Dissatisfaction with COVID-19 vaccination persists, even among health care workers, and this is a major obstacle to the prevention of this pandemic, especially amid the emergence of changes COVID-19 which is more portable and potentially more dynamic.
The main drivers of vaccine dissatisfaction are complacency, convenience, and in particular, lack of confidence and trust in the vaccines. A widespread relative concern expressed by those who are lazy to receive the Pfizer / BioNTech or Moderna vaccine is safety regarding the speed with which these vaccines have been developed. This concern is easy to understand, especially since it has been widely publicized in the media that vaccine development is a complex process that will take several years. So how could these two COVID-19 mRNA vaccines developed in just under one year be considered safe and effective? Both vaccines have shown a efficacy of more than 94% for the prevention of symptomatic infection, with confident safety profiles.
There are a number of factors that directly and deliberately shortened the timeline for the development and distribution of both COVID-19 mRNA vaccines, without compromising vaccine safety. Understanding these factors can motivate both health care workers to get the vaccine themselves and give them 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 pandemic; a remarkable level of financial and other resources including human knowledge, has been brought to an unprecedented spirit of international co-operation and collaboration. Just days after SARS-CoV-2 – the virus that causes COVID-19 – was identified in China, the complete genetic make-up of the virus was revealed. This gave vaccine researchers an early plan for conceptualising vaccine development using different vaccine platform technologies to identify the greatest likelihood to quickly identify potential vaccine candidates.
The Pfizer / BioNTech and Moderna COVID-19 vaccines were the first to receive emergency use approval (EUA) by the US FDA. Both vaccines use mRNA platform technology, which, although new, has been in development for decades, is flexible and effective, and can allow elevated versions of the vaccines to be rapidly developed in response. on the emerging COVID-19 variables. The COVID-19 mRNA vaccines do not use the live virus that causes COVID-19. Instead, they have a genetic code that guides our cells to make proteins that stimulate the immune system to produce antibodies to fight and prevent COVID-19 infection. In addition, mRNA never enters the nucleus of the cell, so it does not affect or interact with our DNA. The cell breaks down and destroys the mRNA shortly after execution of the encoded lead.
Although both received the Pfizer / BioNTech and Moderna EUA vaccines in December, they were administered to participants in phase I studies as early as March 2020, with a primary focus on safety assessment, leading to phases II and III. of the vaccine. tests. The vaccine developers had collected about 8 months of safety data before the vaccines were issued, and to date, more than 59 million doses have been given in the US. This is particularly important, noting that “most immunization-related adverse events would be expected. over the first few weeks to months after receiving the vaccine, “time has elapsed for both the Pfizer and Moderna vaccines. A vaccine safety audit is underway, and according to the CDC,” confident safety profiles at COVID-19 vaccines. “
The manufacturing time of the vaccine was another main reason for adding less time to the distribution of the vaccines. Traditionally, vaccine manufacturing begins to go up once vaccination is approved, however, for the manufacture of COVID-19 mRNA vaccines occurred at the same time as the clinical trials. Of course, this was financially risky, but it was informed by the “conceptual proofing” or biological plausibility of vaccine candidates established in the preclinical trials, and this was reasonable in context a deadly and explosive pandemic. Continuous or retrospective phase I / II / III test design helped to shorten vaccine development timelines.
Significant public interest in participating in phase III trials for the Pfizer / BioNTech and Moderna vaccines has declined throughout vaccine development. This was a boon for vaccine researchers, who employed more than 70,000 participants between the two phase III trials. Even more beneficial for these tests was the fact that they were conducted at the time of a pandemic, which provided the appropriate context to quickly determine whether the vaccines could protect the participants of the trial from developing the disease.
All of these factors combined at an unprecedented time to reduce the duration of vaccine development without compromising overall safety and integrity. To prevent 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, Dobbs Ferry, New York. He is a member of the American College of Epidemiology and a registered statistician of the Royal British Statistical Society.