Margaret Keenan, a 90-year-old grandmother from Britain, became the first person in the world to receive the Pfizer vaccine outside of a trial following its rapid clinical approval on Dec. 2.
Pfizer said in November final results from the late-stage trial of its COVID-19 vaccine showed it was 95% effective.
Below are the main details of the vaccine, progress on supply deals and potential approvals:
TYPE
- The vaccine, called BNT162b2, is based on messenger RNA (mRNA) technology, which uses a chemical messenger to instruct cells to make proteins that mimic the outer surface of the new coronavirus, thereby creating immunity.
- mRNA relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines.
- The new technology has not been approved for any other vaccines so far; Pfizer and BioNTech have already collaborated to develop influenza vaccines based on mRNA.
- The vaccine needs to be kept at minus 70 degrees Celsius (-94 F) or below
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.
- Pfizer has said it will not charge other developed countries a lower price for the vaccine than what the United States will pay.
PROTECTION DURATION
- BioNTech Chief Executive Officer Ugur Sahin has said he is optimistic the immunization effect of the vaccine would last for a year. Scientists do not know how long the effect will last.
PENDING APPROVALS
- India is accelerating its review of Pfizer's vaccine to for emergency use, a senior official said on Dec.7.
- Canadian health authorities could approve the vaccine within the next week, medical officials indicated on Dec. 3.
- The European Medicines Agency said on Dec. 1 that if its experts have received enough data from Pfizer about the vaccine, the agency will complete its reviews by Dec. 29.
- Pfizer and BioNTech submitted approval requests for their vaccine candidates to the European drugs regulator on Dec. 1.
- U.S. FDA granted the vaccine a 'fast track' status in mid-July, and is expected to give more indications of its use this week.
- Pfizer signed a deal worth up to $750 million with BioNTech in March to co-develop the potential vaccine, and it ran clinical trials in April.
- Testing of the vaccine began in the United States in May after trials started in Germany the previous month.
TRIALS
- Trials are continuing globally in 154 locations, including in Germany, Japan, Brazil and in several locations within the United States in participants aged 12 years and older. The global Phase I/II/III trials enrolled about 44,000 volunteers.
