NEW YORK (VINnews) — Massachusets-based biotech company Moderna announced Tuesday that a potential COVID-19 vaccine it has been testing has produced a “robust” immune response in all the patients participating in the early vaccine trials.
The company gave three groups of 45 patients the trial vaccine in different dosages. Preliminary data from the trials were released in May but have now been confirmed and they demonstrate that the vaccine being developed “elicits a robust immune response across all dose levels” according to Moderna’s chief medical officer Tal Zaks. He added in the company’s press release that “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.”
Early results were published in the New England Journal of Medicine on Tuesday, becoming the first US vaccine candidate to publish results in a peer-reviewed medical journal. The results showed that the vaccine worked to trigger an immune response with mild side effects — fatigue, chills, headache, muscle pain, pain at the injection site.
Phase 3 trials are slated to begin on July 27th, making Moderna the first company to initiate Phase 3 trials which cover a wide group of people and test the vaccine for efficacy and safety. The trials will involve 30,000 people taking two doses of the vaccine, one at the beginning of the trial and another four weeks later. The participants include people whose locations or circumstances put them at high-risk of infection. One group will be injected with 100 micrograms of the vaccine on day 1 and again on day 29. A second group will be injected with two doses of a placebo for comparison. The study will be conducted at 87 locations around the US.
Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, said Monday that he was “cautiously optimistic” regarding Moderna’s potential vaccine.
In an editorial comment appended to the New England Journal results, Dr. Penny Heaton, chief executive officer of the Bill and Melinda Gates Foundation, also expressed guarded optimism, stating that “the world has now witnessed the compression of 6 years of work into 6 months. Can the vaccine multiverse do it again, leading to a reality of a safe, efficacious Covid-19 vaccine for the most vulnerable in the next 6?”
There are currently 23 potential coronavirus vaccines in human trials throughout the world, according to the World Health Organization. The U.S. is attempting to develop 300 million doses of a vaccine by January 2021 in an interagency program named Operation Warp Speed.