FDA Approves Additional Bivalent Boosters for Specific Vulnerable Populations

FDA Approves Additional Bivalent Boosters for Specific Vulnerable Populations



UJ
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On Tuesday, the U.S. Food and Drug Administration revised its emergency use authorizations for the Pfizer and Moderna bivalent vaccines, permitting individuals aged 65 and above, along with certain immunocompromised individuals, to receive additional doses ahead of the upcoming fall vaccination initiatives.

The bivalent vaccines developed by Pfizer and Moderna are designed to combat both the original Covid-19 variant and the Omicron variant along with its variants.

These vaccines have been available in the U.S. since September through emergency use authorizations (EUAs), which impose strict guidelines on their administration.

The FDA’s alteration on Tuesday enables specific groups to obtain an extra dose before many others.

Specifically, adults aged 65 and above who have received one dose of a bivalent vaccine are eligible for an additional dose at least four months after the initial dose.

Many individuals with varying levels of immunocompromise who received their first bivalent vaccine dose can obtain a second dose at least two months later. Additional doses may be provided at the discretion of their healthcare professional.

Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children’s Hospital, has advocated for broader access to bivalent boosters for those interested. He commented that today’s FDA guidance is predominantly logical.

“My only concern is the age cutoff of 65. What is the basis for that? Ideally, I would have preferred it set at 60 or even 50,” Hotez stated in an email to UJ.

“For Americans who recognize its significance, additional bivalent boosters should be made accessible. Furthermore, we will soon require guidance regarding another annual booster in the fall. Anticipated information should emerge sometime this summer,” he added.

For immunocompromised children aged 6 months to 4 years, additional bivalent dose eligibility will depend on the vaccine they received previously, according to an FDA news release.

Another significant adjustment is that unvaccinated individuals can now receive a single dose of a bivalent vaccine, rather than multiple doses of the original single-strain vaccines, as stated by the agency. The FDA simplified its guidance for unvaccinated individuals after acknowledging that most Americans have attained some level of immunity against Covid-19, even if through previous infections.

“Available evidence indicates that most individuals in the U.S. over the age of 5 possess antibodies to SARS-CoV-2, the virus responsible for COVID-19, from either vaccination or past infection, which can bolster the protection from bivalent vaccines. COVID-19 remains a legitimate threat to many, and we advocate that individuals consider keeping up with vaccinations, including receiving a bivalent COVID-19 vaccine. Available data persistently demonstrate that vaccines are effective in preventing the most severe outcomes of COVID-19, including severe illness, hospitalization, and death,” remarked Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in a news release.

Children aged 6 months to 5 years who have not yet been vaccinated may now receive a two-dose primary series of the Moderna bivalent vaccine, or a three-dose series of the Pfizer-BioNTech bivalent vaccine if they are between 6 months and 4 years old. Children who are 5 years old may choose between two doses of the Moderna bivalent or one dose of the Pfizer-BioNTech bivalent vaccine.

Children aged 6 months to 5 years who started their vaccinations with monovalent vaccines can now receive a bivalent vaccine dose; however, the total number of doses they are eligible for will depend on their previous vaccination history and the types of vaccines they received.

The agency emphasized that most individuals who have received one dose of a bivalent vaccine are currently not eligible for a second dose.

They also urged everyone who has yet to receive their initial bivalent vaccine dose to do so, as many Americans still fall into that category.

Currently, only about 17% of those eligible, which is less than 1 in 5 Americans, have received the recommended dose.

Over time, adults with diminished immune responses, whether due to age or underlying health issues, have been seeking clarity from doctors regarding the necessity of a subsequent dose of the bivalent vaccines.

Recent data from the CDC indicates that the effectiveness of the bivalent vaccines against emergency room visits and hospitalizations has begun to decrease.

However, the agency has been constrained from making what’s known as a “permissive use” recommendation concerning the boosters, which would permit healthcare providers to offer additional doses to vulnerable patients due to the existing EUA stipulations.

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The revised terms enhance the recommendations of the CDC and its Advisory Committee on Immunization Practices (ACIP) regarding additional doses of the bivalent vaccines. The ACIP is set to meet on Wednesday to discuss the Covid-19 vaccines and is anticipated to support the FDA’s revisions.

For individuals not affected by the recent changes, the FDA indicates it plans to make further vaccination decisions after reviewing recommendations regarding the fall strain composition from its advisory committee in June.

Both Canada and the United Kingdom have provided another series of bivalent boosters to those at highest risk for Covid-19 this spring.