Bharat Biotech’s ‘kid’ Covaxin to Zycov-D to Covovax, India readies battleplan for saving children from Covid

As the Prime Minister Narendra Modi announced vaccination for children belonging to the age group between 15 to 17 years, Bharat Biotech’s Covaxin Covid-19 vaccine got the Drug Controller General of India (DGCI) approval for emergency use for children in the 12 to 18 years age group. The Subject Expert Committee recommended DGCI to grant emergency use to Covaxin for children.

With this Covaxin became the second vaccine to receive a nod from the authoritative body in India for emergency use among children aged between 15 and 17 years of age. The first one is Zydus Cadila three-dose jab which was allowed all above 12 years of age. India too is now on the list of countries who have approved Covid vaccination for children.

Zydus Cadila’s Zycov-D

Zycov-D was the first vaccine to get DGCI nod in August. It is the world’s first and India’s indigenously developed DNA based vaccine against Covid-19. The generic drug maker reported an efficacy rate of 66.6% in a late-stage trial of over 28,000 volunteers nationwide.

The company, as of August, aimed at manufacturing 100 million to 120 million doses annually and has started to stockpile the vaccine.

Vaccines for children under trail or waiting for nod

The Minister of State for Health Bharati Pawar informed the Parliament at the winter session that Serum Institute of India is conducting Phase II/III clinical trials of Nanoparticle Vaccine (liquid), Covovax on 920 subjects. Moreover, Biological E Ltd is also conducting trials for the receptor binding domain of the SARS-CoV-2 gene on 624 subjects.

Serum Institute’s Covovax

SII, one of the world’s biggest manufacturers, sent an application to the DGCI in October for the grant of market authorisation of Covavax for restricted use in emergency situations but the apex body has raised queries and sought more details on the Matrix component used in the vaccine. SII has meanwhile exported 2 crore doses of Covovax to Indonesia .

The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trials conducted in the country as well as interim clinical trial data of safety and efficacy from phase-3 clinical trials conducted in the UK and the US.

Biological E’s Corbevax

Biological E has received approval from DGCI to conduct Phase II/III clinical trials of its receptor binding domain protein subunit Covid-19 vaccine, Corbevax, on children aged 5 to 18 years with certain conditions.

The subject expert committee has asked the company to get the safety data of the first 100 participants in the age group of 12-18 years evaluated by the Data & Safety Monitoring Board) and submit the results to CDSCO before proceeding to the Phase III part of the trials. The company undergoing Phase III trials will apply for emergency use authorisation soon.

In June, The Union Ministry of Health and family welfare booked 30 crore doses of Corbevax.

Johnson and Jonson

USA’s Johnson & Johnson (J&J) has sought the Indian drug regulator’s permission to test its Covid-19 vaccine on the 12 to 17 age group in August. Studies have shown the J&J vaccine has 66 percent efficacy against preventing moderate to severe Covid-19, and about 85 percent efficacy against severe cases.

Covid-19 vaccine in rest of the world

In China, Sinopharm and Sinovac have been approved for children as young as three. Pfixer’s BioNTech will be administered to children between age 5 to 11 in Singapore, Malaysia, Italy, Germany, Norway, Britain, the United States, Columbia, and in Middle Eastern countries like UAE, Israel, Egypt, Bahrain.