FDA clears the way for additional bivalent boosters for certain vulnerable individuals
Cnn
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The US Food and Drug Administration has changed the terms of its emergency use authorizations for the PFIZER and modern bivalent vaccines on Tuesday, allowing people aged 65 and over and some people with weakened immunity to obtain additional doses before this fall vaccination campaigns.
Bivalent vaccines manufactured by Pfizer and Moderna have instructions to combat the original strain of the COVVI-19 virus as well as omicron and its benefits.
They have been available in the United States since September under emergency use authorizations, or EUAS, which closely restrict how vaccines can be given.
On Tuesday, the FDA changed the terms of the authorizations of these vaccines so that some people can get an additional dose in front of most others.
Namely, adults aged 65 and over who have received a single dose of a bivalent vaccine can receive an additional dose at least four months after their first dose.
Most of the individuals with certain immunocompromis degrees who have received a first dose of a bivalent vaccine can obtain a second at least 2 months later. Additional doses can be administered at the discretion of their health care provider.
Dr. Peter Hooz, who codiriges the Center for Vaccine Development in Texas Children’s Hospital, called on the FDA to increase access to bivalent boosters for those who want them. He says that for the most part, today’s advice from the agency has meaning.
“My only question is why the age limit of 65? What was based on” normally I would have preferred that it was reduced to 60 or even 50, “said Hooz in an email at CNN.
“For Americans who understand its importance, we should make the second bivalent boosters available. Finally, we will soon need advice on another annual fall booster. Really that information is coming this summer,” he added.
For immunocompromised children aged 6 months to 4 years, eligibility for additional bivalent doses will depend on the vaccine received previously, the FDA said in a press release.
Another big change is that most non -vaccinated individuals can now receive a single dose of a bivalent vaccine, rather than musical doses of original deformation vaccines, the agency said. The FDA has simplified its recommendation for non-vaccinated individuals after recognizing that most Americans now have some immunity against COVID-19, even if it is just through past infections.
“Evidence is now available that most of the American population aged 5 and over has antibodies against SARS-COV-2, the virus that causes COVID-19, or by vaccination or infection which can be used as a basis for protection provided by bivalent vaccines. COVID-19 continues to be a very real risk for many people, and we encourage people to take into account vaccination, especially with a COVVI-1 tag. Continue to demonstrate that vaccines prevent the most serious results of COVI-19, which are a serious illness, hospitalization and death, “said Dr. Peter Marks, head of the Center for Biologics Evaluation and Research of the FDA, in a press release.
Children aged 6 months to 5 years who have not yet been vaccinated can now receive a two-doses series of the modern bivalent vaccine as a main series, or a three-doses series of the Bivalent Pfizer-Biontech vaccine if they are 6 months old. Children aged 5 can receive two doses of modern bivalent or a single dose of the Pfizer-Biontech bivalent vaccine.
Children aged 6 months to 5 years who have started their monovalent vaccine can now obtain a dose of a bivalent vaccine, but the number of doses for which they will qualify will depend on the number of doses they have already had and the type of vaccine they have received.
The agency stressed that most people who have obtained a dose of a bivalent vaccine are not currently eligible for a second dose.
And they have encouraged all those who have not yet obtained their first dose of bivalent vaccine to do so, and many Americans are still in this bucket.
About only 17% of eligible people, less than 1 in 5 Americans, obtained a recommended dose.
Over time, adults with reduced immune function due to their age or underlying health problem have asked doctors if they need another dose of bivalent vaccines.
The Center for Disease Control and Prevention of the United States has reported early data showing that the effectiveness of bivalent vaccines, even against visits and hospitalizations of emergency rooms, has already started to decline.
But the agency was not free to do what is called a recommendation “for permissive” on boosters, which would allow doctors to offer additional doses to vulnerable patients due to UEA terms.
The updated terms give the CDC and its advisory committee on vaccination practices (ACIP) more freedom to recommend additional doses of bivalent vaccines. The APIP holds a meeting on COVVI-19 vaccines on Wednesday and should approve the modifications of the FDA.
For all those who are not covered by today’s modifications, the FDA says that it intends to make decisions concerning future vaccinations after receiving recommendations on the composition of the autumn strain of its advisory committee in June.
Canada and the United Kingdom have offered another series of bivalent boosters to those who are most at risk of COVID-19 this spring.
