The Pfizer world headquarters stands in Midtown Manhattan in New York City.
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Pfizer and German biotech firm BioNTech announced Saturday that they have submitted a proposal to the U.S. Food and Drug Administration to expand the phase three trial of its coronavirus vaccine to include up to 44,000 participants, a significant increase from its previous target of 30,000.
The companies, which are developing the vaccine together, said in a statement that the trial is proceeding as planned and they expect to have enrolled 30,000 participants by next week.
“The proposed expansion would allow the companies to further increase trial population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data,” the companies said.
Pfizer CEO Albert Bourla said earlier this month that the pharmaceutical company could have results from its late-stage trial as soon as October. On Saturday, the companies reiterated the possibility that they could have data reflecting whether the vaccine is effective or not by the end of October. However, it could take longer to collect enough data to determine whether the vaccine is safe, because it will take months of follow-up work to determine what kind of side effects, if any, the vaccine may cause.
“The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing,” the companies said. “As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October.”
—CNBC’s Meg Tirrell contributed to this report.