New Delhi: The Food and Drug Administration of the US (FDA) on Tuesday said that “In BioNTech – Pfizer’s coronavirus vaccine – there are no safety concerns, but it is 95 per cent protective against Covid-19.”
The FDA review comes in light before Thursday’s meeting where independent experts in the USA will check the details and vote on whether to recommend the use of vaccines.
The FDA also follows the guidance of groups of expert and the USA is in Line to Approve Pfizer Product for Emergency-Use.
In its Latest review – the FDA said that “while the vaccine prevents symptomatic cases – it is not clear if it keeps the disease from being transmitted and that highlights a major unknown. How effective they will be in stemming the spread of coronavirus at a population level. Data from 38000 US trial participants suggest a favourable safety profile with no specific safety concerns identified that would preclude issuance of emergency use.”
The US is the most affected country in the world and reports 15.2 million cases so far and claims more than 2.86 lakh deaths.
Meanwhile, the United Kingdom (UK) has started its vaccination drive from December 8 and the UK is also planning to test the Pfizer shot in combination with another jab from AstraZeneca and Oxford University.
The UK Vaccine Taskforce said that “Studies aimed at determining if using the two vaccines together can enhance immunity are planned for next year.”
Approval for the Oxford shot is likely by year-end and setting the stage for the combination trials, which will involve initial shots from one vaccine.
_Vinayak