The Federal Food and Drug Admin now will authorise the actual release order for the Covid-19 vaccine to be given to American’s on a ’emergency’ basis to combat the pandemic shortly* ….The agency is under pressure from the President to give the approval…And the infection and death numbers keep climbing to record levels daily….The Moderna virus vaccine should be the next to get approval…..
The panel questioned possible adverse reactions to the vaccine from some in the first British treatments…
But in the end?
One of there members of the advisory board said….
….’it would be “immoral and unethical” to not authorize the vaccine.’…
Washington Post….
The key moment came at the end of the meeting when the agency asked its independent advisers: “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 committee voted yes.
If as expected, the FDA follows quickly with an emergency authorization, the shots will start being moved to the states within 24 hours, according to officials at Operation Warp Speed, the Trump administration’s effort to accelerate the development and delivery of vaccines. Inoculations could begin early next week, officials say.
FDA Commissioner Stephen Hahn confirmed Thursday in an interview on NBC’s Today show that the agency intended “to act quickly” if the committee issued a favorable recommendation….
New York Times…
The F.D.A.’s vaccine advisory panel, composed of independent scientific experts, infectious disease doctors and statisticians, voted 17 to 4, with one member abstaining, in favor of emergency authorization for people 16 and older. With rare exceptions, the F.D.A. follows the advice of its advisory panels.
With this formal blessing, the nation may finally begin to slow the spread of the virus just as infections and deaths surge, reaching a record of more than 3,000 daily deaths on Wednesday. The F.D.A. is expected to grant an emergency use authorization on Saturday, according to people familiar with the agency’s planning, though they cautioned that last-minute legal or bureaucratic requirements could push the announcement to Sunday or later.
The initial shipment of 6.4 million doses will leave warehouses within 24 hours of being cleared by the F.D.A., according to federal officials. About half of those doses will be sent across the country, and the other half will be reserved for the initial recipients to receive their second dose about three weeks later….
Note…
The British are already out with their use of the Pfizer vaccine , Canada gave it’s approval 2 days ago…
The vaccine is said to be 94% effective with two doses …50%+ with just the first dose….
China and Russia are out with their own virus vaccines….
image….The Guardian
Update*…
Reports are that the FDA could ok the Pfizer vaccine by tomorrow, Saturday Dec. 13, 2020
Luis Ferré-Sadurní
@luisferre
NEW:
@NYGovCuomo
says New York State’s task force unanimously approved the Pfizer vaccine after Dr. Zucker, the state’s health commissioner, met with them last night.
Cuomo says this will help build confidence. It also hopefully means there’ll be no delays on delivering vaccine
Damn!
Benjy Sarin
White House orders FDA chief to authorize Pfizer-BioNTech vaccine Friday or submit his resignation
Sure, that would make suspicious people even more comfortable in taking the vaccine, knowing that Stephen Hahn approved it not when he thought it right, but to meet an or-else deadline.
That, of course, makes it impossible for Dr Hahn to approve it today, because if he did, he would lose all credibility with both the general public and with his professional scientific-medical community (“First, do no harm.”)
In the Reuters report below, Mark Meadows (WH C/S) said he was being jocular, but even the mildest pressure degrades public and professional confidence that Dr Hahn was applying the strictest possible safeguards, rather than some other consideration, before releasing vaccine into the wild.
WASHINGTON (Reuters) – White House chief of staff Mark Meadows urged U.S. Food and Drug Administration head Stephen Hahn to authorize Pfizer Inc’s COVID-19 vaccine by Friday and quipped that he should prepare to resign if not, a senior administration official said on Friday.
Meadows leaned on Hahn during a phone conversation on Friday. The official told Reuters that Meadows’ comment about resigning “wasn’t a red line,” but was more of a quip with the intention of urging “the FDA to act quickly and get the job done and stop the delays.”
The White House declined to comment, although an administration official said Meadows does request regular updates on the progress toward a vaccine.
Reporting By Steve Holland; editing by Jonathan Oatis
They had a Trump minute over in the White House….
Things are over in a month….
And the experts have gotten media savvy
Nobody likes a smart ass, eh?