Vaccine Development Companies’ Approach to Cultivating Patient Confidence, Trust in COVID-19 Vaccine
In early November, the Novavax COVID-19 vaccine received fast track designation by the Food and Drug Administration (FDA) and had begun its Phase 3 trials in the United States and Mexico.
The small Maryland-based biotech company formulated the vaccine candidate known as NVX-CoV2373, which is being recognized for its potential to be distributed more efficiently on a global scale because of its unique ability to be stored at room temperature.
More importantly, safety and efficacy must be proved for the vaccine through clinical research to proceed as a viable candidate. Novavax assures the public that it is committed to safety even while on the fast track designation.
“While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally, shares Gregory M. Glenn, M.D., President of Research and Development, Novavax, in a press release.
Other vaccine development companies are also being challenged with fast-paced formulation without compromising safety and efficacy; some companies include Pfizer/BioNTech, Moderna, and Johnson & Johnson.
So how exactly do these companies plan to demonstrate vaccine safety and efficacy to the public
1. Using the gold standard method of study and involving ample participants.
According to the New England Journal of Medicine (NEJM), the Novavax COVID-19 vaccine is being analyzed for its efficacy and immunogenicity during a three-phase process. Each phase is conducted in a randomized controlled trial (RCT) format. RCTs are considered the gold standard method study as they reduce bias that is inherent with other study designs.
In Novavax’s Phase 3 trial, they will increase their study population up to 30,000 participants. Researchers analyzing the Pfizer/BioNTech vaccine’s safety and efficacy called BNT162b2 in its Phase 3 trial used a placebo-controlled, randomized, observer-blind study design. The study involved more than 43,000 participants.
2. Addressing diversity in clinical trials.
A recent poll shows that 58 percent of the public would be willing to get a vaccine as soon as it becomes available. Of that percentage, 59 percent of White Americans would get the vaccine compared to 43 percent of Black Americans.
“About half (48%) of Black adults say they are not confident that the development of a COVID-19 vaccine is taking the needs of Black people into account, and over a third (36%) of Hispanic adults say the same about the needs of Hispanic people.” according to a Kaiser Family Foundation (KFF) poll.
After recognizing the pandemic’s disproportionate impact on minority populations, Moderna, in its Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273, made diversity a priority in its research. “Investigators worked with community engagement partners to enroll a diverse pool of participants,” according to a National Institutes of Health (NIH) news release. “37% of trial volunteers are from racial and ethnic minorities.”
More Americans may be on board with getting the vaccine by including higher percentages of diverse populations in COVID-19 clinical trials. Improving these numbers is crucial because a majority of Americans need to be vaccinated to effectively control the spread of the disease. Experts believe this number to be 70 percent of the U.S. population in order to achieve herd immunity.
3. Transparency regarding adverse events.
According to the Good Pharma Scorecard, an initiative that grades a pharmaceutical company’s transparency practices for clinical trials supporting newly approved products, Johnson & Johnson made it to the top of the list. “The Johnson & Johnson SARS-CoV-2 vaccine clinical trials were evaluated as having above-average transparency track records in the scorecard,” according to Statnews.com.
According to a J&J press release, “We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards and our own high ethical and scientific principles.”
Transparency is a main factor in encouraging Americans in getting a vaccine when it’s their turn to get in line. For example, the aforementioned KFF poll revealed that those who expressed reluctance to getting vaccinated were most worried about possible side effects—up to 59 percent of poll takers.
Dr. Anthony Fauci has said that 75% – 85% of the American population will need to be inoculated in order for activity to return to pre-pandemic levels.
Vaccine development companies have a lot to prove in a short time period—such as selecting high-quality three-tiered study types and diverse study populations, and the communication of the study results in a straightforward and transparent effort to eradicate the deadly coronavirus pandemic.
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