Syracuse, N.Y. — Upstate Medical University began injecting people today with an experimental Covid-19 vaccine as part of a large study by the drug company Pfizer that will include 30,000 people in the U.S., Brazil, Argentina and Germany.
Upstate is one of 62 research centers nationwide participating in the study. It is looking for volunteers to participate in the study to evaluate the safety and performance of the potential vaccine.
Four people received the vaccine at Upstate this morning, said Dr. Tim Endy, the chair of microbiology and immunology at Upstate.
There are no approved vaccines to prevent Covid-19 which has been spreading worldwide since early this year.
Pfizer is developing its potential vaccine with BioNTech, a German company. There are many other companies racing to come out with a vaccine as the U.S. grapples with a surge in Covid-19 cases.
Moderna, a Massachusetts biotech company, also began a large clinical trial in the U.S. this week of another Covid-19 vaccine.
The federal government has agreed to pay $1.95 billion to buy 100 million doses of Pfizer’s vaccine by the end of this year if the study shows it is safe and effective. The deal was signed as part of “Operation Warp Speed,” the Trump administration’s effort to accelerate development and production of vaccines and treatments to fight the novel coronavirus.
Dr. Anthony Fauci, the federal government’s top infectious disease expert, said Tuesday he is “cautiously optimistic” a viable Covid-19 vaccine may be available by this fall.
Pfizer said its potential vaccine emerged as a strong candidate based on assessments of its safety and immune response. The company said in a statement there were no serious adverse events among the 120 people who received the vaccine in an earlier study. It said mild to moderate side effects of the experimental vaccine included fever, fatigue and chills.
The study at Upstate will be randomized. That means some participants will receive a placebo and others, the potential vaccine. The majority of the study team won’t know which individuals are receiving the placebo or the experimental vaccine.
To be eligible for the study, individuals must be in good health, between the ages of 18 to 85 and be able to make a two-year commitment to the study. Volunteers will be required to provide blood samples up to two years after receiving the vaccine/placebo. Individuals might be seen up to ten times during the two-year study period. The two-year time frame for the study is important to assess the safety and long-term immune response.
Upstate said individuals will be compensated for their participation and will not incur any expenses for participating in the study.
Individuals who have previously tested positive for Covid-19 are not eligible to participate. Blood tests can show if the vaccine triggers an immune response in participants that could fight off the virus.
During their first two study visits, participants will receive the study vaccine or placebo injection. Nasal swabs to test for Covid-19 will also be collected during these times. During the other study visits to follow, blood samples will be taken.
For seven days after receiving the placebo/study vaccine, participants will be required to keep a daily record of any specific reactions.
Individuals interested in participating in the study can call 315-464-9869 or email trials@upstate.edu for more information.
James T. Mulder covers health news. Have a news tip? Contact him at (315) 470-2245 or jmulder@syracuse.com
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July 30, 2020 at 05:19AM
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Upstate Medical injecting people with experimental Covid-19 vaccine for global study - syracuse.com
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