Header Ads

What's taking the FDA so long?

When will the shots get full FDA approval?

In this week's edition of the Covid Q&A, we look at why it's taking so long for the Food and Drug Administration to approve the mRNA vaccines from Pfizer and Moderna, which are being used under an emergency authorization. In hopes of making this very confusing time just a little less so, each week Bloomberg Prognosis is picking one question sent in by readers and putting it to experts in the field. This week's question comes to us from Dave in Ashland, Oregon. He asks:

Why hasn't the FDA taken the mRNA vaccines out of emergency-use status? My brother is waiting for full approval, and I worry about him. 

As the delta variant of the virus sweeps through unvaccinated populations, many of us are in the same position, worrying about loved ones who are still refusing to get inoculated. Vaccine hesitancy is perhaps the biggest public health crisis in the U.S. right now. 

For an answer to Dave's question, we turn to Patricia Zettler, a former FDA attorney who's now a law professor at Ohio State University. 
 
"As a starting point, FDA doesn't have the power to decide on its own to convert products from an emergency-use authorization to a full approval," she says. Instead, a company like Pfizer or Moderna must first request approval. Pfizer began that process by submitting a biologics license application to the FDA in May, and the agency granted it a priority review. Moderna kicked off the process in June. 

Pfizer filed for full approval of its coronavirus vaccine in May.

Photographer: Eva Marie Uzcategui/Bloomberg

Reviewing those applications, called BLAs, will take time, she says.

"Now that the BLA process is underway, reviewing and approving the BLAs will take a little bit of time. Even though the emergency-use authorizations were based on large, robust clinical trials and other information showing the vaccines' safety and effectiveness, the BLAs will include even more information," says Zettler. The FDA looks at data from longer follow-ups of the trial participants, reviews labeling and safety information, and conducts site inspections.

"There are good reasons for FDA to carefully review the BLAs, both to serve its public health mission and help the public trust in its decisions," she says. 

The FDA said Friday it was taking an "all-hands-on-deck approach" to complete the review, while ensuring that "any vaccine that is authorized or approved meets our rigorous standards for safety, effectiveness and quality."

Zettler can't say for sure when we might expect full approval, but she's hoping for sometime this fall. That puts her in the company of President Joe Biden, who said in July that he expects a similar time frame.—Kristen V. Brown

Thanks to all of you for writing in this week! Next Sunday, we'll be answering the best question we receive again. So if you have any, we want to hear from you. Write to us at CovidQs@bloomberg.net—Kristen V. Brown

Vaccine tracker

Wasted Shots

In a few of the worst-hit states, such as Louisiana and Arkansas, there's a sudden uptick in first shots, yet the U.S. has far more vaccines than it knows what to do with. States request a fraction of the doses allocated to them, and many vials are thrown out. Read more here.

Bloomberg

Bloomberg

 

What you should read

Anti-Vax App Squares Off With Google, Apple
It's testing policies concerning misinformation about vaccines.
Grounded Pilots Swamp Aviation Recruiters
A recruiter got 400 applications in 48 hours for 30 positions.
Delta Struggles Overshadow Infrastructure Win
Biden's White House was caught off guard by the surge in cases.
South Africa's Illegal Rhino Killings Increase
The easing of lockdown restrictions was bad news for the mammals.
What the Real World Tells Us About Covid Shots 
Masks are being recommended in some areas to augment protection.

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