CDC Must Still Approve
Washington, D.C.-(ENEWSPF)- The U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines. Vaccine researchers developed these to more closely target currently circulating variants. They provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines are up to date. They include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.
What You Need to Know
- Individuals 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 2 months since the last dose of any COVID-19 vaccine.
- Individuals 6 months through 4 years of age who have previously 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 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 is confident in the safety and effectiveness of these updated vaccines. The agency’s benefit-risk assessment demonstrates that the benefits outweigh the risks of these vaccines. This is for individuals six months of age and older.
- Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines as described in the respective prescribing information or fact sheets.
- Vaccine researchers expect the updated vaccines to provide good protection against COVID-19 from the currently circulating variants. Barring the emergence of a markedly more virulent variant, the FDA anticipates updating the composition of COVID-19 vaccines annually, just like the seasonal influenza vaccine.
- The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet tomorrow (Sept. 12). They will discuss clinical recommendations on who should receive an updated vaccine. They will further consider 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
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D., 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 12 years of age and older. They are authorized under emergency use for individuals six months through 11 years of age. The bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized in the United States.
Data Supporting the Updated mRNA COVID-19 Vaccines (2023-2024 Formula)
The mRNA COVID-19 vaccines approved and authorized today find support by the FDA’s evaluation of manufacturing data. This supports the change to the 2023-2024 formula. Also, non-clinical immune response data on the updated formulations including the XBB.1.5 component.
- The updated mRNA vaccine manufacturing uses a similar process as previous formulations. In studies that done recently, 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 the extent of neutralization seen with prior versions of the vaccines against corresponding previous variants against which they provide protection. This suggests the vaccines are a good match for protecting against the currently circulating COVID-19 variants.
- We know well benefit-risk profile of previous mRNA COVID-19 vaccines. Hundreds of millions of people in the United States received these vaccines.
Based on an evaluation of the totality of the evidence, the benefit-risk profile is favorable. This is for individuals six 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. Recently receiving a COVID-19 vaccine reduces the risk of such serious outcomes.
Additional Details on Today’s Actions
Specifically, today’s actions include:
- Approval of Comirnaty (COVID-19 Vaccine, mRNA) to include the 2023-2024 formula and a change to a single dose for individuals 12 years of age and older. Comirnaty is a two-dose series for individuals 12 and older.
- Approval of Spikevax (COVID-19 Vaccine, mRNA) to include the 2023-2024 formula, a change to a single dose for individuals 18 and older, and approval of a single dose for individuals 12 through 17. Spikevax is a two-dose series for individuals 18 and older.
- Authorization of Moderna COVID-19 Vaccine for emergency use in individuals six months through 11 years of age to include the 2023-2024 formula. Also, lower the age eligibility for receipt of a single dose from 6 to 5 years of age. The FDA authorizes additional doses for specific immunocompromised individuals ages six months through 11 years, as the fact sheets describe.
- Authorization of Pfizer-BioNTech COVID-19 Vaccine for emergency use in individuals six months through 11 years of age to include the 2023-2024 formula. The FDA authorizes additional doses for specific immunocompromised individuals ages six months through 11 years, as the fact sheets describe.
The FDA granted approval of Comirnaty (COVID-19 Vaccine, mRNA) (2023-2024 Formula) to BioNTech Manufacturing GmbH. The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) was for Pfizer Inc.
ModernaTX Inc. has approval of Spikevax (COVID-19 Vaccine, mRNA) (2023-2024 Formula). ModernaTX Inc. has approval EUA amendment for the Moderna COVID-19 Vaccine (2023-2024 Formula).
This is news from the Food and Drug Administration, released September 11, 2023. We edited and simplified some of the language for the sake of clarity for the majority of us not in the medical profession.