Manas Dasgupta
NEW DELHI, Oct 12: Finally a vaccine for the children has arrived. The subject expert committee on Covid-19 vaccines has recommended the national drug regulator to grant an emergency use authorisation to Bharat Biotech’s Covaxin for the 2-18 age group, the union health ministry sources said on Tuesday.
In another significant development, the centre has decided to withdraw all restrictions on the domestic flights with effect from October 18 as India hit the lowest new case records which was just above 14,000 cases, according to the data released by the health ministry on Tuesday morning.
The clearance given for Covaxin has come at a time when the drug regulator has already approved Zydus Cadila’s DNA Covid-19 vaccine for children aged above 12. With the clearance given for Covaxin, vaccines would now be available for all age group of people in the county.
The recommendation of the SEC regarding Covaxin is based on the pediatric study, that is evaluating the safety, reactogenicity, and immunogenicity of Covaxin. It is being conducted at six sites across the country in healthy volunteers above the age of 2 years, health ministry sources said. The third vaccine that is being tested in children in India is the Covavax that will be manufactured by the Pune-based Serum Institute of India.
The trials of Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine – NVX-CoV2373 – in India is being branded as Covavax by SII. The trials will be conducted across 23 sites across the country. The fourth vaccine that is being tested in children in India is the Hyderabad-based Biological E’s Corbevax. The trials are expected to take place at ten sites across the country.
The Subject Expert Committee (SEC) has submitted its recommendation to the Drugs Controller General of India (DCGI) for granting emergency use authorisation (EUA) to Bharat Biotech’s Covaxin for 2-18 year olds.
According to a senior Central Government official, the Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 in September and submitted the trial data to the DCGI.
The trial was done on three age groups – 2-6, 6-12 and 12 -18.
Experts noted that two doses of Covaxin could be administered to children within a gap of 28 days. For adults, the government has set a 4-6 weeks between the two shots.
“This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group,” a Bharat Biotech statement noted. The company was awaiting further regulatory approvals from the CDSCO prior to product launch and market availability of the vaccine, it added.
India recorded 14,313 fresh coronavirus cases, the lowest in 224 days, taking the infection tally to 3,39,85,920 on Tuesday, while the national Covid recovery rate increased to 98.04%, according to the Union Health Ministry’s data.
The government has announced that the Airlines can operate domestic flights without any capacity restriction from October 18 onwards, the Ministry of Civil Aviation announced on Tuesday keeping in mind the “passenger demand for air travel.” The carriers have been operating 85 % of their pre-COVID domestic services since September 18.
Meanwhile, the Japanese government is learnt to be working on kickstarting COVID-19 booster shots by year-end, deputy chief cabinet secretary Yoshihiko Isozaki said at a news conference on Tuesday. He added that details such as who would get booster shots first and how they would be administered were currently under discussion. New Prime Minister Fumio Kishida told parliament earlier on Tuesday that he plans to have the booster shots publicly funded.
New Zealand expects to administer a record 100,000 COVID-19 vaccine doses in a single day during a mass immunisation drive on October 16, Prime Minister Jacinda Ardern said, as she seeks to accelerate inoculations before easing curbs in Auckland.
Ms. Ardern on Tuesday urged the country’s population over 12 years of age “to roll up sleeves for New Zealand and help make us [one of] the most vaccinated and therefore protected countries in the world”. Some 2.44 million, or 58% of the population over 12, have been fully vaccinated so far.