‘There will be a solution’: FDA committee OKs Pfizer’s COVID-19 vaccine
An FDA advisory committee voted 17 to 4, with one abstention, in favor of authorizing Pfizer and BioNTech’s COVID-19 vaccine candidate for individuals aged 16 years and older.
The FDA Vaccines and Related Biological Products Advisory Committee’s recommendation will play a role in the agency’s decision to grant an emergency use authorization (EUA) to the vaccine. Findings recently published in The New England Journal of Medicine confirmed that vaccine is 95% effective with two doses. The vaccine has already been approved for use in the United Kingdom and in Canada.
“The EUA means that there will be a solution, eventually, to the COVID-19 pandemic, but it will still be some time before the general public has access to these vaccines,” Amesh A. Adalja, MD, senior scholar at Johns Hopkins Center for Health Security, told Healio.
Researchers said the safety of the vaccine over a median of 2 months was similar to that of other viral vaccines. However, U.K. officials recently warned that the vaccine should not be given to patients with a history of allergic reactions following symptoms experienced by two health care workers after their inoculation, CNN reported.
An EUA for Moderna and the NIH’s vaccine candidate, which showed 94.5% efficacy during its phase 3 trial, will also be reviewed by the FDA’s vaccine advisory committee on Dec. 17.
According to WHO, there are currently 52 vaccine candidates undergoing clinical evaluation worldwide. The CDC cites five vaccines — from AstraZeneca, Janssen, Moderna, Novavax and Pfizer — currently undergoing phase 3 clinical trials.
“The first COVID-19 vaccines will be released to the U.S. population under an emergency use authorization this month, with the hope that a significant percentage of the U.S. population will be vaccinated by quarters 2 and 3 of 2021,” Peter J. Hotez, MD, PhD, professor of pediatrics and dean of the National School of Tropical Medicine at the Baylor College of Medicine, told Healio. “Achieving this goal means that we will likely require additional vaccines released through emergency use authorization, including adenovirus-vectored vaccines and protein-based vaccines. It will further require clinical trials in adolescents and children and ultimately vaccinating these populations if we expect to reach the 60% to 80% vaccine coverage that we estimated would be needed to interrupt virus transmission.”
Infectious Diseases in Children Editorial Board Member C. Buddy Creech, MD, MPH, associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program at the Vanderbilt University School of Medicine, said during a press conference that vaccine education efforts for health care workers — who will be among the first to receive the vaccine — will be imperative as doses begin to be distributed.
“We really want to provide as much education around these vaccines as possible to those who will be most benefitted from the vaccine, as well as those who have the highest risk of disease should they not have access to the vaccine,” Creech said. “We really want to make sure that we're communicating effectively to our health care workers, to those who are older and those who will be receiving the vaccine early on.”
Creech also said it is important that physicians are able to differentiate between COVID-19 symptoms and vaccine side effects, like arm soreness, fever and headaches.
Kathleen M. Neuzil, MD, MPH, FIDSA, professor of vaccinology and director of the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, said during a press conference that supply will be an “immediate challenge” to vaccine distribution, and that placebo-controlled vaccine trials should be reassessed once vaccines are more widely available to the public.
“One thing we've learned is that it is better to be right than to be consistent,” Neuzil said. “This is a constantly changing field and we have to continue to look at our assumptions and be sure that we are designing trials with the highest ethics, quality and most recent results and information in mind.”
Creech said the emergence of COVID-19 genetic-based vaccines, particularly those that use messenger RNA technology like the Pfizer/BioNTech and Moderna vaccines, may have wider implications for other infectious diseases, including Ebola.
“We enter into a golden age of vaccinology by having these types of new technologies,” Creech said. “In less than a year, we have taken an understanding of the genetic code for this particular protein of this virus, and we now have a vaccine that is established to be efficacious in clinical trials. That is light speed — that is incredible.”
References:
CDC. Different COVID-19 Vaccines. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html. Accessed December 3, 2020.
CNN. FDA confirms safety data and efficacy of Pfizer's Covid-19 vaccine ahead of Thursday meeting. https://www.cnn.com/world/live-news/coronavirus-pandemic-12-08-20-intl/index.html. Accessed December 8, 2020.
Polack FP, et al. N Engl J Med. 2020;doi:10.1056/NEJMoa2034577.
WHO. DRAFT landscape of COVID-19 candidate vaccines – 2 December 2020. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines. Accessed December 3, 2020.
Perspective
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The development of frankly amazingly effective vaccines to the novel coronavirus in such a rapid time frame is a remarkable success. And it comes at a time when the entire world's population is in such dire need of hope. The mRNA vaccine is based on years of research and provides a promising new direction for infections well beyond SARS-CoV-2. That said, this will still require a massive effort. The distribution chains are complex and expensive, there are still important questions about how effectively these vaccines prevent infection as well as decreasing actual symptomatic COVID-19 illness, and we are already starting to hear concerns about allergic reactions and vaccine side effects — all this against a backdrop of existing vaccine skepticism. Still, this rapid success gives us the hope we need in facing the winter onslaught of the pandemic. Count me as hoping to be at the front of the line to get my jab.
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