|Pfizer Moves to Phase 3 COVID-19 Vaccine Trial|
|Staff Reports, |
12:01PM / Thursday, July 30, 2020
|Gov. Charlie Baker speaks at the research facility at Pfizer Andover that is working on a COVID-19 vaccine.|
Pfizer's Meg Ruesch says the company hopes to seek FDA authorization by October if the trials go well.
ANDOVER, Mass. — A vaccine against the novel coronavirus is being developed in Massachusetts and could be ready by the end of the year.
The Pfizer's Andover Clinical Manufacturing Facility has more than 100 scientists and engineers manufacturing a key component for a vaccine candidate for COVID-19.
"As we continue to fight this virus against COVID-19, a vaccine and a treatment can't come soon enough," said Gov. Charlie Baker during a visit to the research facility on Thursday. "Pfizer is developing one of the most advanced COVID-19 vaccines. Monday, they began Phase 3 of an experimental COVID-19 study that seeks to enroll 30,000 people."
Meg Ruesch, research and development site leader, said Pfizer and German biotech company BioNTech were collaborating on the mRNA vaccine.
"We have recently begun manufacturing a key component called the 'drug substance' for the COVID-19 investigational vaccine candidate," she said. "This manufacture is being undertaken at risk so that we are ready with this drug substance."
The mRNA vaccine introduces a set of genetic instructions for the cell to make a specific protein, said Ruesch, which in this case would be a SARS COVID protein to stimulate an immune response.
She said the company was working on scaling up to be able to manufacture 100 million doses by the end of the year and 1.3 billion by the end of 2021, if clinic trials are successful and regulatory authorization is granted by the U.S. Food and Drug Administration.
Based on the clinical trials that began on Monday, Ruesch said, the hope is to file as early as October for FDA authorization.
"It's all pretty remarkable, but not surprising that we have this type of research and development for this global pandemic happening right here in the commonwealth," said Baker. "A vaccine or treatment is critical to breaking the cycle of this insidious virus, and helping us all return to something more like regular normal all."
The governor also gave his regular update on the progress of the pandemic, noting Wednesday's seeming jump in positive cases of 356 when the numbers had been around 200 or less.
"That number appeared higher on Wednesday because there was a delay in reporting to [the Department of Public Health] from a big hospital group," he said, while also noting there is an increase in testing that may play a part. "DPH has assigned those positive test results to the appropriate day of the test retrospectively."
He also referred to community outbreaks that appeared to be linked to parties or locations not abiding by pandemic protocols of wearing masks and social distancing.
"Our goal, of course is to continue to drive down those numbers. But that's only possible with the vigilance and the discipline of every resident," the governor said, adding that "the reality of COVID-19 is it does not follow any rules. It can spread rapidly if people don't take the appropriate precautions. It's not taking the summer off. And we can't either if we want to continue to fight and contain the virus and keep our economy going."
He described the clusters as private and recreational activity and behavior during which people are not being as cautious as they should be.
"The employer community for the most part is maniacal about abiding by the guidance and the rules and the protocols that have been developed by the commonwealth," Baker said. "One of the points we're gonna try to make to people as we talk about some of these clusters in more detail, which we'll do soon, is to recognize and understand that the weather may be nice and we may have a fairly low positive test rate, but it is no time to let up on the basic tools that manage and support infection control."
The governor also took a moment to reinforce an announcement by the state's Department of Agricultural Resources on Tuesday about the mysterious seeds showing up in people's mailboxes across the country.
About 400 packages have been reported so far.
"We don't believe they're harmful to humans. Please don't plant them. And if you receive one of these packages, please report it to the Mass Department of Agriculture
," he said. "It's critical that they not be planted to protect our environment here in Massachusetts."