Q: I'm worried about the safety of the vaccines. It seems like the FDA approval for the vaccines was too fast.
A: The coronavirus pandemic was an unprecedented event in American history and warranted an unprecedented response. Therefore, the federal government quickly coordinated with and invested in government agencies, academia, pharmaceutical companies and scientists to work together and build upon the already successful vaccine infrastructure. They were committed to developing safe and effective vaccines against COVID-19. In addition, the government made investments in manufacturing capacity allowing faster distribution for vaccines as soon as they were granted FDA emergency use authorization approval.
Those efforts done at the same time were to respond in the fastest and safest way possible to prevent loss of life from COVID-19. There were absolutely no steps skipped in the effort, either from a safety standpoint or from a scientific standpoint. The approved COVID-19 vaccines meet the same rigorous safety and efficacy standards by the FDA as all other types of vaccines in the United States. The vaccines are being rigorously monitored through scientific trials for safety on a continual basis.
On August 23, 2021, the FDA fully approved the Pfizer-BioNTech vaccine for people 16 years and up, moving it beyond emergency use status. Full approval was granted following review of Pfizer data from 44,000 clinical trial participants in the United States and several other countries since the pandemic began. Moderna and Johnson & Johnson are expected to apply for full FDA approval of their vaccines in the fall.
Doctors are not worried about the vaccine. We are worried about COVID-19 and its ability to kill and harm even young, healthy people. Virtually every medical entity in the entire world is responding the same way: encouraging all to get vaccinated to protect themselves and those around them from this horrible virus.
Dr. Nita Shumaker, M.D., practices at Galen North Pediatrics and is a member of the Chattanooga-Hamilton County Medical Society.
READ MORE:
How do the COVID-19 vaccines work?
Concerns about adverse events and long-term effects of COVD-19 vaccines