CNN
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The U.S. Food and Drug Administration on Tuesday changed the terms of its emergency use authorizations for the Pfizer and Moderna dual vaccines, allowing people 65 and older and some people with weakened immunity to get extra doses ahead of this fall’s vaccination campaigns.
The bivalent vaccines made by Pfizer and Moderna contain instructions to fight both the original strain of the Covid-19 virus as well as Omicron and its derivatives.
They have been available in the United States since September under emergency use authorizations, or EUAs, which strictly restrict how the vaccines can be administered.
On Tuesday, the FDA changed the terms of authorization for those vaccines so that some people could get an extra dose before most others.
Notably, adults 65 years of age and older who received a single dose of a bivalent vaccine may receive an additional dose at least four months after their first dose.
Most people with some degree of immunodeficiency who have received a first dose of a bivalent vaccine can receive a second dose at least two months later. Additional doses may be given at the discretion of their health care provider.
Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children’s Hospital, called on the FDA to expand access to bivalent boosters for those who want them. Overall, he said, the agency’s current guidance makes sense.
“My only question is: Why the 65 age limit? What is it based on? Normally, I would have preferred it to be reduced to 60 or even 50,” Hotez said in an email to CNN.
“For Americans who understand its importance, we should offer a second bivalent booster. Finally, we will soon need guidance on another annual booster in the fall. That information will likely be available this summer,” he added.
For immunocompromised children ages 6 months to 4 years, eligibility for additional bivalent doses will depend on which vaccine was previously received, the FDA said in a news release.
Another important change is that most unvaccinated people can now get a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent vaccines, the agency said. The FDA simplified its recommendation for unvaccinated people after acknowledging that most Americans now have some immunity to Covid-19, even if only from past infections.
“There is now evidence that most Americans ages 5 and older have antibodies to SARS-CoV-2, the virus that causes COVID-19, from vaccination or infection, which may provide the basis for protection provided by bivalent vaccines. COVID-19 continues to pose a very real risk to many people, and we encourage individuals to consider staying up-to-date on their vaccinations, including with a bivalent COVID-19 vaccine. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, including severe illness, hospitalization, and death,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a press release.
Children ages 6 months to 5 years who have not yet been vaccinated can now receive a two-dose series of the Moderna bivalent vaccine as their first series, or a three-dose series of the Pfizer-BioNTech bivalent vaccine if they are ages 6 months to 4 years. Children ages 5 years can receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
Children aged 6 months to 5 years who have started their monovalent vaccines can now receive one dose of a bivalent vaccine, but the number of doses they are entitled to will depend on how many doses they have already received and the type of vaccine they received.
The agency stressed that most people who received one dose of a bivalent vaccine are currently not eligible for a second dose.
And they’ve encouraged anyone who hasn’t yet gotten their first dose of a dual vaccine to do so, and many Americans are still in that situation.
Only about 17% of eligible people, or less than one in five Americans, have received the recommended dose.
Over time, adults with reduced immune function due to age or an underlying health condition ask doctors if they need another dose of bivalent vaccines.
The U.S. Centers for Disease Control and Prevention has reported preliminary data showing that the effectiveness of bivalent vaccines, even against emergency room visits and hospitalizations, has already begun to wane.
But the agency was not free to make what’s called a “permissive use” recommendation for boosters, which would allow doctors to offer extra doses to vulnerable patients because of the terms of the EUA.
The new requirements give the CDC and its Advisory Committee on Immunization Practices (ACIP) greater freedom to recommend additional doses of bivalent vaccines. The ACIP is holding a meeting on COVID-19 vaccines on Wednesday and is expected to approve the FDA’s changes.
For anyone not covered by today’s changes, the FDA says it plans to make decisions on future vaccinations after receiving recommendations on the composition of the fall strain from its advisory committee in June.
Canada and the United Kingdom have both offered a new round of dual booster shots to people most at risk of contracting Covid-19 this spring.
