‘There will be a solution’: FDA issues first EUAs for COVID-19 vaccines
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The FDA issued the first two emergency use authorizations for COVID-19 vaccines, making millions of doses available in the United States amid a record-setting increase in cases.
“The development of frankly amazingly effective vaccines against 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,” said Infectious Disease News Chief Medical Editor Paul A. Volberding, MD, professor of medicine and director of the AIDS Research Institute at the University of California, San Francisco.
The emergency use authorizations (EUAs) were preceded by supportive votes by the FDA’s Vaccines and Related Biological Products Advisory Committee, which voted in favor of authorizing Pfizer and BioNTech’s COVID-19 vaccine candidate for patients aged 16 years or older, and to support an EUA for a vaccine developed by Moderna Inc. and the NIH in adult patients.
Findings published in The New England Journal of Medicine confirmed that the Pfizer vaccine is 95% effective. An FDA document published online confirmed that the Moderna vaccine was 94.1% effective in preventing symptomatic COVID-19.
The vaccines, which both use messenger RNA (mRNA)-based technology, are given in two doses — Pfizer’s 21 days apart, and Moderna’s 28 days apart. Distribution of both vaccines began shortly after the EUAs were issued. (Click here to read a full report on the development of the vaccines.)
“The EUAs mean 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 Infectious Disease News.
The CDC’s Advisory Committee on Immunization Practices voted to recommend that health care personnel and residents of long-term care facilities be prioritized in phase 1a of vaccinations, which began in mid-December.
The ACIP recommended that the next phase (1b) include patients aged 75 years or older and frontline essential workers, including first responders, postal workers, grocery store workers and people who work in food and agriculture — “sectors essential to the functioning of society [that] are at substantially higher risk for exposure to SARS-CoV-2,” the committee said.
In the same vote, it recommended that phase 1c include patients aged between 65 and 74 years, patients aged between 16 and 64 years with high-risk medical conditions, and other essential workers.
The availability of two highly effective vaccines “is going to finally turn the tide on this pandemic, and quickly,” said Monica Gandhi MD, MPH, professor of medicine and associate chief of the division of HIV, infectious diseases and global medicine at the University of California, San Francisco.
“The efficacy of the vaccines is higher than we could have imagined a year ago,” Gandhi told Infectious Disease News. “If 70% population level immunity is needed to still viral spread, I think this is achievable in the United States by the summer of 2021.”
Peter J. Hotez, MD, PhD, professor of pediatrics at Baylor College of Medicine and co-director of the Texas Children’s Hospital Center for Vaccine Development, said the votes mean that “a significant percentage of the U.S. population will be vaccinated by quarters 2 and 3 of 2021.”
“Achieving this goal means that we will likely require additional vaccines released through emergency use authorization, including adenovirus-vectored vaccines and protein-based vaccines,” Hotez said. “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.”
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 it is imperative to educate health care workers on the vaccines as doses begin to be distributed. He said it is important that physicians are able to differentiate between COVID-19 symptoms and vaccine side effects, like arm soreness, fever and headaches.
“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 said.
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 the press conference 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 mRNA technology, 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.”
Vaccinating all eligible Americans will require “a massive effort,” said Volberding.
“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,” he said. “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.”
Like many health care workers, Krutika Kuppalli, MD, assistant professor of medicine in the division of infectious diseases at the Medical University of South Carolina, received the first dose of the Pfizer vaccine during the first week it was available.
“I had very mixed feelings in terms of being excited to be in the first round of vaccinations but [also] definitely feeling a little bit sad and feeling a little bit guilty because there are so many people out there who need this life saving therapeutic,” Kuppalli said.
“I really want to make sure that we are able to get it to everyone who needs it,” she said. “I’m very happy that we’re moving forward with this process to try and continue to scale up our vaccine production and vaccine rollout for everybody who needs it and not just here, but really, we need to do this all over the world.”
- References:
- CDC. Different COVID-19 vaccines. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html. Accessed December 3, 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.
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