Pfizer Inc and BioNTech SE have proposed to the authorities to expand their Phase 3 COVID-19 vaccine trial to about 44,000 participants while increasing the diversity of the trial population. The initial target figure for the trial of the covid vaccine that both the companies are jointly developing was up to 30,000 participants, which the companies said they expect to reach by next week.
If the study is successful, the companies could submit the vaccine for regulatory approval as early as October, Pfizer 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,” the companies added in the joint statement on Saturday.
“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,” Pfizer said in a statement.
The vaccine candidate utilizes 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.
Oxford University announced on Saturday it was resuming a trial for a coronavirus vaccine it is developing with pharmaceutical company AstraZeneca, a move that comes days after the study was suspended following a reported side-effect in a U.K. patient.
In a statement, the university confirmed the restart across all of its U.K. clinical trial sites after regulators gave the go-ahead following the pause on Sunday.
“The independent review process has concluded and following the recommendations of both the independent safety review committee and the U.K. regulator, the MHRA, the trials will recommence in the U.K.,” it said. (With Agency Inputs)