India's Drug Controller General Venugopal Somani says the data has been approved after "careful examination”
Highlights:
* The indigenous vaccine Covaxin has been developed by "Bharat Biotech" in association with the Indian Council of Medical Research and the Indian Institute of Virology.
* The third phase of Covaxin has registration of about 22,500 participants.
* COVID-19 has infected more than 10 million people in India and killed about one and a half million people.
Serum Institute of India has manufactured both the vaccines. India's indigenous 'Covaxin' is developed by Bharat Biotech while 'Covishield' has been developed by Oxford University and UK-based drugmaker AstraZeneca.
Public health watchdog, the India Drug Action Network, says it is concerned the local vaccine was approved even though it has yet to go through large-scale trials.
Speaking with SBS Hindi, the correspondent from Mumbai Mr Vishwaratan told that there were some concerns when the Home Minister of Haryana got infected with the virus even after taking biotech vaccine ‘Covaxin’. Later a clarification was given. The vaccine dose was incomplete. Minister was administered only with the first dose of the vaccine.
“He was yet to be given the second follow up dose when he got infected. That cleared the doubts. Now the general public has overcome that anxiety.” told Mr Vishvaratan
Mr Vishvaratan added though a few are questioning about the protocol, “But that would not affect the larger section of the population.”
The country hopes to inoculate 300 million of its 1.35 billion people free of charge in the first six to eight months of this year.
A health worker wearing a face mask holds a syringe with a dummy vaccine to a volunteer during a nationwide dry run for Covid-19 vaccine in Delhi Source: Sipa USA Naveen Sharma
It will be challenging to reach that target.
Mr Vishvaratan said, “The government is quite prepared, but no doubt when the work starts, an assessment of the correct situation will be done.”
“ The large population is not an issue. Instead, it is a solution as it brings awareness on a larger scale.”
Mr Vishvaratan confidently added, “If the target to reach out to 30 crores of the population is not met by the said time or it stretches even till December, it will definitely be completed.”
Both the vaccines were approved for limited use in the country on Sunday 3 January.
India's Drug Controller General Venugopal Somani said vaccine is safe and provides a strong immune response.
"Phase I and Phase II clinical trials (for Bharat Biotech vaccine) were conducted in approximately 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, approximately 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date."
With nearly 1.4 billion people, India is the second-worst affected by the coronavirus after the US, with over 10.3 million cases and over 149000 deaths, though its rate of infection has come down significantly from a mid-September peak.
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