The move extends the availability of additional booster vaccines to healthy older adults. The FDA had previously allowed second booster shots for people 12 years and older with severe immunodeficiency, beginning four months after their first booster shot.
“Current evidence suggests that protection against serious consequences of COVID-19 decreases somewhat over time in elderly and immunocompromised individuals. Based on an analysis of new data, a second booster dose of either the Pfizer-BioNTech or Moderna-COVID-19 vaccine could help increase levels of protection for these higher-risk individuals,” said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research of the FDA, in a press release, “Additionally, the data show that an initial booster dose is critical in protecting all adults from the potentially serious consequences of COVID-19. Therefore, those who have not yet received their initial booster dose will be advised , strongly recommended to do so.”
In making its decision, the FDA said it determined that the known and potential benefits of the second booster shot outweigh the known and potential risks to these populations.
The US Centers for Disease Control and Prevention is expected to follow what is known as a permissive recommendation – a statement that the shots can be used in this age group for those who want them. However, the agency is not expected to officially endorse the recordings.
Failure by the CDC to provide clear endorsement for second booster shots would undo the work of weighing the risks and benefits of another dose of vaccine for individuals, and it has sparked no small amount of dismay from some vaccine advocates, who say the marginal added protection some will not worth the confusion fourth doses cause.
dr Megan Ranney, an emergency medicine physician and academic dean of Brown University’s School of Public Health, says officials have faced policy making throughout the pandemic before they had enough evidence to support it. Ranney sees this as another example.
She says, frankly, it’s not clear everyone needs a fourth dose now. However, having these approvals provides the flexibility to quickly launch additional boosters as needed.
“I see this approval from the Biden administration as an insurance policy on their part,” Ranney says. “It’s a way of allowing people to get the vaccine or the extra boost. But it also gives them the flexibility to roll it out quickly should BA.2 be worse than expected. or God forbid, should there be another variant in the next few months that requires another booster, they can launch it quickly. So that’s how I read it,” she says.
There is general scientific agreement that third doses help boost immunity against serious illness from the virus that causes Covid-19. However, the science is far from decided if, or even when, a fourth dose might be needed, as vaccines continue to offer high levels of protection against hospitalization and death from Covid-19 even as disease protection wears off.
Much of the evidence examining the safety and effectiveness of a second booster shot comes from Israel, which has been recommending a fourth dose of the coronavirus vaccine for adults aged 18 and over since late January.
The FDA said its decision reviewed data from the Israel Ministry of Health on more than 700,000 people aged 18 and over who received a second booster of Pfizer’s BioNTech vaccine at least four months after their first booster. More than 600,000 of these people were over 60 years old. The agency said the data did not reveal any new safety issues related to a fourth dose.
The FDA said data on the safety of the Moderna boosters when used as a fourth dose came from a study of 120 people ages 18 and older who received a fourth dose of the vaccine at least four months after their third vaccination with the Pfizer vaccine. No new safety concerns were identified in the three weeks following the last dose.
Some of the data that the FDA based its decision on comes from previously published studies.
In a large study of more than half a million adults over the age of 60, those who received a second booster or fourth dose of a Covid-19 vaccine were 78% less likely to die during the Omicron wave than those who did a third shot at least four months earlier. But the number of deaths was relatively small in both groups. After 40 days of follow-up, there were a total of 232 deaths from nearly 234,000 people who received just three doses of the Pfizer-BioNTech vaccine, compared to 92 deaths from 328,000 people including younger adults found the fourth booster was safe and brought the antibodies back to the same levels achieved after the third dose. But fourth doses were only moderately effective — about 30 to 40% — at preventing disease. And most workers who fell ill still had high viral loads, suggesting they were able to transmit the infection to others.
Additional studies from the UK show that a booster dose wears off the antibody boost very quickly within a few weeks. Therefore, some experts believe that given the resources available and the diminishing appetite to continue receiving more and more boosters, the United States should wait until there is a clear threat of a new wave of infections to introduce fourth doses. Some see the likely timing of this as next fall.
“If you only have one bullet in your gun to shoot, I would prefer to hold fire until the fall because then cases could really pick up because I don’t think people are going to tolerate a fifth booster,” he said dr William Schaffner, an infectious disease expert at Vanderbilt University.
As of January, Americans ages 12 and older have been eligible for a third dose of vaccine, but only 46% of this demographic has received a third dose.
Schaffner says he’s concerned the fourth dose will confuse people who haven’t yet decided on a third dose.
“I’m very concerned about dividing and not being able to conquer because the news is getting very, very confusing,” he said, “and so I think public health officials and clinicians should continue to focus on the third.” Dose to take people who are entitled.”
THIS IS A BREAKING NEWS STORY AND WILL BE UPDATED.
CNN’s Amanda Sealy contributed to this report.