Only one of three vaccine manufacturers, Pfizer-BioNTech, will have strong enough data showing efficacy of a booster shot to get regulatory approval in time for the White House’s planned rollout of the shots on September 20, a source familiar with the vaccine approval process told Forbes Friday.
Acting FDA commissioner Janet Woodcock
Pfizer will be ready for a September 17 meeting of the FDA’s vaccine review committee, and they are expected to receive approval for at least some groups to receive the boosters shortly afterward.
Moderna’s submission to the FDA didn’t include strong enough data, putting the company a couple weeks behind Pfizer’s anticipated approval—while Johnson & Johnson has submitted no data to date.
That means, as the New York Times first reported Friday, the agencies might not know for weeks whether the Pfizer or Moderna booster doses will be ready for everyone who took the vaccine eight months ago or earlier, as the administration had announced in August.
On Thursday, FDA acting commissioner Janet Woodcock and CDC director Rochelle Walensky told Jeffrey Zients, President Joe Biden’s coronavirus response coordinator, that there was not enough data to support Biden’s plan, announced mid-August, the Times reported.
An administration spokesperson told Forbes that “this is all part of a process that is now underway” it had already planned to wait on FDA approvals and CDC recommendations before pushing out its booster plans.
Moderna and Johnson & Johnson did not return Forbes’ requests for comment, while a spokesperson for Pfizer directed questions to the FDA.
Top federal health officials, including Woodcock, Walensky and Anthony Fauci, President Biden’s top medical adviser, signed a statement on August 18 saying that they were “prepared to offer booster shots for all Americans” on September 20 for people eight months after their second dose, once the FDA approved them and the CDC recommended them. Since Israel approved giving third doses of the Pfizer-BioNTech vaccine to at-risk groups in July, a number of countries, including the U.S., Germany and China, have started giving booster shots or announced plans to do so.
The apparent delay in the process for vaccines inadvertently helps the cause of the World Health Organization (WHO), whose leader, Tedros Adhanom Ghebreyesus, has forcefully argued against rich nations giving booster doses before many poor countries have vaccinated a fraction of their populations. In late August he called for a two-month moratorium on booster shots and asked countries “to share what can be used for boosters” with countries that don’t have enough vaccines, such as those in Africa, where fewer than 3% of people have been fully vaccinated. Tedros and WHO’s chief scientist, Soumya Swaminathan, have both questioned whether booster shots are effective or needed.
This content was originally published here.