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 can be streamlined compared to previous authorizations. CNN is reporting, citing a source familiar with the situation, that the FDA’s third-party advisory panel will not be called in to review the request, although the CDC told CNN that the third-party advisory panel would.
President Biden announced in August that he wanted boosters for everyone amid concerns that vaccine protections are fading over time. Regulators have already approved boosters for a large number of people who are older and for those at higher risk due to underlying conditions or their work or living situation. According to the authorizations, the boosters must be given at least six months after the second injection of the Pfizer and Moderna vaccines with two injections. (Anyone who received the one-time Johnson & Johnson vaccine can get a second dose two months after the first.)
In the meantime, some states and cities are not waiting to extend the authorization to all adults. Colorado, New Mexico and California have approved the shooting, CBS News reported Saturday morning. The New York City Health Commissioner also has: booster shots open to all adults.
Other countries also have wider authorizations for boosters than current US national rules, including Canada and Germany, where they are allowed for all adults, and Israel, where they are allowed for all citizens over the age of 12.
Sax argued in the New England Journal of Medicine blog post that boosters should be approved for all adults, as there is mounting evidence that “our initial vaccine strategies failed to provide lasting protection.”
“It’s not just one study showing that the vaccines lose effectiveness over time — it’s multiple studies, conducted around the world in very diverse settings and with 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 portion of the population who are immunocompromised and do not receive full protection from the vaccines.”
He said offering a booster to all adults would simplify the “way too complicated” messages about who qualifies for a booster. And he pointed out that even so-called “mild” breakthrough cases can be difficult for the people who get them.
“I’ve come to the clear conclusion that every adult should have one,” he said of booster shots.
dr. Ashish Jha, dean of the Brown University School of Public Health, is another proponent of extending booster authorization to all adults. He said in a tweet last week that it was time for all adults to get booster shots.
Infections start to increase
Hospital admissions are increasing
The holidays are coming
The data is getting clearer
It’s time for every 6 month old adult to get a booster
— Ashish K. Jha, MD, MPH (@ashishkjha) Nov 12, 2021
Jha said in another tweet: “If we get a lot of people their booster soon, it will make a significant difference as we go into the holidays.”
dr. Eric Topol, a cardiologist and professor of molecular medicine at Scripps Research in La Jolla, Calif., on Saturday cited a series of reasons for extending the authorization in a series of tweets, including recent studies with “convincing data” showing that boosters increase protection to extremely high levels. .
Why should every adult receive a 3rd injection (booster) if they are eligible (6 months after 1°💉)?
1. A randomized placebo-controlled trial, the gold standard for assessing efficacy, demonstrated efficacy recovery of up to 95.6%, in > 10,000 participants across all age groups https://t.co/zORXc5LuiK
— Eric Topol (@EricTopol) Nov 13, 2021
The Washington Post reports that most senior health officials in the Biden administration — 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’s coronavirus response team — are strong proponents 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 extra protection, especially because the Pfizer and Moderna vaccines have been linked to a rare cardiac side effect in male teens and young men. They have also expressed concern that the focus on boosters could distract frontline personnel from the more critical effort to beat the pandemic, which is to get the first shots to unvaccinated people.
CDC director Rochelle Walensky told senior officials she might not agree with such a broad recommendation. the Post reported, citing an official close to her.
Walensky “promotes the use of vaccine boosters to protect Americans from COVID-19 when medically necessary, and eagerly awaits the opportunity to review data related to Pfizer boosters for ages 18 and older,” a CDC told a CDC spokesperson to CNN in an email. “Any decision will come after a thorough review of science and consultation with internal and external advisors.”
Booster shots in wealthier countries have also received criticism from the World Health Organization. dr. Tedros Adhanom Ghebreyesus, WHO director-general, said Friday that six times more booster shots of the coronavirus vaccine are administered daily around the world than primary doses in low-income countries, calling the inequality “a scandal that must stop now.” . ”
According to CDC data, about 29 million people nationwide have received a booster. 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 has been used in this report.
Martin Finucane can be reached at [email protected]