Covishield vaccine for coronavirus gets approval from DCGI

Covishield, the vaccine developed against the coronavirus by the Pune-based Serum Institute of India has got approval from the Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI) on Jan 1, 2021. 

The approval of the Covishield vaccine came after a row of meetings that began in the morning and end late in the evening. The Subject Expert Committee (SEC) gave its recommendation for the vaccine to the Drug Controller General of India (DCGI). 

DCGI is the department of the Central Drugs Standard Control Organization of the Government of India which is responsible for approving specific drugs, vaccines, sera, and IV fluids in India. 

A source said, “Covishield is likely to be practically available for use within the next week…….Similar to that in the United Kingdom, we’ve approved the vaccine to be given in two doses 4-12 weeks apart.”

Covishield developed by Pune-based Serum Institute of India is similar to the Oxford vaccine developed by the Oxford University vaccine group. The oxford vaccine is marketed by pharma major AstraZeneca and on Thursday it got approval from the health regulator in the UK to be used under emergency conditions. Under this, the company has got a nod to vaccinate people of priority groups and then the larger public, even though the vaccine has still not completed full safety assessment.

Serum Institute of India located in Pune manufactures immunobiological drugs including vaccines. It was founded by the vaccine king of India, “Cyrus S. Poonewala.”

Bharat Biotech who has partnered with the Indian Council of Medical Research (ICMR) for the development of Covaxin has been asked to demonstrate more data related to the efficiency of its vaccine said a source.

For the emergency use approval of the Covishield vaccine, the boards considered the nod by the UK regulator and the data from the 2nd phase trial on Indian candidates. The safety data from phase-1 studies and the increase in antibody levels in the volunteers in response to the vaccine was also speaking in favor of Covishield.

In the UK vaccine shot of the vaccine is recommended to be given in two doses 4-12 weeks apart. The performance of the vaccine is evaluated on the volunteers who were given doses of the vaccine in a difference of four weeks but still, there is no clarity about the duration of effectiveness of a single dose of the vaccine. 

Even with the lack of clarity about the duration of effectiveness of the vaccine UK authority has approved its use due to an increase in the number of cases in recent weeks. The authority has also decided to ensure that the maximum number of people get vaccinated with it and at least everyone receives a single dose of it. 

SII officials said stockpiles of 100 million of the vaccine will be stored in India till the first week of January but the institute has given no clue about how many of these will be available for the Indians. 

The longer dosage interval can be a sign that every Indian will get at least a single dose of the vaccine.

Currently, under phase 2/3 of the trial, the vaccine is being tested on 1,600 volunteers but no results from the test have been published in any scientific journals. 

“The phase 3 trial is ongoing and we will continuously keep reviewing the data……… Other than the case from Chennai of a reported severe adverse event from the vaccine, no other safety events have been reported. We’ve also conclusively ruled out that the said reaction was directly linked to the vaccine” said a source.

The health ministry is yet to comment on it. 

About The Author