India has recorded 12,193 fresh COVID-19 cases in a span of 24 hours, with the number of active cases of the infection going up to 67,556, the Union health ministry said on Saturday.
Proposing the uptake of newly approved COVID vaccine, the CEO of Serum Institute said Omicron XBB & its variants can be severe for the elderly.
Covovax can be administered to those who have already vaccinated with Covishield or Covaxin.
The letter was written by Prakash Kumar Singh, Director, Serum Institute of India (SII) on March 27, they said.
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The Drug Controller General of India (DCGI) on January 16 approved market authorisation for Covovax as a heterologous booster dose for adults who have been administered two doses of either Covishield or Covaxin.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO).
"Covovax will be approved as a booster in the next 10-15 days. It is actually the best booster because it works very well against Omicron, more than Covishield," said Poonawalla.
He said everyone was looking at India, not just in terms of healthcare but because the country managed to take care of a huge and diverse population and also helped 70 to 80 nations during the COVID-19 pandemic.
Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation.
The petitions of Serum Institute of India seeking emergency use authorization to use Covovax among children aged two to seven and seven to eleven will be reviewed by the topic expert committee on COVID-19 of India's drug regulator on Friday, according to official sources.
Covovax, the Covid-19 vaccine manufactured by the Serum Institute of India under licence from US firm Novavax, will be available at Rs 225 per dose, excluding taxes, at private healthcare facilities.
Covovax is the only vaccine manufactured in India that is also sold in Europe and has an efficacy of over 90 percent, Poonawalla said while making the announcement on Twitter.
A dose of Covovax will cost Rs 900 plus GST at private vaccination centres, in addition to a hospital service charge of Rs 150.
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This is the Indian version of the COVID-19 vaccine, manufactured by the the US based Novavax.
"In 10-14 days, Covovax can be available on CoWin at about Rs 900 plus tax," the SII chief executive said.
India's drug regulator had approved Covovax for restricted use in emergency situations in adults on December 28 and in the 12-17 age group, subject to certain conditions, on March 9.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) had, on March 5, recommended permission for conducting the phase-3 clinical trial for Covovax as a booster dose in adults who have been fully vaccinated with either Covaxin or Covishield at least three months ago.
The Pune-based SII said it wants to provide Covovax to private hospitals at Rs 900 per dose plus GST and is also waiting for directions to supply the vaccine to the Centre but has not mentioned the price.
Covovax is manufactured by technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation and has also been granted emergency use listing by WHO.
The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Friday deliberated on SII’s application and recommended granting EUA to Covovax.
In the application for emergency use authorisation (EUA) for the 12-17 year age group, Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, is learnt to have stated that data from two studies on about 2,707 individuals aged 12 to 17 years show Covovax is highly efficacious, immunogenic, safe and well-tolerated in this age group.
The Covid working group of the National Technical Advisory Group on Immunisation is set to discuss this on February 5.
Experts seem to be of the view that using different kinds of vaccines or mixing-and-matching vaccines is quite safe. The 'mixed' third dose's effectiveness is still being studied though.