• Waldenström Macroglobulinemia
  • Melanoma
  • Bladder Cancer
  • Brain Cancer
  • Breast Cancer
  • Childhood Cancers
  • Gastric Cancer
  • Gynecologic Cancer
  • Head & Neck Cancer
  • Immunotherapy
  • Kidney Cancer
  • Leukemia
  • Liver Cancer
  • Lung Cancer
  • Lymphoma Cancer
  • Mesothelioma
  • MPN
  • MDS
  • Myeloma
  • Prostate Cancer
  • Rare Cancers
  • Sarcoma
  • Skin Cancer
  • Testicular Cancer
  • Thyroid Cancer

FDA Panel Recommends Emergency Use Authorization of Pfizer’s COVID-19 Vaccine

Article

The FDA’s Vaccines and Related Biological Products Advisory Committee voted in favor of granting BNT162b2, the COVID-19 vaccine developed by Pfizer and BioNTech, emergency use authorization.

The Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee on Thursday voted 17 to 4 in favor of approving BNT162b2, Pfizer and BioNTech’s COVID-19, under the agency’s emergency use authorization.

The vote, however, does not mean that the agency will immediately decide to authorize the vaccine.

If approved by the FDA, The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices would also vote on if it recommends the vaccine, and who should receive it.

The CDC previously recommended that health care providers and residents and staff of long-term care facilities should be the first to get it, the Washington Post reported.

BNT162b2 is targeted at the SARS-CoV-2, the virus that causes COVID-19, spike glycoprotein (S) antigen that is encoded by RNA and formulated in lipid nanoparticles (LNPs). The vaccine, which is for people 16 years and older, is administered in two doses, 21 days apart.

The committee reviewed data from an ongoing, phase 3, double-blind placebo-controlled trial of the vaccine that included 43,448 participants— 21,720 who were randomized to receive BNT162b2, and 21,728 who were randomized to receive a placebo. In a mid-November analysis, BCT162b2 had a 95% efficacy rate of preventing COVID-19 seven or more days after the second dose.

Patients with cancer often have weakened immune systems, making them more susceptible to contracting COVID-19 or developing more severe complications from the disease.

Common low-grade side effects from the vaccine included mild or moderate pain at the injection site, fatigue and headache.

Check back for more information as this is a developing story.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

Related Videos
Dr. Nitin Ohri in an interview with CURE
Kim Stuck in an interview with CURE
Dr. Sarah Psutka in an interview with CURE at the ASCO Annual Meeting
Kara Morris in an interview with a gray "CURE" background
Dr. Meghan K. Berkenstock interviewing against a gray CURE background
Dr. Alex Francoeur interviewing against a gray CURE background