SII seeks full market authorisation nod for Covishield
Pune-based Serum Institute of India (SII) has applied for full market authorisation for the COVID-19 vaccine Covishield with the drug regulator. SII CEO Adar Poonawala confirmed that the institute has applied for full market authorisation of the drug, stating supplies of the COVID-19 vaccine have exceeded 125 crore doses.
"Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses. The government of India now has enough data for full market authorisation, and therefore @SerumInstIndia has applied to the @CDSCO_INDIA_INF (DCGI) and @MoHFW_INDIA for this permission," Poonawala said in a tweet tagging the Central Drugs Standard Control Organisation (CDSCO) and Ministry of Health and Family Welfare.
SII had partnered with the developer of Covishield, AstraZeneca, for the supply of the vaccine to the government. The vaccine was granted Emergency Use Authorisation (EUA) in January this year.
Covishield has been one of the main Covid-19 vaccines used in India for inoculation. Around 90% population have got Covishield.
The institute had earlier this month sought the drug regulator's approval for Covishield as a booster dose citing adequate stock of the vaccine in the country amid the emergence of new Omicron variants. In an application to the Drugs Controller General of India (DCGI), Prakash Kumar Singh, the Director, Government and Regulatory Affairs at Serum Institute of India (SII) cited that the UK's Medicines and Healthcare products Regulatory Agency has already approved the booster dose of AstraZeneca ChAdOx1 nCoV-19 vaccine.
Notably, the recent emergence of highly transmissible variants of SARS-CoV-2 led to considerations for booster doses to enhance immunity and provide sustained protection from COVID-19. It is being believed that after getting vaccinated against COVID-19, protection against the virus may decrease over time and be less effective against the virus. Therefore, a booster dose after the second dose is needed. A booster dose of COVID-19 vaccines, administered months after primary vaccination, is expected to augment immunity against the virus, including neutralizing capacity against the 'variants of concern'.
Last week, Prime Minister Narendra Modi announced 'precaution doses' for frontline workers and people aged 60 years. In his address to the nation, PM Modi said that those with comorbidities and above 60 years of age on the recommendation of their doctors will be eligible for precaution doses from January 10, 2022 onwards. He also announced that vaccination for children in the age of 15-18 years will begin from January 3.
READ MORE: 'Precaution dose' for healthcare workers and people above 60 with co-morbidities: PM Modi
