‘An Evidence-Based Approach to Covid-19 Vaccination’ is the misleading title of an extraordinary publication by Vinay Prasad and Marty Makary in the New England Journal of Medicine, 20th May 2025. It describes the FDA’s new approach, but if you were hoping for ‘Evidence-Based’ you’ll be sorely disappointed. One could argue that this is a start, in that it does involve withdrawing FDA recommendations for regular boosters for ‘healthy 6 months- to 64 year-olds’ but the state of ‘health’ in the US is so poor that apparently two thirds of Americans are still eligible for the shots. (‘Underlying medical conditions’ include pregnancy, obesity, physical inactivity and smoking, current and former),
The article goes on to describe a requirement for gold standard randomised controlled trials for further vaccines for a healthy population of say 50-64 years with a saline placebo and a 6 month follow-up but again using an end-point related to covid alone rather than all-cause mortality or morbidity. For over-65s or those with comorbidities, only evidence of antibody production is required.
Then on 27th May, a week after the NEJM article, Robert Kennedy, flanked by Jay Battacharia and Marty Makary, announced the changes to the CDC schedule, stating that the vaccines would be withdrawn for healthy under 65s and healthy pregnant women. The statement was somewhat underwhelming, especially Jay Battacharya’s rather wooden performance – another example of the 3-word or 3-phrase mantra: “That ends today. It’s common sense and it’s good science”.
Some cynics were quick to point out that the CDC guidance had not changed, but by 29th May the website was updated though not in quite the way I had anticipated from RFK’s words. The covid vaccine for children now states ‘See notes’ and then outlines a system of ‘shared clinical decision-making’ as follows: “Shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian. Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances.” Only for children with moderate or severe immunocompromise does the CDC actively advise a booster. So for children this actually goes further than the Prasad and Makary article, leaving only immunocompromise as a co-morbidity for recommended covid boosters in under 18s, in line with the current UK guidelines. The Children’s Health Defence have tried to explain the very opaque guidelines – one plus would be that paediatricians would no longer be obliged to recommend the vaccines – at present they risk losing their tenure if they speak out against the jabs. But for adults, there appears to be no change with covid vaccines still recommended as routine including during pregnancy.
Hellbound and Down 