FLC | NIH plans to start pivotal testing of COVID-19 vaccine candidates this summer

NIH plans to start pivotal testing of COVID-19 vaccine candidates this summer

June 10, 2020

The federal government plans to fund and conduct decisive research on three experimental coronavirus vaccines beginning this summer, according to John Mascola, director of the vaccine research center at the National Institute of Allergy and Infectious Diseases.

These phase 3 trials are expected to involve tens of thousands of subjects at dozens of sites around the U.S., Mascola said. Meant to determine a vaccine’s safety and effectiveness, they would mark the final stage of testing.

Moderna Inc.’s vaccine is set to be first, starting in July, followed in August by one co-developed by Oxford University and AstraZeneca PLC, and in September by Johnson & Johnson's, he said.

“We will want to use the investigative resources of the country as best we can to optimize us getting an answer as quickly as possible,” said Larry Corey, a vaccine and infectious-disease specialist at the Fred Hutchinson Cancer Research Center in Seattle and member of a committee advising the National Institutes of Health (NIH) on the design of the coronavirus-vaccine trials.

A Moderna spokesman confirmed the plan for the NIH-funded trial of its vaccine. An AstraZeneca spokeswoman on Tuesday evening said the company’s recent contract with a U.S. health agency would support a large study but couldn’t confirm the start date. A J&J spokesman declined to comment.

Many vaccine candidates fail to make it through the trials.

“There’s a lot of optimism in our community that a vaccine should be possible, but we are very focused on the fact that that has to be proven in clinical trials,” Mascola said in an online video discussion hosted on June 5 by the Fred Hutchinson Cancer Research Center.

An existing network of researchers who have run HIV vaccine studies, which Corey leads, will help to conduct the large coronavirus vaccine studies, he said.

The studies will be designed, Corey said, to show more definitively whether the vaccines safely prevent disease. Researchers would start the phase 3, NIH-funded studies only once they have sufficient evidence from the earlier testing that the vaccines are safe and elicit certain immune responses in people, Corey said. The studies are also subject to clearance by regulators.

Each vaccine study is expected to include roughly 30,000 people, some receiving the experimental shots and others placebo shots, though the final number of participants could vary, Mascola said. Each study will be conducted at more than 50 sites, primarily in the U.S. but possibly including other countries, Corey said.

Researchers will track whether people who receive the vaccines are infected with the virus and develop Covid-19 at lower rates than those who get the placebo. The studies will be conducted in locations where the virus continues to spread, Corey said.

Last month, Moderna said its vaccine, co-designed with NIH researchers, was generally safe and induced immune responses in a small, early-stage study. The second phase of testing just began.

Human testing of the vaccine from AstraZeneca and Oxford’s Jenner Institute has started, but results haven’t been released. J&J said previously it would start human testing by September.

Researchers hope the trials will yield answers within six to eight months of their starts, Corey said. Some vaccine developers have said their shots could become available for emergency use on a shorter timeline, possibly as soon as the fall.

Though each vaccine will be tested in a separate trial, the companies are coordinating certain aspects, such as using the same independent committee to monitor safety, according to Corey. This will allow researchers to better compare how the vaccines perform, and whether certain shots are better suited to certain subpopulations, he said.

Read more in the Wall Street Journal: https://www.wsj.com/articles/coronavirus-vaccine-candidates-pivotal-u-s-...