FDA hopes to simplify and standardize Covid shots without making them interchangeable
The FDA’s advisory committee of outside vaccine experts will meet Thursday to discuss how to simplify the Covid-19 vaccination process, make the strain selection process easier and more regular, and decide whether to use the same strain for both the primary and booster doses.
But despite a desire by the agency to simplify the vaccination production and administration process, the agency acknowledged that, for now, it may be challenging to harmonize different vaccines from Moderna and Pfizer/BioNTech into a single, interchangeable shot.
“The current diversity of vaccine manufacturers and complexities in global supply of COVID-19 vaccines would make a globally coordinated, simultaneous vaccine composition evaluation and recommendation quite challenging,” the agency said in a briefing document released ahead of its Jan. 26 Vaccines and Related Biological Products Advisory Committee meeting.
Known as VRBPAC, the sessions gather outside experts to make recommendations on the vaccine development process, but Thursday’s meeting includes only one question on whether the advisors recommend harmonizing the current primary and booster vaccine composition into the same shot.
The discussion and vote come as uptake of a bivalent booster has stalled in the US, with questions raised about efficacy and a potential new safety signal. At the JP Morgan Healthcare Conference earlier this month, BioNTech executives stressed that they did not think Covid-19 vaccines between different manufacturers would be interchangeable.
Such harmonization has been the agency’s eventual goal: “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,” CBER Director Peter Marks said late last month.
FDA’s plan for the future, according to the briefing documents released on Monday, is to engage VRBPAC in early June of each year regarding strain selection for the fall season, which would be deployed no later than September each year. If a surprising and more dangerous version of the virus emerged, it would meet sooner.
“Of note, circulation of a more pathogenic vaccine-escape variant of SARS-CoV-2 would likely prompt, on an as-needed and emergent basis, an ad-hoc strain selection meeting of VRBPAC,” FDA said.
In addition to transitioning to a single vaccine composition for the primary and booster series, FDA also said that on Thursday it hopes VRBPAC members will consider whether to standardize the vaccine schedule for future rounds to “a two-dose series in certain young children, and in older adults and persons with compromised immunity, and only one dose in all other individuals.”
On efficacy, FDA also brushed off any question marks related to the bivalent boosters from Moderna and Pfizer/BioNTech, particularly among younger, less vulnerable populations, writing:
Although there are limitations specific to each of these effectiveness assessments, these data provide preliminary real-world evidence that support the use of the bivalent mRNA boosters. Although the beneficial effect associated with a reduction in hospitalization and death in these studies is most apparent in older individuals, younger individuals appear to also benefit with a reduction in symptomatic disease and health care utilization.
The advisory committee is also expected to review new data on a potential safety signal. Earlier this month, the CDC and the FDA said they were investigating a “preliminary” sign of an increased risk of stroke in people aged 65 and older. Other governments have found no such signal in their own reviews, and other US datasets have likewise not seen such a risk. The documents released Monday didn’t contain any new information on the issue.