Op-Ed: Why You Should Trust the COVID Vax — Overwhelming, documented evidence of both safety and efficacy (
MedPage Today, 2/27/2021)
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There are a number of factors which directly and intentionally resulted in the shortened timeline for development and rollout of the two mRNA COVID-19 vaccines, without compromising vaccine safety. Understanding these factors can both encourage healthcare workers to get the vaccine themselves and equip them with the information they need to reassure patients.
First, the context of the COVID-19 pandemic is a historic international public health crisis, reminiscent of the 1918 Spanish flu pandemic; an extraordinary level of financial and other resources including human expertise, were brought to bear in an unprecedented spirit of international collaboration and cooperation. Just days following the identification of SARS-CoV-2 – the virus that causes COVID-19 – in China, the entire genetic composition of the virus was published. This provided vaccine researchers an early blueprint for conceptualizing the development of vaccines using different vaccine platform technologies to maximize the probability of quickly identifying potentially viable vaccine candidates.
The Pfizer/BioNTech and Moderna COVID-19 vaccines were the first to be granted emergency use authorization (EUA) by the U.S. FDA.
Both vaccines utilize the mRNA platform technology, which, albeit new, has been in development for decades, is adaptable and efficient, and can allow for booster versions of the vaccines to be quickly developed in response to the emerging COVID-19 variants.
The COVID-19 mRNA vaccines do not use the live virus that causes COVID-19. Rather, they carry a genetic code that instructs our cells to make a protein that triggers the immune system to produce antibodies to combat and prevent COVID-19 infection. Moreover, mRNA never enters the nucleus of the cell, and therefore does not affect or interact with our DNA. The cell breaks down and eliminates the mRNA soon after the encoded instructions are executed.
While both the Pfizer/BioNTech and Moderna vaccines received EUA in December, they were administered to participants in the phase I studies as early as March 2020, with a primary focus on the evaluation of safety, which continued into phases II and III of the vaccine trials. The vaccine developers had amassed about 8 months of safety data before the vaccines were rolled out, and to date, more than 59 million doses have been administered in the U.S. This is particularly important, noting that "most vaccine-related adverse events would be expected over the first few weeks to months after vaccination," a period that has been accomplished for both the Pfizer and Moderna vaccines. Vaccine safety monitoring is ongoing, and according to the CDC, COVID-19 vaccines have "reassuring safety profiles."