White House plans to authorize COVID-19 booster shoots for most Americans, but some experts have their doubts

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The Biden administration is expected as soon as this week to recommend that most Americans get a COVID-19 booster shot after their second dose.

The move would be an about-face from the federal government's earlier recommendation that only the severely immunocompromised need boosters.

Some experts say it's a reasonable response to emerging data about how quickly protection can wane from the most commonly administered mRNA vaccines from Pfizer-BioNTech and Moderna. Others worry there's not enough real-world research to launch another huge vaccination push, especially while so many people around the globe are still waiting for their first shots.

Federal agencies said as recently as Aug. 12 that boosters weren't needed for most Americans, but the administration has been signaling the possible shift for more than a week.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told USA TODAY's Editorial Board Aug. 6 that the vaccines' durability wanes with time and boosters might eventually be necessary.

"We all feel that sooner or later, likely the elderly before the young, it makes sense. That's just the way the immune system is," he said.

Last week, the Food and Drug Administration authorized a third booster dose of the Pfizer vaccine for people who are severely immunocompromised, because they often are not able to produce protective antibodies against COVID-19. But the science has been rapidly evolving, especially as the hyper-contagious delta variant spreads.

The latest news, which broke late Monday night, coincided with an announcement earlier in the day by Pfizer and its partner BioNTech that they had provided initial third-dose safety and immune response data to the FDA.

The move was not an application but, according to Pfizer, was intended to support evaluation of a possible booster dose.

Because it is furthest along, adding a third shot to the Pfizer-BioNTech's vaccination schedule likely would be adopted first, followed by Moderna.

It's not clear if or when a recommendation for a second shot of the Johnson & Johnson vaccine would be made. Long-term data on the company's vaccine, which makes up only 5% of doses administered in the United States, is still being gathered. Because the J&J vaccine was authorized on Feb. 27, even the first recipients received it only five month ago.

The FDA determined people with suppressed immune systems may not have gotten adequate protection from initial doses of the COVID-19 vaccine.
The FDA determined people with suppressed immune systems may not have gotten adequate protection from initial doses of the COVID-19 vaccine.

The push for more widespread use of boosters comes amid reports from Israel and several other studies that show a sharp drop-off in protective antibody levels after six to eight months.

Reports on the website of Israel Ministry of Health show protection from the Pfizer-BioNTech vaccine dropped precipitously after six months, down to 40% to 50% effectiveness against infection, said Dr. Eric Topol, vice president for research at Scripps Research in La Jolla, California, and a national expert on the use of data in medical research

Reports from Qatar and the Mayo Clinic showed similar results.

"It gets down to the 40% to 50% effectiveness range, whereas it used to be 95%,” Topol said.

That would mean that many health care workers and nursing home residents, who were the first to be vaccinated in the United States, could be nearing a fall-off in protection.

Topol emphasized that the vaccines in use in the United States still strongly protect against serious illness and death.

That's the question that concerns Dr. Gregory Poland, director of the Mayo Clinic's Vaccine Research Group. It's not certain that waning antibody levels necessarily mean that everyone who got either the Pfizer-BioNTech or Moderna vaccines will be at risk for breakthrough infections over time.

To answer that, real-world effectiveness data that hasn't yet been published is needed, he said. Poland says it's too early to make announcements about possible third doses for those vaccinated early on.

"Are we seeing people get sick enough to be hospitalized? Are they transmitting disease, and if so, at levels high enough to justify a massive new public health program that's going to attempt to deliver another 328 million doses of vaccine?" he said.

Before such a program could be implemented, the FDA would need to issue full approval for the two-dose vaccines, and the Centers for Disease Control and Prevention would need to weigh in.

"The headlines make it look like it's imminent, but it's not," Poland said.

Other things could be at work

Why the mRNA vaccines become less effective over time isn’t known, but Topol believes it could be a result of the short dosing schedule the United States chose. The two-dose vaccine series was given three weeks apart for the Pfizer shots and four weeks for Moderna.

The United States adopted the spacing Pfizer-BioNTech and Moderna used in their trials. The short spacing might not have allowed the memory B and T cells in the body to develop as robustly as they would if the interval had been longer.

Giving booster doses to the immunocompromised makes sense because those patients can have little or no response to the two-dose series. But people with normal immune systems remain well protected against severe disease and death, said Dr. Monica Gandhi, an infectious disease expert and professor of medicine at the University of California, San Francisco.

"T cells protect us from severe disease, and the T cells generated by the vaccines are holding up amazingly well, with over 99% of the hospitalizations being among unvaccinated adults in the US," she said.

Gandhi said a booster dose of the original vaccines aren't as useful against delta and other coronavirus variants because they were designed for the original strain of SARS-CoV-2, the virus that causes COVID-19.

"The antibodies generated from the spike protein made from the original mRNA or DNA (from J&J) won’t be adapted toward the variants; those antibodies will cover the ancestral strain because that is what the mRNA in the vaccines code for," she said.

A cheap and simple alternative exists to boosters, she noted: wearing masks.

"The majority of the symptomatic breakthroughs among the vaccinated are mild, which can be prevented by fit and filtered masks," said.

Gandhi also suggested the Biden administration's efforts might better be concentrated on vaccinating the 40% of Americans who are eligible for vaccine but haven't yet gotten a shot.

“They are carrying the burden of most of the severe COVID disease in this country,” she said.

Is it the right thing to do?

Others say that with much of the world still unvaccinated, the United States should put its resources toward getting vaccine to those who have none.

If vaccine were not scarce, a booster plan in the United States would make perfect sense, though it would require "crisp, clear" public health messaging to communicate vaccines still work and the unvaccinated should still get them, said Lawrence Gostin, a Georgetown law professor and director of the World Health Organization Collaborating Center on National & Global Health Law.

"But we're not just talking about the United States," he said. "We're talking about a global pandemic. Most low- and middle-income countries haven't even vaccinated their health care workers, and here we're thinking of giving a third dose to our entire population."

The World Health Organization has begged wealthy countries not to give booster doses before at least the most vulnerable in the rest of the world are vaccinated.

"It's a slap in the face," Gostin said. "It sends a signal of lack of caring for the rest of the world."

Instead, he suggests the United States focus on booster doses only for the most vulnerable, the immunocompromised and health care workers.

"If we did that, and at the same time pledged a major global vaccination campaign, then we would be protecting our own population but also showing we realize it's in everybody's interested to keep everyone safe," he said.

The next coronavirus variants are very likely to come from outside the United States, he added, "so it's very much in our national security interests to vaccine the world."

Contributing: Courtney Subramanian

Contact Weise at eweise@usatodaycom

This article originally appeared on USA TODAY: White House plans to call for COVID booster shots, experts have doubts