The Pfizer-BioNTech vaccine has now proved 95% effective in preventing coronavirus and has met the safety criteria needed for emergency authorisation, the firms have said.
Pfizer and BioNTech say they plan to submit the COVID-19 vaccine to the US regulator for emergency use approval “within days” before sharing with others around the world.
The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), is poised to fast-track authorisation of the vaccine, which could mean it is rolled out to priority groups from mid-December.
Final efficacy analysis of the jab showed 95% were protected from the virus within 28 days of the first dose – up from when results of Phase 3 trials were shared last week.
It also proved 94% effective among adults over the age of 65 – who are generally more vulnerable.
“No serious safety concerns” were reported in the analysis, with only 2% of the 43,000 involved reporting a headache and 3.7% reporting fatigue, the companies said.
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