Happy vaccine year
A committee of experts evaluating coronavirus vaccines for approval by the drug regulator recommended on Friday that the candidate developed by the University of Oxford and AstraZeneca (and manufactured in India by the Serum Institute of India) be approved, paving the way. way for the Indians to receive their first doses. Within days.
The recommendations of the Subject Matter Experts Committee (SEC) of the Central Medicines Standards Control Organization (CDSCO) are now being evaluated by the Comptroller General of Drugs of India (DCGI), who will likely follow the advice of the experts and issue a formal approval. The DCGI runs CDSCO, the country’s drug regulator.
“The 10-member expert panel recommended granting EUA (emergency use authorization) to the Serum Institute with certain passengers that includes a tighter control of the beneficiaries to whom the vaccines will be administered. The DCGI is reviewing the report, ”said a person familiar with the process, who asked not to be identified.
Once formalized, the vaccine, known worldwide as AZD1222 but which will be marketed by IBS in India as Covishield, will be the first inoculation of coronavirus in the country.
DCGI VG Somani had hinted on December 31 that the new year would bring positive development on the vaccine front.
Read more | Covishield IBS Approval: Efficacy, Cost, and All About AstraZeneca’s Covid-19 Vaccine
The SEC was also evaluating applications from Pfizer-BioNTech, which was the first to be approved anywhere in the world last month, and from Bharat Biotech, an Indian developer who is currently the most advanced in the process. Pfizer sought more time to appear before the committee and Bharat Biotech’s Covaxin did not get approval, and the SEC sought more data from phase 3 trials that began in mid-November.
The expert committee recommendations for Oxford-AstraZeneca include certain conditions for approval, which will require IBS to closely monitor post-vaccination side effects after vaccines are started, and report to authorities every 15 days for the first two months. After this period, the company will need to create monthly reports of the side effects seen during launch, said a second person familiar with the recommendations, who asked not to be identified.
“The company will also need to create a detailed data sheet for the patient information with possible AEFI (adverse effect after vaccination) and other detailed information that will be given to the recipients,” added this person.
The company will also need to continue to send data from ongoing clinical trials in India, as well as elsewhere outside the country, as soon as it receives it, the official said.
Details on which dosing regimen will be licensed in India will be confirmed after Somani’s formal approval, but India’s approach is likely to follow that of the UK Medicines and Healthcare Products Regulatory Agency (MHRA), which became in the first country to pass AZD1222 after months of continuous evaluation.
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India’s strategy of dosing recommendations will be closely followed, as UK authorities indicated that the vaccine may be more effective if the second dose is given after the manufacturer’s recommended 28 days.
UK authorities said the vaccine can be 80% effective when there are three months between injections, an official involved in the approval of the vaccine said in a briefing on Wednesday, higher than the average the developers themselves had. found.
Later in the same briefing, a British scientist involved in the approval of the vaccine said that one dose of the vaccine is around 70% effective after 21 days and before the second dose is administered.
The vaccine is India’s strongest competitor for high-volume early access. An SII official said in a webinar Thursday that the company had already stockpiled 75 million doses. SII CEO Adar Poonawalla said Wednesday that the company will supply India and Covax on a 50-50 basis as it produces vials.
It is also easier to store and transport than other approved vaccines after due scientific process. AZD1222 can be kept at refrigerator temperature (2-8 ° C) for up to six months, making it compatible with the existing cold chain network in India.
The Pfizer-BioNTech and Moderna vaccines require freezing at -70 ° C and -20 ° C respectively, requiring specialized infrastructure that will be costly to implement.
Read more | Government Expert Panel Approves AstraZeneca / Oxford Covid-19 Vaccine for Emergency Use
Apart from the UK, the vaccine has been approved by Argentina for urgent public use.
In late-stage trials, AZD1222 was shown to be 62% effective 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, but the method did not appear to stand up to MHRA scrutiny.
The Union government has announced that India aims to vaccinate at least 300 million high-risk people against Covid-19 by July this year, a gigantic task in itself, as it would involve administering the injection to 1, 5 million people daily if immunizations started in January.
The approval now shifts the focus from the national capital to Hadapsar in Pune, where the SII has facilities. According to officials who gave details on logistics, special cargo planes with cold boxes and refrigerated vans will begin transporting roads to various parts of the country as soon as the necessary approvals and orders are received.
The state administrations will then distribute vials to the district authorities for delivery to the hundreds of thousands of inoculation centers to be established across India. The process will take several weeks and drills have already been conducted in some regions, with more planned for January 2.
The initial batches of the vaccine will be for the first two priority groups: healthcare and other front-line workers, such as police personnel. After these, the government will begin to vaccinate the general high-risk population: adults over 50 years of age and those younger but with associated comorbidities.
The government aims to reach these people by July.