The U.S. Food and Drug Administration The FDA has taken steps to approve and authorize for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and provide better protection against severe disease outcomes, including hospitalization and death.
The agency's action on Monday relates to the updated 2023-2024 mRNA vaccines manufactured by ModernaTX and Pfizer.
Based on the totality of the evidence and input from FDA's expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron XBB.1.5 variant.
Eligibility
Individuals aged 5 years and older, regardless of prior vaccination, are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least 2 months after the last dose of any COVID-19 vaccine.
In turn, people aged 6 months to 4 years who have been previously vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA vaccine.
Of note, unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated, authorized Moderna COVID-19 Vaccine.
The FDA said in a statement that it is confident in the safety and effectiveness of these updated vaccines, as the agency's risk-benefit assessment shows that the benefits of these vaccines for people 6 months of age and older outweigh their risks.
People who receive an updated mRNA COVID-19 vaccine may experience side effects similar to those reported by people who previously received mRNA COVID-19 vaccines, as described in the respective prescribing information or fact sheets.
The updated vaccines are expected to provide good protection against COVID-19 against currently circulating variants. Barring the emergence of a significantly more virulent variant, the FDA anticipates that COVID-19 vaccines may need to have their composition updated annually, as is done with the seasonal influenza vaccine.
The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet Tuesday to discuss clinical recommendations on who should receive an updated vaccine, as well as additional considerations for specific populations, such as immunocompromised people and older adults.
Manufacturers have publicly announced that updated vaccines will be ready this fall, and the FDA anticipates they will be available in the near future.
“Vaccination remains critical for public health and continued protection against the serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, efficacy and manufacturing quality. We strongly encourage those who are eligible to consider getting vaccinated,” she added.
Each of the updated mRNA vaccines is approved for people 12 years of age and older and is authorized for emergency use for people 6 months to 11 years of age, while, The bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
The updated mRNA vaccines are manufactured using a similar process as the previous formulations. In recent studies, the degree of neutralization observed by the updated vaccines against currently circulating viral variants that cause COVID-19, including EG.5 and BA.2.86, appears to be of a similar magnitude to the degree of neutralization observed with previous versions of the vaccines against the corresponding previous variants against which they had been developed to provide protection.
This suggests that vaccines are a good match for protection against currently circulating COVID-19 variants.
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