Moderna’s coronavirus vaccine shows encouraging early results in human safety trial

The data is encouraging, but it is only a first step. It comes from an interim report on dozens of patients followed over weeks, whereas vaccine studies require broad testing in thousands of patients followed over many months or years.

Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said the data looked promising and it made sense to proceed to a large trial this summer.

Peter Jay Hotez, who is working on developing a coronavirus vaccine at the Baylor College of Medicine, said it would be important to understand the level of antibodies detected in the patients beyond the information provided in a company press release. He pointed to emerging evidence that many recovered patients do not muster high levels after they recover — and that high levels of antibodies are needed to neutralize the virus.

The vaccine showed no worrisome safety signals, aside from redness at the injection site for one patient and some transient “systemic” symptoms in three patients given the highest dose, the company said.

Moderna’s announcement comes days after one of its board members, Moncef Slaoui, stepped down from the board to become chief scientist for Operation Warp Speed, a White House initiative to speed up vaccine development. Slaoui still owns stock options in Moderna, and made an apparent reference to the early data in a Rose Garden news conference on Friday afternoon.

The interim data Moderna announced come from a clinical trial aimed at showing the safety of its experimental vaccine and helping the company select the correct dose. The company has not yet picked the final dose, or announced the size or length of the large trial that it will start in July, which will be the key one that regulators consider to decide whether the vaccine is safe and effective.

“We are very, very happy because first the vaccine was generally safe,” Stephane Bancel, chief executive of Moderna said in an interview. “The piece that was really exciting and was the big question, of course, was can you find antibodies in people in enough quantities” to prevent disease.

Moderna also reported that the vaccine protected mice who were vaccinated and then exposed to the virus, preventing it from multiplying in their lungs. The animal and human data being released by the company have not yet been published.

Moderna’s vaccine uses a genetic material called messenger RNA that codes for the distinctive spike protein that studs the outside of the novel coronavirus. The vaccine delivers the messenger RNA to cells, which then follows the genetic instructions to create the virus protein — allowing the body to learn to recognize and neutralize the pathogen.

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