NEW DELHI: The launch of the vaccine in India will begin with the availability of two injections, Covishield from Oxford-Astra Zeneca and Covaxin homegrown from Bharat Biotech, and the Comptroller General of Drugs of India is expected to issue final approvals that they will probably be announced on Sunday.
The committee of subject matter experts recommended Covaxin for emergency use (USA) approval on Saturday, a day after it reported to the USA to the Serum Institute of India that makes Covishield. DCGI’s process for the formal licensing of both companies will be complete by Saturday night, the sources said.
After extensive deliberations on Friday and Saturday, the SEC, made up of independent experts, recommended granting permission to Bharat Biotech 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 “. “.
Explaining the official statement, a senior official said that Covaxin has been developed on a platform with the full virus or inactivated virus. “These vaccines are generally active against any strain and are effective even if the virus mutates (like the UK strain) because it attacks the whole virus and not any particular strain. With this in mind, the SEC has even recommended the US as a candidate it is in clinical trial mode with ongoing phase 3 trials, “he said.
The official added that the SEC has extensively evaluated the data to ensure the vaccine’s safety and efficacy. Once approved, Bharat Biotech’s Covaxin, developed in conjunction with the Indian Council for Medical Research, will be India’s first locally developed and manufactured vaccine against coronavirus.
“SII has offered a price of Rs 225-250 per dose for the first tranche, while Bharat Biotech has offered Rs 350. For the next batch, prices may vary,” said a source.
The SEC had recommended USA for Covishield from IBS on Friday with conditions such as that the company must provide a fact sheet to vaccine recipients prior to vaccination and notification of adverse events every 15 days.
The SEC has also recommended that the DCGI grant permission to conduct phase 3 clinical trials to Cadila Healthcare for its SARS-COV2 plasmid DNA vaccine candidate. This may take longer to be ready for market launch.
Covaxin is also a two dose vaccine like Covishield and can be stored at 2-8 degrees.
In addition to the marketing authorization, DCGI will approve the label on the vaccine vials. Once the label with the required conditions or details is approved and printed, they will be attached to the vials prior to shipment.
The committee of subject matter experts recommended Covaxin for emergency use (USA) approval on Saturday, a day after it reported to the USA to the Serum Institute of India that makes Covishield. DCGI’s process for the formal licensing of both companies will be complete by Saturday night, the sources said.
After extensive deliberations on Friday and Saturday, the SEC, made up of independent experts, recommended granting permission to Bharat Biotech 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 “. “.
Explaining the official statement, a senior official said that Covaxin has been developed on a platform with the full virus or inactivated virus. “These vaccines are generally active against any strain and are effective even if the virus mutates (like the UK strain) because it attacks the whole virus and not any particular strain. With this in mind, the SEC has even recommended the US as a candidate it is in clinical trial mode with ongoing phase 3 trials, “he said.
The official added that the SEC has extensively evaluated the data to ensure the vaccine’s safety and efficacy. Once approved, Bharat Biotech’s Covaxin, developed in conjunction with the Indian Council for Medical Research, will be India’s first locally developed and manufactured vaccine against coronavirus.
“SII has offered a price of Rs 225-250 per dose for the first tranche, while Bharat Biotech has offered Rs 350. For the next batch, prices may vary,” said a source.
The SEC had recommended USA for Covishield from IBS on Friday with conditions such as that the company must provide a fact sheet to vaccine recipients prior to vaccination and notification of adverse events every 15 days.
The SEC has also recommended that the DCGI grant permission to conduct phase 3 clinical trials to Cadila Healthcare for its SARS-COV2 plasmid DNA vaccine candidate. This may take longer to be ready for market launch.
Covaxin is also a two dose vaccine like Covishield and can be stored at 2-8 degrees.
In addition to the marketing authorization, DCGI will approve the label on the vaccine vials. Once the label with the required conditions or details is approved and printed, they will be attached to the vials prior to shipment.
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