The Moderna coronavirus vaccine trial presents promising data, according to a newly released report from the peer-reviewed New England Journal of Medicine.
Moderna announced that its potential coronavirus vaccine produced a “robust” immune response in all 45 patients during the early stage human trial. With this, Moderna’s stock saw a 16% increase in after-hours trading on the news.
Findings showed that all 45 patients manifested neutralizing antibodies, which scientists consider important for shaping immunity. The clinical trial provided more favorable data that the coronavirus vaccine can protect people from the disease.
The Moderna coronavirus vaccine trial gave each participant a 25, 100 or 250 microgram dose, with 15 people in each dose group. They took two doses of the potential vaccine.
A “robust” immune response in all participants unfolded in all dose cohorts after two vaccinations, according to Moderna. The company added that the levels of neutralizing antibodies in the high dose group were four times higher than in patients who recovered from Covid-19.
“These Phase 1 data demonstrate that vaccination with mRNA-1273 elicits a robust immune response across all dose levels and clearly support the choice of 100 µg in a prime and boost regimen as the optimal dose for the Phase 3 study,” Moderna’s chief medical officer, Tal Zaks, said in a statement. “We look forward to beginning our Phase 3 study of mRNA-1273 this month to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease.”
Moderna issued preliminary information from its early stage trial in May, but it had insufficient data and had not been peer-reviewed yet.
Symptoms
According to Moderna, the coronavirus vaccine was well tolerated overall. However, more than half of the participants presented mild or moderate symptoms such as muscle aches or pain and fatigue at the injection site.
The company noted the ongoing evaluation of the durability of immune response. The participants will be monitored for one year after the second vaccination.
The Moderna coronavirus vaccine trial is just one of several efforts being held to fight Covid-19. Data compiled by Johns Hopkins University showed the virus has infected more than 13 million people and killed at least 573,200 worldwide as of Tuesday. The World Health Organization reported that over 100 vaccines are under development globally.
Moderna announced earlier Tuesday that it would start its late-stage trial for its coronavirus vaccine on July 27. ClinicalTrials.gov states that the trial will involve 30,000 patients across 87 locations. The individuals in the experimental arm will take a 100 microgram dose of the potential vaccine initially and another 29 days later. Some patients will also be given a placebo.
Dr. Fauci's reaction
Dr. Anthony Fauci, White House health advisor, said that any potential coronavirus vaccine may require booster for longer protection.
He said that the effect of the potential vaccine on individuals might be short-lived.
Antibodies can help identify how effective a vaccine is, how often a person might need to receive it, or a booster for longer protection.
Dr. Fauci, the director of the National Institutes of Allergy and Infectious Diseases, was asked about how long antibodies can protect people from infection. He said, “we do not know.”
“With this spike protein that’s being presented in the way that we do it with primes and in some cases boosts, we’re going to assume that there’s a degree of protection, but we have to assume that it’s going to be finite,” he noted during a Q&A discussion with Dr. Francis Collins, director of the National Institutes of Health. “It’s not going to be like a measles vaccine.”
