This is an open letter pointing out the safety issues with a rushed vaccine for COVID-19. It is our hope that you will download this letter and send it to everyone you deem necessary (local officials, public health committees, county commissioners, school boards, local newspapers, medical staff, etc.) Also please consider sharing this information on your social media. THIS LETTER HAS BEEN SENT TO ALL 170 NORTH CAROLINA SENATORS AND REPRESENTATIVES.
Many North Carolinians are anxiously awaiting a COVID-19 vaccine because of the promise it holds to allow people to resume their normal lives, and several companies are rushing to get one to market. After much research, it has become apparent that the coronavirus vaccines being rushed to market are especially vulnerable to safety issues because:
Historical attempts at a coronavirus vaccine were unsuccessful due to safety issues.
Pre-marketing safety trials are insufficient because they are using inadequate sample sizes and short observation periods to watch for adverse reactions. In addition, double-blind, inert placebos are not required.
Proper post-marketing surveillance is compromised by the rushed schedule.
The pharmaceutical companies who will be producing the vaccine have been given immunity to lawsuits no matter how egregious their errors are.
I am writing to ask you to ensure that any COVID-19 vaccine rolled out in NC be properly studied for safety.
Prior attempts at a coronavirus vaccine unsuccessful: Dr. Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine, has stated that scientists have attempted to create a coronavirus vaccine for over 50 years and have been unable to produce one due to safety concerns related to “immune enhancement,” a condition in which vaccinated test subjects become gravely ill when exposed to the wild virus.
Dr. Hotez, who is typically a strong proponent of vaccines, has testified before Congress about the “unique potential safety problems of a coronavirus vaccine.” His recent animal studies for a coronavirus vaccine resembled the “immune enhancement” seen in research 50 years ago. Two children in that initial coronavirus vaccine study died.
Dr. Hotez told Reuters, “I understand the importance of accelerating timelines for vaccines in general, but from everything I know, this [COVID-19] is not the vaccine to be doing it with.”
COVID-19 Vaccine Safety Precautions VS. Safety Precautions for Other Pharmaceuticals
Non-vaccine pharmaceuticals are subject to safety protections such as: pre-marketing studies, post-marketing surveillance, and tort liability. Precautions for vaccines are lacking in all three areas.
Pre-Marketing Studies: Prior to marketing, non-vaccine pharmaceuticals are required to undergo stringent safety studies that include double-blind, inert placebo testing; large sample sizes; a lengthy observation of approximately 5 years; and testing on people who have poor health. Prominent vaccine researcher and promoter, Dr. Paul Offit, has said that trials for a COVID-19 vaccine should have “20,000 who get a vaccine and 10,000 who get a placebo. Then and only then will you know whether a vaccine is safe and effective.”
The COVID-19 vaccine studies fail to address many of these safeguards in testing. For example, in its phase 2 trial, Moderna, the current front-runner in the race for a COVID-19 vaccine, is using a sample size of only 600 people (compared with the 30,000 recommended by Dr. Offit); the follow up period is slated for 13 months; and study participants who are under 18 or have chronic health issues are excluded. Given that an estimated 60% of Americans have chronic health problems, and the vaccine is intended for all Americans (especially the frail), this trial represents a small percent of the people who will be required to take it.
A note about inert placebos: Moderna currently has committed to using an inert placebo in its phase 2 trials. However, unlike with other medications, vaccine manufacturers are not required to use an inert placebo [see item (1) here], and the FDA has allowed coronavirus vaccine manufacturers to back out of using inert placebos. For example, the vaccine currently under development by AstraZeneca initially provided that the control group would receive a saline placebo. After approving this study design, the FDA inexplicably approved changing the control from a “Placebo Control” to “MenACWY,” which is another vaccine for a bacterial infection unrelated to COVID-19. It is ethically and scientifically indefensible to use MenACWY vaccine as a control because its safety profile has never been established in a placebo-controlled clinical trial.
Post marketing surveillance: Once a pharmaceutical is on the market, drug companies conduct surveillance to document unexpected adverse events. Because the plan is to quickly distribute this vaccine to the maximum number of people, there will be little time to catch adverse reactions before millions of people may have incurred harm.
The introduction of the vaccine and its potential adverse side effects should not disproportionately harm members of one race over another. However, under the pretense of equity, Melinda Gates has stated that “black people...and many other people of color” will be the first in the general population to receive the COVID-19 vaccine because “they are having disproportionate effects from COVID-19.” Given the poor safety results in past coronavirus vaccine trials and the insufficient testing of the COVID-19 vaccine, it is unethical to prioritize people of color as the first recipients of a potentially hazardous vaccine. Some have said that vaccinating people of color first is too eerily similar to the Tuskegee experiments.
Tort Law Protections: With the exception of vaccines,pharmaceutical companies are liable for any injury caused by their products. This liability adds an additional layer of incentive for companies to produce a safe product. The US PREP Act waives all liability of pharmaceutical companies who produce a COVID-19 vaccine. This act along with the rushed timeline of development further erodes the safety profile of a COVID-19 vaccine.
We ask you to ensure that any COVID-19 vaccine introduced in NC receive proper safety studies and provide compensation to anyone who is injured, including:
Use of a double-blind, inert placebo in safety studies
A sample size of 20,000 participants and 10,000 who receive placebo
An observation period of at least 1 year for adults, 3 years for children and teenagers, and 5 years for infants and toddlers.
Testing of people of all ages and health statuses
An NC-sponsored injury compensation program to offset the loss of tort liability protections created by the PREP Act
Thank you for addressing these issues.