Pfizer Inc and BioNTech SE proposed on Saturday to the U.S. Food and Drug Administration (FDA) to expand Phase III of its COVID-19 vaccine candidate to about 44,000 participants while increasing the diversity of the population involved in the study.
The initial target number for the test was up to 30,000 participants, which the companies said they hope to hit next week.
The proposed expansion would also allow companies to enroll people up to 16 years old and people with chronic stable HIV, hepatitis C and hepatitis B, they added.
Drug makers rushing to develop a coronavirus vaccine Safe and Effective pledged in July to ensure that their larger clinical trials would include diverse groups of volunteers.
“Diversity in clinical trials is a priority for Pfizer and it is fundamental since the COVID-19 disproportionately impacts communities of color in the United States, ”said the business director of PfizerJohn Young at a US Congressional hearing in July.
If the study is successful, companies could submit the vaccine for your regulatory approval starting in October, putting them on track to supply up to 100 million doses by the end of 2020 and 1.3 billion by the end of 2021.
“As indicated above, based on current infection rates, companies continue to hope that a conclusive reading on efficacy is likely to be obtained by the end of October,” the companies added in the joint statement Saturday.
The vaccine candidate uses chemical messenger RNA to mimic the surface of the coronavirus and teach the immune system to recognize and neutralize it. Although the technology has been around for years, there has never been an approved messenger RNA (mRNA) vaccine.