Vaccine’s early shot
Pfizer bids for emergency clearance in U.S.
Pfizer took its best shot Friday at supplying the first ever COVID-19 vaccine to the U.S. market, asking regulators for emergency clearance of its twodose treatment in a possible milestone moment.
The application from the pharmaceutical giant and its German partner BioNTech was the first of its kind submitted to the FDA for rush authorization of a coronavirus inoculation amid the pandemic.
If the application is approved, Pfizer could begin delivering a limited supply as early as next month for rationed distribution to health care workers, elderly patients and people with underlying medical conditions.
A second wave of the vaccine would later become available to essential workers, teachers and those in homeless shelters and prisons, with children and young adults next.
The request followed two days after Pfizer and BioNTech said that data from Phase 3 clinical trials confirmed the vaccine was safe and 95% effective at preventing mild to severe COVID-19 infections.
“Our work to deliver a safe and effective vaccine has never been more urgent as we continue to see an alarming rise in the number of cases of COVID-19 globally,” Pfizer CEO Albert Bourla said in a statement.
“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.”
Pfizer and BioNTech also announced Friday that they “initiated rolling submissions” with medical regulators in Europe and the United Kingdom, adding that they planned to “submit applications to other regulatory agencies worldwide in the coming days.”
Pfizer enrolled nearly 44,000 people across the U.S. and five other countries in its study, 170 of whom have come down with coronavirus since clinical trials of the treatment began in July.
Only eight of those infected received the vaccine while the other 162 were given the placebo, indicating the efficacy rate of about 95%.
Globally, Pfizer has estimated it could have 50 million doses available the end of the year.
About 25 million doses may become available for U.S. use in December, 30 million in January and 35 million more in February and March. Recipients will need two doses, three weeks apart.
The U.S death toll surpassed a quarter-million people earlier this week, and deaths are hitting their highest level since May. The coronavirus has killed more than 1.3 million people globally, according to Johns Hopkins University.