Pfizer CEO says coronavirus vaccine could be given to Americans before year-end

Pfizer says its coronavirus vaccine being developed in partnership with BioNTech could be given to Americans before the end of this year if trials succeed.

Key Highlights

• Pfizer and BionTech say a conclusive result on the efficacy of their COVID-19 vaccine is likely by the end of October

• The companies sought FDA approval to expand the phase 3 clinical vaccine trial to up to 44,000 participants

• Worldwide, at least 921,097 people have now lost their lives to coronavirus disease since the outbreak emerged in China last December

Pfizer said its coronavirus vaccine being developed in partnership with BioNTech could be given to Americans before the end of this year if trials succeed and the jab is approved by the federal regulators. Albert Bourla, the chief executive of Phizer, said the US drugmaker should know if the experimental vaccine is effective by the end of October. The vaccine

By the end of October, Pfizer should have key data from its late-stage trial for the Food and Drug Administration (FDA), Bourla said during an interview with CBS’ “Face the Nation” on Sunday. He said the drugmaker is already manufacturing the vaccine.

“We started already manufacturing and we have already manufactured hundreds of thousands of doses, so just in case we have a good study readout, conclusive and FDA, plus the advisory committee feels comfortable, that we will be ready,” Bourla said.

Pfizer-BionTech COVID-19 vaccine is moving to the phase 3 clinical trial. On Saturday, the companies submitted an amended protocol to the FDA to expand the enrollment of their phase 3 vaccine trial to up to approximately 44,000 participants - from the originally planned 30,000.

The companies said in a press release that the proposed expansion would allow them to further increase trial population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV, Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data.

Pfizer and BionTech said they continue to expect that a conclusive readout on the efficacy of their vaccine is likely by the end of October. Pfizer- BionTech’s COVID-19 vaccine is one of several candidates that are currently in the late-stage testing. Meanwhile, AstraZeneca announced on Saturday that it would resume its phase 3 trial after temporarily halting global trials last week to investigate an unexplained illness in a woman participant.