Infectious Disease

FDA Committee Approves Pfizer’s COVID-19 Vaccine

December 10, 2020

3 min read

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Healio interviews

Disclosure:
Adalja does not report any relevant financial information. Creech reports serving as principal investigator for several NIH-funded studies of COVID-19 vaccines and therapeutics, including the Janssen and Moderna-sponsored Phase 3 COVID-19 vaccine studies. Hotez reports inventing a COVID-19 vaccine technology from Baylor College of Medicine that was recently licensed exclusively to one company. Neuzil does not report any relevant financial information.

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An FDA advisory committee voted 17-5 for approval of Pfizer and BioNTech’s COVID-19 vaccine candidate for people 16 years and older.

The recommendation of the FDA Advisory Committee on Vaccines and Related Biological Products will play a role in the agency’s decision to give the vaccine an EEA Approval. Results recently published in the New England Journal of Medicine confirmed that the two-dose vaccine was 95% effective. The vaccine has already been approved for use in the UK and Canada.

Amesh Adalja Pullquote

“The EEA means that at some point there will be a solution to the COVID-19 pandemic, but it will be some time before the general public has access to these vaccines.” Amesh A. Adalja, MD, Senior Scholar at the Johns Hopkins Center for Health Security, said Healio.

The researchers said the vaccine’s safety was similar to other viral vaccines over a median of 2 months. However, British officials recently warned that the vaccine should not be given to patients with a history of allergic reactions following symptoms that occurred in two health care workers after they were vaccinated, CNN reported.

Source: Polack FP et al. N Engl J Med. 2020; doi: 10.1056 / NEJMoa2034577.

An EEA for Moderna and the NIH vaccine candidate, which showed 94.5% efficacy during their Phase 3 study, will also be reviewed by the FDA’s Vaccine Advisory Board on December 17th.

According to the WHO, 52 vaccine candidates are currently being clinically evaluated worldwide. The CDC names five vaccines – from AstraZeneca, Janssen, Moderna, Novavax and Pfizer – that are currently in phase 3 clinical trials.

Peter J. Hotez

C. Buddy Creech

“The first COVID-19 vaccines will be released to the US population this month under an emergency license with the hope that a significant percentage of the US population will be vaccinated by Q2 and Q3 2021.” Peter J. Hotez, MD, PhD, Professor of Pediatrics and dean of the National School of Tropical Medicine at Baylor College of Medicine, Healio said. “To achieve this goal, we will likely need additional vaccines that will be released through an emergency clearance, including adenovirus vector vaccines and protein-based vaccines. In addition, clinical trials in adolescents and children are needed to ultimately vaccinate these populations if we assume that our estimated 60% to 80% vaccine coverage is required to disrupt virus transmission. “

Infectious Diseases in Children C. Buddy Creech, MD, MPH, During a news conference, the Associate Professor of Pediatrics and Director of the Vanderbilt Vaccine Research Program at Vanderbilt University School of Medicine said that education efforts for health care workers – who will be among the first to receive the vaccine – will be essential as dosing begins to become.

Kathleen M. Neuzil

“We really want to provide as much education as possible about these vaccines to those who will benefit most from the vaccine, as well as those who are at greatest risk of disease if they do not have access to the vaccine,” Creech said. “We really want to make sure we are communicating effectively with our healthcare workers, those who are older and those who are getting the vaccine early.”

Creech also said it was important for doctors to be able to differentiate between COVID-19 symptoms and vaccine side effects such as arm pain, fever and headache.

Kathleen M. Neuzil, MD, MPH, FIDSA, The professor of vaccine science and director of the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine said during a news conference that supply will be an “immediate challenge” to vaccine distribution and that placebo-controlled vaccine trials should be conducted anew as soon as vaccines become more available to the public.

“One thing we have learned is that it is better to be right than to be consistent,” said Neuzil. “This is a constantly changing field and we must continue to review our assumptions and ensure that we are designing studies that are of the highest ethics, quality, and the latest results and information.”

Creech said the emergence of genetically based COVID-19 vaccines, particularly those that use messenger RNA technology like the Pfizer / BioNTech and Moderna vaccines, could have far-reaching implications for other infectious diseases, including Ebola.

“With these new technologies we are entering a golden age of vaccination,” said Creech. “In less than a year we understood the genetic code for this particular protein in this virus and we now have a vaccine that has been shown to be effective in clinical trials. That’s the speed of light – that’s incredible. “

References:

CDC. Various COVID-19 vaccines. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html. Accessed December 3, 2020.

CNN. The FDA confirms the safety data and effectiveness of Pfizer’s Covid-19 vaccine ahead of Thursday’s 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 vaccine candidates – December 2, 2020. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines. Accessed December 3, 2020.

perspective

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Paul A. Volberding, MD)

Paul A. Volberding, MD

Developing, frankly, amazingly effective vaccines against the novel coronavirus in such a fast time frame is a remarkable achievement. And there comes a time when all of the world’s people desperately need hope. The mRNA vaccine is based on years of research and offers a promising new direction for infections that go well beyond SARS-CoV-2. However, this still requires an enormous amount of effort. The distribution chains are complex and expensive, there are still important questions about how effective these vaccines are in preventing infection and reducing the actual symptomatic COVID-19 disease, and we are already hearing concerns about allergic reactions and side effects of the vaccine – all against background of the existing ones Vaccine skepticism. However, this quick success gives us the hope we need to face the wintry onslaught of the pandemic. Count me as the hope of being up front to get my push.

Paul A. Volberding, MD

Editor-in-Chief, Infectious Disease News

Professor of Medicine

Director of the AIDS Research Institute

University of California, San Francisco

Disclosure: Volberding reports that he chairs a data security supervisory board at Merck and advises Gilead Sciences.

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