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Moderna’s headquarters in Cambridge, Massachusetts.
Joseph Prezioso / AFP / Getty Images
Moderna’s announcement of positive data about a Phase 1 trial of its Covid-19 vaccine in May was met with skepticism by some experts, who noted that the company had not included many details about the trial’s result in its release. press. Now, two months later, that detail is here.
The vaccine “induced anti-SARS-CoV-2 immune responses in all participants, and no limiting safety concerns were identified from the trials,” says an article in the New England Journal of Medicine published Tuesday night. “These findings support further development of this vaccine.”
Moderna’s shares (ticker: MRNA) skyrocketed after the hours after the 5 pm announcement, up 13% and rise at 5:10 pm
Scientists and investors are likely to analyze the newspaper in the coming hours. But initially, two elements seem important to consider: at the 100 microgram dose level, which Moderna will test in its Phase 3 trial starting this month, the vaccine caused neutralizing antibody levels after two doses that were four times higher than those found by researchers in three patients who had recovered from Covid-19 infections.
That’s good news. It is also revealed in the document that the 15 patients at the 100 microgram dose level reported so-called “systemic adverse events” after the second injection of the vaccine. Eighty percent reported fatigue and chills, while 60% reported headaches. Six reported fever.
All reported symptoms disappeared and were of mild or moderate severity.
The document also found that the vaccine elicited T-cell responses in the trial participants, another form of immune response that some scientists believe may be key to preventing Covid-19 infections.
The authors of the article noted that they have so far been unable to trace how long the vaccine-induced immune responses last.
“These safety and immunogenicity findings support the advancement of the mRNA-1273 vaccine to clinical trials at later stages,” the authors wrote.
A separate editorial signed in the New England Journal by Dr. Penny Heaton, CEO of the Bill & Melinda Gates Medical Research Institute, says: “The safety and immunogenicity data in this preliminary report is promising, and supports the continued development of However, we must take into account the complexity of vaccine development and the work that remains to be done before Covid-19 vaccines become widely available. “
Moderna confirmed Tuesday that it plans to start a phase 3 trial of 30,000 participants of its Covid-19 vaccine on July 27. The company is testing a two-dose regimen of a 100 microgram dose of its vaccine, called mRNA-1273, in Phase 3 trial.
According to the Moderna press release, the 14 patients in the phase 1 trial who received 100 microgram doses of the vaccine had an average level of neutralizing antibodies that were 4.1 times higher than the level found in the blood of three patients who -19 infections had been recovered from Covid.
The company’s CEO has said he expects to have data from the Phase 3 Thanksgiving study. Moderna’s shares have risen 283.6% so far this year. The stock rose 4.5% on Tuesday’s trading day.
Write to Josh Nathan-Kazis at [email protected]
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