WASHINGTON – President Joe Biden’s plans to begin booster delivery by September 20 for most Americans who have received COVID-19 vaccines are facing new complications that could delay the availability of third doses for those who received the Moderna vaccine, administration officials said on Friday. .
Biden announced last month that his administration expects boosters to be available to all Americans who have received the mRNA vaccines in a bid to provide longer lasting protection against the coronavirus, pending approvals from the Centers for Disease Control and Prevention and the Food and Drug Administration. .
Those agencies, however, are waiting for critical data before signing the third doses, with Moderna’s vaccine increasingly seen as unlikely to cross the September 20 milestone.
According to an official, Moderna produced insufficient data for the FDA and CDC to recommend the third dose of its vaccine, and the FDA requested additional data that may delay those recalls in October. Pfizer, which is further along in the review process, in part because of data collected on the use of the vaccine in Israel, is still expected to be approved for a third dose for all by September 20. A key FDA panel is due to review Pfizer’s data on boosters on September 17.
Data on boosters for Johnson & Johnson’s single-dose vaccine will not be available for months, as this injection was not approved until February, officials said.
Acting FDA Commissioner Dr Janet Woodcock and CDC Director Dr Rochelle Walensky briefed White House COVID-19 coordinator Jeff Zients and other officials on Moderna’s expected delay on Thursday, said officials.
Most of the 206 million Americans who were at least partially vaccinated against COVID-19 have received the Pfizer vaccine, but about 80 million have received the Moderna vaccine, according to CDC data.
The administration’s public statement on the availability of recalls, a departure from the more deliberate, behind-the-scenes planning that defined its first vaccination campaign, raised concerns from some that the White House was ahead of the science on recalls.
“The announcement in August took a bit of a leap”, said Dr. Stephen Ostroff, former acting commissioner of the FDA under the Obama administration. “They needed to say something, but they could have just said, ‘we’re working on boosters, more to come. “”
The White House said it was simply preparing for the eventual approval of the boosters and that the reviews were “this is all part of a process that is now underway.”
“We are awaiting a full review and approval from the FDA and a recommendation from ACIP,” White House spokesman Chris Meagher said, referring to the CDC’s advisory committee on immunization practices. “When this approval and recommendation is made, we will be ready to implement the plan developed by the best doctors in our country to stay ahead of this virus. “
Even before Biden’s announcement last month, his administration had been preparing for months for the possibility that boosters would be needed, maintaining America’s dose supply and making promotion plans with the same. “intensity” that he brought to the initial vaccination campaign, Zients told reporters on Thursday.
On August 18, Biden introduced the boosters as protection against the more transmissible delta variant of the virus, which is raging across the country and slowing economic recovery after the pandemic, along with potential variants to come.
“Just remember, as a simple rule of thumb: eight months after your second injection, give yourself a booster shot” He then said, adding that health experts aim to be ready to administer them by September 20, pending regulatory approval.
Dr Anthony Fauci, the country’s top infectious disease expert, has become a staunch supporter of the recall campaign, as the Biden administration seeks to reduce the delta variant.
He told reporters on Thursday that he believed it was likely that Americans would all need a third dose of mRNA vaccines to be considered fully vaccinated against COVID-19.
“From my own experience as an immunologist, I would not be at all surprised if the adequate and complete vaccination schedule is probably three doses”, he said.
A formal determination that the third dose is required for “complete vaccination” would have broad implications for schools, businesses and other entities that have implemented immunization mandates.