Bharat Biotech vaccine candidate approved for use in clinical trial mode.
The first COVID-19 vaccine developed in India, Covaxin, has been recommended for “restricted use in emergency situations, subject to multiple regulatory conditions” by the Subject Matter Expert Committee (SEC) of the Central Medicines Control Organization ( CDSCO), here on Saturday. The Comptroller General of Drugs (DCGI) will take one last call to approve the launch of the vaccine in the country.
The recommendation was made after a two-day meeting in which the panel previously submitted Covishield, the vaccine developed by AstraZeneca and Oxford University, and manufactured by the Serum Institute of India (SII) in Pune for DCGI approval on Friday.
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The Ministry of Health in its statement said that the SEC has made three recommendations for the consideration and final decision of the Comptroller General of Drugs of India (DGCI). This includes granting permission for restricted emergency use of the vaccine, subject to multiple regulatory conditionalities to the Serum Institute of India, granting 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, to Bharat Biotech and permission to conduct phase 3 clinical trials to Cadila Healthcare.
Rahul Pandit, a member of the Maharashtra COVID-19 task force who welcomes the developments, said that vaccinating such a large population in a diverse geography is challenging.
“The Oxford-AstraZeneca vaccine is based on a vector that has gone through three major testing stages with an efficacy rate of 70%. However, while the vaccine is safe, there are some people who have severe drug allergies (causing an anaphylactic reaction) and those with compromised immune systems who must first get approval from their doctors before receiving the vaccine. With the okay of the doctor, these two groups should certainly receive the vaccine, “he said.
Dr. Pandit added that as of yet there are no data available for vaccinating children and pregnant patients.
“An advisory in the UK suggested that pregnant patients can take the vaccine only if they are at high risk of contracting the disease, and that it should be taken as late as possible in pregnancy.”
Stating that India received two COVID-19 vaccines before January 2, Medanta Hospital Liver Transplantation Unit Chairman Arvind Soin said: “DCGI has done everything possible to ensure that these are safe vaccines and the use Emergency comes with explicitly stated conditions. We must all step forward to begin building national herd immunity once frontline workers and citizens at risk are vaccinated. “
Meanwhile, the Indian Council for Medical Research (ICMR) said on Saturday that it has successfully isolated and cultured the British variant of Sars-CoV-2, adding that no other country has so far reported success in isolating and culturing the variant, according to ICMR.
“Scientists at ICMR (National Institute of Virology NIV) used Vero cell lines to grow the variant of the virus in the UK,” said the ICMR.
“The UK variant of the virus, with all signature changes, was now successfully isolated and cultured from clinical samples collected from those who returned to the UK,” ICMR noted in its tweet. India has so far reported 29 cases of the new variant of the coronavirus.
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