By Abigail Tadenev and Elisabeth Marnik
Due to the importance of vaccination in helping to end the COVID-19 pandemic, we would like to address the points that Mr. Atlee brought up in his article published on March 25 to ensure that the readership of the Islander has access to accurate information. We are both Ph.D.-trained scientists in the field of biomedical research and so have extensive experience evaluating the types of primary sources cited by Mr. Atlee.
First, use under an FDA Emergency Use Authorization (EUA) does not constitute a “medical experiment.” Experiments are tests where the outcome is unknown. Experiments with the COVID-19 vaccines were done in laboratories to ensure that they generally worked and were safe. Clinical trials were then performed with thousands of people to determine just how effective and how safe they were. Those have been completed, and we know that the vaccine is safe (we acknowledge that everything has risk, but the vaccine is safer than driving a car, certainly) and effective. Data are still being collected. Just this week Pfizer released six months of safety data, which means they’re now eligible for full FDA approval and will seek it shortly.
It was also suggested that alternative treatments exist that are being used elsewhere and would erase the need for a vaccine. The numbers Mr. Atlee gives for death rates in India and Africa are not due to drugs that U.S. regulators refuse to approve. These numbers are due to a combination of factors, including population structure (percentage over 65: India = 6.4 percent, Sub-Saharan Africa = 3 percent, USA = 16.2 percent). People in these areas also tend to live in multigenerational families rather than utilize nursing homes, institutions linked to one-third of U.S. COVID-19 deaths. Other factors include differences in reporting and the fact that residents of India and Africa are more accustomed to pandemics, including Ebola.
As to the alternative treatments mentioned by Mr. Atlee, these are indeed “medical experiments.” For example, Ivermectin is a drug used to treat parasitic infections and its safety and efficacy against SARS-CoV-2, the virus that causes COVID-19, are both questionable. More studies on this and other interventions are warranted and ongoing. There is no evidence that the use of drugs such as Ivermectin could replace the need for a vaccine to help end the pandemic.
It was also suggested that the pandemic is overblown, citing false positive test results and changes in death certification. False positives inflating cases are not a concern. PCR, the laboratory technique used to diagnose COVID-19, is very sensitive. This sensitivity can sometimes lead to false positives in those who had COVID-19 and are no longer contagious; true false positives in persons never infected are very unlikely. As to the issue of death certification, changes were required in this process as COVID-19 deaths are caused by a novel coronavirus. It is well-known that comorbidities, such as hypertension and diabetes, increase the risk of death from COVID-19. However, many of these individuals would not have died if they hadn’t gotten COVID-19. Moreover, if deaths were occurring due to normal causes and were just being coded as COVID-19 deaths, then our total yearly average would not change. However, this is not the case. Data reveal significant excess death, well above the expected average. Finally, we disagree that a death rate of 1 in 167 patients aged 50-64 is “very low.”
It is true that vaccine trials were designed to determine if the vaccines reduced symptomatic disease. This measure was chosen as the most reliable way to determine vaccine efficacy and provide rapid results. If death had been the outcome measure, the studies would have taken much longer, resulting in preventable suffering and deaths in the general population. A reduction in symptomatic cases should lead to a reduction in deaths as well, because fewer people will get sick enough to show symptoms. Indeed, we now have data showing fewer hospitalizations and deaths. We also now have a significant body of evidence showing that vaccines do prevent asymptomatic infections: the mRNA vaccines, Moderna and Pfizer, decreased infection by 90 percent. This means that vaccinated people are not only less likely to become symptomatic, they’re also less likely to even get infected. Thus, the concern over vaccines creating a large number of asymptomatic carriers is unfounded.
Let’s now address efficacy. Contrary to Mr. Atlee’s assertion, those with suspected COVID-19 were all tested, per the FDA trial documents (page 42). They were found to be negative for SARS-CoV-2 via multiple PCR tests. They were also monitored for serious symptoms that would lead a clinician to believe they had COVID-19 and possibly were falsely negative. Only two had progression to significant symptoms but their condition improved rapidly. Their resulting COVID-19-negative categorization is valid given multiple negative PCR tests and quick resolution. Many other viruses can cause similar symptoms. COVID-19 vaccines prevent COVID-19 only, not general colds or flus. It is illogical to argue that the PCR tests are both too sensitive, in claiming cases are being overcounted, and also not sensitive enough, when saying these individuals could really have had COVID-19.
It is unclear if or when booster vaccines may be needed. Viruses cannot mutate without infecting a host first, so vaccines will help prevent mutations that could necessitate boosters. Fortunately, SARS-CoV-2 mutates slower than influenza. Also, if pharmaceutical companies were making these vaccines solely for profit, they’re actually doing themselves a disservice. Disease is much more profitable for pharmaceutical companies and healthcare institutions. If vaccine-preventable diseases had been allowed to spread unchecked over the last 10 years, that would be an estimated $1.9 trillion profit versus the $230 billion of estimated profit off vaccines.
On to vaccine safety. The mRNA vaccines do carry a small risk of a severe allergic reaction known as anaphylaxis. However, this outcome is very rare, it is estimated to be between 2.5-11 per 1 million. These reactions are due to a component of the vaccine known as PEG. This molecule is also in many common medications, including Miralax, and the quantities found in the vaccine are tiny compared to the amount given to a constipated child.
The risk of long-term health effects after these vaccines is very unlikely. Previous experience shows that if an adverse event is going to happen it occurs minutes or days after a vaccine, not years. We also have extensive safety data from other RNA therapies already approved and in trials. The reason there are no other RNA vaccines currently available is because they did not prove effective or are still in trials.
We agree that monitoring adverse reactions is essential. VAERS is one system for monitoring safety, but another new system was not mentioned. This is called v-safe, which is open to anyone who gets vaccinated. It sends a daily survey to the participant tracking any side effects that occur. This system is better than VAERS because it collects reports from vaccinated individuals daily and over 3.8 million people have participated so far. The reports from this system have shown no concerning safety events.
In closing, we strongly encourage everyone to vet their sources of information. Choose science over anecdotes. As we look toward reaching herd immunity (itself a complicated issue) and ending the pandemic, we appreciate how the choice to vaccinate can have far-reaching effects, protecting both those close to us and around the globe.
There are many reasons to get vaccinated: to protect yourself, protect others, thwart variants and because we want this to end as quickly as possible, a point we can all agree on.
Abigail Tadenev, Ph.D., is an associate research scientist at The Jackson Laboratory and resides in Bar Harbor. Elisabeth Marnik, Ph.D., is an assistant professor of molecular biochemistry at Husson University and resides in Ellsworth. These opinions do not necessarily reflect those of their employers.