In the history of vaccine development, never has the global scientific community been so fervently engaged in creating a vaccine as it is now. The novel coronavirus has posed unprecedented challenges unlike any other virus encountered before. Its erratic nature in terms of morbidity and mortality is astonishing. It’s a virus that can be highly lethal for certain vulnerable groups, occasionally severe for otherwise healthy individuals, yet completely asymptomatic in others. The last time a virus so profoundly affected the global economy was during the 1918 influenza pandemic. Our aspirations for a return to social and economic stability hinge on the successful creation of a safe and effective vaccine.
Among the leaders in this urgent effort is Moderna, Inc., based in Cambridge, Massachusetts. Partnering with the National Institute of Allergy and Infectious Diseases, the company began human trials on May 7, involving approximately 600 participants. The primary objective of this initial phase was to assess the vaccine’s safety. Results shared on May 18 indicate not only that the vaccine appears safe but also that it generates the necessary immune response to potentially prevent the disease.
The trial included 45 volunteers who were divided into three groups, each receiving different dosage levels. All groups were given a booster shot one month after their first dose. Moderna reported that participants experienced only mild side effects, such as redness at the injection site, headaches, fever, and flu-like symptoms, all of which resolved within a day—similar to the mild reactions seen with other vaccines, such as the flu shot.
Additionally, Moderna’s scientists sought to confirm that the vaccine successfully induced coronavirus antibodies. Every participant produced antibodies at all dosage levels. Even more encouraging, the first eight individuals who received their second booster shot developed “neutralizing antibodies,” which can prevent the virus from infecting human cells. When these neutralizing antibodies were compared to those of COVID-19 survivors in the community, the antibody levels were similar. It’s important to note that these tests are conducted in a lab setting, meaning none of the participants were exposed to live coronavirus.
The Food and Drug Administration (FDA) has authorized Moderna to proceed to a second phase of testing, which will involve another 600 participants, half of whom are over 55. The company aims to move to a third phase by July, expanding the trials to include thousands of healthy individuals to confirm the vaccine’s efficacy in preventing the disease. Phase III testing is typically conducted under conditions that simulate the vaccine’s routine use.
Moderna’s vaccine leverages mRNA (messenger RNA), a technology that has been explored for years in vaccine development, though none have yet received FDA approval. Compared to traditional vaccines, mRNA vaccines are highly promising due to their rapid development, potency, and cost-effective manufacturing and administration.
Remarkably, it took just 63 days from the time Chinese scientists released the coronavirus genetic sequence to the administration of the first vaccine dose to a human volunteer. Moderna is one of several companies racing to produce a safe and effective vaccine, alongside BioNTech, which is collaborating with Chinese Fosun Pharma and American Pfizer, and CureVac, another German company set to begin human trials this summer. The University of Oxford, in partnership with AstraZeneca, has also reported encouraging results from early trials.
Moderna hopes to provide a vaccine to the public by the end of this year or early 2021. Dr. Jake Collins, the company’s chief medical officer, mentioned in an interview with The New York Times that while they are unsure of the immediate availability of doses, “We’re striving to produce as many millions as possible.”
While we await further developments from scientists, it’s vital to maintain social distancing and wear masks when necessary. For more insights on related topics, check out this post on our other blog here.
In summary, the initial results from Moderna’s coronavirus vaccine trials show promise, with successful antibody production and mild side effects. The ongoing developments in vaccine research are crucial for restoring normalcy.