Header Ads

Covid vaccines still face a few hurdles

Coronavirus Daily
Bloomberg

Covid vaccines still face a few hurdles

Pfizer Inc. and BioNTech SE now have the data they need and requested emergency authorization for their Covid vaccine on Friday that could lead to the shot's use by mid-December.

The race isn't over yet, though. It could take at least three weeks for a U.S. Food and Drug Administration decision as the trial data is probed by agency staff and outside advisers

The next key step is a meeting of FDA staff and outside advisers to sort through the data, and there are two key moments to watch. The first comes two days before the advisers meet, when the FDA typically releases its staff report on the clinical trial data. This will offer some insight into whether the agency is leaning toward authorizing the vaccine. The second is at the end of the meeting, when it will take a non-binding vote on whether FDA should clear the shot for public use.

The FDA staff will be combing through Pfizer's raw data, which the public doesn't have access to, rather than relying on the company's own results to determine the safety and efficacy of the vaccine. The agency and Pfizer will each summarize their findings for the advisory panel.

Moderna Inc. has also released positive interim results from a final-stage trial and has said it's close to seeking emergency authorization of its Covid-19 vaccine. It's unclear whether the shot could be considered alongside Pfizer's during the advisory committee meeting.

Emergency authorization allows drugs and vaccines targeting Covid-19 to reach Americans much faster than through standard approval channels. The FDA review process normally takes about six to 10 months, depending on the candidate's priority status.

And the FDA isn't the only U.S. agency that needs to consider the vaccines. Another group of advisers for the Centers for Disease Control and Prevention also must meet on the vaccine and make recommendations as to who should be first in line to get it. The timing of this meeting is unclear.

Following those steps, the vaccine can start rolling out. Pfizer and federal and state government officials are preparing to help distribute the vaccine within days of an FDA emergency authorization. Help will be on its way.--Anna Edney

Listen up

Can Enclosed Outdoor Dining Really Be Safe?

Restaurants across the country have been building and using outdoor dining spaces since the summer. But as winter approaches, many establishments are converting them into sheds or tents to help keep customers warm. We wondered how safe they really are for patrons.

Photographer: Patricia Suzara

Photographer: Patricia Suzara

 

What you should read

Europe's Retailers Go Online to Rescue Holidays
Stores are building up internet businesses to stave off Amazon.com.
Can Gold's Bull Market Outlive a Pandemic?
Inflation will be key to the precious metal's outlook, just like in 2011.
Pork Piles Up in Europe Amid Virus, Swine Fever
Pig prices in Germany are at their lowest since 2016.
Philippines Offers Tax Breaks for Face Masks
Companies may be exempt from paying income tax for up to six years.
Japan to Suspend Some Domestic Travel Ads
The tourism campaign will be put on hold in virus hotspots.

Know someone else who would like this newsletter? Have them sign up here.

Have any questions, concerns, or news tips on Covid-19 news? Get in touch or help us cover the story.

Like this newsletter? Subscribe for unlimited access to trusted, data-based journalism in 120 countries around the world and gain expert analysis from exclusive daily newsletters, The Bloomberg Open and The Bloomberg Close.

No comments