Flu and COVID combo shots won’t be ready this year, FDA official says
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Vaccines that offer protection against both COVID-19 and influenza with a single shot will likely not be ready in time for this year, a top federal official said Wednesday. However, tweaks to update the current COVID vaccines and drugs are expected soon.
The Food and Drug Administration’s top vaccines official, Dr. Peter Marks, had previously said in September that vaccines to cover both viruses could be deployed this year.
But at a webinar this week by the National Foundation for Infectious Disease, Marks acknowledged the effort had proved “too heavy a lift” for this fall, ending hopes of a combined option for the 2023 fall and winter respiratory illness season.
“I think that had to do with the fact that it was not so clear that annual vaccination against COVID-19 was likely to be necessary, until the past several months. But our goal is for the following season to have that available,” Marks said.
Moderna, Pfizer and Novavax have all announced plans to pursue trials of standalone flu vaccines in addition to versions combined with their COVID-19 shots. Pfizer executives told investors in January they did not expect approval of their combination shot until 2025.
Health authorities had previously voiced optimism that a combo shot would boost uptake. Only 19.5% of adults have gotten an updated bivalent COVID-19 booster dose this past season, compared to nearly half 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 protect against the respiratory syncytial virus — which may need to go into arms around the same time.
Regardless, Marks said the FDA is working on “a robust grouping of data” vetting the safety and effectiveness of administering separate shots for flu and COVID-19 on the same day.
The FDA has previously announced plans to formally study a potential rare safety issue that was flagged this past season with co-administering the COVID and flu shots in seniors.
“People were doing that this year, but we want to have people have even more data to make them feel confident that doing so is both safe and effective,” said Marks.
Other updates to COVID immunizations
His remark comes as the FDA has been working on efforts to “consolidate” the COVID-19 vaccines, following a vote by the regulator’s outside advisers earlier this year to simplify the myriad of doses and formulas used for primary series and booster shots.
“We would have the same vaccine strain composition for all spike based COVID-19 vaccines, which would hopefully allow one to have interchangeability,” said Marks.
Time is running out for the switch. While boosters for most Americans used an updated bivalent recipe targeted to the BA.4 and BA.5 variants this past winter, primary series shots for unvaccinated people still relies on shots made from the original monovalent recipe. That is due to expire and is largely no longer being produced.
“We’re looking at a matter of weeks to, at most, a month or two,” said Marks.
Marks said the FDA is aiming to complete its consolidation of the COVID-19 vaccines long before a planned June meeting to decide on revising shots again for this fall and winter.
On Wednesday, the Administration for Strategic Preparedness and Response said that the looming switch to a commercial market for COVID-19 vaccines is also expected to “align” with this expected “strain change.”
The FDA also expects updates soon that could allow for the return of monoclonal antibody drugs for COVID-19.
Patients with compromised immune systems, who did not get sufficient protection from vaccines and antiviral pills, had relied on the antibody infusions from AstraZeneca’s Evusheld to guard against the virus.
But in January, the FDA announced it was effectively ending the drug’s authorization over the growth of SARS-CoV-2 variants that could now evade its protection.
“There are successors to the monoclonals that are in the process of being updated so that they will get the next generation of variants. And I expect, again, we’ll hear more about those in the coming few months,” said Marks.