COVID-19 Vaccine Gets Authorization Recommendation from FDA Committee

December 11, 2020
Brielle Benyon

BNT162b2 is the first vaccine recommended in the United States for the prevention of COVID-19.

A group of federal advisors have recommended the approval of BNT162b2, the COVID-19 vaccine developed by the pharmaceutical brand Pfizer and BioNTech, today at a Vaccines and Related Biological Products Advisory Committee Meeting.

The FDA is expected to make its decision on an Emergency Use Authorization of BNT162b2 shortly, which could mean that the vaccine is sent out within the next several days. The Centers for Disease Control and Prevention (CDC) would also vote on whether or not they recommend the vaccine, and who should get 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 given in 2 doses, 30 µg each, administered 21 days apart.

The development and testing of BNT162b2 happened under the public-private partnership, Operation Warp Speed, which was created with the goal of bringing a safe and effective vaccine to the market in an expedited manner.

Today’s meeting reviewed data from an ongoing, phase 3, double-blind and placebo-controlled trial of the vaccine that included 43,448 participants — 21,720 were randomized to BNT162b2, and 21,728 were randomized to receive a placebo. In a mid-November analysis, BCT162b2 had a 95% efficacy rate of preventing COVID-19 7 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. Similarly, oncology nurses and other providers working in the health care setting may be at risk as well, especially with personal protective equipment (PPE) shortages across the nation.

While a vaccine to prevent COVID-19 is welcomed and anticipated, there are still lingering questions regarding potential adverse events. Oncology nurses shared their excitement — and concerns – with a vaccine.

The Associated Press also reported that while there were no major safety issues in the BNT16b2 trial, there were 4 cases of Bell’s palsy among individuals who received the vaccine. However, researchers cannot definitively link the development of the condition to the vaccine.

As the BCT162b2 vaccine and others become more available to the public, oncology nurses should discuss the shot with their patients, especially as there are still lingering questions surrounding how well the vaccine works in people with HIV or immune-system disorders.

Nurses should also continue to monitor their patients — regardless of whether or not they get the vaccine – for COVID-19 symptoms. Common low-grade adverse events from the vaccine included mild or moderate pain at the injection site, fatigue, and headache.