The FDA has announced a radical shift in its Covid vaccination policy.
The agency says it will now only recommend Covid vaccines to adults over 65 and people who are immunocompromised.
It marks a major shift from the current policy, which recommends a dose of the updated Covid vaccine to everyone six months and older.
And it could leave millions unable to get the vaccine through their health insurance.
But FDA head Dr Marty Makary says the change is needed, adding there is no clear benefit from vaccinating millions of healthy people against Covid every year.
He says this policy has fostered public distrust and led many to forgo vital vaccinations, such as that against measles — with the US currently battling its biggest outbreak in two decades.
The new policy was revealed in an editorial published Tuesday in the New England Journal of Medicine, authored by Dr Makary and the FDA’s head on vaccines Dr Vinay Prasad.
It is set to be unveiled at a press conference later today, and will likely affect people seeking an updated Covid shot in fall 2025.
The FDA has revealed an overhaul to its Covid vaccine policy. Pictured above is Biden getting an updated Covid vaccine in 2022
They wrote: ‘Over the past two seasons, uptake of the annual Covid booster has been poor. Less than 25 percent of Americans received boosters each year.
‘There may even be a ripple effect: Public trust in vaccination in general has declined, resulting in a reluctance to vaccinate that is affecting even vital immunization programs such as that for measles-mumps-rubella vaccination.’
The change will more closely align the US with other nations, like the UK, Canada and Australia — which all only recommend updated Covid shots to older adults.
Uptake of the updated Covid vaccinations has been falling, with latest CDC data showing barely 20 percent of adults received the shot this viral season.
The pair added: ‘While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe Covid…
‘… the US adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of six months.
‘The US policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations.
‘We reject this view.’
Makary and Prasad said Covid vaccines for young adults would be approved, but only after pharmaceutical companies could demonstrate that they create protective antibody concentrations in the group.
Dr Noel Brewer, a public health expert at the University of North Carolina, Chapel Hill, and who sits on the CDC’s vaccine recommendation committee, told CNN he supported the change.
Updated Covid vaccines will now only be offered to adults aged 65 years and older
‘The proposed policy moves the US into line with other countries. This global view of public health is a welcome development,’ he said.
Dr Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia and a member of the FDA’s vaccines advisory group, disagreed, however.
He said: ‘We have been using an evidence-based approach to Covid vaccination, but they kind of swoop in and believe that for the first time, we’re going to get, as they say, “gold standard” data, robust data, for the first time, because, according to them, we don’t have that, but we do have that.
‘That’s why we’ve made good decisions about the vaccines. That’s why that vaccine is remarkably safe. I mean, the mRNA vaccines are remarkably safe.’
