Are the COVID Vaccines Experimental? Did They Skip Animal Trials?
A vaccine fact check roundup.
|Khaya Himmelman||Apr 20||39||3|
A viral Facebook post lists “6 facts” about the three COVID-19 vaccines currently in use in the United States. These “facts” are listed as follows: “none are FDA approved, all are considered ‘experimental,’ none have completed initial research trials, all were allowed to skip animal trials, none will complete a research trial for 2-3 years, all are free of liability even if one kills you.”
Some of these claims are false or missing context.
First, let’s start with the claim that “none are FDA approved.” While it’s true that no single vaccine has been granted FDA approval, all three vaccines have been given an emergency use authorization by the FDA. Both Moderna and Pfizer are on track to apply for full FDA approval based on the results of their Phase III clinical trials. However, it’s worth mentioning that on April 13 the CDC and FDA released a joint statement recommending a “pause” in the distribution of the Johnson & Johnson COVID-19 vaccine to look into six reported cases of “a rare and severe type of blood clot.”
According to the FDA: “Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies.” The FDA notes on its website that an EUA permits the use of “unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.”
The Center for Disease Control also states: “COVID-19 vaccines were evaluated in tens of thousands of participants in clinical trials. The vaccines met FDA’s rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization (EUA).”
Next is the claim that all of the vaccines are ‘experimental.’ While it’s true that mRNA vaccines are new, the technology is not. The Moderna and Pfizer/BioNTech vaccines are mRNA vaccines. As the CDC explains: “Researchers have been studying and working with mRNA vaccines for decades. Interest has grown in these vaccines because they can be developed in a laboratory using readily available materials. This means the process can be standardized and scaled up, making vaccine development faster than traditional methods of making vaccines.”
Furthermore, according to the CDC, “mRNA vaccines have been studied before for flu, Zika, rabies, and cytomegalovirus (CMV). As soon as the necessary information about the virus that causes COVID-19 was available, scientists began designing the mRNA instructions for cells to build the unique spike protein into an mRNA vaccine.”
The Johnson & Johnson vaccine is a viral vector vaccine, which, per the CDC, scientists have been creating since the 1970s. According to Gavi, the Vaccine Alliance, viral vector vaccines work by “using a modified virus (the vector) to deliver genetic code for antigen, in the case of COVID-19 spike proteins found on the surface of the virus, into human cells. By infecting cells and instructing them to make large amounts of antigen, which then trigger an immune response, the vaccine mimics what happens during natural infection with certain pathogens--especially viruses.” This same viral vector technology has also been used in ebola vaccines.
The claim that “none have completed initial research trials” is false. Results from Pfizer’s Phase III trial were published in the New England Journal of Medicine in December 2020: “A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19.”
Moderna’s Phase III clinical trial results, which were published in the New England Journal of Medicine on December 31, 2020, included 28,207 participants who received the Moderna vaccine or a placebo: “There were 11 COVID‑19 cases in the Moderna COVID‑19 Vaccine group and 185 cases in the placebo group, with a vaccine efficacy of 94.1% (95% confidence interval of 89.3% to 96.8%).”
Lastly, the Johnson & Johnson also completed its Phase III clinical trial, with 44,325 participants, resulting in data suggesting that: “the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.”
The claim that all three COVID-19 vaccines skipped animal testing is also false. Both Pfizer and Moderna tested vaccines on mice and macaques, as reported by the Associated Press. Both drug companies were given approval to test the vaccine on animals while also testing humans during Phase I of clinical trials, per the Associated Press. Johnson & Johnson tested its vaccine on Syrian golden hamsters.
The claim that “none will complete a research trial for 2-3 years” is also false. Continued clinical trial and study of the Pfizer vaccine is listed in the U.S. National Library of Medicine as beginning on April 29, 2020, and an estimated study completion date of April 6, 2023. Moderna’s study completion day listed in the U.S. National Library of Medicine is October 27, 2022, and the estimated study completion date for Johnson & Johnson is January 2, 2023.
Lastly, the claim “all are free of liability even if one kills you” is, for the most part, true. Because the secretary of health and human Services declared the coronavirus a public health emergency and invoked the Public Readiness and Emergency Preparedness Act (PREP Act) in February 2020, drugmakers are largely protected from COVID-19 vaccine related lawsuits, per the Congressional Research Service. However, as written in the PREP Act, pharmaceutical companies are not protected in cases of “willful misconduct.”
The PREP Act “provides immunity from liability (except for willful misconduct) for claims: of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the [secretary of health and human services] to constitute a present, or credible risk of a future public health emergency, to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures…”
The PREP Act also established the Countermeasures Injury Compensation Program to: “provide compensation to eligible individuals for serious physical injuries or death directly caused by the administration or use of pandemic, epidemic, or security countermeasures.”
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