SII demanded full market authorization for this Cowishield
Pune-based Serum Institute of India (SII) has applied for full market authorization for the COVID-19 vaccine Covishield with the drug regulator. SII CEO Adar Poonawalla confirmed that the institute has applied for full market authorization of the drug, adding that the supply of COVID-19 vaccine has exceeded 125 crore doses.
“The COVISHIELD vaccine supply in India has exceeded 1.25 billion. Government of India now has sufficient data for full market authorization, and hence @SerumInstIndia has applied for this permission to @CDSCO_INDIA_INF (DCGI) and @MoHFW_INDIA ,” Poonawalla said in a tweet tagging the Central Drugs Standard Control Organization (CDSCO) and the Ministry of Health and Family Welfare.
SII partnered with Covishield, the developer of AstraZeneca, to supply the vaccine to the government. The vaccine was given Emergency Use Authorization (EUA) in January this year.
Covishield has been one of the main COVID-19 vaccines used for immunization in India. About 90% of the population has got a Coveshield.
The institute had earlier this month sought the drug regulator’s approval for Covishield as a booster dose, citing ample 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, Director of Government and Regulatory Affairs at the Serum Institute of India (SII), quoted that the UK Medicines and Health Care Products Regulatory Agency had already approved booster doses. has given. AstraZeneca ChAdOx1 nCoV-19 Vaccine.
Notably, the recent emergence of highly transmissible variants of SARS-CoV-2 warrants consideration of a booster dose to enhance immunity and provide continued protection from COVID-19. It is believed that after getting vaccinated against COVID-19, protection against the virus may decrease over time and become less effective against the virus. Therefore a booster dose is needed after the second dose. A booster dose of COVID-19 vaccines, administered months after the primary vaccination, is expected to enhance immunity against the virus, including neutralizing ability against ‘forms of anxiety’.
Last week, Prime Minister Narendra Modi announced a ‘precautionary dose’ for frontline workers and those aged 60. In his address to the nation, PM Modi said that people with comorbidities and above 60 years of age will be eligible for the precautionary dose from January 10, 2022 on the recommendation of their doctors. He also announced that immunization for children aged 15-18 would start from January 3.
Read more: ‘Precautionary dose’ for healthcare workers and people above 60 with co-morbidities: PM Modi
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