The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), on Tuesday, voted 19-2 to recommend modifying the current strain composition of available COVID-19 vaccines to target the Omicron variant and its subvariants. The committee members recommended incorporating genetic material from the Omicron variant in the modified boosters.
If the FDA follows the VRBPAC’s recommendation, which it usually does, vaccine makers like Pfizer PFE/BioNTech BNTX, and Moderna MRNA will need to roll out modified boosters of their COVID vaccines to provide better protection from the virus, which has been mutating rapidly.
However, the vote did not specify if the modified boosters should target the Omicron variant or both the Omicron as well as the older ancestral strains of the virus. It was also not clear whether the modified boosters will target the more recent Omicron subvariants, BA.4 and BA.5. which represent more than half of all U.S. COVID-19 cases now. Not only do these variants outcompete the BA.1 Omicron subvariant but have also shown the potential to evade immune protection. This creates a need for adapted vaccine boosters with improved vaccine effectiveness. The FDA will now take the decision of what strain of Omicron the modified booster vaccines should target.
The currently authorized vaccines of Pfizer and BioNTech, and Moderna and their currently available boosters are designed to target the ancestral coronavirus strain that emerged in late 2019. However, Pfizer/BioNTech and Moderna are developing Omicron-based COVID-19 vaccine boosters to address the rise of new and evolving Omicron subvariants. These Omicron-targeted vaccines have shown promise in clinical studies.
Earlier this month, Moderna announced data from an ongoing phase II/III study on its bivalent COVID-19 vaccine booster candidate mRNA-1273.214, targeting the Omicron variant.
The clinical data showed that following one month of administration of a 50 µg dose of mRNA-1273.214, a 5.4-fold increase in neutralizing antibodies against the Omicron subvariants BA.4 and BA.5 was seen in all study participants, regardless of prior infection. In a subset of seronegative participants, the candidate generated a 6.3-fold increase in neutralizing titers against both the Omicron subvariants. Based on these results, Moderna intends to complete the regulatory filing for mRNA-1273.214 in the coming weeks.
Pfizer and BioNTech are also working on new Omicron-based vaccine candidates, both monovalent and bivalent. The bivalent vaccine is a combination of the ancestral strain and the Omicron BA.1 subvariant.
Earlier this week, Pfizer announced data from a phase II/III study on the vaccine candidates. Data from the phase II/III study showed that participants, given the booster dose of both the vaccine candidates, generated a substantially higher immune response against the Omicron subvariant BA.1compared to Comirnaty, Pfizer/BioNTech’s currently authorized vaccine. Pfizer and BioNTech intend to share the above results with the regulatory authorities for approval of the booster vaccines.
Pfizer and BioNTech are also evaluating both the vaccine candidates against the recent Omicron subvariants, BA.4 and BA.5.
The Biden government expects to start a booster campaign in October to prepare for an expected surge in infections in autumn. The Omicron-based vaccine boosters of Pfizer and BioNTech and Moderna should be ready before the campaign begins.
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