In this photo from January 15, 2021, Dr. Yomaris Pena, an internal medicine doctor with Somos Community Care in a COVID-19 extracts the Pfizer COVID-19 vaccine from a vial at a Corsi Houses vaccination site in East Harlem district of New York. U.S. health regulators have authorized additional doses of COVID-19 vaccines in people with weakened immune systems to better protect them from the virus. (Mary Altaffer, Associated Press)
The Food and Drug Administration’s late-night announcement Thursday applies to several million Americans who are particularly vulnerable due to organ transplants, certain cancers or other disorders. Several other countries, including France and Israel, have similar recommendations.
It is more difficult for vaccines to stimulate an immune system suppressed by certain drugs and diseases, so these patients don’t always get the same protection as healthy people – and small studies suggest that for at least some, an extra dose may be the solution.
“Today’s action allows doctors to boost the immunity of certain immunocompromised people who need additional protection against COVID-19,” said Dr. Janet Woodcock, Acting Commissioner of the FDA, in a press release.
The FDA has determined that transplant recipients and others with similar compromised immunity levels can receive a third dose of Pfizer and Moderna vaccines at least 28 days after receiving their second injection. The FDA made no mention of immunocompromised patients who received the Johnson & Johnson single dose vaccine.
The announcement comes as the extra-contagious delta version of the coronavirus is sweeping across much of the country, pushing new cases, hospitalizations and deaths to levels not seen since last winter.
It’s important to note that the FDA’s ruling only applies to this high-risk group, estimated to number no more than 3% of American adults. This is not an opening for booster doses for the general population.
Instead, the health authorities consider the additional dose to be part of the initial prescription for the immunocompromised. For example, since April, France has encouraged these patients to receive a third dose four weeks after their usual second injection. Israel and Germany have also recently started recommending a third dose of the two-dose vaccine.
Separately, U.S. health officials continue to closely monitor whether and when the immunity of the average population declines enough to require boosters for everyone – but for now, vaccines continue to provide strong protection to the general population.
The Centers for Disease Control and Prevention is expected to officially recommend additional injections for certain immunocompromised groups after a Friday meeting of its external advisers.
Transplant recipients and others with weakened immune systems know they are at greater risk than the average American, and some have sought additional doses themselves, even if that means lying about their vaccination status. The change now means high-risk groups can more easily get another injection – but experts warn it’s not yet clear exactly who should.
“This is all going to be very personalized,” warned Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University who is leading a major National Institutes of Health study on supplemental injections for organ recipients. For some people, a third dose “increases their immune response. Yet, to some people, it doesn’t seem. We don’t quite know who is who yet ”.
A recent study of more than 650 transplant recipients found that just over half contained anti-virus antibodies after two doses of Pfizer or Moderna vaccines – although generally less than in otherwise healthy people vaccinated. . Another study of people with rheumatoid arthritis and similar autoimmune diseases found that only those who use particular drugs have very poor vaccine responses.
There is little data on the effectiveness of a third dose and whether it causes safety concerns such as an increased risk of organ rejection. On Wednesday, Canadian researchers reported that transplant recipients were more likely to have high levels of antibodies if they received a third dose than those given a dummy injection for comparison. Other small studies have also shown that some transplant recipients respond to a third dose while others still lack sufficient protection.
The Associated Press’s Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.