Published 16:48 IST, December 2nd 2020
MHRA says 'no corners cut' to approve Pfizer's COVID-19 vaccine, side effects 'very low'
The CEO of MHRA, Dr June Raine reiterated that the “first” priority is the safety of the citizens and assured safety of Pfizer-BioNTech COVID-19 vaccine.
After UK achieved a major milestone by becoming the first country in the world to provide formal authorisation of Pfizer-BioNTech COVID-19 vaccine in a record time, the CEO of MHRA, Dr June Raine reiterated that the “first” priority on immunisation is the safety of the citizens. The Medicines and Healthcare products Regulatory Agency (MHRA) on December 2 assured that the mRNA-based vaccine is 95 per cent effective “irrespective of age, sex or race”.
In the news briefing, it was also informed that the MHRA is working “hard” to deliver the immunisation to all the people starting from the ones most vulnerable people. MHRA said that the Pfizer-BioNTech COVID-19 vaccine is similar to other vaccines that are developed across the world “and the side effects are very low” with no specific precautions or tests required before inoculation. Raine expressed confidence in the approval and assured that the safety of the vaccine has been scrutinised with 'no stone being left unturned'.
“We have sought the advice of the Government's independent body, the Commission on Human Medicines who have critically assessed every piece of evidence for the Pfizer/BioNtech COVID19 vaccine,” British regulator CEO said before adding, “This vaccine (Pfizer-BioNTech COVID-19 vaccine) has only been approved because those strict tests have been done and complied with. Everyone can be absolutely confident that no corners whatsoever have been cut: UK's medicine regulator MHRA chief Dr June Raine”
MHRA credits its rolling review for fast approval
In the news conference, MHRA credited its rolling review process of the Pfizer-BioNTech COVID-19 vaccine that began a few months ago for its speedy approval. Since the process began in June, Raine explained that when companies announced the efficacy of its COVID-19 vaccine, they went ahead with the approval process.
Putting an end to all the questions regarding the safety of the immunisation develop by the US drugmaker with its German partner, Raine assured that the public can be ‘confident’ that all protocols matching the global standards were followed before the formal authorisation was provided in the country. She also hailed the “brilliance” of science before reiterating that the vaccine meets the 'rigorous high standards' of safety.
“The reason we are here today is the brilliance of science and the altruism of all those people who have enlisted in clinical trials to give us the tremendously robust data we have today...The public can be absolutely confident that the standards we have worked to are equivalent to those around the world,” said Judd Raine.
Updated 16:46 IST, December 2nd 2020