CNN
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US Food and Drug Administration corrected terms of emergency use authorizations for the bivalent Pfizer and Moderna vaccines on Tuesday, allowing people 65 and older and some immunocompromised people to receive additional doses ahead of vaccination campaigns this fall.
The bivalent vaccines made by Pfizer and Moderna contain instructions to combat both the original strain of the Covid-19 virus and Omicron and its byproducts.
They were available in the United States. from September under emergency use authorizations (EUAs), which severely limit how vaccines can be administered.
On Tuesday, the FDA changed the authorization conditions for these vaccines to allow some people to get an extra dose sooner than most others.
Specifically, adults age 65 and older who have received a single dose of a bivalent vaccine can receive an additional dose at least four months after the first dose.
Most people with some degree of immunodeficiency who receive the first dose of a bivalent vaccine can receive a second dose at least 2 months later. Additional doses may be administered at the discretion of the attending physician.
Dr. Peter Hotez, who co-directs the Vaccine Development Center at Texas Children's Hospital, is calling on the FDA to expand access to bivalent boosters for those who need them. He says for the most part, the agency's guidance today makes sense.
“My only question is why is the age limit set at 65? What is that based on? Normally I would prefer to see the age lowered to 60 or even 50,” Hotez said in an email to CNN.
“For those Americans who understand its importance, we must make second bivalent boosters available. Finally, we will soon need guidance on another annual fall booster. This information is expected to be available sometime this summer,” he added.
For immunocompromised children ages 6 months to 4 years, eligibility to receive additional bivalent doses will depend on previously received vaccine, the FDA said in a press release.
Another big change is that most unvaccinated people can now receive one dose of the bivalent vaccine, rather than multiple doses of the original single-strain vaccine, the agency said. The FDA has simplified its recommendations for unvaccinated people, recognizing that most Americans now have some immunity against Covid-19, even if it only comes from past infections.
“There is now evidence that a large proportion of the US population aged 5 years and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either through vaccination or infection, which may underpin the protection provided by bivalent vaccines. COVID-19 remains a very real risk for many people, and we encourage people to consider timely vaccination, including the bivalent vaccine against COVID-19. Available data continue to demonstrate that vaccines prevent the most serious consequences of COVID-19, namely severe illness, hospitalization, and death,” said Dr. Peter Marks, head of the FDA's Center for Biologics Evaluation and Research, in the report. press release.
Children 6 months to 5 years of age who have not yet been vaccinated can now receive a two-dose series of the bivalent Moderna vaccine as their primary series, or a three-dose series of the bivalent Pfizer-BioNTech vaccine if they are 6 months to 4 years of age. Children aged 5 years can receive two doses of the bivalent Moderna vaccine or one dose of the bivalent Pfizer-BioNTech vaccine.
Children aged 6 months to 5 years who started receiving a monovalent vaccine can now receive a dose of a bivalent vaccine, but the number of doses they are eligible for will depend on the number of doses they have already received and which vaccine they have received.
The agency stressed that most people who have received one dose of the bivalent vaccine are not currently eligible for a second dose.
And they urged everyone who has not yet received the first dose of the bivalent vaccine to do so, and many Americans are still in that bucket.
Only about 17% of eligible people, less than 1 in 5 Americans, have received the recommended dose.
Over time, adults with weakened immune function due to age or health problems began asking doctors if they needed another dose of bivalent vaccines.
The US Centers for Disease Control and Prevention reported the first data showing that the effectiveness of bivalent vaccines, even against emergency room visits and hospitalizations, has already begun to decline.
But the agency did not have the authority to make so-called “permissive use” recommendations for boosters, which would allow doctors to offer extra doses to vulnerable patients because of the terms of the EUA.
The updated terms give the CDC and its Advisory Committee on Immunization Practices (ACIP) greater discretion to recommend additional doses of bivalent vaccines. ACIP is meeting on Covid-19 vaccines on Wednesday and is expected to approve the FDA changes.
For anyone not affected by today's changes, the FDA says it intends to make decisions about future vaccinations once it receives recommendations on the composition of the fall strain from its advisory committee in June.
Both Canada And United Kingdom This spring, they offered another round of bivalent booster shots to those most at risk of contracting Covid-19.
