That guidance followed the amendment of the Emergency Use Authorizations (EUAs) of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine by the FDA to authorize bivalent formulations of the vaccines for use as a single booster dose at least 2 months following primary or booster vaccination.
The updated vaccines contain two mRNA components of the SARS-CoV-2 virus, one original strain of SARS-CoV-2, and the other one in common between the BA.4 and BA.5 lineages of the Omicron variant of SARS-CoV-2.
With the addition of the updated vaccines, pharmacists now have three seasonal vaccines to administer this year. In addition to the usual flu shots, new vaccines for respiratory syncytial virus (RSV) were approved.
The CDC pointed out that vaccination not only lowers the risk of immediate adverse outcomes from COVID-19 but also reduces the chance of developing long COVID, which can develop during or following acute infection and last for an extended duration.
Public health officials pointed out that most Americans can still get a COVID-19 vaccine for free. Most health insurance plans cover the COVID-19 vaccine at no cost to beneficiaries, while those without insurance or that type of coverage can get free vaccines from local health centers; state, local, tribal, or territorial health departments; and pharmacies participating in the CDC’s Bridge Access Program, which provides no-cost COVID-19 vaccines to adults without health insurance and whose insurance does not cover all COVID-19 vaccine costs. That program is available until the end of 2024.
Children eligible for the Vaccines for Children program also can receive the vaccine without cost from a provider enrolled in that program.
“We have more tools than ever to prevent the worst outcomes from COVID-19,” said CDC director Mandy Cohen, MD, MPH. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”
The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in those aged 18 years and older, while the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose starting at age 12 years.
The FDA advised that the authorized bivalent COVID-19 vaccines, or updated boosters, included an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the Omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the Omicron variant.
That is important, according to the agency, because the BA.4 and BA.5 lineages of the Omicron variant are currently causing most cases of COVID-19 in the United States and are predicted to circulate this fall and winter. Side effects from the bivalent shots are expected to be similar to previous versions of the COVID-19 vaccine.
The FDA added:
• For each bivalent COVID-19 vaccine, it based its decision on the totality of available evidence, including extensive safety and effectiveness data for each of the monovalent mRNA COVID-19 vaccines, safety and immunogenicity data obtained from a clinical study of a bivalent COVID-19 vaccine that contained mRNA from Omicron variant BA.1 lineage that is similar to each of the vaccines being authorized, and nonclinical data obtained using a bivalent COVID-19 vaccine that contained mRNA of the original strain and mRNA in common between the BA.4 and BA.5 lineages of the Omicron variant
• Based on the data supporting each of these authorizations, the bivalent COVID-19 vaccines are expected to provide increased protection against the currently circulating Omicron variant
• With today’s authorization, the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals aged 12 years and older.
• The agency will work quickly to evaluate future data and submissions to support the authorization of bivalent COVID-19 boosters for additional age groups as we receive them.
In terms of eligibility, people aged 18 years and older are eligible for a single booster dose of the Moderna COVID-19 Vaccine, Bivalent if it has been at least 2 months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Those aged 2 years and older are eligible for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if it has been at least 2 months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert M. Califf, MD. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”
The FDA explained that the mRNA in the new booster vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the Omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical, it added.
“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants,” pointed out Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “We sought input from our outside experts on the inclusion of an omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations.”
The new authorization means that the EUA has been revised to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for those aged 18 years and older and 12 years and older, respectively. Monovalent vaccines continue to be authorized for use for administration of a primary series for individuals aged 6 months and older as described in the letters of authorization. In addition, the Pfizer-BioNTech COVID-19 vaccine remains authorized for administration of a single booster dose for individuals aged 5 through 11 years at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 vaccine.
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