FDA authorizes a second COVID-19 booster for adults over 50

The Biden administration on Tuesday approved another COVID-19 booster vaccine for Americans age 50 and older to ward off any future surges while regulators debate if and when extra shots will be necessary for younger Americans.

The Food and Drug Administration said a fourth Pfizer-BioNTech or Moderna vaccine will be available to those who received a previous booster at least four months ago, amid fears that waning immunity will leave older Americans exposed to more severe health outcomes.

“If it were my relatives, I would be sending them out to do this because of the higher level of protection. COVID has had a really disproportionate effect on people 65 years or older and those with comorbidities,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Regulators also said immunocompromised people 12 and older can get another shot of the Pfizer vaccine and people with the same kind of conditions who are at least 18 can get another dose of the Moderna version.

Rochelle Walensky, director of the Centers for Disease Control and Prevention, followed the FDA’s decision with a statement urging those at most risk to come forward.

“This is especially important for those 65 and older and those 50 and older with underlying medical conditions that increase their risk for severe disease from COVID-19 as they are the most likely to benefit from receiving an additional booster dose at this time,” she said.

While not surprising, the FDA decision escalates the debate about what level of protection society is trying to achieve against the coronavirus, whether all ages will need recurring boosters to achieve that level of prevention, and if better vaccines should be in the pipeline.

Tuesday’s decision was driven partly by evidence from Israel, which is ahead of the global curve in using Pfizer shots and has a centralized data-collection system.

The minimum wait time of four months came directly from Israeli data showing the drop-off in immunity and the optimal time to backfill the antibody response.

One Israeli study found 232 people out of 234,868 ages 60 to 100 who received one booster died from the virus compared to 92 of 328,597 people in the study who received an additional booster.

“Our study demonstrates that among the older adult population that had received a first booster dose at least four months earlier, mortality due to COVID-19 during the omicron surge was significantly lower among those who had received an additional booster dose,” researchers wrote.

Dr. Marks said the agency set the cutoff at the age of 50 because one-third of 50- to 65-year-olds have an underlying medical condition.

“We felt we would capture the population that would most benefit from this fourth booster dose,” Dr. Marks said.

At age 79, President Biden would be among those eligible for another shot.

“If his doctor recommends that he receive a fourth booster, then he would,” said Kate Bedingfield, director of White House communications.

COVID case counts, hospitalizations and deaths are at their lowest point since last summer, but the country is warily eyeing the fast-moving BA.2 variant now raging in Europe. Still, it is unclear whether a pandemic-weary public will rush out to get more shots.

Roughly two-thirds of the U.S. population is fully vaccinated with a primary series of shots, and 45% of Americans, or about 97 million people, have received a booster in the form of a third shot after receiving the messenger-RNA vaccines from Pfizer or Moderna or a second dose after the one-shot Johnson & Johnson vaccine.

The additional booster would be the fourth shot for people who take advantage of the new authorization since it applies to the mRNA vaccines. But the push is raising new questions about who really needs another shot to restore antibody levels and whether the goal is to stiff-arm any infection at all or to limit the levels of severe disease.

“It’s clear that the immunosuppressed will benefit, but not everyone above 50 is immunosuppressed to the degree needed to benefit. It’s important to be proactive but there must be a rigorous scientific process underlying the recommendation,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. “The real issue is that the administration is not clear on goals. If protection against severe disease is the goal with these first-generation vaccines, as it should be, it delimits the target population of boosters.”

Experts also said federal officials should be more explicit about whether older adults should get the shots as Americans try to move beyond COVID-19.

“I think that the FDA and [the CDC] are not serving the public well by refusing to clearly state whether they recommend older people in America should receive a second booster or not,” said Lawrence O. Gostin, a global health law professor at Georgetown University.

“Leaving it up to the individual him or herself leaves the public without clear public health guidance. It is becoming deeply frustrating to the U.S. population that they continually need to get more vaccinations. It is undermining trust in COVID-19 vaccines,” he added.

The FDA says it is still working to chart next steps. Officials have scheduled an advisory meeting for April 6 to debate who should get additional boosters in the coming months and whether the vaccines need to be tailored to specific variants as the U.S. debates the best use of a quiet stretch in the pandemic to avoid future shocks.

Dr. Marks said it is likely the general population will need another shot but the April discussion will touch on whether the next round involves the same vaccines or a variant-specific booster.

He said anyone who hasn’t gotten vaccinated should consider it immediately, in case of another wave, and said an initial booster dose is holding up well against disease in adults younger than 50.

“For most people who have been vaccinated and have one booster, your original booster is continuing to provide you with good protection from being hospitalized or dying,” the doctor told reporters on a call.

Dr. Marks said they are examining the booster data for all ages “and will provide updates as additional findings become available.”

The Biden administration is imploring Congress to free up emergency funds to pay for more vaccine doses, treatments and testing, though Republicans want Democrats to tap existing funds or find a way to offset the new spending.

The White House says it has enough vaccines in its inventory to satisfy demand among those over 50, but it would struggle to procure the shot on behalf of the American people if regulators and advisers push boosters for all adults.

“The sooner we have these in place when — God forbid — a new variant hits, the healthier we’ll stay, the more life will stay normal,” Senate Majority Leader Charles E. Schumer, New York Democrat, said Tuesday. “I hope that we can reach an agreement with our Republican colleagues very soon because nobody wants to find themselves in a situation where cases suddenly start rising again and we aren’t ready to respond quickly.”

Looking further ahead, experts said recurring rounds of booster shots might be unsustainable with the public. They’re hopeful that scientists can develop a second generation of vaccines that are more effective and longer-lasting.

“I think the U.S. urgently needs to invest in development of a new generation of vaccines that are effective against all variants, and have longer-term effectiveness,” Mr. Gostin said.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told a recent Washington Post Live event that successive boosters of existing vaccines will simply backfill antibody levels, but there may be underlying parts of the immune system, including so-called memory B-cells, that can fight off disease over the long haul.

“That’s not easily measurable, and it may be that multiple boosters do incrementally increase that, but when it comes to antibodies, not so much.”

For more information, visit The Washington Times COVID-19 resource page.