Pharma giant Pfizer Inc. and its German partner BioNTech SE expect the covid vaccine (BNT162b2) they are jointly developing to be submitted for regulatory review as early as October. Subject to regulatory approval, the companies said that they currently plan to supply up to 100 million doses of coronavirus worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
Here are 10 updates on Pfizer covid vaccine:
1) Pfizer Inc. and BioNTech SE have also released additional data from an early-stage study.
2) The companies said the vaccine was well tolerated with mild to moderate fever in fewer than 20% of the participants. “Across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants,” the companies said.
3) The companies are continuing to analyze data from the Phase 1 trials in the U.S. and Germany, they said in a statement.
4) Pfizer’s vaccine candidate BNT162b2 candidate is already into global advanced trials in up to 30,000 participants that started in July 2020.
5) “The study is now actively enrolling in the U.S., Argentina and Brazil. Additional enrollment is planned in Germany, Turkey and South Africa. The study is an event-driven trial that is planned to enroll up to 30,000 participants between 18 and 85 years of age. The Phase 2/3 trial enrollment to date has exceeded 11,000 participants with a second dose underway,” the companies said
6) The US Food and Drug Administration is planning to hold an advisory panel meeting on October 22 to discuss Covid-19 vaccines.
7) This assumes significance as large-scale clinical trials of the leading vaccine candidates from Moderna Inc, Pfizer Inc and AstraZeneca Plc were launched in recent weeks.
8) Pfizer and BioNTech last month clinched a $2 billion deal to supply an initial 100 million doses of the vaccine to the U.S.
9) Meanwhile, Johnson & Johnson plans to test its Covid-19 vaccine in as many as 60,000 people, twice the number of other big trials being conducted in the U.S.
10) There are more than 160 Covid-19 vaccines being developed worldwide, and about 30 have entered human trials, according to the World Health Organization. (With Agency Inputs)