The Center said no country has experienced such an unprecedented crisis facing humanity as a result of the COVID-19 outbreak in about 100 years.

The extension of the vaccination campaign against COVID-19 to the pediatric population “does not pose a safety risk” to vaccine recipients, the Center told the Supreme Court on Tuesday, citing data according to which 8.91 crore doses of Covaxin have been administered in the age group. aged 15-18 as on March 12.

It said that in the 15-18 age group, the number of reported adverse reactions after immunization (AEFI) is 1,739 (minor), 81 (severe) and six (severe).

The Center told a court of Judges LN Rao and BR Gavai that the desirability or otherwise of vaccinating children is an executive domain decision taken by the government on the advice of domain experts and therefore cannot be subject to judicial review.

The highest court hears arguments over a plea asking for directions for disclosure of data on clinical trials of COVID-19 vaccines and post-shot cases.

“It is pertinent to note that as of March 12, 2022, 8,91,39,455 doses of Covaxin were administered in the age group of 15-18 years. In this age group, the number of reported AEFIs is 1,739 (minor) (0.014 percent), 81 (severe) (0.0009 percent) and 6 (severe) (0.00001 percent)’, Advocate General Tushar Mehta and Additional Solicitor General Aishwarya Bhati said in their short submission on behalf of the Center.

“These data clearly demonstrate that extending the vaccination campaign to the pediatric population poses no safety risk to vaccine recipients,” the Center said.

It addressed the petitioner’s submission concerning serious adverse events in children aged 15-18 years who have been vaccinated in other countries.

“The so-called serious side effects in children mentioned therein relate to mRNA vaccines. These vaccines are completely different from the vaccines administered in India. India is currently not administering mRNA vaccines,” the government said.

“This fact, coming from a person who claims to have special knowledge of the subject, clearly reflects a deliberate attempt at deception,” it said.

It said the issue of pediatric vaccination was taken up at a stage where more than substantial data on the safety and immunogenicity of Covaxin in adults were available and, in order not to take any risks, clinical trials were also conducted in a limited number of children, as according to the protocol approved by the domain experts.

“After no serious side effects were found in the above studies, pediatric vaccination was started in phases, ie from the oldest pediatric age, namely 15 to 18 years,” the Center said.

It said all of these decisions were periodically made by the subject matter expert committee (SECs), which was made up of experts from different domain specialties, and that the decision-making was based on expert advice.

“The arguments that children are less susceptible to Covid and therefore should not be vaccinated are surprisingly coming from a person who claims to be an expert. All pediatric vaccines are always preventive in nature and administered to prevent any potential infection and rule out any potential risk of infection,” it said.

The government also told the highest court that there is growing scientific evidence regarding long-term clinical symptoms (known as “long COVID”) that are still being studied scientifically.

It said that all global agencies such as World Health Organization (WHO), UNICEF, CDC (Centre for Disease Control), US strongly advise for pediatric vaccination in accordance with the global scientific consensus in favor of pediatric vaccination as of date.

The Center said no country in the world has faced such an unprecedented crisis that humanity has been facing for about 100 years as a result of the COVID-19 outbreak.

It said that as of March 13 this year, a total of more than 180 crore doses of COVID-19 vaccines have been administered in the country and 77,314 side effects, representing 0.004 percent, have been reported.

The government told the bank that minor AEFI are events such as injection site pain, mild fever, injection site swelling etc. and these effects are self-limiting in nature and will disappear on their own within a day or two.

It said serious AEFI events include a high fever of 102 degrees and above and anaphylaxis, a serious, potentially life-threatening allergic reaction that needs clinical treatment.

The Center said severe AEFI are those that can lead to death, hospitalization, persistent or significant disability and cluster events.

“In addition, medical treatment is provided free of charge to beneficiaries suffering from AEFIs in all government health facilities. States/UTs have been asked to identify at least one AEFI admin center in each block,” it said.

On the issue raised in the plea regarding the disclosure of segregated clinical trial data, the Center said that due to the nature of the subject, there is a confidentiality associated with certain parts of the clinical trial process that are not may be compromised under the law.

It said that with regard to the raw or segregated data generated at pilot sites, the said data is always requested and examined before emergency use approval or final approval is given by the legal committee of domain experts and by the approving authority.

The plea has asked for instructions to make public the segregated data from clinical trials for vaccines administered in India under the emergency use license granted by the Drugs Controller General of India.

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