FDA Authorizes First Vaccine to Prevent COVID-19 Infection


December 11, 2020 - The FDA has authorized the first vaccine for the prevention of coronavirus disease 2019.


The FDA has granted Emergency Use Authorization to BNT162b2 as the first vaccine to prevent coronavirus disease 2019 in individuals aged 16 years and older.

The authorization, which was granted to Pfizer and BioNTech, follows the first Vaccines and Related Biological Products Advisory Committee meeting from the FDA for the consideration of an Emergency Use Application for a COVID-19 vaccine candidate. The agency found the manufacturing quality and consistency associated with BNT162b2 to be acceptable for approval and stated that they would be working with the vaccine sponsors to work toward finalization and issuance of an emergency use authorization of the product.1

"The [authorization] of the COVID-19 vaccine today is one of the brightest news of 2020. This is first step to eradicate this awful pandemic. Despite the fact that the COVID-19 vaccine trials usually excluded patients with cancer, I would recommend the vaccine in our population," Toni Choueiri, MD, director of the Lank Center for Genitourinary Oncology, director of the Kidney Cancer Center, and senior physician at Dana-Farber Cancer Institute, told OncLive. "I do not believe there will be major safety problems specific to our cancer population. While we cannot, for sure, say that patients getting active chemotherapy drugs can benefit, we have seen examples (eg flu shot) where the vaccine works! The hope is to have at least 1 study in patients with cancer so we can answer the question."

Previously, data from a pivotal phase 3 trial (NCT04368728) examining the vaccine were released.2 Results showed that among 43,448 patients, the vaccine showcased a 95% efficacy with regard to COVID-19 infection prevention in those who did not have prior infection 7 days or longer following the second vaccine dose.

Efficacy with the vaccine observed in the overall patient population was consistent across several subsets evaluated, including age, gender, race, ethnicity, baseline body mass index, or the presence of other underlying comorbidities.

Of a total of 36,523 patients who did not have any evidence of existing or previous SARS-CoV-2 infection at the time of vaccination, 170 COVID-19 cases were reported with onset at least 7 days after the second dose was received. Of those cases, 8 were reported in those who received the vaccine and 162 in those who were given placebo; this translated to a 95.0% vaccine efficacy (95% CI, 90.3-97.6).

Moreover, among patients with and without evidence of prior SARS-CoV-2 infection, COVID-19 was observed in 9 vaccine recipients and 169 placebo recipients, translating to a 94.6% vaccine efficacy (95% CI, 89.9-97.3).

The ongoing phase 3 trial of the vaccine had enrolled more than 44,000 participants, the majority of which have received their second dose. Participants were enrolled at approximately 150 clinical sites spanning the United States, Germany, Turkey, South Africa, Brazil, and Argentina.

In the observer-blind study, participants were randomized in a 1:1 fashion to either the vaccine or placebo. The study consisted of 2 parts. In phase 1 of the research, investigators sought to determine preferred vaccine candidates and dose levels, while in phase 2/3, they assessed the efficacy of the vaccine in an expanded patient.

The primary end points of the trial comprised COVID-19 infection prevention in those who had not been infected with SARS-CoV-2 before vaccination and prevention of COVID-19, irrespective of whether patients had previous SARS-CoV-2 infection. Secondary end points comprised prevention of severe COVID-19 in those patient subgroups. Additionally, investigators are examining whether the vaccine is also able to prevent SARS-CoV-2 infection.

Further data from the trial demonstrated that the cumulative incidence of COVID-19 cases over time, in both arms, began to separate by 12 days following the first dose received. Additionally, a 52.4% vaccine efficacy (95% CI, 29.5-68.4) was reported between dose levels 1 and 2, which indicates early onset of a partially protective effect of vaccination. Maximum protection with the vaccine was reported at 2 doses.

The vaccine also demonstrated a favorable safety profile and proved to be well tolerated. A a median of 2 months of safety information was available for a total of 37,706 patients following dose 2; these findings contributed to the main safety dataset.

The most frequently reported toxicities with the vaccine included transient, mild to moderate pain at the injection site, fatigue, and headache. Notably, these toxicities would typically resolve within 2 days.

“This is a historic moment. I welcome the FDA [authorization], which reflects a remarkable triumph of science over the COVID-19 virus. In my opinion, the development of COVID vaccines is one of the greatest accomplishments in medicine," S. Vincent Rajkumar, MD, consultant in the Division of Hematopathology in the Department of Laboratory Medicine and Pathology and professor of medicine at Mayo Clinic, told OncLive. "This is the first of many vaccines that will likely be [authorized for use]. Im very excited about the various trial results, and I can see an end in sight to this pandemic. I plan to get the vaccine as soon as it is offered to me.”

Balazs Halmos, MD, MS, a professor of medicine at Albert Einstein College of Medicine and director of the Thoracic Head and Neck Program at Montefiore Medical Center, also shared insight on the vaccine with OncLive.

"The...[authorization]...of [a] mRNA-based vaccine should be welcomed by the oncology community with great enthusiasm," Halmos said. "In my view, we should advocate for our patients—especially our more vulnerable ones who are elderly, frail, [have] comorbidities, or are in an immune-suppressed state—to get early access. We should also quickly set up national efforts to study vaccine efficacy in particular patient cohorts, such as post—bone marrow transplant patients."


  1. FDA statement on Vaccines and Related Biological Products Advisory Committee meeting. News release. December 11, 2020. Accessed December 11, 2020. https://bit.ly/3mfa5ah.
  2. Pfizer and Biontech announce publication of results from landmark phase 3 trial of BNT162B2 COVID-19 vaccine candidate in the New England Journal of Medicine. News release. Pfizer and BioNTech SE. December 10, 2020. Accessed December 10, 2020. https://bit.ly/3qNpUbN.
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