The global scientific community has never been more driven to create a vaccine than during the ongoing pandemic. The novel coronavirus has introduced unprecedented challenges, displaying erratic patterns of morbidity and mortality. No virus in recent history has been simultaneously lethal for vulnerable groups, occasionally severe for the young and healthy, and yet entirely asymptomatic for others. The economic disruption caused by COVID-19 is reminiscent of the 1918 influenza pandemic, and the path to restoring social and economic stability relies heavily on the development of a safe and effective vaccine.
Cambridge-based Moderna, Inc. has emerged as a leading contender in this urgent quest. Collaborating with the National Institute of Allergy and Infectious Diseases, the company launched human trials involving around 600 participants starting May 7. The primary objective of this initial phase was to assess the vaccine’s safety. Preliminary results, shared on May 18, indicate that not only does the vaccine appear safe, but it also seems to provoke the immune response necessary to combat the virus.
Trial Details
In the first segment of the trial, 45 volunteers were organized into three groups, each receiving different dosage levels. A booster shot was administered one month after the initial dose. Moderna reported that participants experienced only mild side effects, including redness at the injection site, headaches, fevers, and flu-like symptoms, all of which were short-lived—similar to the mild reactions seen with other vaccines, such as the flu shot.
Antibody Production
Another critical aspect of the trial is determining whether the vaccine stimulates the production of coronavirus antibodies. All participants across the three dosage levels successfully generated antibodies. Even more encouraging, the initial eight individuals who received their second booster shot were found to be producing “neutralizing antibodies,” indicating their antibodies can prevent the virus from infecting human cells. When these neutralizing antibody levels were compared to those of individuals who had recovered from COVID-19, they were found to be comparable. However, it is important to note that these tests are conducted in a laboratory setting, with no exposure to live coronavirus for the participants.
Next Steps
The Food and Drug Administration (FDA) has authorized Moderna to proceed with a second testing phase, which will involve an additional 600 participants, half of whom are over the age of 55. The company aims to initiate a third phase by July, involving thousands of healthy individuals to confirm the vaccine’s efficacy in preventing the disease. This Phase III testing will be akin to “field testing,” designed to simulate real-world vaccine usage.
About the Vaccine
Moderna’s vaccine is based on mRNA (messenger RNA), a molecule that has been explored for years in vaccine development, although none have received FDA approval thus far. mRNA vaccines are particularly promising due to their potency, rapid development time, and cost-effective production and administration.
The swift progress of Moderna is noteworthy; it took just 63 days from the publication of the virus’s genetic sequence by Chinese scientists to the administration of the first vaccine dose to a human volunteer. They are among several companies racing to deliver a safe and effective vaccine, including BioNTech in partnership with Pfizer and Fosun Pharma, as well as CureVac, which plans to begin human trials soon.
Moderna aims to make its vaccine publicly available by late 2020 or early 2021. Dr. Leo Smith, the company’s chief medical officer, stated in an interview that while the exact number of doses available immediately remains uncertain, they are striving to produce as many millions as possible. In the meantime, it’s crucial to maintain social distancing measures and wear masks when venturing out.
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In summary, a promising coronavirus vaccine developed by Moderna has shown safe and encouraging results in its initial testing phase. As the company moves forward with further trials, the scientific community remains optimistic about the potential for a safe vaccine to help return society to normalcy.
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