Posted: May 5, 2020 / 09:09 PM EDT
/ Updated: May 5, 2020 / 09:09 PM EDT
FILE – This undated electron microscope image made available by the U.S. National Institutes of Health in February 2020 shows the Novel Coronavirus SARS-CoV-2. Also known as 2019-nCoV, the virus causes COVID-19. The sample was isolated from a patient in the U.S. On Tuesday, April 21, 2020, U.S. health regulators OK’d the first coronavirus test that allows people to collect their own sample at home, a new approach that could help expand testing options in most states. The sample will still have to be shipped for processing back to LabCorp, which operates diagnostic labs throughout the U.S. (NIAID-RML via AP)
ROCHESTER, N.Y. (WROC) — The University of Rochester Medical Center and Rochester Regional Health are collaborating on a new clinical trial for a COVID-19 vaccine, and you can help.
The study will recruit 90 local participants, from ages 18 to 85, and begin administering the vaccine, developed by Pfizer and BioNTech, to volunteers in the coming days.
“The initial phase of the study involves very healthy individuals, then as you move forward to phase two and three you open it up to the rest of the population,” infectious disease expert Dr. Edward Walsh said during a press conference on Tuesday. Walsh said they want the first round of patients to be healthy so the reaction they are seeing, is the antibodies reacting to the virus, not to any other possible infection.
“The other criteria is that they should not have lung disease, diabetes, hypertension or a BMI over 30 and those are groups of patients who might be higher risk and susceptible for coronavirus infection.”
Rochester is one of only four sites in the U.S. conducting early stage clinical trials of this vaccine, which has also begun testing in Germany. “We have people reaching out to us all the time saying how can I help and this gives people a way to help and give back,” Infectious Disease Expert Dr. Ann Falsey said in the press conference.
Individuals interested in participating in the clinical trial can call 585 922-5944 or email email@example.com.
“It’s a study that will have multiple visits over a two year period with most of the visits concentrated in the first six months,” Falsey said. “It is a commitment to start with on the vaccination date in particular.”
The randomized placebo-controlled clinical trial will recruit 90 individuals in the Rochester area ages 18 to 85 who have not been infected with COVID-19 and will evaluate the safety, tolerability, and immunogenicity of up to four variations of the vaccine. Pfizer contracted with URMC to conduct the clinical trial in Rochester and the recruitment of study volunteers and testing of the vaccine will occur at Rochester General Hospital. The study is the only active COVID-19 vaccine clinical trial in upstate New York, according to officials.
Pfizer Inc. and BioNTech officials announced Tuesday that the first participants have been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week, according to officials.
“The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against COVID-19,” said Pfizer Chairman and CEO Albert Bourla in a statement.
“It is encouraging that we have been able to leverage more than a decade of experience in developing our mRNA platforms to initiate a global clinical trial in multiple regions for our vaccine program in such a short period. We are optimistic that advancing multiple vaccine candidates into human trials will allow us to identify the safest, most effective vaccination options against COVID-19,” said CEO and Co-founder of BioNTech Ugur Sahin in a statement.
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