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Factbox: Development of Pfizer-BioNTech coronavirus vaccine

(Reuters) - U.S. drugmaker Pfizer PFE.N and German partner BioNTech 22UAy.F on Monday became the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine.

FILE PHOTO: Pfizer signs are seen at the third China International Import Expo (CIIE) in Shanghai, China November 5, 2020. REUTERS/Aly Song

The companies said their 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 emergency use authorization in the U.S. of the vaccine for people aged 16 to 85 years 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.

The data showed vaccines could fundamentally change the course of the pandemic. Dozens of drugmakers and research groups around the have been racing to develop vaccines against COVID-19, which has 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 although that was not certain yet.

DATA AND REGULATORY TIMELINE

- Health experts have cautioned that a vaccine can take 12-18 months to be developed and they still needed to see full trial data, which have yet to be peer-reviewed or published in a medical journal.

- U.S. FDA granted the vaccine a ‘fast track’ status in mid-July and the vaccine showed promise in a second early trial.

- The company has said it could file for emergency approval in the United States in November.

- The European Union drug regulator said on Monday it had not yet received results from large-scale trials on the vaccine.

- 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 aims to enroll about 44,000 volunteers. (bit.ly/3lfaaeF)

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.

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

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

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