As promising news on a mRNA-based vaccine candidate buoyed the nation Monday, researchers and volunteers in Rochester continue their work with cautious optimism.
Interim preliminary analysis of data from a coronavirus vaccine study, developed by Pfizer and BioNTech, that the vaccine is 90 percent effective in preventing an infection. The analysis was conducted by an external, independent data-monitoring committee from the Phase III clinical study, which so far has enrolled more than 40,000 subjects from diverse backgrounds.
For the interim analysis, the committee evaluated 94 COVID-positive cases, finding that protection from the virus is achieved 28 days after the initial vaccination, which has a two-dose schedule. Officials did not report any serious safety concerns.
“While we need to keep in mind that the study is ongoing and this is a preliminary analysis, the data is very encouraging,” says Edward Walsh M.D., a professor in the URMC Department of Medicine, Infectious Diseases. “We need to continue the process of rigorous analysis of this and other potential vaccines to ensure they are safe and effective, and this will take time. However, I think it is safe to say that, if these findings hold up, we can start to see the light at the end of the tunnel.”
Walsh and colleague Ann Falsey M.D. have been leading the local arm of the Pfizer/BioNTech study. Falsey is co-director of the URMC Vaccine and Treatment Evaluation Unit. Both are members of the Infectious Disease Unit at Rochester General Hospital.
Rochester has played a role in the testing of the Pfizer/BioNTech vaccine since May, when the first human studies were launched. Technologies used in the development of the vaccine can trace their origins to decades of infectious disease research conducted at URMC, officials say.
Walsh and Falsey documented results of the study in the New England Journal of Medicine that demonstrated the safety of the BNT162b2 vaccine candidate and its capability of stimulating an immune response during the Phase I clinical trial, which studied four variations of the vaccine.
BNT162b2 was chosen to move to Phase III in July. Local volunteers, enrolled through URMC and RRH, were among the first in the country to get a vaccine dose in Phase III.
URMC’s work with Pfizer stems from its research on improving the efficacy of vaccines and developing new vaccines against Hib, a bacterium that causes meningitis and pneumonia, and HPV, the virus that causes cervical cancer, officials say. The investigation on the Hib vaccine resulted in Praxis Biologics, a startup long touted as a success story here. Praxis became Wyeth Lederle Vaccines and, eventually, a part of Pfizer. When Wyeth acquired Praxis, several scientists chose to continue their careers with that company.
The team at Pfizer continued to collaborate with researchers in Rochester and subsequent technological and scientific advances made by URMC researchers studying RSV, a respiratory virus, and seasonal coronaviruses contributed to the COVID-19 vaccine currently being developed by Pfizer and BioNTech, URMC says.
Pfizer and BioNTech plan to continue to gather safety data and submit information to the U.S. Food and Drug Administration. The pharmaceutical giant expects to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion in 2021.
Other vaccine candidates continue to move through trials and milestones as well. Yesterday, Eli Lilly shipped the first 88,000 doses of its investigational COVID-19 vaccine candidate to a national distributor. The company’s move follows an FDA emergency use authorization for the therapy.
Lilly’s Bamlanivimab is authorized for COVID-positive patients who are 12 years of age and older, roughly 88 pounds in weight, and at high risk for progressing to severe COVID-19 and hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. Bamlanivimab continues to be evaluated for safety and efficacy.
At URMC, participants are being enrolled to study the AstraZeneca and University of Oxford vaccine hopeful. Trials of the vaccine, which were briefly suspended in September due to a patient illness, have since resumed. The medical center is expected to join other vaccine evaluations as well.
Falsey, who is a national coordinating investigator for the AstraZeneca vaccine study, says it is necessary to press forward with studies of other potential candidates.
“Given the challenges and logistics of vaccine distribution on a global scale, we will require multiple effective vaccines and we are incredibly grateful to the thousands of people in our area who have stepped forward to participate in vaccine research,” she says.
Smriti Jacob is Rochester Beacon managing editor. All coronavirus articles are collected here.