Moderna’s COVID-19 vaccine has received early results, according to the biotech company, which partnered with the National Institutes of Health (NIH) to develop the vaccine. If studies continue to perform well, the company’s vaccine could be available to the public as soon as the optimistic prediction of January 2021.
“This is absolutely good news and news that we think many have been waiting for for quite some time,” Dr. Tal Zaks, Moderna’s chief medical officer said.
Who is Moderna?
Moderna, based in Cambridge, Massachusetts, is one of eight global developers doing human clinical trials with a vaccine against the novel coronavirus, according to the World Health Organization (WHO), along with American research facilities, Pfizer and Inovio, one lab at the University of Oxford in Britain, and four other labs in China.
The science behind the vaccine
Moderna has vaccinated dozens of study participants and measured antibodies in eight of them. All eight participants developed neutralizing antibodies to the virus at levels reaching or exceeding the levels seen in people who’ve naturally recovered from COVID-19, according to the company.
An antibody is a substance produced by certain cells of the body that counteracts the effects of a disease germ or its poisons, COVID-19 in this case. A neutralizing antibody binds to a virus, disabling it from attacking human cells.
“We’ve demonstrated that these antibodies, this immune response, can actually block the virus,” Zaks said. “I think this is a very important first step in our journey towards having a vaccine.”
FDA approved vaccine timeline
While the vaccine has seen promising results, it’s not certain if it will protect people in the real world. The early data come from the Phase 1 clinical trial, which is a study on a small number of people and focuses on whether a vaccine is safe and elicits an immune response.
Phase 2 trials have been approved by the FDA, which will involve several hundred more people. Moderna plans to start large-scale clinical trials, known as Phase 3 trials, in July, which will involve tens of thousands of people.
Dr. Paul Offit, a member of the NH panel leading the vaccine studies in the US, said before the pandemic, vaccine developers would usually test out their product in thousands of people before moving on to Phase 3, but said Moderna is “extremely unlikely” to have vaccinated that many by July, since they’ve only vaccinated dozens so far.
Offit said it makes sense for Moderna to move into Phase 3 without vaccinating that many people, given that COVID-19 is killing thousands of people each day.
The urgency is clear. Offit responded to the concern of the rush for the vaccine by saying, “This is a different time.”
“That’s a good question, and the truth is, we don’t know that yet,” Zaks said. “We are going to have to conduct formal efficacy trials where you vaccinate many, many people, and then you monitor them in the ensuing months to make sure they don’t get sick.”
So far, the Moderna study subjects who were vaccinated even at 25 and 100 micrograms achieved antibody levels that match or are even higher than people who naturally became infected with coronavirus.
It is not clear whether natural infection equates with immunity to reinfection, and so similarly it’s not clear whether vaccination confers general immunity. More testing and time will tell.