Coronavirus Vaccine Will Bypass Safety Testing
- March 24, 2020
Story at-a-glance
- Researchers are foregoing some of the normally required safety testing in order to get a coronavirus vaccine out as soon as possible. The biotech company Moderna is also relying on a novel manufacturing technique to produce their genetically engineered coronavirus vaccine in record time
- Moderna is using synthetic mRNA to instruct DNA to produce the same kind of proteins COVID-19 uses to gain access into our cells. The idea is that your immune system will learn to recognize and kill the real virus
- It will still be at least a year before the vaccine, if successful in limited human trials, will be available to the public. But that’s a significantly shorter wait time than the 15 to 20 years it normally takes to bring an experimental vaccine to market
- Fast-tracking vaccine development and licensure has considerable risks. It might be ineffective (which is typically the case for the seasonal influenza vaccine), or it might cause serious side effects (as was the case with the fast-tracked H1N1 swine flu vaccine in 2009), or it just might worsen infection rather than prevent it
- The fast-tracked ASO3-adjuvanted H1N1 swine flu vaccine Pandemrix (used in Europe but not in the U.S. in 2009-2010) has been causally linked to childhood narcolepsy, which abruptly skyrocketed in several countries after its release
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
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?
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.
As reported by Reuters, some vaccinated animals got sicker than unvaccinated animals when exposed to the virus. A more reliable way to determine whether this might be a risk for a COVID-19 vaccine is to use an appropriate animal model during the trials, before the vaccine is given to humans.
Europe also accelerated its approval process, allowing manufacturers to skip large-scale human trials12 — a decision that turned out to have tragic consequences13 for an untold number of children and teens across Europe.
Over the next few years, the ASO3-adjuvanted swine flu vaccine Pandemrix (used in Europe but not in the U.S. during 2009-2010) was causally linked14 to childhood narcolepsy, which abruptly skyrocketed in several countries.15,16
Children and teens in Finland,17 the UK18 and Sweden19 were among the hardest hit. Further analyses discerned a rise in narcolepsy among adults who received the vaccine as well, although the link wasn’t as obvious as that in children and adolescents.20
A 2019 study21 reports finding a “novel association between Pandemrix-associated narcolepsy and the non-coding RNA gene GDNF-AS1” — a gene thought to regulate the production of glial cell line-derived neurotrophic factor or GDNF, a protein that plays an important role in neuronal survival.
They also confirmed a strong association between vaccine-induced narcolepsy and a certain haplotype, suggesting “variation in genes related to immunity and neuronal survival may interact to increase the susceptibility to Pandemrix-induced narcolepsy in certain individuals.”
The fact that health authorities seem to have conveniently forgotten this travesty is shocking, considering it was only a decade ago. Do we really want to conduct the same kind of global mass experiment for a relatively mild disease again?
If there were an outbreak of a disease where death was rapid and horrifying, and the lethality high, such as with a hemorrhagic fever virus like Ebola, where the mortality rate can be as high as 50 percent, many people would be willing to risk even lifelong side effects from a fast-tracked vaccine.
But that’s not what we’re facing with COVID-19. According to the U.S. Food and Drug Administration, “the immediate health risk from COVID-19 is considered low.”22 Nor was the H1N1 outbreak a “global killer.”
Yet here we are, facing yet another (potentially mandatory?) fast-tracked vaccine for a disease that will likely have run its course by the time the vaccine comes out. Have we really learned nothing from the Pandemrix debacle?
Looking at the symptoms list for hMPV25 is telling, as the main symptoms include fever, sore throat and cough. The elderly and immunocompromised are at heightened risk for severe hMPV illness, the symptoms of which include difficulty breathing and pneumonia. All of these symptoms also apply for COVID-19.
Time will tell what the outcome here will be. At present, health authorities recommend using the following strategies to minimize the spread of infection:26
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?
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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.’”
Fast-Tracking Vaccines Is Risky Business
Fast-tracking vaccine development has considerable risks. It might be ineffective (which is typically the case for the seasonal influenza vaccine), or it might cause serious side effects (as was the case with the fast-tracked 2009-2010 H1N1 swine flu vaccine), or it just might worsen infection rather than prevent it. As reported by Reuters:10“Studies have suggested that coronavirus vaccines carry the risk of what is known as vaccine enhancement, where instead of protecting against infection, the vaccine can actually make the disease worse when a vaccinated person is infected with the virus.
The mechanism that causes that risk is not fully understood and is one of the stumbling blocks that has prevented the successful development of a coronavirus vaccine.
Normally, researchers would take months to test for the possibility of vaccine enhancement in animals. Given the urgency to stem the spread of the new coronavirus, some drugmakers are moving straight into small-scale human tests, without waiting for the completion of such animal tests.
‘I understand the importance of accelerating timelines for vaccines in general, but from everything I know, this is not the vaccine to be doing it with,’ Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, told Reuters.”Coming from a staunch pro-mandatory vaccination propagandist like Hotez, that’s really saying something. The possibility of vaccine-induced immune enhancement became evident during the development and testing of a SARS vaccine.
As reported by Reuters, some vaccinated animals got sicker than unvaccinated animals when exposed to the virus. A more reliable way to determine whether this might be a risk for a COVID-19 vaccine is to use an appropriate animal model during the trials, before the vaccine is given to humans.
Fast-Tracked Swine Flu Vaccine Caused Serious Harm to Youths
One excellent example of what can go wrong when a vaccine is fast-tracked is that of the H1N1 swine flu vaccine released in Europe during the swine flu pandemic of 2009-2010. As reported by WebMD,11 in July 2009, the U.S. National Biodefense Safety Board unanimously decided to forego most safety and efficacy tests to get the vaccine out by September of that year.Europe also accelerated its approval process, allowing manufacturers to skip large-scale human trials12 — a decision that turned out to have tragic consequences13 for an untold number of children and teens across Europe.
Over the next few years, the ASO3-adjuvanted swine flu vaccine Pandemrix (used in Europe but not in the U.S. during 2009-2010) was causally linked14 to childhood narcolepsy, which abruptly skyrocketed in several countries.15,16
Children and teens in Finland,17 the UK18 and Sweden19 were among the hardest hit. Further analyses discerned a rise in narcolepsy among adults who received the vaccine as well, although the link wasn’t as obvious as that in children and adolescents.20
A 2019 study21 reports finding a “novel association between Pandemrix-associated narcolepsy and the non-coding RNA gene GDNF-AS1” — a gene thought to regulate the production of glial cell line-derived neurotrophic factor or GDNF, a protein that plays an important role in neuronal survival.
They also confirmed a strong association between vaccine-induced narcolepsy and a certain haplotype, suggesting “variation in genes related to immunity and neuronal survival may interact to increase the susceptibility to Pandemrix-induced narcolepsy in certain individuals.”
The fact that health authorities seem to have conveniently forgotten this travesty is shocking, considering it was only a decade ago. Do we really want to conduct the same kind of global mass experiment for a relatively mild disease again?
If there were an outbreak of a disease where death was rapid and horrifying, and the lethality high, such as with a hemorrhagic fever virus like Ebola, where the mortality rate can be as high as 50 percent, many people would be willing to risk even lifelong side effects from a fast-tracked vaccine.
But that’s not what we’re facing with COVID-19. According to the U.S. Food and Drug Administration, “the immediate health risk from COVID-19 is considered low.”22 Nor was the H1N1 outbreak a “global killer.”
Yet here we are, facing yet another (potentially mandatory?) fast-tracked vaccine for a disease that will likely have run its course by the time the vaccine comes out. Have we really learned nothing from the Pandemrix debacle?
Flu Immunization May Increase Risk of Coronavirus Infection
A study23 in the January 10, 2020, issue of the Vaccine journal also offers food for thought. As noted in this study, “Influenza Vaccination and Respiratory Virus Interference Among Department of Defense Personnel During the 2017-2018 Influenza Season”:“Receiving influenza vaccination may increase the risk of other respiratory viruses, a phenomenon known as virus interference. Test-negative study designs are often utilized to calculate influenza vaccine effectiveness.
The virus interference phenomenon goes against the basic assumption of the test-negative vaccine effectiveness study that vaccination does not change the risk of infection with other respiratory illness, thus potentially biasing vaccine effectiveness results in the positive direction.
This study aimed to investigate virus interference by comparing respiratory virus status among Department of Defense personnel based on their influenza vaccination status. Furthermore, individual respiratory viruses and their association with influenza vaccination were examined.”Results were mixed. Interestingly enough, while seasonal influenza vaccination did not raise the risk of all respiratory infections, it was in fact “significantly associated with coronavirus and human metapneumovirus” (hMPV). Those who had received a seasonal flu shot were 36% more likely to contract coronavirus infection and 51% more likely to contract hMPV infection than unvaccinated individuals.24
Looking at the symptoms list for hMPV25 is telling, as the main symptoms include fever, sore throat and cough. The elderly and immunocompromised are at heightened risk for severe hMPV illness, the symptoms of which include difficulty breathing and pneumonia. All of these symptoms also apply for COVID-19.
Recommended Infection Prevention Strategies
Based on the evidence, the odds of creating a safe-for-all vaccine without rigorous long-term studies are slim to none. Some people are bound to get hurt, which is why it doesn’t make sense to rush a vaccine unless the disease is severe and has a high death rate.Time will tell what the outcome here will be. At present, health authorities recommend using the following strategies to minimize the spread of infection:26
- Frequently wash your hands with soap and water for at least 20 seconds. For further details, see “The Impact of Effective Handwashing Against Infection”
- Avoid touching your eyes, nose and mouth
- If you need to cough, cough into your flexed elbow or disposable tissue. Discard the tissue in a trash can and wash your hands
- If feeling unwell, stay home and avoid public spaces
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