The vaccine was developed by Moderna and the National Institute of Allergy and Infectious Diseases, which conducted the Phase 1 trial. Moderna reported some of the results in mid-May, and the vaccine is in intermediate-stage trials, with a final stage. slated to start at 30,000 adults on July 27.
“No matter how this is cut, this is good news,” Dr. Anthony Fauci, the leading infectious disease specialist for the US government, told the Associated Press.
Moderna, whose shares rose more than 200 percent this year as the company bulldozed the media and fueled expectations, was criticized for not sharing supporting data. That is what the magazine published on Tuesday.
It was shown that after the volunteers received a second injection, neutralizing antibodies were detected in all the participants who were evaluated, at levels well above that of 38 patients with confirmed diagnoses of COVID-19.
The study authors, however, noted that they couldn’t say how long that immune response lasted, a crucial question when weighing the effectiveness of a vaccine. Participants will be monitored for one year after receiving their second injection to see if they remain immune.
Dr. Penny Heaton, executive director of the Bill & Melinda Gates Medical Research Institute in Cambridge, wrote in an editorial at NEJM that the data was promising, but asked for caution.
“Many phase 3 trials fail due to incorrect identification of the dose that best balances safety and efficacy,” he wrote.
Unlike traditional vaccines, which use a weakened or killed virus to stimulate an immune response, Moderna’s vaccine is based on genetic material called messenger RNA or mRNA. The vaccine inserts portions of the coronavirus RNA into cells, which then make a part of the virus to make antibodies.
The company, which has no products on the market, is not uncommon in the biotechnology world, setting a record in the pharmaceutical industry by producing its vaccine in 42 days after receiving the genetic sequence of the virus. However, no messenger RNA vaccine has been approved to prevent any disease, although Moderna is one of many seeking to do so with the coronavirus.
Other mRNA vaccines being tested include one developed by pharmaceutical giant Pfizer and German biotech firm BioNTech.
More than half of the 45 participants who received the Modern vaccine reported side effects that included fatigue, chills, headaches, body aches, and pain at the injection site. This was more common after the second vaccination, particularly at the highest dose, but none of the side effects were considered serious.
The 45 early-stage volunteers in Seattle received doses of 25 micograms, 100 micrograms, and 250 micrograms.
Dr. Tal Zaks, medical director of Moderna, said the Phase 1 data “demonstrates that vaccination with mRNA-1273 elicits a robust immune response at all dose levels and clearly supports the choice” of 100 micrograms in a prime and boost regimen. The optimal dose for the phase 3 study.
“We hope to begin our Phase 3 study of mRNA-1273 this month to demonstrate the ability of our vaccine to significantly reduce the risk of COVID-19 disease,” he said.
The project has received $ 483 million from the Federal Advanced Biomedical Research and Development Authority. It is one of at least four possible COVID-19 vaccines that are supported by Operation Warp Speed, a federal government initiative to accelerate the development of countermeasures against the virus.
Moderna released details of its final-stage vaccine trial Tuesday on a government website, confirming that the widely awaited trial was still on track to begin this month. Moderna said the trial is expected to begin July 27 and will enroll 30,000 adults at high risk of contracting the coronavirus.
The test sites will begin registering people next week, a Moderna spokesperson said.
Jonathan Saltzman can be contacted at [email protected]
