WASHINGTON (REUTERS, BLOOMBERG) - A White House plan to offer Covid-19 vaccine booster shots will most likely start this month with only the vaccine made by Pfizer and BioNTech, a narrower initiative than anticipated, a source familiar with the matter said on Friday (Sept 3).
United States President Joe Biden had expected to launch a campaign to administer 100 million booster shots on Sept 20. But US vaccine makers other than Pfizer have lagged in seeking authorisation of an additional dose.
A panel of experts that advises the Food and Drug Administration (FDA) on vaccines plans to meet on Sept 17 to discuss additional doses of Pfizer's shot.
US health regulators are seeking additional coronavirus booster shot data from Moderna.
Moderna announced on Friday that it had "completed" its submission of data to the FDA for authorisation of boosters.
The FDA has been seeking more data as Moderna's submission rolled in, the people added.
In particular, the FDA is looking for more information on the efficacy of a 100mcg dose - the same as the first two shots people received - not just the 50mcg booster submitted by Moderna as a potential booster, one of the people said.
Whether the apparent impasse will spark a lengthy delay, or ultimately be resolved, is unclear.
Dr Anthony Fauci, Mr Biden’s chief medical adviser, told MSNBC in an interview on Friday that it did not appear the information needed for Moderna would be available in time for a Sept 20 roll-out.
"It may be a delay for a few weeks. We don't know," Dr Fauci said.
The FDA will now pore over the Moderna submission as it weighs its next steps.
The FDA and the Department of Health and Human Services (HHS) did not immediately respond to requests for comment. The White House referred inquiries to HHS.
"We consider our submission complete," said a Moderna spokesman. "We can't comment on the FDA review... and what that will entail."
Moderna also submitted booster-shot data to the European Medicines Agency for a conditional marketing approval, the company said in a statement late on Friday.
Johnson & Johnson has not yet asked regulators to approve a booster for its one-dose shot, and last week said it was in discussions with the FDA on the subject.
As infections from the Delta variant rise, the Biden administration is concerned that Covid-19 infections among people who are fully vaccinated are a sign that vaccine protection is waning. It has pushed boosters as a way to rebuild immunity.
White House spokesman Chris Meagher said that the government is awaiting a full review and approval by the FDA and advisers to the Centres for Disease Control and Prevention.
"When that approval and recommendation are made, we will be ready to implement the plan our nation's top doctors developed so that we are staying ahead of this virus."