FDA Fully Approves Pfizer’s COVID Vaccine, NCCN Supports Mandatory Vaccination

The National Comprehensive Cancer Network (NCCN) has issued support for mandatory COVID-19 vaccinations for health care workers as the FDA issues full approval to the Pfizer-BioNTech COVID-19 vaccine, according to press releases issued by the NCCN and the FDA.^1,2

To date, the FDA has granted 2 emergency use authorizations to COVID-19 vaccinations developed by Janssen and Moderna and 1 full approval to a COVID-19 vaccination by Pfizer-BioNTech. At the end of January 2021, the NCCN suggested that all patients who were receiving active cancer treatment receive the COVID-19 vaccine. The approval of the Pfizer-BioNTech vaccine is for people 16 years of age and older. However, the Emergency Use Authorization previously granted to the vaccine still stands for children 12-15 years of age.

According to the FDA, a clinical trial found that the Pfizer-BioNTech vaccine is 91% effective at preventing COVID-19. Additionally, the study followed 12,000 recipients for safety for at least 6 months. Common adverse events included fatigue, pain at injection site, pain, and swelling at injection site.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research in a press release. “We have not lost sight that the COVID-19 public health crisis continues in the United States [US] and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the US"

According to guidelines previously released by the NCCN, patients with active cancer are at an increased risk of complications from SARS-CoV-2, and steps must be taken to limit spread among high-risk populations. Additionally, there are no reports of increased risk of side effects from the vaccine in patients with cancer compared to the general population. Patients who are enrolled in clinical trials should not defer vaccination.³

However, despite the proven safety and efficacy of vaccinations at reducing infection, severe disease, hospitalization, and death from COVID-19, 1 in 3 patients with cancer and cancer survivors are unlikely to get or unsure about the COVID-19 vaccinee, according to a March Survey by the Leukemia and Lymphoma Society. 

According to the NCCN, it’s important the people in close proximity to patients with weakened immune systems are vaccinated against the virus in order to protect them from illness.

"Patients with cancer are more susceptible to COVID-19 complications and may not mount effective immune responses to vaccination, so it is incumbent on healthcare workers to be immunized against COVID-19. In so doing, we help to create a cocoon effect in which vulnerable individuals are protected from COVID-19 by vaccinating those who care for these patients," said Robert W. Carlson, MD, chief executive officer of NCCN, in a press release.

"Cancer care providers have a responsibility to their patients and colleagues to do everything they can to reduce the spread of COVID-19; that includes getting vaccinated,” Carlson added. “We know cancer patients already face a higher risk from COVID-19 and must be protected during their many interactions with healthcare workers. According to the science, vaccines are our best option to safely protect ourselves and the people around us from this potentially deadly disease."

_REFERENFES:

_{1.Cancer guidelines organization supports mandatory COVID-19 vaccination for health workers. News Release. NCCN. August 19, 2021. Accessed August 23, 2021. https://bit.ly/3mnY1r1.}

_{2.FDA approves first COVID-19 vaccine. News Release. FDA August 23, 2021. Accessed August 23, 2021. https://bit.ly/3y8Ylwg.}

_{3.Recommendations of the NCCN COVID-19 Vaccination Advisory Committee. NCCN. June 9, 2021. Accessed August 23, 2021. https://bit.ly/3kjsMe1.}