Any U.S. FDA-approved COVID-19 vaccine must be both effective and safe

It is axiomatic that any vaccine to be deployed extensively in the U.S. or elsewhere should receive approval only after rigorous testing for both safety and efficacy. With more than six million cases and 200,000 fatalities, possibly rising to 400,000 deaths, the U.S. urgently needs a safe and effective vaccine.

Notwithstanding assurances provided by Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, that masking, social distancing and avoiding crowds will reduce the incidence rate, the U.S. population, industry and consumer activity will only be restored to normalcy with the assurances of a safe vaccine. Unfortunately, political rhetoric, confused messages from the CDC and hints of administration interference in scientific opinions and releases have created uncertainty. Factors creating a lack of confidence among potential recipients include possible bias in compilation of COVID data, the hydroxychloroquine debacle and accelerated (“warp-speed”) progress in development of a vaccine. Currently only half of those surveyed indicate that they would be in the first line to receive an approved vaccine.

The reality is that the Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration will be required to pass an opinion on Emergency Use Authorization (EUA) for the vaccines currently undergoing Phase-3 evaluation. Epidemiologists and scientists in the U.S. are committed to randomized controlled trials involving in excess of 30,000 patients.

The possible dangers of a premature approval of a vaccine whether for altruistic or political purposes are well understood and recognized by most all medical experts concerned. It is hoped that data from the Phase-3 trials will indicate safety and effectiveness based on statistically significant protection in the face of natural challenge. The first vaccines to be approved will probably not be the last to be deployed, as continuous development and refinement will be necessary as occurred with vaccines against poliomyelitis and numerous other diseases. Given that initial development and manufacturing challenges have been largely resolved, it now remains to convince the public of the safety and efficacy of the products. Presumably, the administration has a detailed plan for widespread administration of a vaccine that requires a complicated cold chain. Resolution of COVID-19 in the U.S. depends on public acceptance and extensive deployment of an effective and safe vaccine.

About Joseph Giambrone:

Joseph Giambrone is a professor emeritus in Auburn University’s Department of Poultry Science with a joint appointment in the Department of Pathobiology in the College of Veterinary Medicine. During his graduate research career at the University of Delaware, he was part of a research group that developed the first vaccine against an antigenic variant of an avian coronavirus. During a sabbatical leave during his tenure at Auburn, he was part of a research group in Australia that sequenced the entire genome of antigenic variant of a coronavirus of chickens. During his 42-year research career as a molecular virologist, immunologist and epidemiologist, he has made critical advancements in understanding the ecology of viral pathogens, led efforts to improve detection and surveillance of viral diseases and developed new and effective vaccines and vaccine strategies to protect commercially reared chickens as well as pathogens, such as avian influenza viruses, which have spilled over into human populations. His research has had a profound impact on practices used today to reduce the incidence and severity of viral diseases of commercially reared poultry as well in human populations.