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Daily Mail
20-05-2025
- Health
- Daily Mail
Trump's FDA announces radical change to Covid vaccine schedule that will affect millions
The FDA has revealed a radical shift in its Covid vaccination policy. The agency says it is now set to only recommend Covid vaccines to older adults over 65 and people who are immunocompromised. It marks a major shift from the current policy, recommending a dose of the updated Covid vaccine to everyone aged six months and over. And it could leave millions unable to get the vaccine through their health insurance. But the FDA head Dr Marty Makary says the change is needed, adding that there is no clear benefit from vaccinating millions of healthy people against Covid every year. He says it has fostered public distrust and led many to forgo vital vaccinations, such as that against measles — with the US recording its biggest outbreak in two decades this year. 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. 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 in free-fall, with latest CDC data showing barely 20 percent of adults received the shot this respiratory virus 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 authoritzation 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.' The pair 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 that 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.' The FDA is set to announce the policy in a press conference at 1pm today.
Wall Street Journal
20-05-2025
- Health
- Wall Street Journal
Trump Administration Toughens Requirements for Covid Vaccine Approval
The Trump administration released a more stringent set of guidelines for approving Covid-19 vaccines, requiring more evidence for new shots for healthy adults and new Covid vaccines for many children and adults will be required to undergo randomized, controlled trials before receiving Food and Drug Administration approval, FDA Commissioner Dr. Marty Makary and the agency's new vaccines chief, Dr. Vinay Prasad, wrote Tuesday in the New England Journal of Medicine. The agency expects it will be able to approve the shots for adults older than 64 and high-risk groups based on antibody testing but will encourage drugmakers to conduct more randomized trials for those shots too. The original Covid-19 shots were tested in large, randomized controlled trials against placebos. Subsequent versions, updated to match new strains, were tested to ensure they triggered immune systems to fight the virus. Such testing looks for antibodies in people who have received the shots and is easier to conduct than trials looking at whether the shots prevent hospitalization or other outcomes.
