Clinicians and Administrators
mRNA vaccines have been studied for more than a decade (Maruggi et al., 2019). mRNA vaccines have the capacity to overcome novel vaccine compositions and overcome many of the mass manufacturing barriers faced currently (Jackson et al., 2020). Because of the attention to mRNA research in the past number of years, COVID-19 researchers were not starting from scratch.
mRNA is non-infectious and clinical trials have shown no risk of infection or insertional mutagenesis. In other words, there is no risk of creation of mutations of DNA due to artificial mRNA (Pardi et al., 2018). mRNA is degraded and excreted by natural, normal cellular processes (Pardi et al., 2018). mRNA’s ability to induce the body’s immune reaction (immunogenicity) can be manipulated to enhance safety (Kariko et al., 2008; Thess et al., 2015). Studies have shown promise that mRNA vaccines will demonstrate ideal qualities of a vaccine. In particular, mRNA vaccines have shown safe outcomes in animals and are adaptable for rapid application to new infectious diseases (Pardi et al., 2018; Petsch et al., 2012; Bahl et al., 2017).
mRNA vaccines have been studied previously in cancer settings, and have shown promising results in prolonged disease-free survival in many cases (Pardi et al., 2018). Other cases of mRNA elicited potent immunity to infectious diseases include its efficacy in Zika, rabies, and influenza (Alberer et al., 2017; Van Driessche et al., 2009; Pardi et al., 2018). See here for a table of mRNA vaccine strategies that have been developed and here for a list of clinical trials employing mRNA vaccines against infectious diseases.
Additionally, the short manufacturing time inherent in mRNA production is advantageous to avoid contamination with other viruses, a concern presented in the production of other vaccines (Pardi et al., 2018).
In addition to the extensive investigation into mRNA vaccine safety over the last few years, the global collaboration from experts in the field lends credibility to the vaccine’s safety. Regulatory experts from around the world were convened in a WHO forum to review the data around the Pfizer/BioNTech vaccine, a key part of the risk-versus-benefit analysis (WHO, 2020). Additionally, the U.S.’s Operation Warp Speed accelerated the development of the vaccine by facilitating public and private partnerships with more than a dozen leading biopharmaceutical companies and national and international organizations, such as the CDC, FDA, and the European Medicines Agency (EMA) (National Institutes of Heatlh, 2020).
In a review of the safety and efficacy of the mRNA COVID-19 vaccine, study participants underwent randomization in which 43,448 participants received the vaccine. The study determined that a two-dose regimen of “BNT162b2 conferred 95% protection against COVID-19 in persons 16 years of age or older.” The safety of a 2-month period was similar (or comparable) to other viral vaccines (Polack et al., 2020). The rushed timeline did NOT compromise the accuracy of the vaccines. In fact, the influenza vaccine is only 40-60% effective in preventing the influenza virus (CDC, 2019).
Although data suggests that receiving the vaccine is safe, it is also important to note some adverse reactions may occur as a result of receiving a dose of the vaccine. There have been reports of severe allergic reactions (anaphylaxis) from receiving the vaccine. Those who have a history of severe allergic reactions to the ingredients in the vaccine should speak with their doctor (CDC, 2020).
General Public, Patients, and Family Members
For both vaccines, the laboratory-made mRNA within the vaccine is blanketed in a fatty layer, which serves to protect against the immune system when the vaccine is administered. Once the vaccine is inside a cell, the cell makes one of several proteins of SARS-CoV-2.
Then, the immune system will respond to that protein and produce antibodies, without actually having been infected with the COVID-causing virus itself. Therefore, if the person does come into contact with SARS-CoV-2 virus in their community, they already have the antibodies ready to neutralize the virus when it is in smaller quantity. The first dose helps the immune system create a response against SARS-CoV-2, the virus that causes COVID-19. The second dose further boosts the immune response for longer term protection.
Understanding how COVID-19 vaccines work
Understanding COVID-19 mRNA vaccines