This decision extends the availability of additional boosters to healthy older adults. The FDA previously authorized additional injections for anyone 12 years of age or older who is severely immunocompromised. This group can now receive a primary series of three doses and a two-dose booster, for a total of five doses.
“Current evidence suggests that protection from severe COVID-19 outcomes in older and immunocompromised individuals has diminished over time. Based on analysis of emerging data, Pfizer-BioNTech or Moderna COVID-19 vaccines A second booster dose of the drug may help improve the level of protection in these high-risk populations,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “Furthermore, the data suggest that an initial booster dose is critical to help protect all adults from the potentially serious consequences of COVID-19. Therefore, those who did not receive an initial booster dose are strongly encouraged to do so. »
In making its decision, the FDA said it determined that the known and potential benefits of the second booster outweigh the known and potential risks to these populations.
The U.S. Centers for Disease Control and Prevention is expected to follow so-called licensing recommendations — states that the vaccine can be used in this age group. However, the agency is not expected to officially recommend these snapshots.
If the Centers for Disease Control and Prevention fails to give clear approval for a second booster immunization, it will hinder work to weigh the risks and benefits of another dose of the vaccine for individuals and cause great panic among some vaccine advocates. get is not worth the confusion caused by the fourth dose.
Throughout the pandemic, officials have faced decision-making before they have enough evidence to support it, said Dr. Megan Laney, an emergency physician and dean of the Brown University School of Public Health. Ranney sees this as another example.
It’s unclear if everyone needs a fourth dose now, but getting those approvals would provide the flexibility to quickly roll out more boosters if needed, she said.
“I think this endorsement from the Biden administration is one of their insurance policies,” Laney said. “It’s a way for people to get a vaccine or an extra booster. But it also gives them flexibility, so if BA.2 is worse than we expected, then they can deploy it quickly. Or God forbid, if in the There’s another variant in the next two months that needs another booster, and they can roll out quickly. So that’s how I read it,” Laney said.
The general scientific consensus is that a third dose helps build immunity to severe illness caused by the virus that causes Covid-19. But science is far from certain if, or even when, a fourth dose is needed, as the vaccine continues to provide a high degree of protection against hospitalizations and deaths from Covid-19, even as protection from the disease diminishes.
Much of the evidence examining the safety and efficacy of the second booster shot comes from Israel, which has been recommending a fourth dose of the coronavirus vaccine for adults 18 and older since late January.
In making its decision, the FDA said it considered data from the Israeli Ministry of Health on more than 700,000 people aged 18 and older who received a second booster shot of the Pfizer-BioNTech vaccine at least four months later, their first remind. More than 600,000 of them are over 60 years old. The agency said the data showed no new safety concerns related to the fourth dose.
When used as a fourth dose, the FDA said safety data for the Moderna booster dose came from a study of 120 people 18 and older who received a fourth dose of the vaccine at least four months later. Their third dose of the Pfizer vaccine . . no new safety concerns were identified for three weeks after the last dose.
Some of the data the FDA relies on to make its decision comes from previously published studies.
Other studies from the UK have shown that antibody boosts with booster doses wear off rapidly within a few weeks. As a result, some experts believe the U.S. should wait until there is a clear danger of a new wave of infections before deploying a fourth dose of the vaccine, given the resources available and the waning willingness to continue receiving a growing number of recalls. Some think that could happen next fall.
“If you only have one bullet in your gun to fire, I’d rather wait until the fall, when cases really start to increase,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University.
Americans 12 and older have been eligible for a third dose of the vaccine since January, but only 46% of the population has received it.
Schaffner said he is concerned that the fourth dose will upset people who have not yet decided to take a third dose.
“I’m very concerned about division and invincibility because the message is going to be very, very confusing,” he said, “so I think public health officials and clinicians should continue to focus on introducing a third dose in eligible populations.”
CNN’s Amanda Sealy contributed to this report.