ANDOVER, Mass. (WPRI) — Pfizer could file for approval for its potential COVID-19 vaccine as early as October, according to Dr. Meg Ruesch, the pharmaceutical company’s vice president of worldwide research and development.
While authorization of the treatment is dependent on a review by the U.S. Food and Drug Administration (FDA) and clinical data, Pfizer hopes to win approval by the end of the year, Ruesch said Thursday during a news conference with Gov. Charlie Baker at the company’s Andover, Mass., facility.
“As we continue to fight against COVID-19, a vaccine and a treatment can’t come soon enough,” Baker said. “Pfizer is developing one of the most advanced COVID-19 vaccines.”
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Earlier this month, Pfizer reported positive findings from the preliminary trials and on Monday, announced the study would be moving ahead to the next phase.
“Clinical data for the vaccine has been encouraging so far,” Ruesch said.
The vaccine is manufactured in Andover, then purified and shipped as a frozen solution for further manufacturing and to be filled into vials, according to Ruesch.
She said they are working to manufacture as much of the vaccine as possible, so it will be ready if the clinical trials are successful and it wins FDA approval.
“We have the potential, subject to technical success and regulatory authorization, to manufacture up to 100 million vaccine doses by the end of the year and up to 1.3 billion doses by the end of 2021,” she said.
Reusch said scientists are also studying the production process in an effort to make larger batches and implement testing protocols, but reassured that the quality will not be compromised.
“The review process will be rigorous and in collaboration with the FDA,” she added.
Pfizer is seeking 30,000 people for their clinical trial, mostly in places that have seen high COVID-19 rates. People involved will receive two injections, three weeks apart.
The Massachusetts Department of Public Health reported 304 new confirmed cases and 15 new deaths on Thursday.
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