNTech coronavirus vaccine and start saving lives. Trump tweeted this morning that despite his attempts to free the agency from bureaucracy, it is still a “big, old slow turtle.”
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!!!
— Donald J. Trump (@realDonaldTrump) December 11, 2020
Trump pointed out that his pushing has moved the time table up on a vaccine by five years. He told F-D-A Director Steve Hahn to quit playing games and approve the vaccine.