FDA Approves More Bivalent Boosters for Vulnerable Individuals!
FDA Expands Access to Pfizer and Moderna Bivalent Boosters for Older Adults and Immunocompromised Individuals
In a move aimed at further protecting vulnerable populations from Covid-19, the U.S. Food and Drug Administration (FDA) has amended the terms of emergency use authorizations (EUAs) for the Pfizer-BioNTech and Moderna bivalent vaccines. The updated guidance, announced on Tuesday, allows people ages 65 and older, as well as certain individuals with weakened immunity, to receive additional doses of the bivalent vaccines ahead of the upcoming fall vaccination campaigns.
The bivalent vaccines, which provide protection against both the original strain of the virus as well as its variants, have been available in the United States since September 2022 under EUAs that have tightly restricted their administration. However, the FDA has now expanded access to these boosters for eligible individuals in an effort to further strengthen immunity against Covid-19.
According to the new guidance, most individuals with certain degrees of immunocompromise who have received a first dose of a bivalent vaccine can get a second dose at least 2 months later, with additional doses to be administered at the discretion of their healthcare provider. This update comes after calls from experts, such as Dr. Peter Hotez, who co-directs the Center for Vaccine Development at Texas Children’s Hospital, to increase access to bivalent boosters for those who want them. However, some experts have questioned the age cutoff of 65 years and suggested it could have been lowered to 60 or even 50 to provide further protection for older adults.
In addition to expanding access to boosters for older adults and immunocompromised individuals, the FDA also simplified its recommendation for unvaccinated individuals. Most unvaccinated individuals may now receive a single dose of a bivalent vaccine, instead of multiple doses of the original single-strain vaccines, as evidence suggests that most Americans now have some immunity against Covid-19 due to past infections or vaccinations.
Dr. Peter Marks, head of FDA’s Center for Biologics Evaluation and Research, emphasized the importance of staying current with vaccination, stating that vaccines continue to be effective in preventing severe illness, hospitalization, and death from Covid-19.
The updated guidance also includes recommendations for children ages 6 months through 5 years. Children who have not yet been vaccinated may now receive a two-dose series of the Moderna bivalent vaccine as their primary series, or a three-dose series of the Pfizer-BioNTech bivalent vaccine if they are 6 months through 4 years of age. Children who are age 5 may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine. Children who have already started on their monovalent vaccines can now also receive a dose of a bivalent vaccine, depending on the number of doses they've already had and what kind of vaccine they received.
While the FDA has expanded access to bivalent boosters for older adults, immunocompromised individuals, and young children, it's important to note that most people who have received one dose of a bivalent vaccine are not currently eligible for a second dose. However, the agency encourages those who haven't yet received their first dose to do so, as data has shown that vaccines are effective in preventing severe outcomes of Covid-19.
The CDC and its Advisory Committee on Immunization Practices (ACIP) are expected to endorse the FDA's changes in their upcoming meeting on Covid-19 vaccines. The FDA also stated that decisions about future vaccinations will be made after receiving recommendations on the fall strain composition from its advisory committee in June.
The FDA's updated guidance follows similar moves by other countries, such as Canada and the United Kingdom, which have offered.
In conclusion, the recent updates to the emergency use authorizations for the Pfizer and Moderna bivalent vaccines by the U.S. Food and Drug Administration mark a significant development in the ongoing fight against Covid-19. These changes now allow individuals aged 65 and older and those with weakened immunity to receive additional doses of the bivalent vaccines before this fall's vaccination campaigns. This decision comes after growing evidence of waning effectiveness of the vaccines over time and the need to provide enhanced protection to vulnerable populations.
Furthermore, the FDA's decision to simplify the recommendation for unvaccinated individuals by allowing them to receive a single dose of a bivalent vaccine, rather than multiple doses of the original single-strain vaccines, reflects the evolving understanding of the immunity against Covid-19 in the population. However, it is important to note that despite these updates, the majority of eligible individuals in the U.S. have not yet received a recommended dose of the bivalent vaccine, emphasizing the need for continued efforts to promote vaccination and protect public health.
With the CDC and its Advisory Committee on Immunization Practices (ACIP) now having greater flexibility to recommend additional doses of the bivalent vaccines, it is expected that more individuals, including those with reduced immune function, will be able to access the boosters for added protection against Covid-19. As other countries like Canada and the United Kingdom have already started offering additional rounds of bivalent boosters to those at highest risk, the FDA's decision is in line with global efforts to combat the evolving variants of the virus.
As we await further recommendations from the FDA's advisory committee on the fall strain composition in June, it is crucial for individuals to stay informed and follow guidance from healthcare providers to ensure timely and appropriate vaccination. The availability of bivalent vaccines and the FDA's updates to the emergency use authorizations provide a positive step forward in our ongoing battle against Covid-19, and it is imperative for everyone to continue working together to protect ourselves and our communities from this ongoing global health crisis.