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Op-Ed: Why You Should Trust the COVID Vax

COVID-19 vaccine hesitancy persists, even among healthcare workers, and this presents a major barrier to stemming this pandemic, particularly amidst the emergence of more transmissible and potentially more virulent COVID-19 variants.

Key drivers of vaccine hesitancy are complacency, convenience, and most of all, lack of confidence and trust in the vaccines. A salient and widespread concern expressed by those who are hesitant to get either the Pfizer/BioNTech or Moderna vaccine is safety in relation to the speed at which these vaccines were developed. This concern is understandable, especially given that it has been widely publicized in the media that vaccine development is a complex process that takes many years. So how could these two mRNA COVID-19 vaccines developed in just under one year be evaluated as safe and effective? Both vaccines have demonstrated a level of efficacy of more than 94% for preventing symptomatic disease, with reassuring safety profiles.

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.”

The vaccine manufacturing timing was another key factor that contributed to the reduced duration for rollout of the vaccines. Traditionally, vaccine manufacturing begins to scale up once a vaccine is authorized, however, for the mRNA COVID-19 vaccines manufacturing took place in parallel with the clinical trials. Indeed, this was financially risky, but was informed by the “proof of concept” or biological plausibility of the vaccine candidates established in the preclinical trials, and was justified in the context of a deadly and explosive pandemic. The continuous or overlapping phase I/II/III trial design also helped to shorten the vaccine development timelines.

Widespread public interest in participating in the phase III trials for the Pfizer/BioNTech and Moderna vaccines also reduced the duration of vaccine development. This was a luxury for vaccine researchers, who recruited more than 70,000 participants between the two phase III trials. Even more advantageous to these trials was the fact that they were conducted during a raging pandemic, which provided the ideal context to quickly determine if the vaccines could protect the trial participants from developing the disease.

All of these factors came together at an unprecedented moment to minimize the duration of vaccine development without compromising safety and overall integrity. To stem the pandemic, we need to show people – including healthcare workers – that the vaccines are both effective and safe.

Rossi A. Hassad, PhD, MPH, is an epidemiologist and professor at Mercy College, in Dobbs Ferry, New York. He is a member of the American College of Epidemiology and a fellow and chartered statistician of Britain’s Royal Statistical Society.

Source: MedicalNewsToday.com