The University of Rochester Medical Center (URMC) is joining hospitals around the world in conducting a phase 3 clinical trial for a potential coronavirus vaccine, known as AZD1222.
Just last week, however, the trial was put on hold.
The vaccine is being developed by AstraZeneca and the University of Oxford, the latter of which started their trials a few months before the United States. UK researchers reported that one subject had an extreme negative reaction, which they were concerned was related to the vaccine. In response, AstraZeneca immediately paused trials until an internal investigation is completed.
“AstraZeneca [made] the correct decision to stop the trial,” Dr. Angela Branche, co-head of URMC’s Vaccine Treatment & Evaluation Unit, said. “These kinds of investigations are part of every clinical trial. We call [it] a pausing rule, which allows [the] pause of the study to investigate anything that may occur that may impact safety.”
According to CNN, the case was considered rare enough not to affect the whole trial.
“We don’t know when to resume [the trial] yet, but it won’t take too long,” Dr. Michael Keefer, co-head of URMC’s HIV unit, said.
Branche also believes the trial at URMC is going to restart in the near future. “The material from [the internal investigation] is under review by FDA, who is trying to make sure the U.S. agrees with their conclusion and the study to be perceived,” she said.
The two units are working on three different trials with another one hosted at Rochester General Hospital. “It is a community-wide effort,” Keefer said. “We work together to solve the problems.”
URMC has a long history of vaccine research and development. Keefer, who has had more than 30 years of experience at the URMC vaccine department, said the COVID-19 vaccine is based on several approaches that have been used in past years for the HIV vaccine.
As cities across the country open back up, the URMC faculty members warned the UR community that now isn’t the time to relax. The COVID-19 virus is something that the majority of humans don’t have past experience with, Branche said. There is no pre-existing immunity against it in the human body — making COVID-19 a “novel virus.”
“If you are exposed to it, there is a high possibility that you will get it,” Branche explained. “The infection will continue, potentially [at a] low-level or at least [until] 70% are vaccinated or get infected.”
“It’s still important to wear a mask and keep social [distancing],” Keefer said. “This buys scientists time to conduct research on COVID vaccine trials.”