HHS ends mRNA projects, public health experts raise concerns about the impact
'This represents a significant setback for our preparedness efforts in responding to infectious-disease outbreaks,' said Dawn O'Connell, the former assistant secretary of preparedness and response at HHS during the Biden Administration. If viruses change, mRNA can be quickly rebooted and manufactured.
But HHS Secretary Robert F. Kennedy jnr has criticised mRNA vaccines, arguing that they are ineffective at fighting upper respiratory infections and keeping up with the mutations of a virus.
Kennedy has a history of disparaging the mRNA coronavirus vaccines, in 2021 falsely calling them the 'deadliest vaccine ever made'. He has also said there was a 'poison' in it – claims refuted by medical experts.
He has also been under pressure from anti-vaccine activists who say he has not done enough to remove mRNA vaccines from the market.
The full scope of mRNA projects terminated was not immediately clear. Multiple companies mentioned by HHS did not immediately respond to questions. A spokesman for Moderna, which previously lost funding to develop an mRNA bird flu vaccine, said the company was not aware of new contract cancellations.
The AstraZeneca programme that HHS is restructuring is an RNA-based pandemic influenza vaccine that is in early stages of development. The company is exploring options for next steps, a spokeswoman said.
An inhaled mRNA treatment for flu and Covid being developed at Emory University was terminated. Some late-stage projects are proceeding, such as early human testing of an mRNA-based H5N1 candidate being developed by Arcturus Therapeutics 'to preserve prior taxpayer investment', according to HHS.
Gritstone Bio, which HHS said had a project proposal rejected, already ceased operating earlier this year after declaring bankruptcy.
A terminated contract to Tiba Biotech was for a H1N1 flu treatment that was not based on mRNA, but a different RNA technology. The company received a stop work order yesterday.
'This comes as a surprise given the Department's stated goal of winding down mRNA vaccine development,' Jasdave Chahal, Tiba's chief scientific officer, said in an email.
'Our project does not involve the development of an mRNA product and is a therapeutic rather than a vaccine.'
'It's going to deter innovations,' said Dorit Reiss, a professor at the University of California College of the Law at San Francisco, whose research focuses on vaccine law and policy.
'Why invest in new technologies if the government can not only refuse to fund them, but if it's going to cancel already promised contracts?'
HHS said in its statement that 'other uses of mRNA technology', such as cancer treatments, are not affected by the announcement.
But researchers are worried that the Trump Administration's criticism of the mRNA technology would have a chilling effect on one of the most promising fields in medicine.
In 2023, Katalin Kariko and Drew Weissman shared the Nobel Prize in medicine for fundamental work on mRNA that enabled the development of coronavirus vaccines.
'It's absolutely perplexing why this is happening,' said Jeff Coller, a professor of RNA biology and therapeutics at Johns Hopkins University who has studied mRNA for more than three decades.
'You have to sort of scratch your head to wonder why the secretary is directing these sort of actions against probably one of the most powerful platforms in medicine that has come along in the last 20 years.'
Misleading assessments
Six scientific and medical experts said Kennedy and HHS offered misleading assessments of mRNA technology as they announced the termination of research.
Here are the issues they flagged with some of the statements:
'The data show these vaccines fail to protect effectively against upper respiratory infections like Covid and flu,' Kennedy said in a statement.
It's true that mRNA vaccines can be ineffective at preventing coronavirus infections, although data from the Centres for Disease Control and Prevention shows they still offer some protection.
But several scientific experts noted the primary purpose of vaccination is to prevent hospitalisations and death, which the mRNA vaccines have effectively done, according to CDC data.
The FDA has not approved an mRNA flu vaccine, so experts said it was premature to make sweeping claims about its potential efficacy.
The decision affects US$500 million in projects, including Covid-19 and flu vaccines. Photo / Getty Images
'One mutation and the vaccine becomes ineffective,' Kennedy said in a video.
The coronavirus keeps evolving in a way that makes it easier to infect people who have some immunity from vaccination or prior infection. Medical experts said the mRNA vaccines have been resilient in maintaining protection against severe outcomes.
Manufacturers have also been able to update formulas annually to better target new variants.
'That is actually one of the most powerful aspects of mRNA vaccines: that you can, in real time, develop new mRNAs against the virus as the virus changes,' Coller said. 'I'm not sure why that would be considered a bad thing.'
'We've seen now these epidemics of myocarditis,' Kennedy said at a news conference.
Coronavirus vaccines designed using mRNA carry a very small risk of myocarditis, which is inflammation of the heart, from the coronavirus vaccine, particularly in young men.
However, medical experts said the data shows there is not an 'epidemic' of the condition; in fact, the rates of myocarditis and other heart illness are much higher from the virus instead of the vaccine.
Jessica Malaty Rivera, an infectious-disease epidemiologist, said this rhetoric was part of the pandemic revisionist 'revenge tour'.
'Calling it an epidemic is absolutely misleading,' she said.
'Technologies that were funded during the emergency phase but failed to meet current scientific standards will be phased out in favour of evidence-based, ethically grounded solutions – like whole-virus vaccines and novel platforms' - HHS statement
Scientific experts said a variety of vaccine types are often required to fight emerging infectious diseases. In some cases, whole-virus vaccines have been known to have serious side effects.
Peter Hotez, a physician and co-director of the Texas Children's Hospital Centre for Vaccine Development, said he was surprised to hear HHS tout whole-virus vaccines because China had used a whole-virus vaccine for coronavirus that was 'pretty mediocre', Hotez said.
Kennedy is 'pushing a technology that is actually probably the most problematic of all vaccines we could pick', Hotez said.
Rachel Roubein, Sabrina Malhi and Daniel Gilbert contributed to this report.
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