The U.S. Food and Drug Administration. ?FDA, for its acronym in English? took action to approve and authorize the emergency use of updated COVID-19 vaccines, formulated to more closely target currently circulating variants and provide better protection against serious consequences of the disease, including hospitalization and death.
The action taken this Monday by the agency is related to the updated mRNA vaccines for 2023-2024 manufactured by ModernaTX and Pfizer.
Based on the totality of the evidence and input from FDA expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron XBB.1.5 variant.
Eligibility
People ages 5 and older, regardless of prior vaccination, are eligible to receive a single dose of an mRNA COVID-19 vaccine updated at least 2 months after the last dose of any COVID-19 vaccine.
In turn, people ages 6 months to 4 years who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA vaccine.
Notably, unvaccinated individuals ages 6 months to 4 years are eligible to receive three doses of the updated authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the authorized Moderna COVID-19 Vaccine and updated.
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 demonstrates that the benefits of these vaccines for people 6 months of age and older outweigh their risks.
People who receive an updated COVID-19 mRNA vaccine may experience side effects similar to those reported by people who previously received COVID-19 mRNA vaccines, as described in the respective prescribing information or fact sheets. .
The updated vaccines are expected to provide good protection against COVID-19 against the variants currently circulating. Unless a notably more virulent variant emerges, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done with the seasonal influenza vaccine.
The Advisory Committee on Immunization Practices of the US Centers for Disease Control and Prevention (CDC) will meet this 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 people.
Manufacturers have publicly announced that the 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 highly encourage those who are eligible to consider getting vaccinated,” he 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 previous formulations. In recently conducted studies, the degree of neutralization observed by 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 vaccines against the corresponding previous variants against which they had been developed to provide protection.
The above suggests that vaccines are a good combination to protect against the COVID-19 variants currently circulating.
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