CNN
—
US Food and Drug Administration Revision emergency use licensing terms for Pfizer and Moderna’s dual-valent vaccines on Tuesday, allowing people 65 years of age and older and some people with weakened immunity to receive additional doses before vaccination campaign this fall.
The bivalent vaccine produced by Pfizer and Moderna contains instructions against both the original strain of the Covid-19 virus as well as Omicron and its byproducts.
They are already available in the US since September under an emergency use authorization, or EUA, which severely restricts how vaccines are administered.
On Tuesday, the FDA changed the licensing terms for those vaccines so that some individuals can receive an additional dose before most others.
Specifically, adults 65 years of age and older who received a single dose of bivalent vaccine can receive an additional dose at least four months after the first dose.
Most people with some degree of immunocompromise who received the first dose of bivalent vaccine can get a second dose at least 2 months later. Additional doses may be administered at the discretion of their healthcare provider.
Peter Hotez, co-director of the Vaccine Development Center at Texas Children’s Hospital, has called on the FDA to increase access to divalent boosters for those who want them. For the most part, today’s guidance from the agency makes sense, he said.
“My only question is why the age limit of 65? What is that based on? Usually, I want to go down to 60 or even 50,” Hotez said in an email to CNN.
“For Americans who understand how important it is, we should provide second divalent boosters. Finally, we’ll soon need guidance on another annual fall boost. Perhaps that information will come this summer,” he added.
The FDA said in a press release that for immunocompromised children 6 months to 4 years of age, eligibility for a supplemental dose of bivalent will depend on the vaccine previously received.
The agency says another major change is that most unvaccinated people can now receive a single dose of the double-dose vaccine, instead of multiple doses like the original monovalent vaccine. The FDA has simplified its recommendation for unvaccinated people after realizing that most Americans now have some immunity against Covid-19, even if it’s only due to infections. previous illness.
“There is now evidence that most of the US population age 5 and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either through vaccination or infection. This may be the basis for the protection provided by the divalent vaccine. COVID-19 continues to be a very real risk for many, and we encourage individuals to consider maintaining immunizations, including the divalent COVID-19 vaccine. Available data continue to demonstrate that vaccines prevent the most serious consequences of COVID-19, which are severe illness, hospitalization and death,” said Dr Peter Marks, head of the Center for Evaluation and FDA Biological Research, said in a report. New information posted.
Children 6 months to 5 years of age who have not been vaccinated can now receive the Moderna bivalent vaccine as the main series, or a three-dose series of Pfizer-BioNTech bivalent vaccine if the child is 6 months old. 4 years old. Children 5 years old can receive two doses of Moderna’s bivalent vaccine or one dose of Pfizer-BioNTech’s bivalent vaccine.
Children 6 months to 5 years of age who started getting the monovalent vaccine can now get a single dose of the bivalent vaccine, but the number of doses a child is eligible to receive will depend on the number of doses they received and the type of vaccine. vaccines they received.
The agency stressed that most people who have received a single dose of the bivalent vaccine are not currently eligible for a second dose.
And they encouraged everyone who hasn’t had their first dose of the bivalent vaccine to do so, and many Americans are still in that situation.
Only about 17% of those eligible, less than 1 in 5 Americans, received the recommended dose.
As time went on, adults with reduced immune function due to age or underlying health problems asked their doctors if they needed an extra dose of the bivalent vaccine.
The US Centers for Disease Control and Prevention reported early data that the effectiveness of the bivalent vaccine, even for emergency room visits and hospitalizations, has begun to wane. .
But the agency has not been free to make so-called “permissible use” recommendations on boosters, which would allow doctors to provide additional doses to vulnerable patients. due to the terms of the EUA.
The updated provisions give CDC and the Advisory Committee on Immunization Practices (ACIP) more freedom in recommending additional doses of the divalent vaccine. ACIP will hold a meeting on a Covid-19 vaccine on Wednesday and is expected to endorse the FDA’s changes.
For those not covered by today’s changes, the FDA said it intends to make a decision about future immunizations after receiving recommendations on fall strain composition from the advisory committee. consultation in June.
Both Canada and UK delivered another round of bivalent boosters to those most at risk of Covid-19 this spring.
