New Delhi: The review of Oxford University’s Covid-19 vaccine candidate is “ongoing”, said the UK’s top drug regulatory agency Monday.
The UK became the first country to approve and roll out Pfizer’s Covid-19 vaccines. It has already begun the first Covid-19 vaccination programme in the world, with vaccine shots of the Pfizer/BioNTech product being given to elderly people and healthcare workers.
Now, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is reportedly planning to approve Oxford University-AstraZeneca’s vaccine before the end of this year.
The move is likely to boost the vaccine candidate’s chances of getting the necessary approvals in India.
“Our rolling review of the Oxford/AstraZeneca Covid-19 vaccine is ongoing,” an MHRA spokesperson told ThePrint in an emailed reply.
The agency further added that “no vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met”.
“Our process for approving vaccines is designed to make sure that any Covid-19 vaccine authorised meets the expected high standards of safety, quality and effectiveness,” the spokesperson said, adding that “any vaccine must undergo robust clinical trials in line with international standards, with oversight provided by the MHRA…”
The MHRA, which is responsible for ensuring the availability of safe and efficacious medicines, medical devices and vaccines in the country, said the agency looks at how the vaccine protects people from Covid-19 and the level of protection it provides. “The data on product stability and storage conditions” is also being seen.
“Information on each step of manufacturing and on the controls used to make sure that each batch of vaccine is consistently of good quality (is also considered). And there are many others,” the spokesperson said.
Also read: Govt expert panel asks Serum Institute to revise protocol for trial of Novavax Covid vaccine
‘It’s not just us that’s involved in approval of vaccines’
Replying to a question of what steps the agency is following to approve the vaccines, the MHRA spokesperson said, “No stone should be left unturned. It’s not just us that’s involved.”
“Our scientific and clinical experts look at the safety, quality and effectiveness (of) data for a vaccine. We robustly and thoroughly review it with scientific rigour. We pore over pages of information and data, looking at lots of things — from the laboratory studies to the clinical trials, and more.”
After all these, the agency said, “it seeks advice from the government’s independent advisory body, the Commission on Human Medicines.”
“They critically assess the data too before advising the UK government on the safety, quality and effectiveness of any vaccine.”
“We involve members of the public — they are instrumental too in these assessments. They freely give their views and opinions and we listen. They play a crucial role in the assessment and decision-making process. And that is so important.”
MHRA’s go-ahead may boost chances of approvals in India
The trials for the Oxford vaccine in India are being carried out by the Pune-based Serum Institute of India (SII) at multiple sites, and the company has also applied for its emergency authorisation use. The application was reviewed by the Indian regulator and is pending for approval.
If the UK approves the product, it may help the vaccine candidate receive approval from Indian regulators as well.
“The CDSCO (Central Drugs Standard Control Organisation) may clear the SII’s Oxford vaccine within a couple of days of MHRA’s green nod to the vaccine candidate in the UK,” said a source from CDSCO, the country’s apex health regulatory agency.
“The states have been informed to keep the vaccinators ready expecting the immunisation program to kick start from January,” the source added.
Also read: UK likely to approve Oxford Covid vaccine by year-end, may help boost its chances in India