Americans with weakened immune systems will be allowed to get three shots of Covid-19 vaccine after U.S. regulators authorized giving an extra dose to the most vulnerable people.
The U.S. Food and Drug Administration’s action expands the use of vaccines fromModerna Inc.and the partnership ofPfizer Inc.andBioNTech SEfor organ transplant recipients and patients with other conditions like cancer that hobble the body’s natural infection-fighting response. The decision doesn’t apply to other fully vaccinated individuals, the agency said in astatement.
The U.S. is currently facing a surge of infections spawned by the highly infectious delta variant, with more than 117,000 new cases diagnosed yesterday. The FDA’s move was designed to protect those people most likely to be harmed or die from an infection, even after a standard course of shots.
“The country has entered yet another wave of the Covid-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease,” said Acting Commissioner Janet Woodcock. “After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines.”
Vaccine Access
The decision could further exacerbate the vaccine inequality that exists across the world. The U.S. is joining countries including Israel, Germany and France in offering boosters to vulnerable groups, while nations including Russia and the United Arab Emirates are giving them even more broadly. The European Union’s drugs regulatorsaidFriday that it’s coordinating with vaccine makers and reviewing data on third shots.
Meanwhile, dozens of countries have such limited access to the vaccines that they have immunized fewer than 10% of their populations.
The FDA’s decision was supported by a study published in the New England Journal of Medicine on Wednesday, showing that a third dose of Moderna’s vaccine significantly raised levels of Covid-fighting antibodies in 55% of transplant patients. Among those who got a placebo rather than the extra shot, just 18% generated the desired antibody levels, thestudyfound.
“Ifeelvery relieved that they are doing this, because it will save lives,” said Janet Handal, a kidney transplant recipient. “I wish that they had done it sooner.”
While the U.S.-authorized Covid-19 vaccines are highly effective at preventing severe disease, hospitalization and death in most people, booster shots are especially important for transplant patients and others with weak immune systems, who often don’t get adequate responses to their first vaccine course. Immune compromised people compose about 3% of adults, Rochelle Walensky, director of the Centers for Disease Control and Prevention, said on a press call.
Many patients had sought out extra doses on their own as findings emerged on their responses to vaccines. Dorry Segev, a professor of surgery and epidemiology at Johns Hopkins University, said his research team has observed more than 200 transplant recipients who have gotten third shots, and he suspects many more immunocompromised patients have done so as well.
Advisers for the CDC raised concerns at a meeting last month about patients getting additional doses in an unsupervised manner and the inequities that could arise.
“The people who’ve gotten it now are the people who navigate the health care system well, who are willing to go to great lengths,” Segev said. FDA approval “would then expand access of these boosters in a more equitable way to people who might not be as good as navigating the health care system and might have been too shy or too worried about pursuing something.”
The FDA’s action allows for a third shot at least 28 days after the initial two-dose regimen in organ transplant recipients and patients with conditions “considered to have an equivalent level of immunocompromise.” Immune compromising conditions include blood cancers, HIV, multiple sclerosis and many others. In some cases, patients’ conditions weaken the immune system; in others, it’s their medications. Among the various conditions, the degree of immune suppression may differ.
Not all patients may develop an antibody response after the third dose, as research so far has shown. Until there’s more information about how much protection patients have after a third dose and until the delta wave subsides, patients should still continue to mask and social distance, Segev said.
Only those with weakened immune systems will be offered boosters, White House chief medical adviser Anthony Fauci said on NBC’s ”Today” show. For other vaccinated groups, such as the elderly, data is being collected to determine if or when their protection goes “below a critical level.”
“Right now at this moment, other than the immune-compromised, we’re not going to be giving boosters to people, but we will be following them very carefully, and if they do need it, we’ll be ready to give it to them,” he said.
About 60% of eligible Americans, age 12 and older, are fully vaccinated, according to the CDC. And while the pace of immunization is rising after falling sharply from a high point in mid-April, the Biden administration is urging people to get shots as infections surge in the U.S., fueled by the delta variant.
An advisory committee to the CDC is also set to discuss booster doses of Covid–19 vaccine for immunocompromised patients on Friday.
Handal and other transplant recipients formed Transplant Recipients and Immunocompromised Patient Advocacy Group during the pandemic that has urged the FDA to streamline approval of additional doses for those with weakened immune systems.
“People that are immunocompromised are continuing to live with the fear that everyonefeltin the early days of Covid,” Handal said in an interview. They’re carrying on with their lives as the world opens up, but “it’s just an undercurrent of fear, and it’s exhausting to live with.”