James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Health Law & Business, in “FDA Has Broad Regulatory Options for Mixing Covid Boosters,” by Jeannie Baumann. (Read the full version – subscription required.)
Following is an excerpt:
U.S. vaccine regulators have broad authority to allow mix-and-match Covid-19 vaccine boosters under its emergency powers, even if Johnson & Johnson and other companies don’t apply for it….
“That raises some interesting questions because, generally speaking, the sponsor of the EUA would be the party in charge of determining which booster could be used,” James A. Boiani, an FDA regulatory attorney with Epstein Becker & Green P.C., said….
The FDA will likely ask vaccine makers to apply for a mix-and-match booster authorization voluntarily, Boiani said.
“The way it would generally work would be for FDA to informally request that. They might tell the sponsor, ‘We’d really like you to ask us for this authorization,’” he said.
The FDA could also make a public health requirement to require mixing and matching of booster shots, but Boiani said that’s a step that hasn’t happened before. “It’s an odd situation, and it does sort of depend on how much FDA wants to try and push the envelope in terms of forcing this on parties that would want it right now,” he said. “I think the first instance will be FDA is going to try and encourage them and CDC would probably try and publicly pressure manufacturers to voluntarily allow for this.”…
Emergency use authorizations mean providers can’t go off-label like they would for a fully approved medical product, but the FDA could opt not to enforce that part of the EUA, essentially allowing mixing and matching of boosters by exercising enforcement discretion, Zettler and Boiani both said.
The Centers for Disease Control and Prevention also could act as a sponsor to request heterologous boosting, Boiani said. This wouldn’t be unprecedented since the CDC acted a sponsor for Zika tests and the HHS’s Office of the Assistant Secretary for Preparedness and Response sponsored emergency requests for convalescent plasma and the now-revoked EUA for hydroxychloroquine. But he said such an approach would be an odd move by the agency.
“It’s highly unusual for FDA to do something on its own without having the sponsor come to it,” he said. “This is unusual for them to add on different medications when a sponsor’s saying that’s not what we’re asking for authorization for, and you’re expanding it without our consent. That just doesn’t happen.”
