ROCHESTER, N.Y. (WROC) — Researchers are making progress in the race to create and distribute an effective COVID-19 vaccine.
Dr. Jeff Harp from Highland Family Medicine discussed the role Rochester is playing with the locally-based Phase 3 clinical trials Tuesday during News 8 at Sunrise.
Rochester Regional Health and the University of Rochester are recruiting participants for the clinical trial. Dr. Harp began by explaining the phases of vaccine development. Phase 0 is the initial development of the vaccine, including testing in animals. Phase 1 is the first human testing phase, using up to 100 participants to determine dosing and overall safety. This takes months to complete. Phase 2 checks effectiveness and safety, usually in several hundred participants, and generally takes months to years to complete. Phase 3 is a larger study of safety and effectiveness involving thousands of participants. It may also compare the vaccine with other available vaccines. This phase usually takes years to complete. He noted the Phase 3 trial of the UK developed vaccine is scheduled to end in October of 2022.
Worldwide, five vaccines are in Phase 3 testing. Rochester is one of many sites testing the second vaccine developed in the U.S. The goal is to test the vaccine in 30,000 volunteers at 120 sites throughout the country. “Researchers hope to recruit up to 200 local participants, focusing on people aged 18 to 85 who are in high-risk groups due to exposure, ethnicity, and/or age. After vaccination, the participants will track symptoms for up to two years.”
Usually Phase 3 would run for years but the U.S. is on ‘warp speed’ with respect to vaccine development. “One of the vaccines in phase 3 trials began phase 3 trials before phase 2 trials were finished, not the usual process,” explained Dr. Harp. “Dr. Fauci recently expressed hope that an effective vaccine would be ready late this year or early next year, much quicker than the development process would usually take. However, to put an effective vaccine into general use we would first need to manufacture and administer 300 million or so doses just in the U.S., not to mention the rest of the world.”
Dr. Harp concluded that while it looks like there may be a vaccine in sight, and that it may be in general use a year from now, the related message is that until then our best defense is to continue protecting others and ourselves through masking, physical distancing, hand hygiene, and disinfecting.