PRA Experts Address Doubts About the Safety and Efficacy of COVID-19 Vaccines

One of the positives to emerge from our battle against COVID-19 has been public interest in vaccine development.

Key Highlights

Simply put, there was no “corner-cutting” in the development of COVID-19 vaccines. It was an “all hands-on deck” approach to save lives.

Harris W. Dalrymple, PhD (Med), PhD (Law)
Harris W. Dalrymple, PhD (Med), PhD (Law)
Executive Director, Center for Pediatric Clinical Development

Vaccine development used to be a relatively unconsidered part of medicine in the public view. Now, it has become a frequent topic of conversation and focus from the media—and for good reason. Developing a COVID-19 vaccine was the most cost-effective approach to ending this pandemic. Now that multiple vaccines are becoming progressively more accessible, the end of the pandemic may be in sight.

As one would expect, large pharmaceutical companies such as Pfizer, Johnson & Johnson, and AstraZeneca have been key players in developing COVID-19 vaccines in record time. Similarly, regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been instrumental in expeditiously authorizing the use of these vaccines under emergency conditions. Smaller organizations such as BioNTech, Moderna, Valneva, and Curevac have also greatly contributed and found places in the public press.

However, in recent years, a mistrust of pharmaceutical companies and their motivations has grown. This mistrust has contributed to concerns around the safety, efficacy, rapid development, and rollout of COVID-19 vaccines.

While these vaccines were developed quickly, they were developed carefully. In most vaccine development programs, the design stage of development can take two to five years and the regulatory stage can take one or two years. For these COVID-19 vaccines, the manufacturers and regulatory agencies focused all resources they could on development, managing to reduce the design stage and review stage to a handful of months.

“It’s important to keep in mind this was an all-in approach by these regulators and manufacturers,” says Lynlee Burton, MBA, Head of the Center for Vaccines and Emerging Infectious Diseases. “Corners were not ‘cut’—processes were accelerated by the regulators. Manufacturers took on calculated risks by running processes in parallel that would normally occur sequentially.”

The mRNA and adenovirus technology leveraged in the COVID-19 vaccines is not new technology; it has been clinically studied for decades.

Lynlee Burton, MBA, Head of the Center for Vaccines and Emerging Infectious Diseases

Development was further accelerated by many years of cumulative knowledge based on related research and prior clinical development programs. SARS-CoV-2, the virus that leads to COVID-19, is similar to SARS and MERS—diseases scientists have already studied and developed investigational vaccines to prevent.

“The mRNA and adenovirus technology leveraged in the COVID-19 vaccines is not new technology; it has been clinically studied for decades,” says Lynlee. “This prior research was applied to this similar disease and accelerated the typical development process.”

Pharmaceutical and biotechnology companies know that there is always a chance that an investigational vaccine may not be safe and efficacious, despite every available piece of evidence suggesting it is. Note that big pharma GlaxoSmithKline and Sanofi are not in this vaccine race—their vaccine failed to meet the acceptable efficacy requirements determined by regulatory agencies.

“Truthfully, besides all the hard work that went into it, our industry got lucky. The efficacy we have found in these vaccines is extremely promising to bring this pandemic to its end. We are lucky that these vaccines work—and they do work,” says Lynlee.

Darin Seehafer, Sr. Director of the Center for Vaccines and Emerging Infectious Diseases, adds “Globally, participant enrollment in these trials was also much easier than a typical vaccine trial—the public was aware and vested in bringing these vaccines to market.”

Just look at the speed participants enrolled: over 30,000 participants enrolled in each of these programs during the same time frame in the United States in a matter of a few months. That’s far faster than a typical vaccine development program. The difference between COVID-19 and other vaccine programs has been the rate at which participants enrolled and the heightened public interest.

The authorizations these vaccines received are also a direct result of their rapid development. Regulatory agencies instituted a “rolling review” process—looking at the data as it was generated rather than reviewing all at once when the whole program was complete. The Pfizer, Moderna, and J&J vaccines received Emergency Use Authorizations (EUAs) by the FDA in the US.

Our experts discuss the future of vaccine development in this Healthline article

“These authorizations are not final approvals—these will come once sufficient long-term follow-up data are available—but they do mean the relevant regulatory agencies, having reviewed the information from over 30,000 participants in each of these development programs, believe the data are sufficient to allow these vaccines to be given to the public,” says Darin.

They were authorized quickly because we are in an emergency. All involved organizations and agencies moved into a position to solve it. By focusing all the time and resources they could into vaccine development, they accelerated the process.

Beyond the EUAs issued by regulatory agencies, future regulatory licensure of COVID-19 will be based on the specific safety and efficacy standards as similarly applied to other vaccines.

“These vaccines were not fully licensed because there was no way to accelerate our understanding of the mid-term and long-term benefits relative to the safety and efficacy of the vaccines in immunized individuals. That understanding will only come with processing vaccine data over time,” says Isaac Rodriguez-Chavez, PhD, Senior Vice President and Head of the Global Center of Excellence for Decentralized Clinical Trials.

The vaccine rollout has already administered 910 million doses globally (at time of writing), providing real world evidence for the effectiveness of these vaccines in populations at large. As time progresses, information from these vaccinations will contribute to the understanding of the long-term effects and will provide the bases for safety and efficacy assessment needed for final licensure of the vaccines.

Drug development takes the collective experience and expertise of many people and many tried and tested processes. The timeline of these vaccines may seem overwhelmingly short, but the best practices implemented, the experience utilized, and the hours dedicated to their development was the amalgamation of decades of scientific and clinical research.

Simply put, there was no “corner-cutting” in the development of COVID-19 vaccines. It was an “all hands-on deck” approach to save lives.

PRA’s Center for Vaccines and Emerging Infectious Diseases applies solutions designed to deliver rapid and predictable outcomes, as well as cost-effective trials that prevent the spread of unnecessary disease.



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