A Little Bit of Good News
On July 14, 2020, the New England Journal of Medicine published the first peer-reviewed study that provided a little bit of good news in the ongoing fight against COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID) and Moderna, a pharmaceutical company based in Massachusetts, may have developed a vaccine that could slow down the increasing number of COVID-19 cases and ideally, bring the pandemic to an end. Healthy adults who received this investigational vaccine against the SARS-CoV-2 virus were able to produce antibodies that neutralized viral activity and prevented it from entering host cells. By preventing entrance into cells, the virus will not be able to reproduce and go on to infect their human hosts.
The Phase 1 clinical trial began in March, with 45 healthy adults, between 18-55 years of age, who received 2 vaccinations 28 days apart at doses of either 25, 100 or 250 micrograms. After the second vaccinations, all participants produced antibodies against the SARS CoV-2 virus. The study also reports that the levels of antibodies the patients develop after the second vaccination seem to provide stronger protection than if the patients actually caught COVID-19. No serious, “trial-limiting safety concerns” were reported, though side effects occurred more commonly at higher doses and after the second vaccination and include “fatigue, chills, headache, myalgia, and pain at the injection sites.”
Nevertheless, we should all take this good news with cautious excitement and hope. Although the vaccine produces antibodies, it does not necessarily mean that these participants will not catch COVID-19 in the future. There is no data yet on how long the antibodies last or if the vaccines will provide similar results when tested in a larger population that includes the older and much more vulnerable population. Moderna has already moved onto Phase 2, where the vaccines will be tested in a larger group of 600 adults. Unusually, its Phase 3 clinical trials will overlap as Moderna plans to begin this phase later in July where 30,000 participants will be vaccinated with the 100-microgram dose. For reference, clinical trial phases of drug development follow in succession, with months to years in between. However, given the devastation that COVID-19 has wrought in the past year, with over 13 million global cases and counting, the urgency of developing a preventative vaccine is felt by scientists all over the world.
Phase 3 is where many drugs fail to gain FDA-approval. Only 25-30% of drugs will move on to Phase 4, where a newly approved drug will be made available to the entire population. However, even if Moderna’s vaccine is unable to ultimately be the vaccine the world is hoping for, it will always be the vaccine that gave us a little bit of hope and a little bit of good news when we really needed something to get us through 2020. In the meantime, please continue to wear your masks, wash your hands and social distance. The sooner that we cooperate, the sooner we will be able to see each other again.