Moderna Reports Positive Data on Vaccine Trial

Moderna (MRNA) has successfully reported positive results from its phase-1 clinical trial of its Covid-19 vaccine candidate, mRNA-1273. It was led by the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID).

On Monday morning, Moderna, a Cambridge, Massachusetts based pharmaceutical company, announced the success of its phase-1 clinical trial.

“When combined with the success in preventing viral replication in the lungs of pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials,” said the company’s chief medical officer Tal Zaks.

The Phase-I clinical trial included 45 people in total. The results of 8 of the participants showed that they developed neutralizing antibodies – believed to be significant in providing protection from the virus—at different levels in comparison to Covid-19 patients who had recovered.

According to the company’s immunogenicity data records, the results showed that participants across the three levels of doses – 25 micrograms, 100 micrograms, and 250 micrograms – were seroconverted by day 15 after a dose each. By day 43, precisely two weeks after the second dose, the levels of binding antibodies in the participants of the 25 micrograms dose were similar to those seen in blood samples of Covid-19 patients who had recovered. While the 100ug dose participants’ binding antibodies were seen to have exceeded those of Covid-19 recovered patients.

Moderna’s Covid-19 vaccine candidate has proved its capability to prompt an immune response in the human body. After getting tested on a small group of patients, it was found to be safe and well-tolerated. The only side effect, so far, was redness around the area the shots were administered, as reported by the company.

During a conference call with investors, Moderna CEO Stephane Bancel said they “could not be happier about this interim data. Adding that, the results show that the vaccine has a “high probability to provide protection from Covid-19 disease in humans.”

At an early stage, the interim Phase I data demonstrated that the mRNA-1273 vaccine causes an immune response of “the magnitude caused by natural infection starting with a dose as low as 25 micrograms,” according to Zaks.

Some physicians not involved with the trials have outrightly expressed their optimism about the Phase-I results, even though the vaccine is still at its early stages. Dr. Iahn Gonsenhauser, chief quality and patient safety officer at the Ohio State University Wexner Medical Center, said: “It’s great news to see what appears to be a potentially effective vaccine has been created and appears safe.”

A professor in the division of infectious disease and organ transplantation at Northwestern University Feinberg School of Medicine, Chicago, Dr. Michael Ison, also expressed his thoughts about the matter. He said the results looked “pretty good,” advising that it would be best to continue to monitor the patients for a while as there are still questions concerning the level of protection the antibodies can offer.

While the Phase-I trial has proven successful, the vaccine would not be sent out to the public as the company would have to continue research, launching into phase II. Its phase-II trial would be updated to two dose levels of 50 micrograms and 100 micrograms.