Will COVID-19 boosters soon be approved for all adults?

A coronavirus vaccination being preparedCraig F. Walker/Globe Staff

Are all adults in the United States soon going to be eligible for a COVID-19 vaccine booster shot?

Pfizer Inc. is asking federal regulators to authorize its shot for a booster for all adults, several states have already jumped ahead and broadened their authorizations, and some experts are arguing it’s a wise move as winter approaches and a possible COVID-19 comeback looms on the horizon.

“As we head into the winter, with cases increasing again — and Europe providing a potential warning of what we’ll be seeing soon in the USA — it’s time to just make these third doses available to all who want them,” Dr. Paul Sax, clinical director of the Division of Infectious Diseases, argued in a blog post last week on the New England Journal of Medicine website.

Pfizer’s request will be reviewed first by the US Food and Drug Administration and then by the US Centers for Disease Control and Prevention. The process may be streamlined, compared with previous authorizations. CNN reports, based on a source familiar with the situation, that the FDA’s outside advisory panel will not be called in to review the request, though the CDC told CNN its outside advisory panel would be.

President Biden announced in August he wanted boosters for everyone because of concerns that the vaccines’ protection fades over time. Regulators have already approved boosters for a wide swath of people who are older as well as those who are at higher risk because of underlying conditions or their work or living situations. The authorizations call for the boosters to be given at least six months after the second shot of the Pfizer and Moderna two-shot vaccines. (Anybody who got the one-shot Johnson & Johnson vaccine can get a second dose two months after the first.)

In the meantime, some states and cities aren’t waiting to broaden the authorization to all adults. Colorado, New Mexico, and California have authorized the shots, CBS News reported Saturday morning. The New York City health commissioner has also opened up booster shots to all adults.

Other countries also have broader authorizations for boosters than the current US national rules, including Canada and Germany, where they’re allowed for all adults, and Israel, where they’re authorized for all citizens older than 12.

Sax argued in a New England Journal of Medicine blog post that boosters should be authorized for all adults because there’s a growing amount of evidence that indicates “our initial vaccine strategies did not provide durable protection.”

“It’s not just one study showing the vaccines are losing their effectiveness over time — it’s multiple studies, conducted all around the world in highly diverse settings and using different vaccines,” he said.

Sax also pointed out that symptomatic cases can spread the infection to others, “which is especially worrisome for the not insignificant proportion of the population who are immunocompromised and don’t get full protection from the vaccines.”

He said offering a booster to all adults would simplify the “way too convoluted” messaging about who’s eligible for a booster. And he pointed out that even so-called “mild” breakthrough cases can be tough on the people who get them.

“I’ve come to the straightforward conclusion that it should be any adult who wants one,” he said of booster shots.

With vaccine effectiveness waning, case numbers rising, and no concerning safety signals from boosters so far, is it time to recommend a booster for all adults?
Here I argue yes. Plus, simplifies @CDCgov guidance.
Latest: https://t.co/EQmhTzQVRV @drlucymcbride @EricTopol

— Paul Sax (@PaulSaxMD) November 12, 2021

Dr. Ashish Jha, dean of the Brown University School of Public Health, is another proponent of broadening the booster authorization to all adults. He said in tweet last week that it was time for all adults to get booster shots.

Infections are starting to rise

Hospitalizations are inching up

The holidays are approaching

The data is becoming increasingly clear

It is time for every adult 6 months out to get a booster

— Ashish K. Jha, MD, MPH (@ashishkjha) November 12, 2021

Jha said in another tweet, “Getting lots of folks their booster soon will make an important difference as we go into the holidays.”

Dr. Eric Topol, a cardiologist and professor of molecular medicine at Scripps Research in La Jolla, Calif., in a series of tweets Saturday, cited a number of reasons for broadening the authorization, including recent studies with “compelling data” that show boosters restored protection to extremely high levels.

Why should every adult get a 3rd shot (booster) when eligible (6 months after 1°💉)?
1. A randomized, placebo-controlled trial, the gold standard for assessing efficacy, showed restoration of efficacy to 95.6%, in >10,000 participants across all age groupshttps://t.co/zORXc5LuiK

— Eric Topol (@EricTopol) November 13, 2021

The Washington Post reports that most of the Biden administration’s senior health officials — including Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases; Surgeon General Vivek H. Murthy; and Dr. David Kessler, chief science officer of the White House coronavirus response team — are strong supporters of booster shots for all adults, according to people familiar with their views.

But there is also debate within the administration about whether the broader authorization is needed, the Post reported. Some CDC officials and advisers are not convinced that young, healthy people need additional protection, especially since the Pfizer and Moderna vaccines have been linked to a rare cardiac side effect in male teenagers and young men. They’ve also raised concerns that focusing on boosters may distract front-line personnel from the more critical effort to defeat the pandemic, which is to get the first shots to unvaccinated people.

CDC Director Rochelle Walensky told high-ranking officials she might not agree to such a broad recommendation. the Post reported, citing an official close to her.

Walensky “is supportive of using vaccine boosters to protect Americans from COVID-19 when medically necessary and eagerly awaits the opportunity to review data related to Pfizer boosters for those 18 years and older,” a CDC spokesperson told CNN in an email. “Any decision will come after a thorough review of the science, and consultation with internal and external advisors.”

Booster shots in wealthier countries have also drawn criticism from the World Health Organization. Dr. Tedros Adhanom Ghebreyesus, director-general of WHO, said Friday that six times more booster shots of coronavirus vaccine are being administered around the world daily than primary doses in low-income countries, calling the disparity “a scandal that must stop now.”

According to CDC data, about 29 million people have received a booster nationwide. In Massachusetts as of Friday, 730,169 people had received booster doses of the Pfizer, Moderna, or Johnson & Johnson vaccine.

Material from Globe wire services was used in this report.