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FDA Authorizes Pfizer, Moderna's Omicron-Based Boosters

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The FDA granted emergency use authorization (EUA) to Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna’s (MRNA - Free Report) Omicron BA.4/BA.5-adapted bivalent vaccines for use as a single booster dose. These boosters can be given at least two months following primary or booster vaccination. 

These “updated boosters” contain an mRNA encoding the spike protein present in the original vaccine as well as an mRNA encoding the spike protein that is common in the Omicron BA.4 and BA.5 variants. While Moderna’s Omicron booster is approved for individuals 18 years of age and older, Pfizer/Moderna’s version is approved for people 12 and older.

Pfizer/BioNTech and Moderna developed the Omicron BA.4/BA.5-adapted bivalent vaccines at the FDA’s recommendation a couple of months back as the subvariants, BA.4 and BA.5, are the most prevalent variants of concern in the United States as of now. The current vaccines weren’t very effective against the BA.4/BA.5 subvariants

The FDA, back then, had recommended developing a variant-adapted vaccine that also addresses the spike protein of the Omicron BA.4/BA.5 subvariants. Accordingly, vaccine makers like Pfizer, BioNTech, and Moderna began rapidly working on modified boosters of their COVID vaccines to provide better protection from the virus,which has been mutating rapidly. Pfizer/BioNTech’s and Moderna’s Omicron BA.4/BA.5-adapted bivalent vaccines have been developed in less than three months from the FDA’s recommendation.

The companies’ filings seeking authorization of the updated boosters were based on clinical studies on their bivalent Omicron BA.1-adapted vaccines as well as pre-clinical data from studies on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines.

However, unlike all previous approved COVID-19 vaccines, these booster shots’ approval is not supported by data from any human clinical studies demonstrating the effectiveness of the vaccine, which has been questioned by some health experts. However, it is believed by some that these new booster shots are basically the same as the original shots except for the modifications related to the BA.4/BA.5 subvariants. The FDA insisted that these booster shots are safe and effective and should provide better protection against currently circulating variants. Though clinical studies on the Omicron BA.4/BA.5-adapted bivalent vaccines have already started, the results will not be available before some months.

It is expected that the BA.4 and BA.5 will lead to increased infection rates in the fall and winter seasons.

Pfizer and Moderna have already signed supply contracts with the U.S. government for its Omicron BA.4/5 adapted booster doses. The Omicron boosters are expected to be used for the Biden government’s booster campaign in autumn. Pfizer/BioNTech said the vaccines are available for shipping immediately, while Moderna’s vaccines are expected to be available nationwide in the coming days. However, the Centers for Disease Control and Prevention (CDC) needs to first give a green signal to these booster shots before they can be rolled out.

Pfizer and Moderna’s monovalent COVID-19 vaccines have been the most successful ones and have been given to millions in the country since they were launched in December 2020 and brought billions of revenues for the companies. The Omicron shots can boost their revenues further, specially as some raised questions about the companies’ growth drivers beyond their COVID vaccines once the pandemic enters the endemic stage and eventually ends.

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