Expansion of vaccination drive to incorporate minors doesn’t pose security danger to recipients, Government tells SC

By PTI

NEW DELHI: The growth of COVID-19 vaccination drive to incorporate the paediatric inhabitants “does not pose a safety risk” to the vaccine recipients, the Centre instructed the Supreme Court on Tuesday whereas referring to knowledge as per which 8.91 crore doses of Covaxin has been administered within the age group of 15-18 years as on March 12.

It mentioned that within the age group of 15-18 years, the variety of opposed occasions following immunization (AEFI) reported are — 1,739 (minor), 81 (severe) and 6 (extreme).

The Centre instructed a bench of Justices L N Rao and B R Gavai that desirability or in any other case of vaccinating kids is a choice within the govt area taken by the federal government as per the recommendation of area specialists and, subsequently, will not be subjected to judicial overview.

The high court docket is listening to arguments on a plea looking for instructions for disclosure of information on medical trials of COVID-19 vaccines and post-jab circumstances.

“It is relevant to note that as on March 12, 2022, 8,91,39,455 doses of Covaxin have been administered in the 15-18 years age group. In this age group, the number of AEFIs reported are 1,739 (minor) (0.014 per cent), 81 (serious) (0.0009 per cent) and 6 (severe) (0.00001 per cent),” Solicitor General Tushar Mehta and Additional Solicitor General Aishwarya Bhati mentioned of their temporary submission on behalf of the Centre.

“It is evident from this data that the expansion of vaccination drive to include the paediatric population does not pose a safety risk to the vaccine recipients,” the Centre mentioned.

It handled the petitioner’s submission concerning severe opposed occasions in kids in age group 15-18 who’ve been vaccinated in different international locations. “The so-called severe opposed occasions in kids referred therein are with regard to mRNA vaccines. These vaccines are utterly completely different from the vaccines being administered in India. At the current second, India is just not administering mRNA vaccines,” the federal government mentioned.

“This fact coming from a person claiming to have special knowledge of the subject clearly reflects intentional attempt to mislead,” it mentioned.

It mentioned the query of paediatric vaccination was taken up at a stage the place greater than substantial knowledge on security and immunogenicity of Covaxin in adults was accessible and with a view to not taking any danger, medical trials had been additionally carried out in a restricted variety of kids as per the protocol accredited by the area specialists.

“Having found no serious adverse event in above referred trials, the paediatric vaccination was initiated in a phased manner i.e. starting from the eldest paediatric age ground i.e. 15 to 18 years,” the Centre mentioned.

It mentioned all these choices had been taken by the topic skilled committee (SECs) periodically which included specialists from varied area specialities and the choice making was primarily based upon skilled recommendation.

“The arguments that children are less susceptible to Covid and, therefore, should not be vaccinated, is surprising coming from a person claiming to be an expert. All paediatric vaccines are always preventive in nature and are administered so as to avoid any possible infection and eliminating any potential risk of infection,” it mentioned.

The authorities additionally instructed the apex court docket that there’s rising scientific proof concerning extended medical signs (generally known as “long COVID”) which continues to be underneath scientific research.

It mentioned all world businesses just like the World Health Organisation (WHO), UNICEF, CDC (Centre for Disease Control), USA are emphatically advising for paediatric vaccination in accordance with the worldwide scientific consensus in favour of paediatric vaccination as on date.

The Centre mentioned no nation on this planet has confronted such an unprecedented disaster which is confronted by humanity because of the COVID-19 outbreak since about final 100 years.

It mentioned as on March 13 this yr, a complete of over 180 crore doses of COVID-19 vaccines has been administered within the nation and 77,314 opposed occasions, which involves 0.004 per cent, have been reported.

The authorities instructed the bench that minor AEFI are occasions similar to ache at injection web site, delicate fever, swelling at injection web site and many others and these results are self-limiting in nature and resolve on their very own inside a day or two.

It mentioned extreme AEFI are occasions similar to excessive fever of 102 diploma and above and anaphylaxis, a extreme, doubtlessly life-threatening allergic response which must be clinically handled.

The Centre mentioned severe AEFI are these which can end in dying, hospitalization, persistent or important incapacity and cluster occasion.

“Furthermore, medical treatment is being provided free of cost to beneficiaries who suffer AEFIs in all government health institutions. States/UTs have been asked to identify at least one AEFI management centre in each block,” it mentioned.

On the problem raised within the plea concerning disclosure of segregated medical trial knowledge, the Centre mentioned that by the very nature of the subject material, there’s a confidentiality connected to sure elements of the medical trial course of which can’t be compromised underneath the legislation.

It mentioned as far as the uncooked or segregated knowledge generated at trial websites are involved, the mentioned knowledge is all the time known as for and examined earlier than grant of both emergency use approval or closing approval by the statutory committee of area specialists and by the approving authority.

The plea has sought instructions to make public the segregated knowledge of medical trials for vaccines which might be being administered in India underneath the emergency use authorisation granted by the Drugs Controller General of India.

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