CBER's Peter Marks says Covid-19 shots to mirror flu shots: Manufacturers will be interchangeable
On Jan. 26, the FDA’s vaccines adcomm will meet to discuss the future of Covid-19 booster shots and variant strain selection moving forward, and CBER Director Peter Marks yesterday previewed some of what will be discussed in that meeting.
As the bivalent booster uptake has stalled, particularly among children, Marks is now pointing to ways to simplify the process.
The VRBPAC adcomm won’t only look at what the composition of these Covid-19 vaccines should be, and what’s the timing for selecting new strains, but also how often strain selection should take place, he said, noting that the FDA is “trying to get to some sense of normalcy for how we treat vaccinations.”
While noting the varied vial sizes and types of vaccinations for different age groups from Pfizer and Moderna, which creates challenges for keeping things straight for pharmacists, he pledged to simplify the process so that it more closely mirrors the influenza shot model, with caveats around the differences between Covid-19 and the flu.
Marks, speaking in conversation with Dana DeShon, chair of the professional association for pediatric nurse practitioners’ immunization special interest group, as part of the Covid-19 Vaccine Education and Equity Project, answered a question on whether a child under 4 years old who completed the Moderna primary series could receive a Pfizer booster:
“The issue would be that for these vaccines, unless they’ve moved into a new age range, we recommend the under 4s stick with the same brand,” Marks said.
But he added that this question circles back to the reason for holding this adcomm, noting:
This is one of the issues that needs some simplification because ultimately we’d like things to be as simple as they are with influenza vaccines where it doesn’t matter what manufacturer’s vaccine you’ve received. It would be nice to essentially swap out. That will be considered at that time, and hopefully within a couple of months there will be better guidance in that regard.
Pfizer and Moderna did not immediately respond to questions on making their shots the same.
The CDC also notes on its website that while all flu vaccines will protect against the same 4 flu viruses, different flu vaccines are manufactured differently, and different preparations have different indications licensed by the FDA, such as for a specific age range. In addition, LAIV (the nasal spray flu vaccine) is not recommended for use in some populations, the CDC says.
The differences between the Moderna and Pfizer Covid-19 vaccines came to a head with the recent booster authorizations.
For Pfizer and BioNTech’s Covid vaccine, the FDA recently authorized a new bivalent third dose for children 6 months through 4 years of age who have not yet received the third dose of the three-dose primary series with the monovalent version. But the monovalent version of Pfizer-BioNTech’s vaccine remains authorized for administration as the first two doses of the three-dose primary series in individuals 6 months through 4 years of age, and as a two-dose primary series for individuals 5 years of age and older, and as a third primary series dose for individuals 5 years of age and older who are immunocompromised.
For Moderna, its bivalent booster, just as it is for those 6 years and older, is now authorized for children 6 months through 5 years of age at least 2 months after completion of primary vaccination with the monovalent Moderna vaccine.
Similar to Pfizer, Moderna’s monovalent version is also authorized as a two-dose primary series in individuals 6 months and older and as a third in the primary series dose for individuals 6 months of age and older who are immunocompromised.
