India’s drugs regulator has approved Serum Institute of India’s (SII) coronavirus vaccine,Covovax, for emergency use in adults and children aged 12 and above, company officials said on Wednesday.
The SII now plans to apply for an emergency use authorisation (EUA) for those below 12 years of age, officials said.
“Novavax in global trials has demonstrated more than 90% efficacy. @SerumInstIndia ‘s brand Covovax has completed bridging studies in India & has been granted Emergency Use Authorisation by DCGI for adults & for children above the age of 12. Younger age groups will follow shortly,” Adar Poonawalla, SII’s chief executive officer, said in a tweet on Wednesday.
The Drugs Controller General of India (DCGI) gives the requisite approval, including emergency approval, before a pharmaceutical product can be used in India.
Covovax, which is the second anti-Covid vaccine manufactured by SII after Covishield, has been developed by US-based Novavax Inc. In August 2020, Novavax announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate, in low and middle-income countries.
The vaccine is a protein subunit vaccine that delivers a full spike of the Sars-Cov-2 to train the immunity. It is the only other vaccine apart from the mRNA platform doses to demonstrate an efficacy of over 90% against symptomatic disease (against the original Sars-Cov-2 virus), but its production and development was delayed due to several factors, including raw material shortages. The mRNA platform, unlike the other high efficacy Covid-19 vaccine doses that are based on newer methods, has been used for decades in other immunisations with an established safety record. The dose is also easier to store and transport than the mRNA vaccines that require super freezing.
{{/usCountry}}The vaccine is a protein subunit vaccine that delivers a full spike of the Sars-Cov-2 to train the immunity. It is the only other vaccine apart from the mRNA platform doses to demonstrate an efficacy of over 90% against symptomatic disease (against the original Sars-Cov-2 virus), but its production and development was delayed due to several factors, including raw material shortages. The mRNA platform, unlike the other high efficacy Covid-19 vaccine doses that are based on newer methods, has been used for decades in other immunisations with an established safety record. The dose is also easier to store and transport than the mRNA vaccines that require super freezing.
{{/usCountry}}The SII in October last year submitted its application to the DCGI for EUA grant to Covovax.
“The application was thoroughly examined and the expert panel recommended it for restricted use in emergency situation,” said a government official familiar with the development, on condition of anonymity.
Meanwhile, Biological E has also sought EUA for its anti-Covid vaccine, Corbevax, in children aged 5-12, according to people familiar with the matter. The vaccine, which is India’s first indigenously developed Receptor Binding Domain (RBD) Protein sub-unit Covid-19 vaccine, received EUA for 12-18 age group last month.The expected cost of the vaccine is ₹145, excluding taxes. It will be administered two times within prescribed intervals of 28 days.