A leading vaccine candidate for COVID-19 has shown that it can safely produce a “rapid and strong” immune response in humans. That’s according to the developer, biotech company Moderna whose interim phase 1 study results were published the New England Journal of Medicine.
This is good news, and yes, Moderna says that neutralizing antibodies were observed in 100% of its evaluated participants. Remember, the body’s immune system fights off infections by producing antibodies. They’re called neutralizing antibodies because when they find the virus, they bind to it. They basically grab a hold of it to neutralize and disable it. Now, all 45 participants in the stage 1 trial not only produced neutralizing antibodies, but their levels were very similar to people who had caught the virus and recovered from COVID-19. So this sounds very promising.
What about side effects, how did people react to the vaccine?
Overall, there were mild side effects like pain at the injection site. All of the participants were given two shots, about a month apart. And the more common effects after the second shot were fatigue and chills, with 80% of the volunteers experiencing those symptoms. Also, 60% developed a headache and 53% had muscle pain. But all of these symptoms didn’t last very long. And it’s not uncommon to experience these types of side effects when it comes to vaccinations in general.
Here’s the most important question we all want to hear the answer to: do we know yet if the vaccine protected the participants from the coronavirus?
It’s still too soon to answer that. When it comes to the clinical development of new vaccines, there is a three-phase process. Phase 1 focuses on a small number of participants. The goal is to check how safe the vaccine is and see if it does what it’s developed to do. Phase 2 expands the number of participants and has a longer time length than Phase 1. Lastly, phase 3 involves thousands of people and that’s when a vaccine is really evaluated to see just how effective and safe it is. Now Moderna is expected to begin phase 3 in just a couple of weeks with 30,000 participants at 87 locations across the US. It will be a placebo-controlled study. So one group will get the vaccine, and another group will get injected with a placebo. Everyone will be followed for two years.
So if everyone is followed for two years, are we waiting that long before the general public can get vaccinated if all goes well?
Moderna hopes to have some strong data from their phase 3 trial concerning their vaccine’s safety and effectiveness by the end of the year. If all goes well, it could be made available to high-risk populations under the FDA’s Emergency Use Authorization. And Moderna says it’s still on track to produce about 500 million doses per year, with the possibility of manufacturing 1 billion doses per year beginning in 2021.