The US Food and Drug Administration external panel has endorsed the authorization of Pfizer’s COVID-19 vaccine for emergency use.
Yesterday, FDA’s Dr. Stephen Hann appeared on CBS This Morning to discuss the upcoming vote by the committee to recommend the approval process for the Pfizer COVID vaccine.
An FDA advisory committee is meeting today to discuss whether to recommend the country's first #coronavirus vaccine.@US_FDA commissioner Dr. Stephen Hahn (@SteveFDA) joins us to discuss the approval process and concerns about potential side effects. pic.twitter.com/Q1RLXOCCCS
— CBS This Morning (@CBSThisMorning) December 10, 2020
The AP reports – “Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committee’s recommendation.”
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.
“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.
Still, experts estimate at least 70% of the U.S. population will have to be vaccinated to achieve herd immunity, the point at which the virus can be held in check. That means it could be several months before things start to get back to normal and Americans can put away their masks.
Pfizer has said it will have about 25 million doses of the two-shot vaccine for the U.S. by the end of December. But the initial supplies will be reserved primarily for health care workers and nursing home residents, with other vulnerable groups next in line until ramped-up production enables shots to become widely available on-demand — something that will probably not happen until the spring.
Next week, the FDA will review a second vaccine, from Moderna and the National Institutes of Health, that appears about as protective as Pfizer-BioNTech’s shot. A third candidate, from Johnson & Johnson, which would require just one dose, is working its way through the pipeline. Behind that is a candidate from AstraZeneca and Oxford University.
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.
JUST IN—FDA advisory committee votes:
“Based on totality of scientific evidence available, do benefits of the Pfizer-BioNTech vaccine outweigh its risks for use in individuals 16 & older?”
📌‘No’ votes seem to be for lack of age 16-17 data. #COVID19
— Eric Feigl-Ding (@DrEricDing) December 10, 2020
The Democrat Party media and Facebook’s censorship arm (so-called “fact-checkers”) have been deligently working to strip President Trump of the credit he deserves for the incredible work he and his team led by Vice President Pence, have done to bring this COVID vaccine to the American public before the end of the year.
Breitbart reports -The Covid-19 [coronavirus] vaccine developed by Pfizer and BioNTech is being produced as part of the Trump administration’s Operation Warp Speed, the revolutionary public-private partnership launched earlier this year to speed the development, production, and distribution of vaccines to protect against the virus.
The companies announced that they were developing the vaccine in collaboration with Operation Warp Speed in July.
“No, Pfizer’s apparent vaccine success is not a function of Trump’s ‘Operation Warp Speed,” a Washington Post headline declared.
That contradicts a story in the Washington Post in July about the agreement with Pfizer, which included the subhead: “The contract is the largest yet under the Trump administration’s Operation Warp Speed program, and will start with 100 million doses.”
“We were never part of the Warp Speed,” Pfizer Vice President Kathrin Jansen told the New York Times. “We have never taken any money from the U.S. government, or from anyone.”
The first part of that statement is false and the second part of the statement is misleading. Pfizer had decided that it would pursue the vaccine on its own, taking the financial risk that the drug would not wind up being effective. And unlike other companies pursuing a vaccine, Pfizer did not receive up-front financial backing before it began developing and manufacturing its vaccine.
Pfizer did receive fast-track designation from the Food and Drug Administration and a promise by the U.S. government to buy 100 million doses for the public at a price of $1.95 billion if the drug proved safe and effective. That contract is part of the Warp Speed project.