Pre-ordering for Bivalent COVID-19 Boosters Began Before EUA

In a highly unusual situation, pharmacies were urged to pre-order bivalent COVID-19 booster shots even before the Food and Drug Administration granted emergency use authorization to the vaccine products. Bot Moderna and Pfizer Inc.-BioNTech sought EUAs for vaccines that add an Omicron BA.4/5 spike protein component to the current composition. Here is more information.

ATLANTA – Prior to emergency use authorization of new bivalent COVID-19 booster shots by the Food and Drug Administration, pharmacies, as well as jurisdictions and federal entities, were able to participate in two waves of pre-ordering of the products.

New vaccines from Moderna and Pfizer Inc.-BioNTech add an Omicron BA.4/5 spike protein component to the current composition. They are designed to be administered as a single booster dose to those who previously completed a primary series of COVID-19 vaccines, according to a planning guide from the national Centers for Disease Control and prevention.

The pre-ordering periods, Waves 1 and 2, started in mid-August and were scheduled to end around Aug. 30. The CDC advises that additional details regarding the timing of pre-ordering for Moderna and Pfizer-BioNTech pediatric bivalent vaccines will be updated based on available information, adding, “It is expected that at least one bivalent vaccine for children ages 11 years and younger may be authorized within a short time following the authorization(s) of bivalent vaccines for people ages 12 years and older. Sites should plan to manage necessary freezer and refrigerator space when developing their overall fall vaccine plans.”

“It is anticipated that bivalent COVID-19 vaccine booster doses may initially be authorized for people ages 12 years and older (Pfizer-BioNTech) and for people ages 18 years and older (Moderna), followed by younger pediatric age groups,” according to the information. “It is also anticipated that the bivalent COVID-19 vaccines will only be authorized as a single dose in people who have completed a primary vaccination series but would not vary by number or type of prior booster doses received.”

As of mid-August, the federal government had procured 175 million doses of bivalent COVID-19 vaccine for distribution and administration for fall and early winter when both the original vaccines and the bivalents would be used, past of vaccination status, the report notes.

The CDC is recommending that pharmacists and other vaccine providers offer simultaneous administration of all age-appropriate doses of vaccines for children, adolescents, and adults for whom no contraindications exist at the time of the healthcare visit.

It adds that, because “the demand for seasonal flu vaccines will also increase during this time, providers may have some concerns regarding vaccine storage space, according to the document. 

Both Pfizer and Moderna announced that they have requested emergency use authorization from the Food and Drug Administration for their vaccines. Pfizer has a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older, while Moderna has the BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222 and an application is for a 50 µg booster dose for adults 18 years of age and older.

Pfizer’s bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is present in the original Pfizer-BioNTech COVID-19 Vaccine, together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant, according to the companies. Pre-clinical data showed a booster dose of Pfizer and BioNTech's Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older was expected to start in August.

Moderna’s mRNA-1273.222 targets both the original strain of SARS-CoV-2 as well as the BA.4/BA.5 subvariants of the Omicron strain, according to a press release. Moderna's application to the FDA is based on preclinical data for mRNA-1273.222 as well as clinical trial data from a Phase 2/3 studying mRNA-1273.214, a bivalent booster vaccine targeting the Omicron BA.1 subvariant.

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