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In a major development, the United Kingdom on Wednesday became the first nation to approve the Pfizer-BioNTech vaccination for public use. The COVID-19 mRNA vaccine candidate will be rolled out from next week, informed UK health secretary Matt Hancock. The complete delivery fulfilment is expected by the end of 2021.
British regulator Medicines and Healthcare products Regulatory Agency (MHRA) granted a temporary authorization on the emergency supply of the jab. The decision was based on a rolling submission from clinical studies that demonstrated a 95 per cent efficacy.
US-based pharma giant Pfizer (NYSE: PFE, PFE:US) and its German research partner BioNTech SE (NASDAQ: BNTX, BNTSX:US) had shared the analysis from Phase 3 trials last month. The organizations claimed that their vaccine for SARS-CoV-2, the virus that causes the coronavirus, displayed consistent effectiveness across age, gender, race and ethnic demographics.
Both the companies are prepared to release the first doses of the vaccine in UK markets immediately, said a statement from drug maker Pfizer. They had earlier signed deals to supply 40 million doses in stages to the UK by 2020-2021.
Authorization decisions from the US Food and Drug Administration (FDA) and EU European Medicines Agency (EMA) are also expected in December.
Britain's emergency use authorization marks a historic moment in the fight against the devasting pandemic, Pfizer said in a statement.
The MHRA will now decide which priority groups will receive the first dose of the vaccine such as healthcare staff, elderly, home care residents, etc.
The Pfizer- BioNTech vaccine needs to be stored at -70°C (-94°F) and requires specialized freezers. However, Pfizer has vast expertise in cold-chain shipping and an established infrastructure to supply the vaccines.
As per preliminary projections, the combined manufacturing network of Pfizer and BioNTech can supply up to 50 million vaccine doses in 2020 and nearly 1.3 billion doses by 2021.