Bharat Biotech Covaxin safe to use, efficacy meets WHO standards: Joint Drugs Controller

Published On 2021-01-18 06:00 GMT   |   Update On 2021-01-18 07:20 GMT

New Delhi: Allaying the apprehensions associated with the safety of the vaccine developed by Bharat Biotech, S. Eswara Reddy, Joint Drugs Controller, Central Drugs Standard Control Organisation (CDSCO), said on Saturday that Covaxin has satisfactory efficacy level and there is nothing to worry.

Speaking at the JITO Professional Forum (JPF) through video conferencing, Reddy said that according to the World Health Organization (WHO), the minimum efficacy of any vaccine should be at least 50 per cent, which is considered as the passing mark for any vaccine.

Indicating at Covaxin's efficacy meeting the WHO standard, Reddy said, "We assure that the vaccine is safe and the efficacy (of Covaxin) is to the satisfaction."

Reddy spoke on the subject 'Making Sure Vaccine is Safe'.

He added that the government will closely monitor all those receiving the Covid vaccine dose. "A robust programme has been built to monitor all the beneficiaries," Reddy said.

He emphasised that vaccination is extremely important to break the chain of transmission of novel coronavirus.

Reddy also spoke on the aspect of immunity of these vaccines. "It is clearly not known as to how long the immunity will last (for these vaccines)," he said.

However, Reddy added that usually it is expected that the vaccines will give lifelong immunity.

Citing the data involved in Covaxin approval, he said that the Phase 3 trials involved 24,000 subjects; and for Covishield, manufactured by the Serum Institute of India, the government has UK's Phase 3 efficacy data.

Reddy said that India has the infrastructure to develop 2 billion vaccine doses per annum, and it can very well meet its domestic demand, and also import vaccines to other countries.

He also elaborated on the methodology deployed to calculate the efficacy of the vaccines, and stressed that all procedures were followed leading to the vaccination drive.

Another speaker at the webinar, G.C. Khilnani, Chairman, pulmonary and critical care and sleep medicine, at the PSRI Hospital in Delhi, said that normally it takes 8 to 10 years to develop a vaccine. The Indian Covid vaccine's Phase 2 and 3 trials were combined, due to which the vaccine could be preapared in nine months.

Moments after Prime Minister Narendra Modi launched the vaccination drive across the country virtually on Saturday morning, the jab was administered to a sanitation worker at the AIIMS in New Delhi. The government is targeting to vaccinate close to 30 crore people in the next five to six months.

Read also: Covaxin administered without phase-3 trial: Bharat Biotech ready to pay compensation in case of side effects



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Article Source : IANS

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