The Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO) has given its nod to Bharat Biotech’s Covaxin for children in the age group of 2-18, news agency ANI reported quoting official sources. The expert committee has sent the recommendation to the Drugs Controller General of India (DCGI), which is expected to give its go-ahead soon. Developed by the Hyderabad-based Bharat Biotech in a collaboration with the Indian Council of Medical Research (ICMR), Covaxin is India’s indigenous vaccine and is currently being administered to adults.
Bharat Biotech had conducted phase 2 and 3 clinical trials of its COVID-19 vaccine on children below the age of 18. The trials were completed in September 2021 and the company had submitted its results to the DGCI at the start of this month. As it is expected to get the DGCI’s nod soon, let us take a look at what we know so far.
Covaxin For Kids
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- It isn’t known yet when the COVID-19 immunisation drive for children will begin. However, several media houses have reported that children with underlying health issues might get vaccinated starting October-November. But, there has been no official confirmation yet.
- The paediatric Covaxin is different from the one being given to adults. As per News18, the paediatric Covaxin will be administered using a pre-filled syringe, which is known to be more accurate than its multi-dose vial counterpart.
- The dosage will be the same, i.e. 0.5 ml.
- However, in the case of vials, the dosage is often inaccurate, as at times it gets more or less than the recommended dosage of 0.5 ml. This is especially crucial for young children, who might not be able to withstand the more than recommended dose.
- Taking to Twitter, Bharatiya Janata Party (BJP) MP PC Mohan wrote that Covaxin had received the recommendation of the SEC. It will use the PFS mechanism and the two doses will be given in the gap of 28 days. “Congratulations India,” he tweeted.
The Subject Expert Committee (SEC) approves paediatric #Covaxin for children between 2-18.— P C Mohan (@PCMohanMP) October 12, 2021
The paediatric Covaxin will use a pre-filled syringe or PFS mechanism.
Children will receive two doses of the vaccine separated by 28 days.
Congratulations India ���� pic.twitter.com/k1DlsjDGwm
More About Covaxin
Here is all you need to know about Covaxin:
- Covaxin is India’s first indigenous COVID-19 vaccine.
- It is administered in two doses in a gap of four to six weeks.
- The vaccine showed 93.4% efficacy against severe symptomatic COVID-19 cases, the Hyderabad-based company said following the phase 3 clinical trials. It is 63.6% effective in the case of symptomatic COVID cases. It was also found to be 65.2% effective against the highly virulent delta variant, which wreaked havoc in India when the country was hit by the ferocious second COVID wave in April-June.
- The vaccine, just like many other COVID-19 vaccines uses the dead version of the virus to initiate an immune response.
- It got the DCGI’s nod for adults on January 3 this year. At the time, the vaccine got in the centre of some criticism due to the absence of phase 3 clinical trial data.
Covaxin is not the first COVID-19 vaccine to be approved for kids. In August, Ahmedabad-based Zydus Cadila three-dose vaccine, ZyCov-D, had received the DCGI’s recommendation for those aged 12 and above. However, its use hasn’t started yet. Pune-based Serum Institute of India (SII) has also started the clinical trials of Covovax for children in the age group of 7 to 11. The vaccine isn’t India’s indigenous and has been developed by the American pharmaceutical firm Novavax.