India may wait for UK nod before Oxford vaccine call
https://www.hindustantimes.com/india-ne ... aSAUN.html
India may need to wait till authorities in the United Kingdom clear the coronavirus vaccine developed by University of Oxford and AstraZeneca as experts from India’s drug regulators sought this data before proceeding with an assessment of their own, according to details of discussions at the first meeting to review options for the country.
The vaccine candidate, being manufactured and tested in India by the Serum Institute of India (SII), is among three that have applied for an emergency approval. The others include Pfizer-BioNTech’s mRNA vaccine that last week became the first to be approved following late-stage trials anywhere in the world, and an indigenously developed shot called Covaxin by Hyderabad’s Bharat Biotech.
“After detailed deliberation, the committee recommended that the firm should submit the following data/information for further review: 1. Updated safety data of the Phase II/III clinical trial in the country; 2. Immunogenicity data from the clinical trial in UK and India; (and) 3. The outcome of the assessment of UK-MHRA for grant of EUA (emergency use authorisation)”, according to recommendations by the Central Drugs Standard Control Organisation (CDSCO)’s Subject Expert Committee (SEC).
HT has seen the document.
The SEC’s assessments will be sent as recommendations to the CDSCO, which will take the final call.
The committee also asked Bharat Biotech, which presented
Phase I/2 data, to present data from its Phase 3 trials. “After detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing Phase III clinical trial in the country for further consideration,” the committee recommended.
Wednesday’s meeting marks the formal beginning of assessments of Covid-19 vaccine candidates that may have derived enough data to judge its safety and efficacy. This data is usually available only in Phase 3 studies and once enough infections are recorded to reach a particular checkpoint.
At present, Bharat Biotech’s trial is far from this milestone – its enrolment began on November 11 and protective antibodies develop only 42 days from the date of the first shot.
The third manufacturer, Pfizer, sought more time to appear before the committee. Pfizer’s vaccine candidate, developed in partnership with Germany’s BioNTech, was approved by UK’s MHRA last week. But on Wednesday, health authorities in the UK advised caution after two people given the dose developed non-serious allergic reactions.
“Pfizer sought and was granted some more time before it could make a presentation before the committee. The other two manufacturers explained the data gathered so far and were asked to provide some additional information, which they have promised to submit,” said an official from the health ministry. A second official in the government, who asked not to be named, said Pfizer has been told they can approach whenever they are ready. The next SEC meeting is likely to be scheduled once the two manufacturers submit their data.
The second official quoted above, who asked not to be named, said the committee has already received “thousands of pages of data” and a decision is likely “very soon” once the information sought is provided.
“The panel, comprising of domain experts who are not government officials, sought additional clarifications from both manufacturers which are technical and scientific in nature. Both SII and Bharat Biotech have promised to come back with the additional clarifications. The next meeting is expected to happen as soon as they are ready with the information,” this person said, asking not to be named.
Oxford University’s Sarah Gilbert and UK’s Medicines and Healthcare products Regulatory Agency (MHRA) chief executive June Raine told ITV that it was still not clear when the Oxford-AstraZeneca shot can be cleared. Raine said MHRA was still receiving data, and no timeline could be given on when a decision was expected, ITV reported on Wednesday. Both of the Indian government officials cited above said the approval process is likely to involve thorough reviews and the process could take at least a couple of weeks.
“A decision cannot be taken on whether a vaccine is to be approved or not within two hours. This is a routine procedure. If you take for example
Pfizer, it had applied for an emergency use authorisation with the US FDA on November 24 and they have had only two meetings of their committee so far. They had applied to the UK authorities on November 20 and it has just been approved. It will take time for the committee to go over the data,” said the health ministry official the cited above.
Both SII and Bharat Biotech declined to comment.
Pfizer’s vaccine is the furthest along, having completed clinical trials in entirety and showing 95% efficacy. However, there has been no trial in India for the vaccine. The Oxford-AstraZeneca, to be manufactured and marketed by the Serum Institute of India, is currently conducting a phase III trial in India with 1,600 participants across 15 sites. The vaccine has shown an efficacy of 62% when volunteers were given two full doses of the vaccine. A half dose followed by full dose regimen — which was initially given by accident during UK testing of the vaccine — was found to be 90 effective.
Bharat Biotech, which has developed Covaxin in collaboration with the government’s Indian Council of Medical Research, has just completed phase I and II trials, the data for which hasn’t been made public yet. The phase III trials that started in mid-November has so far only enrolled about 5,000 of the total 26,000 sample needed. Most volunteers have only received the first dose of the vaccine, with the second to be administered 28-days later.
