Govt panel okays phase-3 trials of Covovax as booster dose
What's the story
The subject expert committee (SEC) of India's drug regulatory authority Central Drugs Standard Control Organization (CDSCO) has recommended phase-3 clinical trials of Covovax as a booster dose against COVID-19 in adults, Mint reported. Notably, Covovax is yet to be included in the country's inoculation program. In December, the Drugs Controller General of India had approved it for restricted use in emergency situations in adults.
Context
Why does this story matter?
The recommendation will further boost India's vaccination efforts against COVID-19. India administered over 178.7 crore COVID-19 vaccine doses till 10 am on Sunday. The active COVID-19 caseload and positivity rates are also witnessing a steady decline over the past few weeks. On Sunday, the country reported less than 6,000 new COVID-19 cases. Notably, WHO has already listed Covovax as an emergency use vaccine.
Details
Study would evaluate safety, immunogenicity of the vaccine
CDSCO had previously recommended phase-3 clinical research of another vaccine, Sputnik Light, as a booster dose. Later, Prakash Kumar Singh, Director of Government and Regulatory Affairs of the Serum Institute of India (SII), requested permission for phase-3 clinical trials of Covovax as a booster dosage in adults. He claimed that the trials will assess the vaccine's safety and immunogenicity.
ICMR
Covovax has shown effectiveness against Omicron
The Indian Council for Medical Research and SII have successfully conducted phase 2 and 3 trials of Covovax in a controlled manner for use in adults. It was after the recommendations by Data Safety Monitoring Board that its emergency use was permitted. The vaccine has shown enhanced effectiveness against the new Omicron strain and has the potential to become India's "perfect booster injection."
Vaccine
How does Covovax work?
Covovax, like previous COVID-19 vaccines, targets the SARS-CoV-2 coronavirus' spike protein, which allows the virus to enter the human cell. Novavax did this by utilizing moth cells to make lab-created clones of the spike protein. Following the administration of this vaccine, a person's body is expected to recognize the modified spike protein as a foreign substance and develop immunity to it.