The Decks are being cleared for children to be included in India's Covid vaccination campaign, with the government's Subject Expert Committee (SEC) proposing the grant of an Emergency Use Authorisation (EUA) for Bharat Biotech's Covaxin in the age group of 2-18 years on Tuesday.
With the SEC's recommendation to the Drug Controller General of India (DGCI), India is only one step away from formally approving the vaccination for children. According to sources, the DGCI is anticipated to approve the SEC's suggestion soon, possibly putting another 25 crore people inside the vaccine umbrella.
Bharat Biotech is also anticipating a decision from WHO on its separate application for EUA of Covaxin in adults.
Globally, the SEC's green signal is first issued by an expert panel of a national regulator for the 2-18 age group. On October 26, a US expert panel is set to examine a request from pharma giant Pfizer for EUA of its Covid vaccine in the age group of 5-12 years in that nation.
So far, India has authorized Zydus Cadila's vaccination for children above the age of 12. Pfizer's double dose has been suggested for children aged 12 and above in the United States and a single dose for the same age group in the United Kingdom. The UK authority has also authorized Moderna's vaccination for people over the age of 12.
Bharat Biotech, located in Hyderabad, welcomed the SEC clearance, saying, "This constitutes one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group. We are now awaiting additional regulatory approvals from the CDSCO (Central Drugs Standard Control Organization) before launching Covaxin for children and making it available NI the market."
The SEC decision will have far-reaching public health consequences, with schools and universities reopening in phases around the country. Once the DGCI gives a green flag, the next critical step would be to identify priority groups among individuals aged 2 to 18, such as those with comorbidities.
"Because this is the first time this has happened, there is a chance that the drug regulator may impose certain restrictions when it grants the EUA. There may be a regulation that vaccinations should take place exclusively in health facilities or under a certain level of surveillance," sources added.
Once the formal EUA clearance is given, the high-powered National Expert Group on Vaccine Administration for Covid-19 (NEGVEC) "will make a final decision on which category of children will be prioritized for vaccination," according to sources.
On October 4 the final decision on Covid vaccination for children will be made in the first half of this month, including rules on which categories would be prioritized and a timetable.
India has administered a total of 96.33 crore doses of Covid vaccinations across the country and is anticipated to surpass the 100 crore milestone in the coming days. Official figures show that 73% of the projected adult population has gotten the first dosage, while 29% is completely vaccinated.
According to the statistics, approximately 11.08 crore cumulative doses of Covaxin have been delivered in the nation so far. Bharat Biotech, on the other hand, has yet to acquire EUA from the WHO, which would allow Covaxin recipients to travel abroad without strict constraints.
According to company sources, WHO will make a final decision "within the next few days". They stated that the international body's Strategic Advisory Group (SAGE) has finished its assessment and that another expert group would meet soon to evaluate technical matters.
The SAGE on Immunization held a meeting from October 4-7 and assessed Covaxin on October 5.
During the review, Bharat Biotech gave a 30-minute presentation on safety and efficacy data from clinical trial results as well as post marketing. According to SAGE, "a policy recommendation will be provided when the vaccine is Emergency Use listed by WHO."
