Northeastern expert Neil Maniar says restricting annual COVID-19 vaccine access to those over 65 is ‘taking a step backward’
In a pivot from what it calls the “one-size fits all” approach to COVID-19 vaccination updates, the Trump administration announced Tuesday it will no longer routinely approve the annual shots for younger adults and children.
Adults over 65 and those with medical conditions that put them at severe risk of complications from COVID-19 will maintain access to the yearly shots sometimes referred to as boosters.
But manufacturers will have to conduct clinical trials to determine whether vaccination is beneficial for healthy younger adults and children.
The policy is a major change over the past few years when COVID-19 vaccine update approvals were streamlined similar to the way annual flu shots are approved.
The new direction raises issues of access for people who want the annual vaccine to reduce the severity of COVID-19 infections as well as the potential for hospitalization and death, says Neil Maniar, director of Northeastern University’s master of public health program.
“There’s this whole group in the middle for which (the annual vaccine) is not recommended and that means it might not be covered by insurance,” Maniar says.
“That is certainly one of the concerns.”
Same as the flu, COVID-19 “can have a severe impact on individuals who are otherwise healthy,” Maniar says. “If we’re saying we’re going to limit coverage for this, we are really taking a step backward.”
In an article in the New England Journal of Medicine, officials from the U.S. Food and Drug Administration said the new policy will bolster people’s faith in vaccination, saying that fewer than 25% of Americans receive annual COVID-19 boosters.
Sign up for NGN’s daily newsletter for news, discovery and analysis from around the world.
“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had COVID-19 three times and has received six doses of a COVID-19 vaccine will benefit from the seventh dose,” they wrote.
“This policy will compel much-needed evidence generation,” the FDA said.
“It gives the impression that these vaccines came about without any research,” Maniar says. “There was a considerable amount of research and testing that took place.”
It’s important to continue to study the vaccines, Maniar says. But he says requiring controlled clinical trials before allowing younger people to access the annual vaccines poses many challenges, including the difficulty of enrolling people in such trials at a time when research funding is being reduced.
“It’s really creating a perfect storm for another public health crisis,” he says.
The FDA estimated that 100 million to 200 million Americans will have access to the annually updated vaccines. The agency also wrote that other high-income countries recommended the COVID-19 vaccine mainly for older people.
Maniar says it’s one thing to say the vaccine is optional for those under 65 versus restricting their access to the shots.
“COVID has not gone away. There are still thousands of cases. There are still deaths from COVID that occur in every state,” Maniar says.
He says the new policy “underestimates the potential severity of this disease. The COVID vaccine is really about making sure you don’t get really sick and end up in the hospital or dying.”