The vaccine being developed by Moderna was recently submitted for regulatory approval by the Food and Drug Administration at the end of November, becoming the second leading drug to reach this breakthrough this month. The company also filed for emergency use authorization after discovering that the drug was 94.1% effective against COVID. Even more promising, the biotech firm stated that the vaccine was 100% effective at inhibiting severe cases of the disease.
The results demonstrated from the trials conducted by Moderna were standard across all demographics including race, age, and gender. No safety concerns have arisen thus far, with only a few mild side effects such as headaches and fatigue.
According to the FDA, a meeting is supposed to take place on December 17th to further discuss the submission of both the Moderna vaccine and the vaccine that was submitted by Pfizer and their partner BioNTech. Both drugs have a similar efficacy rate according to their latest stage trials and involve inserting a special mRNA code into the body. This essentially tricks the body into developing a response via the immune system. If either drug is approved, this would be a historical milestone as no mRNA-based drug has ever won approval in the past.
A professor at the Leibniz Institute in Germany, Hajo Zeeb, stated that the submission of two vaccines with a high efficacy rate is highly encouraging. According to Zeeb, “I would be surprised if something different came out in the FDA process, and I think these are highly likely to be approved.”
The United States federal government granted Moderna over $1 billion to begin developing a potential vaccine along with $1.5 billion to help with distribution to the public. Their trial included 30,000 people split into two groups, one who received the vaccine and one who received a placebo. The trial resulted in only 196 cases of COVID-19. Only 11 of these cases were from the group who received the actual vaccination. Even more astounding, not one participant from the trial became seriously ill.
The developments of potential coronavirus vaccines have produced a since of optimism from the general public and from the stock markets. However, as the data is only representative of a very small sample of the population and from a limited number of trials, it is important to remain cautious. The vaccine will also take time to become FDA approved and to be officially rolled out to the public. Hopefully, the same levels of effectiveness will be observed as the vaccines are distributed to a larger number of individuals.