Pfizer Inc and BioNTech SE have proposed to authorities to expand their Phase 3 COVID-19 vaccine trial to approximately 44,000 participants while increasing the diversity of the trial population. The initial target figure for the covid vaccine trial that the two companies are jointly developing was up to 30,000 participants, which the companies said they hope to hit next week.
If the study is successful, companies could submit the vaccine for regulatory approval starting in October, Pfizer said.
“As indicated above, based on current infection rates, the 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 proposed expansion would allow companies to further increase the diversity of the test population, including adolescents up to 16 years old and people with chronic and stable HIV (human immunodeficiency virus), hepatitis C or hepatitis B, as well as provide additional safety and efficacy data, “Pfizer said in a statement.
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.
The University of Oxford announced Saturday that 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 UK patient. United.
In a statement, the university confirmed the restart at all of its UK clinical trial sites after regulators gave the go-ahead following Sunday’s hiatus.
“The independent review process has concluded and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA, trials will resume in the UK,” he said. (With contributions from the agency)
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