Emergency Use Authorization is Experimental Use
12/22/20: Operation Warp Speed Covid-19 vaccines have recently received emergency use authorization by the U.S. Food and Drug Administration. These novel coronavirus vaccines were developed in less than one year’s time, making them among the fastest vaccines ever made and mass-deployed to the public. Given the breakneck speed of their development and release, it seems reasonable to ask: Are Covid-19 vaccines safe?
In the United States, two pharmaceutical companies (Moderna and Pfizer) are the frontrunners in the Covid-19 vaccine race. Both Moderna and Pfizer use a first-of-its-kind technology called messenger RNA (mRNA) in their Covid vaccines. These mRNA vaccines can be best described as experimental medical interventions, because we do not have long-term safety data and therefore do not know about potential long-term consequences associated with their use (e.g. if they might affect fertility or cause autoimmune disease or cancer down the road).
It is okay to participate in a human medical experiment if one chooses to do so willingly, but we should be fully informed as to the nature of the experiment and its risks and benefits. One very important thing to note when it comes to Covid-19 vaccines is that a person will not be able to sue the vaccine manufacturers for any injury, disability, or even death resulting from the vaccine. This is because the U.S. government has given complete indemnity to vaccine manufacturers immunizing them from liability for injuries and deaths caused by vaccinations.[1]
William Haseltine, a former professor at Harvard Medical School and Harvard School of Public Health, wrote the following in a Forbes article titled Covid-19 Vaccine Protocols Reveal That Trials Are Designed To Succeed:
“These [vaccine clinical trial] protocols do not emphasize the most important ramifications of Covid-19 that people are most interested in preventing: overall infection, hospitalization, and death… It appears that these trials are intended to pass the lowest possible barrier of success.”
Peter Doshi, associate editor of The BMJ (British Medical Journal), echoes this sentiment writing:
“None of the trials currently under way [to evaluate the safety and efficacy of Covid-19 vaccines] are designed to detect a reduction in any serious outcome such as hospital admission, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.”[2]
This raises an important question: If a vaccine only prevents symptoms of Covid-19 but does not prevent infection and transmission of the virus, how useful will that be in ending the pandemic? Furthermore, what would be the justification for making these vaccines mandatory?
Kristen Choi, a nurse and researcher, described what it was like getting Pfizer’s Covid-19 vaccine and published her experience in the peer-reviewed journal JAMA Internal Medicine. She writes:
“The experience after the second [Covid-19 vaccine] injection was different. My arm quickly became painful at the injection site, much more than the first time. By the end of the day, I felt light-headed, chilled, nauseous, and had a splitting headache. I went to bed early and fell asleep immediately. Around midnight, I woke up feeling worse—feverish and chilled, nauseated, dizzy, and hardly able to lift my arm from muscle pain at the injection site. My temperature was 99.4 °F (37.4 °C). I tossed and turned, sleeping little during the rest of the night. When I woke up again at 5:30 am, I felt hot. Burning. I took my temperature and looked at the reading: 104.9 °F (40.5 °C). This was the highest fever I can ever remember having, and it scared me…”[3]
According to a report by CNBC: “Another participant in Pfizer’s [Covid-19 vaccine] trial said he was up all night after the first shot from the pain of the injection. The booster injection he received caused more of that same pain in his arm, followed by intense flu-like symptoms that hit him around 1 a.m. He couldn’t sleep that night without an electric blanket, and shook so hard that it became uncontrollable and he cracked part of his tooth from chattering them. ‘It hurt to even just lay in my bed sheet’ he said, before he decided to see a doctor.”
Tiffany Dover, a critical care nurse at CHI Memorial Hospital in Tennessee, fainted while speaking on camera just fifteen minutes after receiving her Pfizer Covid-19 vaccine. Upon regaining consciousness, she told reporters that she has a condition that often causes her to faint when she experiences pain. Fortunately, there was someone nearby to catch her and protect her head as she lost consciousness and dropped to the ground.
In clinical studies of Pfizer’s Covid-19 vaccine, adverse reactions in participants included: pain at the injection site (84.1%); fatigue (62.9%); headache (55.1%); muscle pain (38.3%); chills (31.9%); joint pain (23.6%); fever (14.2%); and injection site swelling (10.5%).[4]
Clinical studies of Moderna’s Covid-19 vaccine revealed an even higher frequency of adverse reactions in participants including: pain at the injection site (92%); fatigue (70%); headache (64.7%); muscle pain (61.5%); joint pain (46.4%); chills (45.4%); nausea/vomiting (23%); fever (15.5%); and swelling at the injection site (14.7%).[5]
In addition to the above-mentioned adverse side effects, allergic reactions to Covid-19 vaccines also seem to be an issue. According to an article in The Guardian: Two healthcare workers in the United Kingdom had severe allergic reactions shortly after receiving Pfizer’s Covid-19 vaccine. This prompted a UK Regulatory Agency to put out a precautionary statement warning:
“Any person with a history of a significant allergic reaction to a vaccine, medicine or food should not receive the Pfizer/BioNtech vaccine. Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.”
CNN reported on a similar story in the United States: “For the third time in three days, an Alaska health care worker had an allergic reaction after receiving a dose of the new Pfizer Covid-19 vaccine.” One of the healthcare workers reported she had no known allergies, though she once experienced a reaction to a bee sting. Another had no prior history of vaccine allergies. Along the same lines, the Idaho Statesman reported two healthcare workers had severe allergic reactions shortly after receiving Pfizer’s Covid-19 vaccine. Similarly, Fox news reported a Chicago-area hospital temporarily paused coronavirus vaccinations after four workers experienced adverse reactions to Pfizer’s Covid-19 vaccine.
Many questions remain as to the true safety profile of Covid-19 vaccines. One of the biggest unanswered questions is: Will Covid-19 vaccines cause disease enhancement when vaccine recipients encounter the SARS-CoV-2 virus?