FDA Continues to Monitor Safety of Current COVID-19 Vaccines Available to the Public
The FDA ensures it is doing its best to make sure each vaccine is completely safe to get.
- By Shereen Hashem
- Apr 22, 2021
The public trusts the FDA that all medical products, including the COVID-19 vaccines, are safe and effective. As a part of the standard process for inspecting all manufacturing facilities, the FDA recently completed an inspection of Emergent Biosolutions. This is a proposed manufacturing facility for the Johnson & Johnson vaccine.
Johnson & Johnson announced its facility is not authorized to distribute the vaccine in the U.S. The FDA investigations that are conducted are thorough and carefully thought out. These assessments include going through records, manufacturing procedures, staff training, facility operation and product quality. According to an article, during the inspection of Emergent Biosolutions that ended Tuesday, the FDA cited a number of requirements and standards that were not met.
The FDA is intended to identify these conditions then help identify a path to move forward to fix the issues and be safe. Emergent Biosolutions agreed to pause new productions while it undergoes additional testing and will be thoroughly evaluated before potentially distributing again.
These actions, however, are unrelated to an ongoing evaluation by the FDA and CDC of a specific blood clot reported in a very small number of people after receiving the Johnson & Johnson vaccine.
The FDA wants to ensure the COVID-19 vaccines that are distributed to everyone in the country have met the highest standards for quality, safety and effectiveness.
Shereen Hashem is the Associate Content Editor for Occupational Health & Safety magazine.