MODERNA VACCINE DETAILS PROTOCOL

The biotech company Moderna released a 135-page document on Thursday that details how it is conducting the late-stage trial of its coronavirus vaccine, and how safety and efficacy will be determined, according to The New York Times.

The document suggests that the first analysis of the trial data may not be conducted until late December, and that there may not be enough information then to determine whether the vaccine works. Subsequent analyses, scheduled for March and May, are more likely to provide an answer.

The company is among the front-runners in the global race to produce a vaccine to fight the pandemic. Moderna’s vaccine uses genetic material from the virus, known as mRNA, to prompt cells in the body to make a fragment of the virus that will train the immune system to fight off an infection.

The vaccine is now in a Phase 3 study that enrolled more than 25,000 of its intended 30,000 volunteers, and Dr. Tal Zaks, Moderna’s chief medical officer, said the enrollment should be complete in the next few weeks.

About 28 percent of the participants are Black, Latino or from other groups that have been particularly hard hit by the disease. A diverse enrollment has been considered essential.

Half of the participants receive the vaccine, and half receive a placebo shot consisting of salt water. Two shots are needed, four weeks apart. Then the participants are monitored to see if they develop symptoms of COVID-19 and test positive for the virus.

Side effects of the vaccine are also tracked, with participants recording symptoms in electronic diaries, taking their own temperatures, making clinic visits and receiving periodic phone calls to assess their condition. The vaccine can cause transient reactions like a sore arm, fever, chills, muscle and joint pain, fatigue and headaches.

To determine the vaccine’s efficacy, COVID-19 cases are counted only if they occur two weeks after the second shot. Some patients are already two weeks beyond the second shot, but Dr. Zaks said he did not know if any trial participants had contracted COVID-19 yet.

A total of 151 cases — spread between the vaccine and placebo groups — will be enough to determine whether the vaccine is 60 percent effective. The Food and Drug Administration has set the bar at 50 percent.

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