On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a vaccine to prevent the COVID-19 coronavirus caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the United States.
The available data provide clear evidence that the vaccine may be effective in preventing COVID-19 and support that the known and potential benefits outweigh the known and potential risks. In making the determination, FDA said that it ensures it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.
“While not an FDA approval, today’s emergency use authorization holds the promise to alter the course of this pandemic in the United States,” Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, said. “With science guiding our decision making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. Today’s achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.”
The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. It triggers the recipient’s body to produce copies of the spike protein, which recruits the immune system to react defensively, producing an immune response against SARS-CoV-2.
The vaccine is administered as a series of two doses, three weeks apart. The available safety data to support the EUA include 37,586 participants enrolled in an ongoing, randomized, placebo-controlled international study, the majority of whom reside in the United States. Participants were randomized 1:1 to receive two doses of either the vaccine or a saline placebo and followed for a median of two months after receiving the second dose. The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced the side effects after the second dose once the body mounted an immune response.
The vaccine was 95% effective in preventing COVID-19 among the participants, with 8 COVID-19 cases in the vaccine group and 162 in the placebo group. Of the 170 total COVID-19 cases, 1 in the vaccine group and 3 in the placebo group were classified as severe. At this time, FDA said that data are not available to make a determination about how long the vaccine will provide protection, nor does the evidence demonstrate that it prevents transmission from person to person.
The manufacturer and vaccination providers must report the following to the Vaccine Adverse Event Reporting System for the vaccine: all administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death.
What This Means for Patients With Cancer
“Currently, we have no guidance on giving the vaccine to people with cancer, a history of cancer, or current or past cancer treatment,” Lisa Kennedy Sheldon, PhD, ANP-BC, AOCNP®, FAAN, ONS’s clinical and scientific affairs liaison, said. The clinical trials for the EUA also excluded people who were receiving immunomodifying or -suppressing treatments.
The American Society of Clinical Oncology and Infectious Disease Society of America are meeting on December 17, 2020, to discuss the implications of using the vaccine in patients with cancer. More information will be available after the meeting.