A committee of experts assessing coronavirus vaccines for approval by the drugs regulator recommended on Friday that the candidate developed by University of Oxford and AstraZeneca (and manufactured in India by Serum Institute of India) be cleared, paving the way for Indians to receive their first doses within days.
The recommendations of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) are now being assessed by the Drugs Controller General of India (DCGI), who is likely to heed to the advice of the expert committee and issue a formal approval. The DCGI heads CDSCO, the country’s drugs regulator.
“The 10-member expert panel has recommended granting EUA (emergency use authorisation) to Serum Institute with certain riders that includes stricter monitoring of beneficiaries who will be given the vaccine shots. The DCGI is going through the report,” a person aware of the process said, asking not to be named.
Once formalised, the vaccine – globally known as AZD1222 but to be marketed in India by SII as Covishield – will be the first coronavirus inoculation in the country.
DCGI VG Somani had hinted on December 31 that the new year would bring a positive development on the vaccine front.
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The SEC was also assessing applications by Pfizer-BioNTech, which was the first to be approved anywhere in the world last month, and by Bharat Biotech, an Indian developer that at present is the furthest along in the process. Pfizer sought more time to appear before the committee and Bharat Biotech’s Covaxin was not granted approval, with the SEC seeking more data from the Phase 3 trials that began in mid-November.
The expert committee’s recommendations for Oxford-AstraZeneca include certain conditions for the approval, which will require SII to closely monitor post-vaccination side-effects after immunisations begin, and to submit a report to authorities every 15 days for the first two months. After this period, the company will need to create monthly reports of observed side-effects during the roll-out, a second person aware of the recommendations said, asking not to be named.
“The company will also need to create a detailed fact sheet for patient information with possible AEFI (adverse effect following immunisation) and other detailed information that will be handed out to recipients,” this person added.
The company will also need to keep submitting data from ongoing clinical trials in India as well as other locations outside of the country as soon as they are received, the official said.
Details about what dosing regimen will be cleared in India will be confirmed after the formal approval by Somani, but India’s approach is likely to follow that of the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, which became the first country to approve AZD1222 after a months-long rolling assessment.
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India’s strategy of dosing recommendations will be closely watched since authorities in the UK indicated the vaccine may have a higher efficacy if the second dose is given later than the 28-day recommended by the manufacturer.
The UK authorities said the vaccine can be 80% effective when there are three months between shots, an official involved in approving the vaccine said at a briefing on Wednesday, higher than the average that the developers themselves had found.
Later in the same briefing, a British scientist involved in the approval of the vaccine said one dose of the vaccine is around 70% effective after 21 days and before the second dose is given.
The vaccine is India’s strongest contender for early access to large volumes. An SII official said on Thursday at a webinar that the company had already stockpiled 75 million doses. SII’s chief executive Adar Poonawalla on Wednesday said the company will be supplying India and Covax in a 50-50 manner as and when it produces vials.
It is also easier to store and transport than the other vaccines approved after due scientific process yet. AZD1222 can be kept at refrigerator temperatures (between 2-8°C) for up to six months, which makes it compatible with India’s existing cold chain network.
Vaccines by Pfizer-BioNTech and Moderna require freezing to -70°C and -20°C respectively, requiring specialised infrastructure that will be costly to deploy.
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Apart from the UK, the vaccine has been approved by Argentina for urgent public use.
In late stage trials, AZD1222 showed it had 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, but the method did not appear to stand up to the scrutiny of MHRA.
The Union government has announced that India targets to vaccinate at least 300 million high-risk people against Covid-19 by July this year – a mammoth task in itself as it would involve administering the shot to 1.5 million people daily if immunisations were to begin in January.
The approval now shifts the focus from the national Capital to Hadapsar in Pune, where SII has facilities. According to officials who gave details about the logistics, special cargo planes with cold boxes and refrigerated vans will start ferrying vials to various parts of the country as soon as requisite approvals and orders are in.
State administrations will then distribute vials to district authorities for delivery to the hundreds of thousands of inoculation centres to be set up across India. The process will span over several weeks and drills have already been carried out in some regions, with more planned on January 2.
Initial lots of the vaccine will be for the first two priority groups—health care and other frontline workers such as police personnel. After these, the government will begin vaccinating the high-risk general population – adults above 50 and those younger but with associated comorbidities.
The government has targeted reaching these people by July.