Serum gets nod for Novavax trial in 7-11 age group
What's the story
The Serum Institute of India (SII) has received the approval to conduct trials of the Novavax COVID-19 vaccine in children aged between seven and 11 years.
The Drugs Controller General of India (DCGI) on Tuesday gave the green signal to the company, sources told the media.
The move is significant because India now looks to protect children as they start returning to schools.
Details
SII currently testing the vaccine in 12-17 group
"After detailed deliberation, the committee recommended for allowing enrollment of subjects of 7-11 years of age group as per the protocol," a subject expert panel of the Central Drugs Standard Control Organisation (CDSCO) said, according to Reuters.
Notably, the SII is currently conducting a trial of Novavax's shot in the 12-17 age group. Safety data for the first 100 participants has already been presented.
Trials
Novavax to be tested on children aged 2 and above
Trials of the Novavax vaccine, called Covovax in India, will be conducted on children aged two and above.
The next set of trials will include two to six-year-olds and roughly 920 children will be covered overall.
However, approval for the youngest group is still awaited.
The blinded, randomized, placebo-controlled study is aimed at testing the immunogenicity, tolerability, and safety of the said vaccine.
Vaccine
Jab is safe and over 90% effective, firm says
Novavax, a firm based in Maryland, United States, says its COVID-19 vaccine is safe and over 90% effective.
It cited results from a Phase-III clinical trial of nearly 30,000 participants, conducted across the US and Mexico.
It is a recombinant nanoparticle protein-based COVID-19 vaccine and involves two 0.5 ml doses given intramuscularly, 21 days apart.
The jab is stored at 2-8 degree Celsius.
Other updates
Novavax, SII recently applied for WHO approval
Last week, Novavax and Serum said they had applied for an Emergency Use Listing (EUL) of the vaccine with the World Health Organization (WHO).
The approval is mandatory to allow the export of the vaccine.
Novavax and SII have collective commitments to provide more than 1.1 billion doses to COVAX, a global vaccine distribution program supported by the WHO.
Vaccination
Other vaccines for children in India
Presently, Zydus Cadila's vaccine is the only one to be approved for use in children in India.
However, it is yet to be launched over supply and pricing issues.
Bharat Biotech has also completed COVAXIN's trials on children and is currently analyzing the data.
India has administered over 86 crore vaccine doses and aims to inoculate a billion people by this year.