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Factbox: Development of Pfizer-BioNTech coronavirus vaccine

(Reuters) - Drugmaker Pfizer said on Wednesday that final results from the late-stage trial of its COVID-19 vaccine showed it was 95% effective, and that it would apply for emergency U.S. authorization within days.

FILE PHOTO: Biontech and Pfizer logos are seen on display in this illustration taken November 10, 2020. REUTERS/Dado Ruvic/Illustration

Pfizer said efficacy of the vaccine was consistent across age and ethnic groups, and that there were no major side effects, a sign that the immunization could be employed broadly around the world.

The final analysis of the vaccine from U.S. company Pfizer and German partner BioNTech comes one week after initial results from the trial showed the vaccine was more than 90% effective.

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 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

- U.S. FDA granted the vaccine a ‘fast track’ status in mid-July.

- The European Medicines Agency said on Wednesday that 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, Late stage June 2021 (reut.rs/3kdU2J1)

Germany Recruiting/Active June 2021

Japan Not yet recruiting Nov. 2021 (reut.rs/32tz0Qr)

South Africa Recruiting June 2021

Turkey Recruiting June 2021

U.S. Recruiting/Active June 2021 (bit.ly/35IlXfW)

REGULATORY REVIEWS

(most recent first)

REGION SUBMISSION/REVIEW STATUS FORMAL FURTHER

APPLICATION

Britain Rolling Review Launched Not submitted

in late

Oct

Canada Rolling review Launched Not submitted

in Oct

Europe Rolling review Launched Not submitted

in Oct

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 million Unknown

euros ($446

million)

Japan 120 million Undisclosed First half of

2021

Europe Up to 300 million Undisclosed To start by

end of 2020

Canada Unknown Undisclosed Unknown

U.S. 100 million plus $1.95 billion Unknown

option for 500 million for 100

more million doses

UK Increased to 40 Undisclosed 10 million by

million in Nov., had the end of

agreed 30 million in 2020

July

(Sources: Reuters reporting, press releases, clinical trial registries, World Health Organization)

($1 = 0.8405 euros)

Reporting by Pushkala Aripaka and Vishwadha Chander in Bengaluru; Editing by Josephine Mason, Carmel Crimmins and Aurora Ellis

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