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FDA Gives Nod for Using Bivalent Jab for All COVID Vaccinations

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To simplify the COVID-19 immunization schedule for a majority of the country’s population, the FDA amended the emergency use authorization (EUA) granted to mRNA-based vaccines developed by Pfizer (PFE - Free Report) /BioNTech(BNTX - Free Report) and Moderna (MRNA - Free Report) .

Following the EUA amendment, the current bivalent COVID-19 vaccines developed by Pfizer/BioNTech and Moderna would be used for all doses administered to individuals aged six months and older. Subsequently, the monovalent/original vaccines developed by these companies are no longer authorized for use in the United States.

In the United States, the currently-authorized bivalent vaccines contain an mRNA encoding the spike protein in the monovalent vaccine and an mRNA encoding the spike protein common in the Omicron BA.4 and BA.5 variants.

Subsequent to this action, unvaccinated individuals can get themselves directly immunized with a bivalent COVID-19 vaccine. For a majority of the country’s population, which has already received a monovalent COVID-19 vaccine but is yet to receive a bivalent dose, the FDA states that they are eligible to receive a single dose of the bivalent vaccine developed by Pfizer/BioNTech or Moderna. Individuals who have already received a bivalent vaccine are not eligible for a second dose.

For older adults (aged 65 years and older) and certain immuno-compromised individuals who have already received a bivalent vaccine, the FDA has authorized a single additional dose of the bivalent vaccine.

In the case of children aged six months through five years of age who have received a monovalent vaccine, the FDA stated that the administration of bivalent vaccines will depend on the type and number of monovalent vaccine doses received. Unvaccinated children in this age group are eligible to receive a two-dose series of Moderna’s bivalent vaccine. If these unvaccinated children are receiving Pfizer/BioNTech’s bivalent vaccine, those aged between six months and four years are eligible for a three-dose regimen while those aged five years are eligible for a single dose only.

These decisions have been taken by the FDA based on the recommendations of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting held this January. The panel members recommended simplifying the COVID-19 immunization schedule and harmonizing the strain composition of all COVID-19 vaccines. Prior to this EUA amendment, the approved/authorized COVID-19 vaccines had different compositions and immunization schedules, which led to multiple complexities while using the vaccine. This gave rise to complications in vaccine administration and uptake.

The FDA also announced its intention to hold a meeting of the VRBPAC this June to discuss strain composition of COVID-19 vaccines for the 2023 fall season. Like the influenza vaccines, the VRBPAC will determine which specific COVID-19 strains and lineages are likely to circulate in the future. Based on the VRBPAC’s recommendations, the FDA will notify COVID-19 vaccine makers, like Moderna and Pfizer/BioNTech, to update their COVID-19 vaccines to counter these selected strains. The agency expects the vaccine developers to make the updated vaccine formulations available later this year during the fall season.


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