(Reuters) – Britain on Wednesday became the first country in the world to approve the Pfizer-BioNTech COVID-19 vaccine for use and said that it will be rolled out from early next week.
Drugmaker Pfizer said last month final results from the late-stage trial of its COVID-19 vaccine showed it was 95% effective.
Pfizer said efficacy of the vaccine was consistent across age and ethnic groups, and there were no major side effects, a sign that the immunization could be employed broadly around the world.
Dozens of drugmakers and research groups have been racing to develop vaccines against COVID-19, which has killed more than 1.3 million people, shuttered businesses and left millions out of work around the globe.
Below are the main details of the vaccine and progress on supply deals and potential approvals:
TYPE
– 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 vaccines so far; Pfizer and BioNTech have already collaborated to develop influenza vaccines based on mRNA.
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.
PROTECTION DURATION
– BioNTech Chief Executive Officer Ugur Sahin said he was optimistic the immunization effect of the vaccine would last for a year. Scientists do not know how long the effect will last.
DATA AND REGULATORY TIMELINE
– The European Medicines Agency said on Tuesday 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.
– Canada could approve Pfizer’s vaccine “around December”, a senior official at Canada’s drug regulator said on Thursday.
– U.S. FDA granted the vaccine a ‘fast track’ status in mid-July.
– The European Medicines Agency said in November Pfizer and BioNTech had submitted data from large-scale trial of their potential COVID-19 vaccine for the agency’s rolling review, but had not yet applied for approval.
– 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. (bit.ly/3lfaaeF)
– Below are the different countries, in alphabetical order, where trials are being conducted or are planned:
REGION STATUS EXPECTED PRIMARY COMPLETION
Argentina Recruiting June 2021
Brazil Recruiting, June 2021 (reut.rs/3kdU2J1)
Late stage
Germany Recruiting/Ac June 2021
tive
Japan Not yet Nov. 2021 (reut.rs/32tz0Qr)
recruiting
South Recruiting June 2021
Africa
Turkey Recruiting June 2021
U.S. Recruiting/Ac June 2021 (bit.ly/35IlXfW)
tive
REGULATORY REVIEWS
(most recent first)
REGION SUBMISSI STATUS FORMAL FURTHER
ON/REVIE APPLICATION
W
Britain Emergenc Granted Approved
y Use temporary
authorization
Europe Emergenc Launched in Applied
y Use Dec
United Emergenc Launched in Applied
States y Use Nov
Canada Rolling Launched in Not
review Oct submitted
TARGETED DOSES
– Currently the companies expect to produce globally up to 50 million doses of the coronavirus vaccine in 2020, enough to protect 25 million people
– The companies expect to manufacture up to 1.3 billion doses in 2021.
SUPPLY DEALS
(most recent first)
REGION DOSES FUNDING EXPECTED FURTHER
DELIVERIES
Germany Unknown 375 mln euros Unknown
($446 mln)
Japan 120 mln Undisclosed First half of
2021
Europe Up to 300 Undisclosed To start by
mln end of 2020
Canada Unknown Undisclosed Unknown
U.S. 100 mln $1.95 bln for Unknown
plus 100 mln doses
option
for 500
mln more
UK Increased Undisclosed 10 mln by the
to 40 mln end of 2020
in Nov,
had
agreed 30
mln in
July
(Sources: Reuters reporting, press releases, clinical trial registries, World Health Organization)
($1 = 0.8405 euros)
Reporting by Pushkala Aripaka, Vishwadha Chander and Yadarisa Shabong in Bengaluru; Editing by Aurora Ellis and Shounak Dasgupta