Bharat Biotech's Covaxin Becomes India's First Indigenous Covid-19 Vaccine To Get Subject Expert Committee nod

 The Covid-19 vaccine developed by Bharat Biotech and ICMR (Indian Council Of Medical Research) has been approved by the subject expert committee for restricted Emergency Use Authorization (EUA).

The COVAXIN is the India's first indigenous coronavirus vaccine to be approved by the Subject Expert Committee(SEC) of  Central Drugs Standard Control Organization (CDSCO). This comes a day after an expert panel of the CDSCO recommended the granting permission for restricted Emergency Use Authorization for 'Covishield' vaccine, developed by Oxford University and Swedish drug maker AstraZeneca.

The final decision on its approval will however be taken by the Drug Controller General Of India(DCGI).

The Union Health Ministry on Saturday also confirmed that the SEC of the  Central Drugs Standard Control Organization has recommended granting permission to the Serum Institute of India for restricted emergency use of Covishield in India, subject to multiple regulatory conditionalities.

America's Pfizer was the first to apply for the accelerated approval on December 4 ,followed by the Serum Institute on December 6.

Bharat Biotech had applied for emergency use authorization on December 7.The expert panel at that time asked the firm to submit its safety and efficacy data from the ongoing phase 3 clinical trial for further consideration.

Both the vaccine candidates have been recommended for restricted emergency use which comes with few riders. For Oxford vaccine, the panel has imposed certain regulatory provisions,including that the shot is indicated for active immunization in individuals of 18 years or more to prevent the disease and that it should be administered intramuscularly in two doses at an interval of four to six weeks.

Bharat Biotech's vaccine candidate is an inactivated one which are developed by inactivating(killing) the live micro-organism that cause the disease. This destroys the pathogen's ability to replicate,but keeps it intact so that the immune system can still recognize it and produce an immune response.There are many inactivated vaccines against Hepatitis A,Influenza,Polio,Rabies, which offer "excellent protection",Bharat Biotech has said.

Bharat Biotech has claimed that Covaxin can protect against the mutated Covid-19 strain that surfaced in the United Kingdom last month.The new strain has been detected in India,  Denmark , Netherlands ,Australia ,Italy ,Sweden ,France ,Spain ,Switzerland ,Germany,Canada,Japan,Lebanon and Singapore so far.

"Coronavirus is expected to have a lot of mutation and you can be assured that this vaccine will also protect against that (mutated) virus because of two hypotheses...So you have these two components in inactivated vaccine.It will also take care of those mutations,"Bharat Biotech Chairman Krishna Ella said.

India has now two Covid-19 vaccines ready for roll-out as the country conducted a nationwide dry run of its vaccination drive.The mock exercise was meant to test the vaccine delivery network and Co-WIN,the digital platform developed to help with this.The dry run also check the preparedness to deal with adverse events that might rise after vaccination.No vaccines were administered during the dry run.

The Central government plans to vaccinate nearly 30 crore people in the first phase of drive.It will be offered to one crore health care workers,along with 2 crore frontline workers and 27 crore elderly above age of 50 years most of whom have co-mobilities.