Safety testing for vaccines typically leaves much to be desired to begin with, but when it comes to fast-tracked pandemic vaccines, safety testing is accelerated and becomes even more inadequate. It looks like that will be the case with plans underway to fast-track a COVID-19 vaccine to market.
As reported by STAT News,1 researchers are foregoing some of the normally required safety testing in order to get a genetically engineered coronavirus vaccine out in record time. What’s more, at least one vaccine manufacturer is relying on an entirely novel technique to produce their coronavirus vaccine in partnership with the National Institutes of Health, while by-passing traditional animal testing before conducting human clinical trials. STAT News reports:2
“‘I don’t think proving this in an animal model is on the critical path to getting this to a clinical trial,’ said Tal Zaks, chief medical officer at Moderna, a Cambridge, Mass.-based biotech that has produced a Covid-19 vaccine candidate at record speed …
Yet ethicists aren’t so sure that the eventual benefits of rushing this unproven vaccine into clinical trials will outweigh the risks. ‘Outbreaks and national emergencies often create pressure to suspend rights, standards and/or normal rules of ethical conduct.
Often our decision to do so seems unwise in retrospect,’ wrote Jonathan Kimmelman, director of McGill University’s biomedical ethics unit, in an email to STAT.
The question is complicated by the newness of the science at play. The technology that has allowed Moderna to craft an experimental vaccine so fast has not yielded a single immunization that’s made it to market so far.
It’s a trendy idea: Instead of injecting people with a weakened pathogen or proteins from the surface of a pathogen, so that our bodies will learn to fight off such infections in the future, scientists are betting on a kind of genetic hack, a lab-made concoction that gets the body to produce its own virus-like bits which it will then train itself to combat.”
Fear Surrounding Pandemics Makes for Good Testing Grounds
Ethical questions really should be in the forefront of everyone’s mind, considering pandemic hysteria can easily make people take risks they normally might never consider.
Right now, the British company hVIVO,3 which conducts influenza research, is offering healthy volunteers £3,500 (approximately $4,500) in exchange for being infected with a mild coronavirus (strains 0C43 and 229E specifically), both of which cause milder symptoms than COVID-19 and have been in circulation for quite some time.4,5
Infected volunteers will receive antiviral medications and undergo testing in the hopes of finding something that will assist researchers in developing a vaccine against COVID-19. Moderna, however, is using a technology to develop a vaccine that has never been approved by the U.S. Food and Drug Administration.
Moderna is using synthetic messenger RNA (mRNA) to instruct DNA to produce the same kind of proteins COVID-19 uses to gain access into our cells. As reported by STAT News, the idea is that “Once those … dummy virus particles are there … our bodies will learn to recognize and clobber the real thing.”
Moderna is partnering with the National Institute of Allergy and Infectious Diseases (NIAID) and started recruiting healthy volunteers March 3, 2020.6 In all, 45 men and non-pregnant women between the ages of 18 and 55 will be paid $1,100 to receive two injections of the vaccine, 28 days apart.
The side effects at three different dosages will be evaluated. These clinical trials are taking place before there’s any scientific evidence that the vaccine actually works as intended and doesn’t cause severe side effects in animals.
Considering COVID-19 infection has a high survival rate, with 80% suffering asymptomatic or only mild illness,7 is it really wise to use this outbreak as a testing ground for experimental, untested vaccine manufacturing methods?
Mice Don’t Respond to COVID-19 the Way Humans Do
According to the NIAID, an animal trial using conventionally bred mice also began March 3, 2020, with supposedly promising results. The problem is, regular mice do not have the same susceptibility to the virus as humans,8 so testing on regular mice is unreliable and may cause a false sense of security if this type of animal is used to prove safety and effectiveness.
During the SARS epidemic 15 years ago, mice engineered to be susceptible to that virus were developed, but once the SARS epidemic and related research died down, most of the colonies were destroyed.
Researchers are now working on breeding new litters of these SARS susceptible mice, but that takes time, and Moderna isn’t waiting. Even so, the fact that phase 1 human trials are starting before animal testing has been completed does not mean there will be a vaccine available for the general public any time soon.
STAT News points out it will likely be at least one year before a COVID-19 vaccine would be released for use by the public. Still, that’s a significantly shorter wait time than the 15 to 20 years it normally takes to bring an experimental vaccine to market.
“Moderna itself acknowledges that the task is daunting, and this effort might not succeed,” STAT News writes.9 “‘We have not previously tested our rapid response capability and may be unable to produce a vaccine that successfully treats the virus in a timely manner, if at all,’ the company wrote in a document filed with the Securities and Exchange Commission.
What the company doesn’t say is that it has not yet brought a single product to market, even in non-emergency times. The majority of candidate vaccines fail.
If against all odds, this rushed project does work out, then the company needs to be extra careful about monitoring what happens to those people who get it, said Arthur Caplan, head of medical ethics at New York University’s Grossman School of Medicine. ‘The more you speed it up … the greater the obligation you have to track what’s going on when you get it out into the real world.’”