FDA Advisors Recommend Pfizer Drug Approval
Health secretary Alex Azar said on Wednesday that after the FDA meeting, “we could then have a vaccine within days, and be administering it to the most vulnerable by next week”.
The decision to officially recommend the vaccine’s approval comes after a panel of 23 held a meeting to determine whether or not the drug’s benefits outweigh its risks. The vaccine has already been approved for the public in the UK, Canada, Bahrain and Saudi Arabia and is now waiting to be formally approved by the FDA’s vaccine chief, something that is expected to be announced within the coming days.
Recommendation for the drug’s approval comes just a day after the country recorded more than 3,000 deaths in a 24-hour period, the highest coronavirus total for a single day anywhere in the world.
“The American public demands and deserves a rigorous, comprehensive and independent review of the data,” said FDA’s Dr Doran Fink, who added that agency scientists had been working nights, weekends and over Thanksgiving to get that done.
The government’s vaccine distribution program, Operation Warp Speed, has previously said that vaccine deliveries will commence within a day of the FDA announcing that it has approved a vaccine. Pfizer has 6.4 million doses prepared for the US for its first rollout round at the end of December if approval is granted and because two shots are required per person, only three million out of 330 million will initially receive the vaccine.
“Last week COVID-19 was the number one cause of death in America. For black, Latino, and Native Americans are nearly three times as likely to die from it. COVID-19 is a mass casualty,” President-elect Joe Biden said during a speech this week.
“For families and friends left behind is a gaping hole in your heart that will never be fully heal. As a country, we’ve been living with this pandemic for so long, we’re at risk of becoming numb to its toll on all of us.
“We’re resigned to feel that there’s nothing we can do and we can’t trust one another. That we must accept death, pain and sorrow. We’re in the midst of this deadly pandemic that’s infected almost 15 million Americans. One out of every 22 people in our country, often with devastating consequences of health,” Biden continued.
Centers for Disease Control and Prevention officials have said that the country’s 21 million healthcare workers should receive priority for the vaccine first, as well as the three million Americans currently living in long-term care homes.
There has been disagreement on how states should distribute it to other groups beyond this, however, with the approximately 87 million essential workers expected to be next in line and states having to decide which industries to prioritize.
“At this very moment, what is the outgoing administration asking the Supreme Court to do in the United States Supreme Court? To repeal the entirety of the Affordable Care Act when we need it most. A law that’s on the front lines against the pandemic, protects more than a hundred million Americans who live with pre-existing conditions, which will increase now including those with lung scarring and heart damage as a consequence of COVID-19,” Biden said.
“It provides coverage for more than 20 million Americans who get the care they need if they’re showing symptoms of COVID-19. The law that fulfils our moral obligation here in America, healthcare is a right for all, not a privileged for a few. But as all of you know, I know that out of our collective pain, we’re going to find a collective purpose to control the pandemic, to save lives and to heal as a nation.”
Federal officials have said that groups not at a high risk are expected to receive their vaccinations in the spring of 2021. A second vaccine, developed by Moderna, is also awaiting FDA approval and like the Pfizer vaccine, requires two shots to be taken.
“My first 100 days won’t end the COVID-19 virus, I can’t promise that. But we did not get into this mess quickly, we’re not going to get out of it quickly. It’s going to take some time,” Biden said.
“But I’m absolutely convinced that in 100 days, we can change the course of the disease and change life in America for the better. First, my first 100 days is going to require, I’m going to ask for a masking plan. Everyone for the first 100 days of my administration to wear a mask.
“It will start with my sign in order on day one to require masks where I can under the law, like federal buildings, interstate travel on planes, trains and buses. I’ll also be working with the governors and mayors to do the same in their states and their cities. We’re going to require masks wherever possible. But this goes beyond government action.”
Harrison Discombe is a Contributing Editor at The National Digest based in the United Kingdom. You can reach him at inquiries@thenationaldigest.com.
