Covishield and Covaxin have received conditional clearance from the FDA

*Paromita Das 

The Drugs Controller General of India (DCGI) gave provisional market approval to two of the most commonly used COVID-19 vaccines in India, Covishield and Covaxin, on 3 February 2022.

According to official sources, the two vaccinations have received standard market authorisation for use in the adult population.

Despite receiving market permission, the vaccines will not be offered in medical stores, according to sources. The vaccines can now be purchased by hospitals and other health facilities, but immunization data must be given to DCGI every six months. This information will also need to be updated on the CoWIN app.

The New Drugs and Clinical Trials Rules, 2019, were used to provide the market authorisation, which is subject to certain requirements.

According to sources, the vaccine manufacturers, the Serum Institute of India (Covishield) and Bharat Biotech (Covaxin), will be required to submit data from ongoing clinical studies as well as vaccines to be delivered for programmatic setup.

The companies would also have to keep track of any bad reactions that occur after inoculation.

The request to award normal market authorisation to the two vaccines was cleared by the Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee (SEC) on COVID-19 on January 19.

“The terms include provision for programmatic settings, including registration on the CoWIN platform, as well as a six-monthly submission of safety data.”

Despite the development, the minister reaffirmed that the government’s free COVID-19 vaccine campaign will continue.

While Hyderabad-based Bharat Biotech created Covaxin in-house, the Pune-based SII manufactures Covishield under licence from the University of Oxford and Swiss pharma giant AstraZeneca, who jointly developed the vaccine.

 

On October 25, Prakash Kumar Singh, SII’s director of government and regulatory affairs, filed an application with the DCGI seeking normal market approval for Covishield.

The DCGI then requested more information and papers from SII, which Singh just provided.

He is said to have commented, “Such a large-scale immunisation with Covishield and containment of COVID-19 infection is in itself a witness of the vaccine’s safety and efficacy.”

On January 3 of last year, the DCGI issued Covaxin and Covishield Emergency Use Authorization (EUA). On January 16, 2021, the COVID-19 immunisation campaign began in the country.