BRITAIN will start rolling out the COVID-19 vaccine developed by Pfizer and BioNTech on Tuesday, the first Western country to start vaccinating its general population in what was hailed as a decisive watershed in defeating the coronavirus.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency use approval last week to the vaccine, which needs complex and super-cold storage requirements.
Pfizer said last month 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:
- The vaccine candidate, 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°C (-94 F) or below.
Dosage and expected cost
- Based on the supply deal with the United States, the price tag amounts to US$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.
- BioNTech CEO 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.
- India is accelerating its review of Pfizer’s vaccine to for emergency use, a senior official said on Monday.
- Canadian health authorities could approve the vaccine within the next week, medical officials indicated on Thursday.
- The European Medicines Agency said on Dec 1, that if its experts have received enough data from Pfizer about the candidate vaccine against the coronavirus, the agency would complete its reviews by Dec 29.
- Pfizer and BioNTech submitted approval requests for their vaccine candidates to the European drugs regulator last week.
- US 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 US$750 mil 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 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. – Dec 8, 2020