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Expert panel approves Covaxin for restricted use


Experts from India’s drug regulators recommended allowing the use of the Oxford-AstraZeneca and Bharat Biotech coronavirus vaccines in India, the government said on Saturday, paving the way for formal confirmation before which inoculations massive can start in the second most populous country in the world. .

The endorsement by the Committee of Experts on the Subject (SEC) of the candidate made by the University of Oxford and the British pharmaceutical AstraZeneca was communicated on Friday by officials who were aware of the news. This vaccine is being manufactured in India by the Serum Institute of India, which will market it as Covishield.

The second endorsement, which carries additional conditions that the use of the candidate can only be “in clinical trial mode” by Hyderabad-based Bharat Biotech, was unexpected as the developer has not yet determined the efficacy data. and it was described as puzzling by independent experts. .

The Bharat Biotech vaccine, known as Covaxin, is in phase III trials that began in mid-November. The SEC recommended that it be granted permission “for restricted use in emergency situations of public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains,” the ministry of health and family welfare said in a statement on Saturday.

Read more | Bharat Biotech recruits 23,000 volunteers for Covaxin phase 3 clinical trial

Explaining what emergency use means, a member of the expert panel, who did not want to be identified, said: “This pandemic is an emergency situation, and this vaccine has been allowed to be used in this situation for lack of any other. . alternatives before us to control the pandemic. One company alone will not be able to meet the country’s requirements, as India is a huge country, so Covaxin is the only other option at the moment. “

“The clinical trial mode would mean that the data that currently exists is not enough to call it a complete therapy. It is working more experimentally, ”this person added.

It appears that the implementation of the Bharat Biotech vaccine will be more restricted than the vaccine manufactured by the Serum Institute of India, which has an efficacy rate of 62%.

“The Serum Institute vaccine will be the main vaccine. The Bharat Biotech vaccine is a backup for emergency situations, which can occur if there is a sudden increase in cases or reinfection, ”Dr. Randeep Guleria, director of AIIMS, told NDTV.

Dr. Gagandeep Kang, professor in the department of Gastrointestinal Sciences at Christian Medical College (CMC), Vellore, and one of the nation’s leading vaccine experts, said: “We don’t actually have USA (emergency use authorizations), so I have no idea what the language in today’s statement means, except that it’s different for Covishield and Covaxin. ”

Read more | Covaxin Approval: Everything You Need To Know About The Efficacy And Price Of The Bharat Biotech Covid-19 Vaccine

The SEC recommendations have been sent to the Comptroller General of Drugs of India, Dr. VG Somani, who heads India’s drug regulator, the Central Drug Control and Standards Organization (CDSCO).

“The approval is confirmed. Now it is a mere formality for the national drug controller to issue an order, “said a senior health ministry official, who asked not to be identified.

The final grant from the DCGI could place India among a handful of countries, including the US and the UK, that have started vaccinating. Both the US and UK have also approved two vaccines, but in their case, all candidates have completed the required scientific process.

So far, the Oxford-AstraZeneca candidate, known worldwide as AZD1222, remains India’s strongest competitor to facilitate the immunization of tens of thousands of people. SII officials have said in recent weeks that they may have between 40 and 50 million doses ready to ship to India shortly.

Dubbed the “world’s vaccine,” the Oxford antidote is easier to store and transport than vaccines approved in other Western countries. It can be kept at refrigerator temperature (2-8 ° C) for up to six months, a feature that makes it easy to utilize India’s vast immunization infrastructure.

Read more | India may be the only country with 4 almost ready vaccines, says Prakash Javadekar

Like the Oxford vaccine, Bharat Biotech’s Covaxin is also easy to store and transport, and is produced indigenously. The company aims to produce up to 300 million doses a year and did not disclose whether it has stored any volumes.

“Bharat Biotech has announced the successful recruitment of 23,000 volunteers and continued progress towards achieving the goal of 26,000 participants for the phase 3 multi-site clinical trial of Covaxin in India. The Clinical Trials … is India’s first and only Phase III efficacy study for a Covid-19 vaccine, and the largest Phase III efficacy trial ever conducted for any vaccine in India. Covaxin has been evaluated in approximately 1,000 subjects in phase I and phase II clinical trials, with promising results for safety and immunogenicity, with acceptance in international peer-reviewed scientific journals, ”the company said in a statement Saturday.

In December, the company released data from phase I / II trials showing that the majority of volunteers who received the dose developed antibodies and these were comparable to antibodies developed after natural infection.

The efficacy data, which the company has said in its protocol will be analyzed on 130 infections, has yet to be announced. The developers calculate the efficacy when they reach the preset number of infections, at which point they “unblind” the trial to see how many of them were in people who actually received the vaccine (compared to a placebo).

If the number of infections among those vaccinated is at least 50% lower, the vaccine is considered to have a 50% efficacy rate, the minimum bar that any coronavirus vaccine must meet for approval.

Covishield, based on an adenovirus vector, has shown an efficacy rate of 62% in trials conducted in the UK and Brazil.

Read more | Reading the Clues from the Early Covaxin Trial Data

The Bharat Biotech vaccine is based on an inactivated virus platform, one of the oldest known methods of developing an inoculation. This technique has been used historically for several other diseases, including hepatitis A, influenza, polio, and rabies.

The country is also preparing to carry out the largest vaccination program in the world, with all states and territories in the Union conducting mock inoculation in a pre-launch test.

Union Health Minister Harsh Vardhan announced on Saturday that injections given in the first phase of India’s inoculation campaign will be free. The government aims to vaccinate 300 million people in the high-risk category of the population by July-August in this phase.

On Saturday, the SEC also granted Ahmedabad-based Zydus Cadila permission to conduct phase 3 trials of its candidate vaccine.

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