The Central Licensing Authority on Sunday granted permission to Hyderabad-based Bharat Biotech to manufacture ‘Covaxin’ for sale and distribution, after the indigenous coronavirus vaccine received regulatory approval for emergency use.
“The Central Licensing Authority has granted permission to Bharat Biotech International Ltd to manufacture for sale of the pharmaceutical formulation,”.
Earlier on Sunday, Drug Controller General of India (DCGI) V.G. Somani announced that Bharat Biotech’s ‘Covaxin’ has been approved for “restricted use in emergency situation”. The approval has also been given to Serum Institute of India’s ‘Covishield’ vaccine.
The Subject Expert Committee of Central Drugs Standards Control Organisation had recommended restricted use of Covaxin “in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains”. Officals say that it will be used as backup in case of spike in cases.
Covaxin has to be administered in two doses and can be stored at 2-8 degree Celsius. This is a major relief for India which has the second highest number of infections in the world after the US.
Bharat Biotech is India’s first indigenous vaccine for coronavirus. The inactivated virus vaccine is developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
“Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist,” Krishna Ella, Chairman and Managing Director of the pharmaceutical firm said following the approval.
Amid the criticism of the Drug Controller General of India (DCGI) for granting approval for emergency use of Covid-19 vaccine Covaxin, its manufacturer Bharat Biotech claimed on Sunday that its vaccine generated excellent safety data with robust immune responses to multiple viral proteins that persist.
Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, the Hyderabad-based company said in a statement.
“The evaluation of Covaxin has resulted in several unique product characteristics including long term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad spectrum neutralising capability with heterologous SARS-CoV2 strains, thus potentially reducing or eliminating escape mutants,” it said.
“It has also shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. Its most critical characteristic is the demonstrated safety profile, which is significantly lower than several other vaccines with published data,” it added.
DCGI has come under flak from various quarters for approving Covaxin even before the completion of Phase 3 trials. Critics wondered how the regulator could approve the vaccine in the absence of the data from Phase 3.
The DCGI’s approval to Covaxin came a day after the Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) made the recommendation.
Adar Poonawalla, CEO, Serum Institute of India (SII) said on Sunday that the Covishield, India’s first Covid-19 vaccine will roll out in the coming weeks.
Poonawalla said SII risks on stockpiling the vaccine have paid off.
His statement came minutes after the Drugs Controller General of India (DCGI) announced the approval for Covishield developed by AstraZenca and Oxford. Poonawalla added the vaccine is safe, effective and ready for rollout.
“Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks”, he said in a tweet.
“Thank you Hon. Sri@narendramodiJi, Hon. Sri@drharshvardhanJi @MoHFW_INDIA @ICMRDELHI @DBTIndia #DCGI_India @UniofOxford @AstraZeneca @gavi @GaviSeth @gatesfoundation and @BillGates for your support”, he added.