FDA panel paves the way for America’s first coronavirus vaccine approval

[Chris Smith]

• The FDA Advisory Committee reviewed the Pfizer/BioNTech vaccine candidate on Thursday, streaming the entire procedure online to increase transparency. The panel recommended the emergency use of the new drug.
• The FDA could grant emergency use authorization for the vaccine as soon as Friday.
• Pfizer and BioNTech announced their COVID-19 vaccine is safe and highly effective a few weeks ago, confirming they would ask for Emergency Use Authorization in the US and go through similar processes in Europe.
• The British drug authority approved the vaccine for emergency use a few days ago, with vaccination campaigns having already begun ahead of the FDA’s review meeting.

Pfizer and BioNTech were the first companies to announce interim efficacy data for the final stage of research. The drug was more than 90% effective at blocking severe illness, the two companies said in mid-November. They were also the first to announce the final results for Phase 3, revealing their drug was 95% effective and that it was well tolerated across all age groups. The companies announced plans to file the full paperwork for Emergency Use Authorization (EUA) in the US, Europe, and the UK. The British government was the first to issue emergency approval for the drug, with the local vaccination campaign having started just a few days ago.

The US Food and Drug Administration (FDA) scheduled the official review of the Pfizer/BioNTech for Thursday, December 10th, releasing the full documentation online a few days ahead of the advisory committee’s meeting. The entire review process, which started early on Thursday, was streamed online on YouTube.

BGR's Top Deal of the Day​

Best-selling coronavirus face masks that work better than 3M N95 masks are on sale at Amazon for just $2.12 each $42.49 Available from Amazon Prime. BGR may receive a commission. Buy Now

Continue reading...

Today's Top Deals

1. Honeywell makes cloth masks that work as well as N95s, and they’re now on Amazon
2. People are hoarding groceries again – stock up on these 5 things while you can
3. Sorry, but these 10 awesome Amazon deals are for Prime members only

Trending Right Now:

1. Dr. Fauci says this one thing spreads COVID-19 more than anything else
2. Dr. Fauci says these 2 states have had the best COVID-19 response
3. Dr. Fauci says to not let people in your home if they’ve done this

FDA panel paves the way for America’s first coronavirus vaccine approval originally appeared on BGR.com on Thu, 10 Dec 2020 at 17:48:42 EDT. Please see our terms for use of feeds.

Via BRG - Boy Genius Report