About 100 research groups around the world are pursuing vaccines against the coronavirus, with nearly a dozen in early stages of human trials or poised to start. Finding out for sure if any of the vaccines work in the real world comes next. (May 4)
After four months of working in labs, pharmaceutical giant Pfizer has started testing humans in the U.S. with a potential vaccine for the coronavirus — a serum that could be mass produced at Pfizer’s Kalamazoo site depending on its success.
The trial involves 360 volunteers across the country, and the first subjects have already been injected with their doses, Pfizer announced on Tuesday. These volunteers are healthy adults ages 18-55. Older adults ages 65-85 will only receive the vaccine if the doses given to the younger group show to be safe and effective.
“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,” Pfizer CEO and Chairman Albert Bourla said in announcing the trial.
Pfizer company logo at the company’s headquarters in New York. (Photo: Richard Drew, Associated Press)
The medical community, meanwhile, is watching both optimistically and cautiously as vaccines trials can take years, sometimes decades. And moving too quickly could prove to be dangerous, experts have cautioned, not to mention the unknown risks of infecting healthy people with a virus with no cure, as is being done in the current trial involving Pfizer.
“If we aren’t deliberate and careful, we could harm people. We have to remember that.” Mayo Clinic Dr. Gregory A. Poland told the Association of American Medical Colleges in late March. “All that has to happen is one significant harmful side effect and you have to start over.”
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As of Tuesday, eight candidate vaccines were in clinical evaluation, four in China, one in Britain, one in the European Union and two in the United States, according to the World Health Organization. None are yet at Phase III trials, in which a vaccine is tested on large numbers of people to see if it works, is safe or has side effects.
In the Pfizer trial, the pharmaceutical company developed the COVID-19 vaccine in partnership with German biotech company BioNTech, with another 200 patients enrolled in trials in Germany.
The potential vaccine works like this: It contains instructions on how to make viral proteins that trigger an immune response in coronavirus-infected patients.
Doses are currently being given at NYU Grossman School of Medicine and the University of Maryland School of Medicine. Volunteers will also soon be getting their doses at the University of Rochester Medical Center/Rochester Regional Health and Cincinnati Children’s Hospital Medical Center.
According to Pfizer, the trial includes four vaccine candidates, each representing a different combination of mRNA format and target antigen. This allows for the evaluation of the various mRNA candidates simultaneously, in order to identify the safest and potentially most effective candidate in a greater number of volunteers.
“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.
During the clinical trial, BioNTech will provide the vaccine from its manufacturing labs in Europe. Should the trial prove successful, Pfizer hopes to use its three U.S. sites to mass produce the vaccine, including its facility in Kalamazoo.
The goal and hope is to produce millions of vaccine doses in 2020 and hundreds of millions more in 2021.
Pfizer-owned sites in Michigan, Massachusetts and Belgium have already been identified as manufacturing centers for COVID-19 vaccine production, with more sites to be selected.
The Food and Drug Administration, which regulates vaccines, will have the final say and is reviewing the scientific, ethical and feasibility questions raised by the rapid development of any potential COVID-19 vaccine.
A bipartisan group of 35 lawmakers on April 20 sent a letter to the heads of the U.S. Health and Human Services and the Food and Drug Administration calling for “a more rapid testing and approval process.”
“Every week of delay in the deployment of a vaccine to the seven billion humans on Earth will cost thousands of lives,” the letter said. “Justifiable risks may be taken.”
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