Pfizer head Albert Bourla said during an appearance on CBS’s “Face the Nation” that, based on the company’s studies, the efficacy of the vaccine candidate it is developing in partnership with BioNTech SE will be known by the end of next month.
“Yes, in our base case, we have quite the good—it’s more than 60 percent that we will know if the product works or not by the end of October,” Bourla told host Margaret Brennan. “But of course that doesn’t mean that it works. It means that we will know if it works.”
Bourla said that while the company isn’t certain whether Americans will be able to receive a CCP (Chinese Communist Party) virus vaccine before the new year, they are “preparing for it,” if its vaccine candidate is proven to be safe and effective by federal regulators such as the Food and Drug Administration (FDA).
“I cannot say what the FDA will do, but I think it is a likely scenario and we are preparing for it,” Bourla said, referring to potential vaccine distribution by the end of the year.
“We started already manufacturing and we have already manufactured hundreds of thousands of doses, so just in case we have a good study readout, conclusive and FDA, plus the advisory committee feels comfortable, we will be ready.”
Moderna and AstraZeneca are also conducting large-scale final-stage trials in the United States for COVID-19 vaccines.
Pfizer’s experimental vaccine, called BNT162b2, is a messenger RNA (mRNA), meaning that it relies on segments of genetic material delivered into cells to help stimulate an immune response.
While the technology can be used to fast-track the vaccine’s development over other methods, a setback of mRNA vaccines includes requiring to store and distribute them at extremely cold temperatures to prevent them from degrading.
Pfizer’s experimental vaccine, for example, must be stored and distributed at -94 degrees Fahrenheit, and must be stored in a refrigerator at below 46 degrees Fahrenheit for 24 hours once thawed.
These requirements “will make it very difficult for community clinics and local pharmacies to store and administer,” Centers for Disease Control and Prevention officials told the Advisory Committee on Immunization Practices (ACIP).
Pfizer has almost finished enrolling 30,000 people in its phase 3 vaccine trial. Bourla said the company is also working toward enrolling 44,000 people “to increase the diversity of the population” and to expand to more vulnerable populations.
“For example, we go to younger people. Right now, the study recruits from 18 to 85. Now we will go to 16 years old. Also, we will go to people with special conditions, chronic conditions like HIV patients,” the CEO said. “I think we should strive to have as more diverse population as possible.”
Bourla said that in the coming weeks, Pfizer will work on recruiting more people of color, including Latinos and African Americans, to take part in the trial. Currently, the study’s participants are 60 percent White and 40 percent people of color, with older volunteers making up 44 percent of the group, he added.
In July, the Trump administration announced that it will pay Pfizer close to $2 billion for a December delivery of 100 million doses of its COVID-19 vaccine, following FDA authorization or approval.
Health and Human Services (HHS) Secretary Alex Azar said at the time that under the agreement, the United States could purchase an additional 500 million doses. Pfizer and BioNTech said Americans will receive the vaccine at no cost.