GROTON, CT (WFSB) - The U.S. government placed an order for what could amount to 600 million doses of a potential COVID-19 vaccine.
Pfizer announced the agreement, under the White House's fast tracking initiative "Operation Warp Speed," on Wednesday morning.
“Not the pot of gold at the end of the rainbow, but gives us hope that science is going to lead the way past this," said Gov. Ned Lamont during a news conference Wednesday morning at the drug maker's facility in Groton.
John Burkhardt, Pfizer vice president of Drug Safety, said early results are promising, and they are now moving to a clinical phase with a goal of testing 20,000 to 30,000 patients.
Pfizer was granted a ‘fast track,’ meaning they can communication with regulators in real time. Pfizer must still show its vaccine is safe.
“The short answer is we just do not compromise safety,” Burkhardt said.
Lamont said he was proud of the work being done in Connecticut on the virus front.
"Pfizer's one of the lead horses in this race right now, there might be several winners. We need several winners," Lamont said.
He addressed Wednesday's announcement during a news conference:
The federal government placed an initial order of 100 million doses for $1.95 billion. It can then acquire up to 500 million more doses.
“We’ve been committed to making the impossible possible by working tirelessly to develop and produce in record time a safe and effective vaccine to help bring an end to this global health crisis,” said Dr. Albert Bourla, Pfizer chairman and CEO. “We made the early decision to begin clinical work and large-scale manufacturing at our own risk to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted. We are honored to be a part of this effort to provide Americans access to protection from this deadly virus.”
Pfizer said Americans would receive the vaccine for free, which would be consistent with U.S. government’s commitment for free access for COVID-19 vaccines.
Early results show the vaccine would need two doses, given three weeks apart. Burkhardt said there are a lot of unanswered questions, including how long that immunity lasts, and how many people need a vaccine to reach herd immunity -- a threshold where even people without the vaccine are protected.
“I think we're just learning so much about this virus, so much about the infection,” he said.
Pfizer is also working on a treatment for patients infected by coronavirus. That could be available in hospitals beginning in October.
The drug maker, which partnered with the German company BioNTech for the vaccine, said it remains on track to begin an anticipated "Phase 2b/3" safety and efficacy trial later this month. It could seek regulatory review as early as October 2020.
The global manufacturing of up to 100 million doses could happen by the end of 2020 with potentially more than 1.3 billion doses by the end of 2021.
While the announcement shows progress, Gov. Lamont said people need to remain vigilant about wearing masks and keeping social distance.
“Expanding Operation Warp Speed’s diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” said Department of Health and Human Services Secretary Alex Azar. “Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of this vaccine to the American people.”
The "BNT162" program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world. BioNTech is the market authorization holder worldwide and will hold all trademarks for the potential product. Both collaborators are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making.