Coronavirus | Covaxin gets central drugs authority panel approval for restricted use

A health worker administers Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research, during phase- 3 trials for the vaccine candidate at the People’s Medical College in Bhopal on December 7, 2020.   | Photo Credit: PTI

India’s first indigenously developed COVID-19 vaccine, Covaxin, has been recommended for “restricted use in emergency situation, subject to multiple regulatory conditionalties” by the Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO), here on Saturday. The Drugs Controller General (DCGI) will take a final call on approving rollout of the vaccine in the country.

The recommendation was made following a two-day meeting which earlier saw the panel sending Covishield, the vaccine developed by AstraZeneca and Oxford University, and manufactured by Pune's Serum Institute of India (SII) for DCGI approval on Friday.

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The Health Ministry in its statement said the SEC has made three recommendations for the consideration and final decision of the Drugs Controller General of India (DGCI). This includes grant of permission for restricted emergency use of vaccine, subject to multiple regulatory conditionalities to Serum Institute of India, grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to Bharat Biotech and grant of permission to conduct Phase 3 clinical trials to Cadila Healthcare.

Rahul Pandit, member of Maharashtra’s COVID-19 task force welcoming the developments said vaccinating such a huge population in a diverse geography is a challenge.

“The Oxford-AstraZeneca vaccine is vector-based which has gone through three significant trial stages with 70% efficacy rate. While the vaccine is safe, however, there are some people who have severe drug allergies (leading to anaphylaxis reaction) and those with compromised immune systems who need to first take approval from their doctors before they take the vaccine shot. With the doctor’s go-ahead, these two groups should certainly get the vaccine,” he said.

Dr. Pandit added that as of now, no data is available for vaccination of children and pregnant patients.

“An advisory in the UK suggested that pregnant patients can take the vaccine only if they are at a high risk of contracting the disease, and that it should be taken as late in pregnancy as possible.”

Stating that India has been given two COVID-19 vaccines by January 2, chairman, Liver Transplant Unit, Medanta Hospital Arvind Soin said, “The DCGI has gone to great lengths to ensure these are safe vaccines and the emergency use comes with explicitly stated conditions. We must all come forward to start building up national herd immunity once frontline workers and at-risk citizens are inoculated.”

Meanwhile, the Indian Council of Medical Research (ICMR) on Saturday said it has successfully isolated and cultured the U.K. variant of Sars-CoV-2, adding that no other country has so far reported success in isolation and culture of the variant, according to ICMR.

“Vero cell lines were used by the scientists of ICMR- National Institute of Virology NIV to culture the UK-variant of the virus,” said ICMR.

“U.K. variant of the virus, with all signature changes, is now successfully isolated and cultured from the clinical specimens collected from UK-returnees,” noted ICMR in its tweet. India has so far reported 29 cases of the new coronavirus variant.

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Printable version | Oct 22, 2021 3:00:16 PM |

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