Covid-19 vaccine: Pfizer, BioNTech to expand Phase 3 trials, expect results by October

Pfizer Inc. and BioNTech SE on Saturday announced that they are planning to expand the Phase 3 trials for their experimental Covid-19 vaccine.

The companies have submitted an amended protocol for their trials to the US Food and Drug Administration. They plan to enrol up to 44,000 participants in the expanded trials “which also allows for the enrollment of new populations.”

The companies are expecting the results of the trials to be out by October 2020.

“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 said in a joint statement.

The enrollment trial is going as planned, expecting to meet its initial target of up to 30,000 participants 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.

The vaccine candidate BNT162b2 aims to train the immune system to recognize and neutralize the novel coronavirus by using a chemical messenger RNA to mimic the surface of the virus. If the trials are successful, Pfizer and BioNTech expect to supply 100 million doses of its vaccine globally by 2020.

“Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021,” the companies had said in a statement earlier this week.

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