The United Kingdom (UK) may become the first country to approve Pfizer Inc and BioNTech SE's COVID-19 vaccine candidate as the companies surge ahead with their production plans before the official rollout across the world.
As the coronavirus cases continue to rise, the UK plans to move quickly into the approval process, and clearance to Pfizer and BioNTech SE could come by next week, Bloomberg reported, citing unnamed sources.
So far, only China and Russia have approved the COVID-19 vaccines for general populace. The UK government expects the rollout of the vaccine before Christmas by skipping EU regulators as it prepares for Brexit transitions. The UK's drug regulator, Medicines and Healthcare Products Regulatory Agency, has said it will process clearance for Pfizer vaccine in "the shortest time possible" without compromising on safety.
In the US too, Pfizer has applied for an emergency use authorisation for its COVID-19 vaccine after collecting the safety data necessary to apply to the US Food and Drug Administration, CEO Albert Bourla said.
The two companies (Pfizer and BioNTech) found their vaccine candidate - BNT162b2 - to be 95 per cent effective against COVID-19. During the early analysis, the vaccine had shown 90 per cent efficacy but the final analysis involving 170 participants showed 95 per cent efficacy. The announcement by Pfizer came after another US pharma company, Moderna Inc, claimed its vaccine was 94.5 per cent effective against COVID-19 earlier this month.
Notably, Pfizer, BioNTech, Moderna, and Russia's Sputnik V are the only vaccines that have claimed over 90 per cent efficacy of their respective candidates so far. While Russia had already rolled out Sputnik V for the masses in August, the recently announced data results on the efficacy of Moderna, Pfizer, and BioNTech's vaccine raise high hopes.
The Phase-3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. Around 42 per cent of global participants and 30 per cent of US participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of US participants are 56-85 years of age.