(Reuters) - U.S. drugmaker Pfizer and German partner BioNTech on Monday became the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine.
The companies said the vaccine was more than 90% effective and they have so far found no serious safety concerns, priming it for possible speedy regulatory approvals.
Pfizer expects to seek broad U.S. emergency use authorisation in the U.S. of the vaccine for people aged 16 to 85 in coming weeks.
To do so, it will need to have collected two months of safety follow-up data on around half of the study’s roughly 44,000 participants, expected in late November.
Pfizer and BioNTech, which already collaborate to develop mRNA-based vaccines for influenza, currently expect to produce globally up to 50 million doses of the coronavirus vaccine in 2020 - enough to protect 25 million people - and up to 1.3 billion doses in 2021.
Below are the main details of the vaccine and Pfizer’s progress on supply deals and potential approvals:
- The vaccine candidate, called BNT162b2, is based on messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines
DOSAGE AND EXPECTED COST
- Based on the supply deal with the United States, the price tag amounts to $39 for what is likely to be a two-dose course of treatment.
- Pfizer has said it will not charge other developed countries a lower price for the vaccine than what the United States will pay.
- BioNTech Chief Executive Ugur Sahin said he was optimistic the immunisation effect of the vaccine would last for a year although that was not certain yet.
DATA AND REGULATORY TIMELINE
- U.S. FDA granted the vaccine a ‘fast track’ status in mid-July and the vaccine showed promise in second early trial.
- The company has said it could file for emergency approval in the United States in November.
- Pfizer signed a deal worth up to $750 million with BioNTech in March to co-develop the potential vaccine, and target clinical trials in April.
- Testing of vaccine began in the United States in May after trials started in Germany the previous month.
Reporting by Pushkala Aripaka and Vishwadha Chander in Bengaluru; Editing by Josephine Mason and Carmel Crimmins
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