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COVID-19 Vaccine  May 18, 2020  11 days ago
BREAKING! COVID-19 Vaccine: Warning That Immune Enhancement Dangers Likely To Emerge From Accelerated COVID-19 Vaccine Testing
BREAKING! COVID-19 Vaccine: Warning That Immune Enhancement Dangers Likely To Emerge From Accelerated COVID-19 Vaccine Testing
COVID-19 Vaccine  May 18, 2020  11 days ago
COVID-19 Vaccine:  Governments and pharmaceutical companies around the world are rushing to develop a COVID-19 vaccine either with the aim of profiteering from it either through monetary forms or thru diplomatic superiority as the disease is silently rampaging the global population and taking casualties along the way.


 
However credible and knowledgeable medical researchers are concerned that rushing a vaccine could end up worsening the infection in some patients rather than preventing it.
 
Past studies have indicated 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 individual is infected with the coronavirus. https://www.nature.com/articles/s41577-020-0323-4 or https://www.pnas.org/content/117/15/8218 or
http://apjai-journal.org/wp-content/uploads/2020/03/AP-200220-0772.pdf
 
This mechanism that causes that risk is not fully understood and is one of the stumbling blocks that have prevented the successful development of a coronavirus vaccine.
 
Typically it would take months to test for the possibility of vaccine enhancement in animal models. Given the urgency to stem the spread of the new SARS0CoV-2 coronavirus, some vaccine makers are moving straight into small-scale human tests, without waiting for the completion of such animal tests.
 
Dr Peter Hotez, Head of the National School of Tropical Medicine at Baylor College of Medicine warned, “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 Hotez worked on development of a vaccine for SARS (Severe Acute Respiratory Syndrome) in 2003 and found that some vaccinated animals developed more severe disease compared with unvaccinated animals when they were exposed to the virus.
 
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 He explained, “There is a risk of immune enhancement. The way you reduce that risk is first you show it does not occur in laboratory animals.”

Though most of the global experts have concluded that accelerated testing is a must, there are some countries and companies that are taking the risk to bypass it.
 
Unfortunately during a specially convened World Health Organization (WHO) working conference in mid-February, designed to co-ordinate a global response to the new SARS-CoV-2 coronavirus, medical researchers representing government-funded research organizations and pharmaceutical companies around the world agreed that the threat was so great that vaccine developers should move quickly into human trials, before animal testing is completed, according to sources.
 
Dr Marie-Paule Kieny, a former assistant director-general at the WHO, who co-chaired the conference, told media in private, “If one wants to have a vaccine as quickly as possible. One has to balance this with the risk that one imposes on a very small number of people, and do all one can do to mitigate this risk as much as possible.”
 
However, the agreed strategy of that meeting, which was not open to media, has not been officially publicized by the WHO. It does not reflect any official position adopted by the WHO, a United Nations body whose job it is to help shape global health policy.
 
Typically, regulatory oversight of vaccine makers and vaccine research is in the hands of national regulators. The most powerful of those, the US FDA has signaled that it is in agreement with the consensus and will not stand in the way of accelerated testing schedules. The US FDA has made so many blunders recently even in the chloroquinine, hydroxychloroquinine and remdesivir and the Abbot rapid test kits.
 
The US FDA had no comment specifically on animal testing for vaccine enhancement.
 
FDA spokeswoman Stephanie Caccomo said in a statement, “When responding to an urgent public health situation such as the SARS-CoV-2 coronavirus, we intend to exercise regulatory flexibility and consider all data relevant to a certain vaccine platform.
 
However, COVID-19 vaccine developers are still required to conduct routine animal testing to make sure the vaccine itself is not toxic and is likely to help the immune system respond to the virus.
 
In America alone, some 27 coronavirus vaccine candidates are being developed by research institutes and vaccine makers including America’s Johnson & Johnson and France’s Sanofi SA. The US government has earmarked more than US$4 billion for COVID-19 treatments and vaccines.
 
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Moderna Inc, which is working with the US-funded National Institutes of Health (NIH), has already started human testing in Seattle but results have been kept confidential so far.
 
NIH told media that testing for the specific risk of vaccine enhancement in animals will proceed simultaneously with human trials, which it said should establish whether it is safe to expose larger numbers of people to the vaccine. However, Moderna did not respond to requests for comment.
 
Leading virologist and vaccine researcher, Dr Gregory Poland from Mayo Clinic in Rochester, Minnesota, expressed doubts about that approach.
 
He said, “This is important, but it has to be done in a way that reassures scientists and the public that these (vaccines) are not only efficacious, but safe.”
 
Dr Hotez said he was surprised human trials were going ahead. “If there is immune enhancement in laboratory animals vaccinated with the Moderna vaccine, that’s a showstopper.”
 
Another company Inovio Pharmaceuticals Inc, which is developing a COVID-19 vaccine in collaboration with a Chinese company, has also started human clinical trials in 30 US volunteers rather than wait for animal studies on vaccine enhancement.
 
The company plans has also started human safety trials in China.
 
Past tragic lessons from other vaccines and prior work on coronaviruses have raised some warning flags for vaccine developers.
 
The most infamous example occurred in an American trial in the 1960s of a vaccine created by the NIH and licensed to Pfizer Inc to fight respiratory syncytial virus (RSV), which causes pneumonia in infants. The vast majority of babies who received the vaccine developed more severe disease, and two toddlers died.
 
An even more infamous recent example occurred in the Philippines, where some 800,000 children were vaccinated with Sanofi’s dengue vaccine, Dengvaxia. Only afterward did the company learn that it could increase the risk of more severe disease in a small percentage of individuals.
 
Significant research, including that conducted by Dr Hotez, has shown that coronaviruses in particular have the potential to produce this kind of response. But testing for the risk of vaccine enhancement is time-consuming because it requires vaccine researchers to breed mice that are genetically altered to respond to the virus like humans. Work on these and other animal models is just getting under way in several laboratories around the world.
 
Unfortunately Moderna, Inovio and several other vaccine developers are not waiting for that process to be completed and have already launched human trials in record time for a virus that was only discovered in December.
 
Moderna and Inovio are claiming that their vaccines are likely to have a lower risk of vaccine enhancement because they are made using newer technology that focuses on specific genes on the outer ‘spike’ portion of the virus.
 
It was said that coronavirus vaccines that caused vaccine enhancement were typically made using an inactivated version of the entire virus.
 
Interestingly neither company has produced a licensed vaccine to date.
 
Just like in the case of the chloroquinine and hydroxychloroquinine fiasco where no one has taken responsible for deaths that these drugs had caused to certain COVID-19 patients as the corrupted Trump administration had managed to conceal things, we expect to see a massive mess emerging from the vaccines that the US are accelerating in development for fast usage in large human trials.
 
For more on COVID-19 Vaccine developments, keep logging to Thailand Medical News.
 
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