India can wait for UK approval ahead of Oxford vaccine call
India may need to wait until UK authorities approve the coronavirus vaccine developed by the University of Oxford and AstraZeneca, as experts from India’s drug regulators sought this data before proceeding with an evaluation. own, based on the details of the discussions at the first meeting to review the options for the country.
The candidate vaccine, manufactured and tested in India by the Serum Institute of India (SII), is among three that have applied for emergency approval. The others include Pfizer-BioNTech’s mRNA vaccine that last week became the first to be approved after late-stage trials anywhere in the world, and a locally developed vaccine called Covaxin by Bharat Biotech of Hyderabad.
“After detailed deliberation, the committee recommended that the company submit the following data / information for further review: 1. Updated safety data from the Phase II / III clinical trial in the country; 2. Immunogenicity data from clinical trial in UK and India; (y) 3. The result of the UK-MHRA evaluation for the US grant (emergency use authorization) ”, in accordance with the recommendations of the Subject Matter Experts Committee (SEC) of the Central Organization for Standard Control of Medications (CDSCO).
HT has seen the document.
The SEC’s evaluations will be sent as recommendations to the CDSCO, which will take the last call.
The committee also asked Bharat Biotech, who presented
Data from Phase I / 2, to present the data from its Phase 3 trials. “After detailed deliberation, the committee recommended that the company submit 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 evaluations of Covid-19 vaccine candidates who may have obtained enough data to judge its safety and efficacy. These data are generally only available in phase 3 studies and once enough infections are recorded to reach a particular checkpoint.
Currently, the Bharat Biotech trial is far from this milestone: its enrollment began on November 11, and protective antibodies develop only 42 days from the date of the first injection.
The third manufacturer, Pfizer, sought more time to appear before the committee. Pfizer’s candidate vaccine, developed in partnership with Germany’s BioNTech, was approved by the UK’s MHRA last week. But on Wednesday, UK health authorities advised caution after two people who received the dose developed non-serious allergic reactions.
“Pfizer looked and was given a little more time before they could make a presentation to the committee. The other two manufacturers explained the data collected so far and were asked to provide additional information, which they promised to send, ”said an official from the Ministry of Health. A second government official, who asked not to be named, said they told Pfizer they can come over when they’re 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 to be made “very soon” once the requested information is provided.
“The panel, made up of experts in the domain who are not government officials, sought additional clarification from both manufacturers that 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 occur as soon as they are ready with the information, ”said this person, who asked not to be identified.
Sarah Gilbert from the University of Oxford and UK Medicines and Healthcare Products Regulatory Agency (MHRA) Executive Director June Raine told ITV that it was still unclear when the Oxford-AstraZeneca vaccine can be approved. Raine said the MHRA was still receiving data and that no timeline could be given on when a decision was expected, ITV reported Wednesday. The two Indian government officials cited above said the approval process is likely to involve extensive reviews and the process could take at least a couple of weeks.
“You cannot make a decision on whether or not a vaccine will be approved in two hours. This is a routine procedure. If you take Pfizer for example, you applied for an emergency use authorization with the US FDA on Nov. 24 and they’ve only had two meetings of their committee so far. They had applied to the UK authorities on 20 November and it had just been approved. It will take time for the committee to review the data, ”said the Ministry of Health official quoted above.
Both SII and Bharat Biotech declined to comment.
Pfizer’s vaccine is the most advanced, having completed full clinical trials and showing 95% efficacy. However, there have been no trials in India for the vaccine. Oxford-AstraZeneca, which will be manufactured and marketed by the Serum Institute of India, is currently conducting a phase III trial in India with 1,600 participants at 15 sites. The vaccine has shown an efficacy of 62% when volunteers received two full doses of the vaccine. A half dose followed by a full dose regimen, which was initially administered by accident during UK vaccine trials, was found to be 90 effective.
Bharat Biotech, which has developed Covaxin in collaboration with the government’s Medical Research Council of India, has just completed phase I and II trials, the data of which has not yet been released. Phase III trials that began in mid-November have so far only enrolled about 5,000 of the total 26,000 samples needed. Most volunteers have only received the first dose of the vaccine, and the second should be given 28 days later.
(With input from Saubhadra Chatterji)