The federal government has reached an agreement $3.2 billion paid To secure new supplies of Pfizer/BioNTech Covid-19 vaccines, including those specifically for the now-dominant variant of omicron.
The agreement announced Wednesday night covers the purchase of 105 million doses of the vaccine. The government also has the option to purchase up to 300 million more doses. The deal follows a meeting of the FDA advisory committee on Tuesday, which voted 19-2 to recommend adding the omicron component to the Covid-19 booster injection. Most committee members support a bivalent vaccine that protects against the original SARS-CoV-2 virus as well as the BA.1 omicron subvariant. New versions of these vaccines still require FDA authorization, followed by a recommendation from the Centers for Disease Control and Prevention.
Ahead of the advisory committee meeting, Pfizer and BioNTech reported two vaccine candidates for omicron, one monovalent and the other bivalent, with clinical data now showing them trigger a high immune response against variants. These vaccine candidates were compared to company-approved Covid-19 vaccines. Pfizer and BioNTech said they have shared data with the FDA and plan to seek emergency use authorization. Moderna also reported clinical data Support for bivalent boosters Applies to omicron and its sub-variants. The company said it was preparing to offer these new vaccines starting in August for vaccinations this fall. Moderna has yet to enter into a new supply agreement with the government.
The U.S. Department of Health and Human Services said the Pfizer/BioNTech vaccine covered by the new contract will be earmarked for a vaccination campaign scheduled for this fall. The contract includes a combination of adult and pediatric doses. First, some of these doses will be provided in single-dose vials.While multi-dose vials reduce packaging and storage costs, Advantages of single-dose vials Including a lower risk of contamination and less wasted vaccines. Pfizer and BioNTech said “at risk” production of these vaccines has begun to ensure adequate supplies are prepared for the fall vaccination campaign. They expect vaccine deliveries could begin as early as late summer.
The new vaccine contracts come amid uncertainty over funding for the pandemic response. Earlier this month, Congress failed to authorize additional Covid-19 funding. The new vaccine contract is partly funded from previously authorized $10 billion reallocated for the Covid-19 response.
Morningstar healthcare strategist Karen Andersen said in a note to investors she expects the FDA to direct Moderna and Pfizer to ramp up production of bivalent vaccines containing omicron in early July. Availability by this fall is expected to protect people before cooler weather brings another wave of the virus, she added. Regarding the bivalent and omicron vaccines that Novavax and Sanofi are developing, Andersen said mRNA vaccine makers still have an advantage because of the manufacturing capabilities they have built up during the pandemic.
“We expect competition to be a bigger factor in the next few years as the virus is likely to slow down and make it easier for other technologies to increase capacity,” Anderson said. “With several other companies also developing mRNA-based vaccines, we still don’t think Moderna and BioNTech have built an economic moat.”
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