FDA official says flu and COVID combo shots won’t arrive on time this year

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A top federal official said Wednesday that vaccines that provide protection against both COVID-19 and influenza with a single shot likely won’t be ready in time for this year. However, a change is expected soon to update the current COVID vaccines and drugs.

Dr. Peter Marks, the Food and Drug Administration’s top vaccine official, said earlier in September that vaccines covering both viruses could be rolled out this year.

but on a webinar By the National Foundation for Infectious Diseases this week, Marks acknowledged the effort proved “too heavy a lift” for this fall, ending hopes of a joint option for 2023 fall and winter respiratory illness season,

“I think it had to do with the fact that it was not so clear that the annual vaccination against COVID-19 was likely to be necessary until the last several months. But our goal is to have one available for next season,” Marks said. .

Moderna, Pfizer and Novavax have all announced plans to pursue trials of standalone flu vaccines Apart from the joint editions with their COVID-19 shots. Pfizer executives told investors in January that they did not expect approval of their combination shot until 2025.

Health officials previously expressed optimism that a combo shot would be quicker. Only 19.5% of adults have received an update Bivalent COVID-19 Booster This past season, that’s about half of those who say they got a flu shot.

A combo shot could also simplify an increasingly complex annual vaccination schedule ahead of the expected rollout of new RSV vaccines — to prevent respiratory polynuclear virus — which may require going into arms around the same time.

Regardless, Marks said the FDA is working on “a strong set of data” on the safety and effectiveness of giving separate shots for flu and COVID-19 on the same day.

The FDA previously announced plans to formally study a potentially rare safety issue that was flagged this past season with the co-administration of COVID and flu shots in seniors.

“People were doing it this year, but we want people to have even more data so they can be confident that doing it is both safe and effective,” Marks said.

Other Updates on COVID Vaccination

His comments come as the FDA is working on efforts to “consolidate” COVID-19 vaccines, following a vote by the regulator’s outside advisers earlier this year. to ease Myriad of dosages and formulas used for primary series and booster shots.

“We will have the same vaccine strain composition for all spike-based COVID-19 vaccines, which will hopefully allow an interchangeability,” Marks said.

Timed out for switch. While boosters for most Americans last winter used an updated bivalent recipe targeted for the BA.4 and BA.5 variants, primary series shots for unvaccinated people still rely on shots made from the original monovalent recipe. Are. It is about to expire and is largely no longer being produced.

“We’re looking at cases ranging from a few weeks to a month or two at the most,” Marks said.

Marx said the FDA is aiming to complete its consolidation of COVID-19 vaccines long before a planned June meeting to decide whether to revise the shots again for this fall and winter.

On Wednesday, the Administration for Strategic Preparedness and Response said the emerging switch to a commercial market for COVID-19 vaccines is also expected to “align” with this expected “stress change.”

The FDA is also expecting an update soon that could allow the return of monoclonal antibody drugs for COVID-19.

Patients with compromised immune systems, who had not received sufficient protection from vaccines and antiviral pills, relied on infusions of antibodies from AstraZeneca’s EuShield to protect against the virus.

But in January, the FDA announced it was effectively ending the drug’s authorization over development of a SARS-CoV-2 variant that could now escape its protection.

“There are successors to the monoclonals that are in the process of being updated so that they have next-generation variants. And I expect we’ll hear more about them again in the coming months,” Marks said.

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