Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time.
Pfizer started human trials Tuesday in New York and other states in its race to develop a vaccine for COVID-19.
The pharmaceutical giant, including its research and development team in Rockland County, announced people were receiving doses of trial vaccines at NYU Grossman School of Medicine in Manhattan and the University of Maryland School of Medicine.
It is seeking a way to block the spread of the novel coranavirus, which causes the COVID-19 respiratory illness.
The University of Rochester Medical Center and Rochester Regional Health will begin enrollment soon for the vaccine trials at Rochester Regional Health, Pfizer officials said in a release.
Cincinnati Children’s Hospital Medical Center will also be participating.
The trial in the U.S., which is part of a partnership with the German biotech company BioNTech, will enroll up to 360 healthy subjects into two age cohorts, ages 18 to 55 and 65 to 85.
It is part of a global development program that included trials completed in Germany last week, Pfizer officials said.
Serum samples are processed in an automation lab at Pfizer Vaccine Clinical Research in Pearl River Sept. 18, 2017. (Photo: Peter Carr/The Journal News)
In the Rochester area, the randomized placebo-controlled clinical trial will recruit 90 people who have not been infected with COVID-19 and will evaluate the safety, tolerability, and immunogenicity of up to four variations of the vaccine, according to a statement issued by University of Rochester Medical Center, or URMC.
The study is the only active COVID-19 vaccine clinical trial in upstate New York, URMC officials said.
“COVID-19 is a highly infectious and deadly disease and there is a tremendous urgency to develop a vaccine that will help us fight this global pandemic,” said Dr. Edward Walsh, a URMC professor and member of the Rochester General Hospital infectious diseases unit.
“While the scientific and medical community are moving at an unprecedented speed to advance vaccine candidates, it is critical that this effort be conducted in a rigorous manner that evaluates the safety and efficacy of potential vaccines,” Walsh said, adding the new clinical trial is “the first step in that process.”
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Trial COVID-19 vaccine production underway despite unknownsBuy Photo
Serum samples are processed at Pfizer Vaccine Clinical Research in Pearl River Sept. 18, 2017. (Photo: Peter Carr/The Journal News)
While there are about 100 potential COVID-19 vaccines in various stages of development, the Pfizer and BioNTech experimental vaccine is one of only seven that have advanced to human clinical trials worldwide, URMC said.
In anticipation of a successful clinical development program, Pfizer and BioNTech are working to scale up production of a COVID-19 vaccine for global supply, the companies said.
Pfizer plans to activate its manufacturing network and invest in an effort to produce an approved COVID-19 vaccine as quickly as possible for those most in need around the world, the company said.
The program should allow production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021.
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Pfizer-owned sites in Massachusetts, Michigan and Missouri have been identified as manufacturing centers for COVID-19 vaccine production, with more sites to be selected.
Pfizer’s manufacturing site in Puurs, Belgium has also been picked for producing the vaccine.
It is one of several projects taking the leap to ramp up production before knowing if a vaccine works, a crucial element in getting it to market faster to curb the COVID-19 pandemic, USA TODAY reported.
Pharmaceutical giant Johnson & Johnson, for instance, has begun work to meet its promise of producing a billion doses of its vaccine, even with human trials months away, said Macaya Douoguih, the company’s head of clinical development of vaccines.
The move is risky financially, but it could shave a year or more off of the process.
“It’s absolutely unprecedented, and it shows the strong commitment by our industry to eradicate COVID-19 and get any future vaccine to patients as quickly as possible, despite the incredible risks involved,” said Phyllis Arthur, vice president of Infectious Diseases & Diagnostics Policy at the biotechnology industry group BIO.
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David Robinson is the state health care reporter for the USA TODAY Network New York. He can be reached at email@example.com and followed on Twitter: @DrobinsonLoHud
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