With the White House aiming for a Sept. 20 start date for COVID-19 booster shots for adults in the U.S., the countdown has begun for the U.S. Food and Drug Administration (FDA) to review booster data from vaccine companies.
Moderna (MRNA), meanwhile, is focused on halving its booster shot, from the current 100 microgram dose. The company submitted to the FDA an initial round of data to support the half dose this week. According to Moderna officials, the lower dosage has production benefits and could free up a billion doses a year.
Regulatory officials said Moderna's submission included insufficient data. Moderna did not immediately respond to requests for comment, but the company said in a statement that it completed its submission for booster doses Friday.
U.S. Surgeon General Vivek Murthy previously said the booster start date for those who received two doses of the vaccine was contingent upon FDA and Centers for Disease Control and Prevention (CDC) approval and guidance, but officials are now reportedly pushing back against the timeline and are asking for more time, according to the New York Times.
The officials said that Moderna's vaccine authorization, specifically, would not be ready by Sept. 20.
Experts are increasingly looking at the idea of a third shot as being part of the primary regimen of COVID-19 vaccinations, throwing into question the billions of dollars that vaccine makers were projected to earn, if boosters were an annual need like the flu.
Pfizer (PFE) and BioNTech (BNTX), which has the only fully-approved COVID-19 vaccine in the country, have submitted a third dose for review. Their booster shot will be discussed at a Sept. 17 FDA vaccine advisory meeting.
Both Pfizer and Moderna CEOs told Yahoo Finance they believe an annual booster dose will be necessary. They are also working on a mRNA flu vaccine and a vaccine that would combat the flu and COVID-19.
White House Chief Medical Adviser Dr. Anthony Fauci recently said full protection from the coronavirus will come from a three-dose course.
"From my own experience as an immunologist, I would not at all be surprised that the adequate full regimen for vaccination would likely be three doses," Fauci said Thursday. "But we'll have to just wait and make sure that that's the case when the data get presented to the FDA."
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