FDA Approves Simplified Use of Bivalent mRNA COVID-19 Vaccines

The U.S. Food and Drug Administration has modified the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines, making the vaccination schedule simpler for most people. The revised EUAs authorize the use of the current bivalent vaccines (original and omicron BA.4/BA.5 strains) for all doses given to individuals aged 6 months and above, including for additional doses for certain populations. As a result, the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer permitted for use in the United States.

Key Information:

• The FDA has authorized changes to the vaccination schedule for the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines for most individuals.
• Individuals who previously received a monovalent COVID-19 vaccine and have not yet received a dose of a bivalent vaccine may receive a single dose of a bivalent vaccine.
• Most individuals who have already received a single dose of the bivalent vaccine are not currently eligible for another dose, pending the FDA’s decision on the fall strain composition, which is expected to be made after an advisory committee meeting in June.
• Individuals aged 65 years and older who have received a single dose of a bivalent vaccine may receive one additional dose at least four months after their initial bivalent dose.
• Most immunocompromised individuals who have received a bivalent COVID-19 vaccine may receive a single additional dose at least 2 months following a dose of a bivalent COVID-19 vaccine. Additional doses may be administered at the discretion of their healthcare provider, depending on the intervals determined.
• Most unvaccinated individuals may receive a single dose of a bivalent vaccine instead of multiple doses of the original monovalent mRNA vaccines.
• Children 6 months through 5 years of age who are unvaccinated may receive a two-dose series of the Moderna bivalent vaccine or a three-dose series of the Pfizer-BioNTech bivalent vaccine.
• Children who are 5 years old may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
• Children 6 months through 5 years of age who have received one, two, or three doses of a monovalent COVID-19 vaccine may receive a bivalent vaccine, but the number of doses will depend on the vaccine and their vaccination history.

According to available data, the vast majority of the U.S. population aged 5 years and above have developed antibodies against SARS-CoV-2 due to vaccination or prior infection. The use of bivalent COVID-19 vaccines for all doses administered to individuals aged 6 months and older is supported by the data below and post-marketing data, including real-world data from millions of people, including young children, who have received monovalent and bivalent mRNA COVID-19 vaccines. For individuals aged 65 years and above, a second bivalent dose is supported by evidence showing immunity waning over time and its restoration by an additional dose. Immunocompromised individuals may also require additional doses based on evidence from previously conducted studies.

The efficacy and safety of the Moderna COVID-19 Vaccine, Bivalent is established through the FDA’s evaluation of clinical trial data from the monovalent Moderna COVID-19 Vaccine in individuals aged 6 months and above, as well as investigational data from the bivalent Moderna COVID-19 Vaccine (consisting of the original and omicron BA.1 strains) in individuals aged 18 years and above.

Furthermore, the FDA has analyzed immune response data from clinical trials that included 1,376 individuals aged 6 years and older without prior SARS-CoV-2 infection and 145 individuals aged 6 years and older with prior SARS-CoV-2 infection who had received two doses of monovalent Moderna COVID-19 Vaccine. The data showed that the immune response after a single dose of vaccine was similar among participants with prior infection and those without, who received two doses.

The data obtained from clinical trials with the investigational bivalent Moderna COVID-19 vaccine (original and omicron BA.1) and the monovalent Moderna COVID-19 Vaccine are applicable to the Moderna COVID-19 Vaccine, Bivalent as they are produced using the same manufacturing process.

The FDA’s analysis of clinical trial data on the monovalent Pfizer-BioNTech COVID-19 Vaccine for use in individuals 6 months of age and older, as well as an investigational bivalent Pfizer-BioNTech COVID-19 vaccine (original and omicron BA.1) in individuals greater than 55 years of age, provide the basis for the safety and effectiveness of Pfizer-BioNTech COVID-19 Vaccine, Bivalent. In addition, safety data from individuals 6 months of age and older who received Pfizer-BioNTech COVID-19 Vaccine, Bivalent (original and omicron BA.4/BA.5), and immune response data from individuals 6 months through 4 years of age were also considered.

Furthermore, the efficacy of a single dose is substantiated by observational data from England that evaluates the effectiveness of one dose of the monovalent Pfizer-BioNTech COVID-19 Vaccine. The data reveals that among individuals aged 12 to 17 who had received only one dose of the vaccine, those with prior infection from alpha, delta, or omicron variants had a greater degree of protection against symptomatic omicron infection as opposed to those without any evidence of prior infection.

The data collected from the investigational Pfizer-BioNTech bivalent COVID-19 vaccine (original and omicron BA.1) and the monovalent Pfizer-BioNTech COVID-19 Vaccine are applicable to the Pfizer-BioNTech COVID-19 Vaccine, Bivalent since these vaccines are produced utilizing the same manufacturing process.

The updates and authorizations today have led to the consolidation and revision of the fact sheets for the Moderna COVID-19 Vaccine, Bivalent, and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Instead of separate fact sheets for different authorized age groups, each vaccine now has one fact sheet for healthcare providers and one for recipients and caregivers.

The authorizations granted today are the result of discussions held during a meeting with the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on January 26th. During this meeting, the committee unanimously recommended standardizing the strain composition of COVID-19 vaccines used in the United States and simplifying the vaccine dosing schedule.

The FDA plans to convene a meeting of its VRBPAC in June to address the strain composition of COVID-19 vaccines for the fall of 2023. Similar to the annual meetings held for influenza vaccines, the agency will request guidance from the committee on which SARS-CoV-2 variants and lineages are expected to circulate in the following year. After the selection of specific strains, the FDA anticipates that vaccine manufacturers will create updated formulations of the vaccines for distribution in the fall.