In a significant move to bolster public health amid ongoing concerns about Covid-19, the U.S. Food and Drug Administration (FDA) has revised its emergency use authorisations for the bivalent vaccines developed by Pfizer and Moderna. This change, announced on Tuesday, allows individuals aged 65 and older, alongside certain immunocompromised individuals, to receive additional doses ahead of the anticipated vaccination efforts this autumn.
New Guidelines for Booster Shots
The updated guidance permits seniors who have already received a single dose of a bivalent vaccine to obtain an additional shot no sooner than four months after their first. Similarly, individuals with specific immunocompromising conditions can receive a second dose at least two months after their initial bivalent vaccination. Healthcare providers now have the discretion to administer further doses based on individual patient needs.
Dr. Peter Hotez, co-director of the Centre for Vaccine Development at Texas Children’s Hospital, has voiced his support for broadening access to these bivalent boosters. He expressed a desire for the age threshold to be lowered, suggesting that it should extend to those aged 60 or even 50. “For those Americans who understand its importance, we should make second bivalent boosters available,” he stated in correspondence with CNN.
Changes for Young Children and Unvaccinated Individuals
For children aged 6 months to 4 years, eligibility for additional bivalent doses will depend on the type of vaccine they have previously received. Meanwhile, unvaccinated individuals can now receive a single bivalent vaccine dose, a simplification prompted by the FDA’s recognition that a significant portion of the population already possesses some level of immunity, whether through prior infections or vaccinations.
Dr. Peter Marks, head of the FDA’s Centre for Biologics Evaluation and Research, reiterated the importance of vaccination. “COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination,” he advised. The data indicates that vaccines effectively mitigate severe outcomes associated with the virus.
Current Vaccination Landscape
Despite the expanded access, vaccination rates remain concerning. Just 17% of those eligible for a bivalent vaccine have received their recommended dose, highlighting a substantial gap in coverage. The FDA’s revisions aim to address this issue, allowing for greater flexibility in vaccination protocols, which may encourage more individuals to seek out boosters.
The CDC has acknowledged the waning effectiveness of the bivalent vaccines against severe illness, hospitalisation, and emergency room visits. However, the agency had previously been restricted in its ability to recommend additional doses due to the conditions set by the emergency use authorisation. The latest changes provide the CDC and its Advisory Committee on Immunization Practices (ACIP) more latitude to endorse further vaccinations, with a meeting scheduled to discuss these new guidelines.
Why it Matters
These recent amendments by the FDA mark a pivotal step in the ongoing battle against Covid-19, particularly as we approach the autumn vaccination period. With numerous individuals still unvaccinated and the landscape of immunity shifting, these changes could help bridge the gap and ensure that the most vulnerable populations receive the protection they need. As other countries, including Canada and the United Kingdom, have already begun offering additional boosters, the U.S. is poised to enhance its vaccination strategy and safeguard public health in the face of evolving threats from the virus.
