A second wave of Covid driven by the Delta variant engulfed the country in May-June bringing the health system to its knees and leaving people gasping for help.
Healthcare and frontline workers and citizens above 60 years of age with comorbidities would be administered the third dose of the same vaccine they had been given before.
The gap between second dose of COVID-19 vaccine and the third, which is being called a 'precaution dose,' is likely to be nine to 12 months, official sources said on Sunday.
The Subject Expert Committee on COVID-19 of the CDSCO on October 12 after deliberating Bharat Biotech's EUA application had recommended granting emergency use approval to Covaxin for use in the 12-18 years age group with certain conditions.
According to officials, an additional dose of vaccine is different from a booster dose.
The presence of spike protein facilitates a virus' entry into the host cell and is responsible for making it transmissible and causing infection.
The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.
The quantity of Covid vaccines to be exported will be decided by the government every month to ensure there is no dearth of domestic availability.
The aim is also to push for post-mortem for organ donation even after sundown if adequate infrastructure is available.
Covaxin was found to have 78 per cent efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements, said the global health body.
There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
The Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
With talks underway between the central government and Zydus Cadila over the pricing of the COVID-19 vaccine ZyCov-D, the pharma company is learnt to have proposed a price of Rs 1,900 for its three-dose jab that can be given to those above 12 years of age.
The development comes after Prakash Kumar Singh, the Director, Government and Regulatory Affairs at SII, informed the Union health ministry that the firm would be able to supply 20.29 crore doses of Covishied in the month of September.
Not enough data has been generated locally to decide on the need for a booster dose of COVID-19 vaccine for those fully inoculated, say experts amid the possibility of a third wave of the viral disease hitting the country between September and October.
The panel also recommended giving approval to Bharat Biotech for carrying out a study on interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154, but asked the Hyderabad-based firm to remove the word "interchangeability" from the study title and submit a revised protocol for approval.
An expert panel of India's Central Drug Authority on Tuesday recommended granting permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covid vaccine Covovax on children aged 2 to 17 years with certain conditions, official sources said.
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
India will share the development story of Co-WIN, the digital platform that helped it launch and implement a nationwide COVID-19 vaccination programme, with more than 20 countries that have shown interest in adopting the portal to run their own inoculation drives.
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