FDA announces shift in Covid vaccine policy
The FDA has announced a radical shift in its Covid vaccination policy. The agency says it is now set to only recommend Covid vaccines to adults over 65 and people who are immunocompromised. It would mark 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 also says the policy has fostered public distrust and led many to forgo vital vaccinations, such as those 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 was then unveiled at a press conference today, with Dr Prasad saying it will now be considered by the FDA's vaccine advisory committee. It will likely affect people who are seeking an updated Covid vaccine in fall 2025, but Dr Prasad insisted most will still be able to get the vaccine. As well as offering it to the 57.8 million who are over 65 years old, he said the shot would also be available to the estimated 100 to 200 million people who have an underlying condition putting them at higher risk of Covid.
The CDC maintains a list of at least 20 conditions that raise the risk of suffering from severe Covid, including in it conditions like obesity and physical inactivity. Dr Prasad said: 'America is deeply divided on the policy of repeat Covid-19 vaccine doses or boosters. 'There are some Americans out there who are worried that the FDA has not fully documented and interrogated the safety harms of these products and they are categorically opposed to these products.
'There are also some Americans, we also have to recognize, who are desperate for additional protection, and they demand these products. 'But the truth is that most doctors, and most of the public, are entirely uncertain [about whether they need to get a Covid booster].' At least 70 percent of Americans had received at least one dose of the Covid vaccine by May 2023, amid major concern over the virus during the pandemic.
But the vast majority have forgone the booster doses, with data showing that just 23 percent came forward for them last year — despite an FDA-backed recommendation that everyone aged six months and over should get the dose. The US has been out of step with other western nations on boosters, with most — including the UK, Canada and Australia — now only recommending them for older adults. The proposal is set to be considered by the FDA's Vaccines and Related Biological Products Advisory Committee at its meeting on Thursday, which will make a recommendation.
The FDA commissioner, Dr Makary, will then make a final call on whether to change the vaccine guidance. The CDC's vaccine body — the Advisory Committee on Immunization Practices — may also then make a recommendation on Covid booster vaccines. In the NEJM paper, 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. '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.'
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