An Evidence-based approach to Covid-19 Vaccination??

or A Week is a long time in Politics!

Dr Ros Jones

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by Jay Battacharia and Marty Makary, announced the changes to the CDC schedule, stating that the vaccines would be withdrawn for healthy under 65s and healthy pregnant women.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.

Meanwhile, ‘GOOD NEWS’ a large Moderna contract for its mRNA bird flu vaccine has been cancelled, but ‘BAD NEWS’ the likely even more dangerous self-amplifying mRNA vaccine from Arcturus Holdings now appears to be the front runner instead. Just praying the plug is pulled on their funding too – time will tell but with it already rolling out in Japan and approved in Europe, time is not on the side of caution.

The $64,000 question is are we seeing the first steps in a process of taking this disastrous technology off the market or is this a so-called limited hangout to make us think we are winning this long hard battle? Numerous dissenting voices have raised their concerns but others are still saying ‘Watch this space’.

Here is a somewhat more convincing statement from Jay Bhattacharya posted in April of his view that the mRNA technology is fundamentally flawed with the low uptake by the American public being a cause for celebration. This is a far cry from the WHO or the EU who remain determined to stamp out any misinformation or vaccine hesitancy. And finally, if you haven’t yet watched it, please go to YouTube where award-winning film Follow the Silenced was aired on 16th May and as of writing is still there. It features Robert Kennedy Jr greeting the vaccine injured well ahead of his recent appointment. The film is tough viewing even if you’ve been following all the trials of the vaccine injured. Perhaps one to share with friends and colleagues on the basis that pictures will always speak louder than words.

See also Clare Craig’s article: Is the FDA a mutinous ship?

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