The US federal government intends to spend $500 million on a project to develop universal vaccines that can protect against multiple virus variants at the same time.
That's the conclusion of an article in the Wall Street Journal, citing emails it had accessed, which suggests the move marks a shift away from next-generation COVID-19 vaccines like Novavax's next-generation shot – reportedly turned down by the FDA with a request for a new clinical trial.
That has raised concerns that annual updates to seasonal vaccines for respiratory diseases might all require new trials, which would be unworkable in practice and likely unviable commercially.
According to the WSJ, the universal vaccine project is being pioneered by two recently appointed senior scientists in the NIH, Drs Matthew Memoli and Jeffery Taubenberger, and will focus on an older technology based on inactivated whole viruses to develop broadly protective jabs against both coronaviruses and influenza viruses.
If confirmed, the sizeable project comes against a backdrop of massive cuts to the Department of Health and Human Services (HHS) budget – reported by some to be in the region of $40 billion – and the loss of around 20,000 jobs across the agencies it oversees, including the NIH.
It's worth noting that many of the senior figures in the HHS and its agencies – including HHS Secretary Robert F Kennedy Jr, FDA Commissioner Martin Makary, and NIH Director Jay Bhattacharya – are recognised as holding views contrary to prevailing scientific wisdom on COVID-19 immunisation programmes.
The Guardian newspaper reported this week that a spokesperson for the HHS said that "The COVID-19 pandemic is over, and HHS will no longer waste billions of taxpayer dollars responding to a non-existent pandemic that Americans moved on from years ago."
Along with the delay to the Novavax vaccine review, funding has also been dropped for local vaccination programmes, emerging and infectious disease surveillance capacity has been reduced, and programmes to address COVID-19 disparities in underserved communities have been axed.
Meanwhile, a well-known vaccine sceptic has been appointed to probe the well-debunked link between vaccines and autism, and Peter Marks, formerly head of the FDA's Centre for Biologics Evaluation and Research (CBER), resigned with a warning about efforts to undermine US immunisation programmes under Kennedy.
The new project ties in with comments made by Kennedy in an interview with CBS News last month in which he said that " for respiratory illnesses, the single antigen vaccines have never worked [and HHS] is actually shifting our priorities to multiple antigen vaccines."
Placebo testing requirement
Also this week, it has been reported by the Washington Post that Kennedy intends to require all new vaccines to undergo placebo-controlled trials – even for well-studied diseases like measles and polio – in what it calls "a radical departure from past practices." Questions have already been voiced about the ethics of exposing patients to a placebo for diseases with potentially serious or life-threatening complications.
For now, it's not clear what form the new policy would take, or the vaccines that would be in scope, although HHS said the flu vaccine would not be included and the aim is to increase "transparency."
"Except for the COVID vaccine, none of the vaccines on the CDC's childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products," the Department told the Post.
https://pharmaphorum.com/news/us-planning-500m-project-universal-vaccines-wsj
