By IDSE News Staff
The FDA approved and authorized for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death.
The mRNA vaccines for 2023-2024 manufactured by ModernaTX and Pfizer-BioNTech have been updated to include a monovalent component that corresponds to the omicron subvariant XBB.1.5.
The updated mRNA COVID-19 vaccines approved and authorized are supported by the FDA’s evaluation of manufacturing data to support the change to the 2023-2024 formula and nonclinical immune response data on the updated formulations, including the XBB.1.5 component.
The 2023-2024 mRNA vaccines are manufactured using a similar process as previous formulations. In recently conducted studies, the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5 and BA.2.86, appears to be of a similar magnitude to that of neutralization observed with versions of the vaccines against corresponding prior variants against which they had been developed to provide protection. This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants.
The benefit–risk profile of previously authorized and approved mRNA COVID-19 vaccines is well understood, as these vaccines have been administered to hundreds of millions of people in the United States, the agency said.
Based on an evaluation of the totality of the evidence, the benefit–risk profile is favorable for individuals who are 6 months of age and older to receive an updated COVID-19 mRNA vaccine. Although serious outcomes from COVID-19 are less common in younger individuals, they do occur, and it has been demonstrated that receiving a recent COVID-19 vaccine reduces the risk for such serious outcomes.
Individuals who are 5 years of age and older regardless of previous vaccination are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least two months since the last dose of any COVID-19 vaccine.
Those who are 6 months through 4 years of age who had been vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA COVID-19 vaccine (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
Unvaccinated individuals who are 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’s benefit–risk assessment demonstrated that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks, the agency said in a statement.
People who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by those who previously received mRNA COVID-19 vaccines.
The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants. Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.
The CDC’s Advisory Committee on Immunization Practices will meet on Sept. 12 to discuss clinical recommendations about who should receive an updated vaccine, as well as further considerations for specific populations, such as immunocompromised and older individuals.
Manufacturers have publicly announced that the updated vaccines would be ready this fall, and the FDA anticipates that the updated vaccines will be available in the near future.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, MD, PhD, the 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, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
The updated mRNA vaccines are each approved for individuals who are 12 years of age and older and under an emergency use authorization (EUA) for those who are 6 months through 11 years of age. As part of this action, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
Specifically, the actions include:
- The approval of Comirnaty (COVID-19 vaccine, mRNA) to include the 2023-2024 formula, and a change to a single dose for individuals who are 12 years of age and older. Comirnaty was previously approved as a two-dose series for individuals 12 years of age and older.
- The approval of Spikevax (COVID-19 vaccine, mRNA) to include the 2023-2024 formula, a change to a single dose for individuals 18 years of age and older, and approval of a single dose for individuals who are 12 through 17 years of age. Spikevax was previously approved as a two-dose series for individuals 18 years of age and older.
- EUA of Moderna COVID-19 vaccine in individuals who are 6 months through 11 years of age to include the 2023-2024 formula and lower the age eligibility for receipt of a single dose from 6 to 5 years of age. Additional doses are also authorized for certain immunocompromised individuals aged 6 months through 11 years, as described in the fact sheets.
- EUA of the Pfizer-BioNTech COVID-19 vaccine in individuals who are 6 months through 11 years of age to include the 2023-2024 formula. Additional doses are also authorized for certain immunocompromised individuals aged 6 months through 11 years, as described in the fact sheets.
