FDA’s top vaccine official Dr. Peter Marks says that vaccines that protect against both COVID-19 and influenza with a single shot are unlikely to be ready for deployment this year.
Dr. Marks, who heads the FDA’s Center for Biologics Evaluation and Research (CBER) had suggested in September that vaccines to cover both viruses could be rolled out this year.
At a webinar conducted by the National Foundation for Infectious Diseases (NFID) this week, Dr. Marks said that the initiative had proved “too heavy a lift” for this fall, ending hopes for a COVID and flu shot combo for the upcoming 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,” he added.
In January, an expert panel of the FDA voted unanimously in favor of simplifying the COVID-19 vaccinations, which currently consist of both monovalent and bivalent shots. They also suggested that individuals should obtain updated COVID shots regularly.
Also, at the JPM conference, Pfizer (PFE) announced plans to launch its BioNTech (BNTX)-partnered COVID-flu messenger RNA shot in 2024 or later. Late last year, the companies started the dosing in a Phase 1 trial for that purpose.
Moderna (MRNA) also plans to introduce a vaccine combo for flu and COVID as soon as next year, Chief Executive Stéphane Bancel told Bloomberg in January. With its Q3 2022 results, the company said that its Phase 1/2 trial for the vaccine combination mRNA-1073 was fully enrolled.
In December, Novavax (NVAX) announced the start of a Phase 2 trial for a vaccine combination containing its protein-based COVID shot and an influenza vaccine candidate. The multi-site study involving approximately 2.3K adults aged 50 through 80 is expected to generate topline data in mid-2023.