The homegrown government-backed vaccine has been developed by Bharat Biotech, a 24-year-old vaccine maker, which has a portfolio of 16 vaccines and exports to 123 countries. It is an inactivated vaccine which means that it is made up of killed coronaviruses, making it safe to be injected into the body. Bharat Biotech used a sample of the coronavirus, isolated by India's National Institute of Virology. When administered, immune cells can still recognise the dead virus, prompting the immune system to make antibodies against the pandemic virus. The two doses are given four weeks apart. The vaccine can be stored at 2C to 8C. Bharat Biotech says it has a stockpile of 20 million doses of Covaxin, and is aiming to make 700 million doses out of its four facilities in two cities by the end of the year.

It all began when the regulator said the vaccine had been approved for "restricted use in emergency situations in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains". Experts wondered how a vaccine was cleared for emergency use by millions of vulnerable people when its trials were still underway. Both the manufacturer and drug regulator say Covaxin is "safe and provides a robust immune response". But the All India Drug Action Network said it was "baffled to understand the scientific logic" to approve "an incompletely studied vaccine". It said that there were "intense concerns arising from the absence of the efficacy data".

Bharat Biotech has defended the approval, saying Indian clinical trial laws allowed "accelerated" authorisation for use of drugs after the second phase of trials for "unmet medical needs of serious and life-threatening diseases in the country". It has promised to provide efficacy data for the vaccine by February.

Journal of Antivirals & Antiretrovirals is using Editorial Manager System for quality in review process. Editorial Manager is an online manuscript submission, review and tracking systems used by most of the best open access journals. Review processing is performed by the editorial board members of journal or outside experts; at least two independent reviewers approval followed by editor's approval is required for acceptance of any citable manuscript.

Send your manuscript at www.longdom.org/submissions/antivirals-antiretrovirals.html or as an e-mail attachment to our Editorial Office at manuscripts@longdom.org

The homegrown government-backed vaccine has been developed by Bharat Biotech, a 24-year-old vaccine maker, which has a portfolio of 16 vaccines and exports to 123 countries. It is an inactivated vaccine which means that it is made up of killed coronaviruses, making it safe to be injected into the body. Bharat Biotech used a sample of the coronavirus, isolated by India's National Institute of Virology. When administered, immune cells can still recognise the dead virus, prompting the immune system to make antibodies against the pandemic virus. The two doses are given four weeks apart. The vaccine can be stored at 2C to 8C. Bharat Biotech says it has a stockpile of 20 million doses of Covaxin, and is aiming to make 700 million doses out of its four facilities in two cities by the end of the year.

It all began when the regulator said the vaccine had been approved for "restricted use in emergency situations in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains". Experts wondered how a vaccine was cleared for emergency use by millions of vulnerable people when its trials were still underway. Both the manufacturer and drug regulator say Covaxin is "safe and provides a robust immune response". But the All India Drug Action Network said it was "baffled to understand the scientific logic" to approve "an incompletely studied vaccine". It said that there were "intense concerns arising from the absence of the efficacy data".

Bharat Biotech has defended the approval, saying Indian clinical trial laws allowed "accelerated" authorisation for use of drugs after the second phase of trials for "unmet medical needs of serious and life-threatening diseases in the country". It has promised to provide efficacy data for the vaccine by February.

Journal of Antivirals & Antiretrovirals is using Editorial Manager System for quality in review process. Editorial Manager is an online manuscript submission, review and tracking systems used by most of the best open access journals. Review processing is performed by the editorial board members of journal or outside experts; at least two independent reviewers approval followed by editor's approval is required for acceptance of any citable manuscript.

Send your manuscript at www.longdom.org/submissions/antivirals-antiretrovirals.html or as an e-mail attachment to our Editorial Office at manuscripts@longdom.org