Gerald Sastra/The Cougar
The U.S. Food and Drug Administration issued the first emergency use authorization for a vaccine to prevent coronavirus on Dec. 11 After the vaccine’s manufacturer, Pfizer, and their partner BioNTech met the FDA’s criteria to be approved for the emergency use authorization.
To be approved, one of the requirements for vaccine makers was to make sure their products were 50 percent effective. Analysis from Pfizer’s trials shows the vaccine surpassed the goal, revealing that it is over 90 percent effective.
With the Pfizer vaccine being the only one approved, biotech company Moderna also nears approval as their vaccine’s preliminary results look promising.
Even with the FDA and Centers for Disease Control and Prevention taking the required safety precautions, UH College of Medicine founding dean Dr. Stephen Spann explains the vaccine is very safe.
“There has been a careful analysis from reputable scientists across the country, showing the benefits from the vaccine are substantial with small side effects,” Dr. Spann said. “These small side effects, such as pain at the injection site and headaches, means your immune system is responding to it.”
While they differ slightly, both the Pfizer and Moderna vaccines use the virus’s messenger RNA, genetic material our cells use to synthesize proteins.
The vaccines use a small piece of the virus’s mRNA to instruct cells in the body to make the distinctive spike protein – proteins the virus uses to proliferate and infect the host cells.
Copies of the spike protein do not cause disease, but trigger the immune system to learn how to react and produce a swift immune response against the virus.
In learning how to produce an efficient response, our immune cells will encounter the spike protein to produce antibodies, which will latch onto the same protein of the virus. The attachment allows the antibodies to mark the virus for destruction, preventing it from infecting other cells.
Eventually, the vaccine will aid special cells in our immune system, memory B-cells and memory T-cells, to retain information about the disease for possible future infections.
As vaccinations began Dec. 14, there has been rising skepticism about the vaccine. Its quick emergence to the public has made many reluctant to take it as many question its safety.
Despite the skepticism as the vaccine continues to roll out, Dr. Spann has high hopes that more people will have the confidence to take it.
However, amid this concern, there have not been any reported signs that the Pfizer vaccine causes harmful symptoms or side effects.
As vaccination continues, the FDA and the CDC will be collecting data and closely monitoring the safety of the vaccine. They will address any safety concerns that might arise in as much of an efficient and timely manner as they can.
Any arising safety concerns can lead to the EUA revocation if it proves to no longer meet the FDA’s criteria.
Dr. Spann explains with the vaccine being 95 percent effective, only five percent have the risk of being infected. This efficacy rate is far better than the flu, a similar viral disease with an efficacy rate between 40 and 60 percent.
“Eventually, with more people taking it, we can reach herd immunity – where enough people are immunized, leading to protection from the virus and erasure social restrictions,” Dr. Spann said.
“The skepticism is understandable, but it is important to ask if the benefit of taking the vaccine outweighs the risk. And if you were to ask scientists and physicians, they are saying the benefits definitely outweigh the risk.”
