UpDate: An emergency use authorization request for the COVID-19 vaccine developed by Pfizer and BioNTech was expected to be filed with the FDA on Friday, the US government and BioNTech’s co-founder said.
This type of Food and Drug Administration authorization is temporary or conditional and is granted in response to an emergency situation such as a pandemic.
“Pfizer’s partner BioNTech has announced that tomorrow they intend to file for emergency use authorization at the FDA,” health secretary Alex Azar told a press conference Thursday in Washington.
BioNTech co-founder Ugur Sahin earlier told AFP in a Zoom interview: “The documents will be finalized today and tomorrow and submitted to the FDA.”
The FDA did not say how long it would take to review the data on vaccine efficacy and safety, the 2 main criteria.
The scientific head of the US operation to develop a vaccine, Moncef Slaoui said Monday that the green light would probably come in December
UpDate: Pfizer COVID Vaccine Deliveries Could Start ‘Before Christmas
Pfizer Inc. and BioNTech could secure emergency US and EU authorization for their COVID vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said Wednesday.
The vaccine’s efficacy was found to be consistent across different ages and ethnicities – a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people.
The U.S. Food and Drug Administration could grant emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin said on TV Wednesday. Conditional approval in the EU could be secured in 2-H of December, he added.
“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” he said.
The success rate of the vaccine developed by the U.S. drugmaker and German partner BioNTech was far higher than what regulators had said would have been acceptable. Experts said it was a significant achievement in the race to end the pandemic.
While the results of Pfizer’s Phase 3 trial is now known, as part of Operation Warp Speed the drug giant has already struck a $1.95-B deal with the US Department of Health and Human Services and the Department of Defense to provide Americans with 100-M doses of its COVID-19 vaccine after it is licensed at no cost to recipients with an option for 500-M additional doses. The agreement is part of President Trump’s Operation Warp Speed.
Pfizer and BioNTech have a deal with the UK government for 30-M initial doses.
The FDA’s guidance for a vaccine to receive Emergency Use Authorization requires only a median of 2 months of safety data following the 2nd dose, which Pfizer expects by the 3rd wk of November and start its pilot delivery program as it us 95% effective.
At that point, they are hoping to bring the experimental vaccine to market, with promises to produce up to 50-M vaccine doses in Y 2020 and up to 1.3-B doses, globally, in Y 2021.
Upon Pfizer’s announcement that their vaccine showed 90% effectiveness, shares rose 16%.
If and when the vaccine does become available, be sure to carefully weigh the risks Vs the benefits before making a choice of whether or not to receive it.
It may help in your decision to know that if you are under 40 anni, your risk of dying from COVID-19 is just 0.01%, meaning you have a 99.99% chance of surviving the infection, and you could improve that to 99.999% if you are metabolically flexible and vitamin D replete.
Eat healthy, Be healthy, Live lively