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Moderna, the Massachusetts biotechnology company behind a leading effort to create a coronavirus vaccine, announced promising early results Monday from its first human safety tests.
The eagerly-awaited data provide a first look at one of the eight vaccines worldwide that have begun human testing. The data have not been published in a scientific journal and are only a preliminary step toward showing the experimental vaccine is safe and effective.
“I would certainly take this as good news, and it’s certainly worth moving forward” into later stage trials, said Daniel Salmon, director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health. “There’s just historically, if you look at vaccine development, lots of vaccines that look good out of phase one that don’t turn out to be good products.”




What antibody tests can teach us about potential coronavirus immunity

Antibody testing has garnered the attention of many researchers and government officials in the fight against the coronavirus outbreak. (John Farrell, Jonathan Baran/The Washington Post)
The data released Monday by Moderna is encouraging, but represents only a first step in a long process to bring a vaccine to market. It comes from an interim report on dozens of patients followed over weeks, whereas vaccine approval requires broad testing in thousands of patients followed over many months or years.
Moderna also reported that the vaccine protected mice who were vaccinated and then exposed to the virus, preventing it from multiplying in their lungs.
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.
 Vaccine experts have said that these accelerated development timelines are theoretically possible, but extremely optimistic — and depend on everything going right. They stress that it will be crucial to gather convincing data the vaccines are safe and effective before using them broadly — and the new data are promising but preliminary, from the earliest phase one trials that test safety in healthy people.
Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said the data looked promising and it made sense to proceed to a large trial this summer.

 “The fact that the vaccine elicited neutralizing antibody amounts comparable or higher to those found in convalescent sera [plasma] is very encouraging,” said Arturo Casadevall, chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, who is spearheading the initiative to test plasma as a treatment.
 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 news release. He pointed to emerging evidence that many recovered patients do not muster high levels after they recover — and that high levels of antibodies may be needed to neutralize the virus.
  The vaccine showed few safety signals, aside from redness at the injection site for one patient and some transient “systemic” symptoms in three patients given the highest dose — which the company will not be using in future trials.
The interim data comes 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.
This month, the company received permission from the Food and Drug Administration to begin a 600-person, phase two trial to begin to test the effectiveness of the vaccine.
“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.
The company’s stock, along with the Dow Jones industrial average, soared on the report that eight participants who received low and medium doses of Moderna’s vaccine had blood levels of virus-fighting antibodies that were similar or greater than those in recovered covid-19 patients. That suggests, but doesn’t prove, that it triggers some level of immunity.