Expanding vaccination campaign to include minors poses no safety risk to recipients, government tells Supreme Court


New Delhi: Expanding the COVID-19 vaccination campaign to include the pediatric population “does not pose a safety risk” to vaccinees, the Center told the Supreme Court on Tuesday while referring to data that 8, 91 crore doses of Covaxin were administered in the 15-18 age group as of March 12.
He said that in the 15-18 age group, the number of adverse events after vaccination (AEFI) reported were – 1,739 (minor), 81 (serious) and six (serious). The Center told a panel of judges LN Rao and BR Gavai that whether or not to vaccinate children is a decision in the executive realm made by the government on the advice of experts in the field and, therefore, cannot not be subject to judicial review.

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The higher court is hearing arguments on a plea seeking directions for the disclosure of data on clinical trials of COVID-19 vaccines and post-jab cases.

It is relevant to note that as of March 12, 2022, 8,91,39,455 doses of Covaxin have been administered in the 15-18 age group. In this age group, the number of reported AEFIs is 1,739 (minor) (0.014%), 81 (severe) (0.0009%) and 6 (severe) (0.00001%), the Solicitor General Tushar Mehta and Additional Solicitor General Aishwarya Bhati said in his brief presentation on behalf of the Center.

“These data indicate that expanding the vaccination campaign to include the pediatric population does not pose a safety risk to vaccinees,” the Center said. It dealt with the petitioner’s observation regarding serious adverse events in children aged 15 to 18 who had been vaccinated in other countries.

The so-called serious adverse events in children mentioned there relate to mRNA vaccines. These vaccines are completely different from the vaccines administered in India. Currently, India does not administer mRNA vaccines. This fact from a person claiming to have special knowledge of the subject clearly reflects an intentional attempt to mislead, the government said.

He said the issue of pediatric vaccination was addressed at a stage when more than substantial data on the safety and immunogenicity of Covaxin in adults were available and in a bid to be on the safe side, clinical trials were also conducted in a limited number of children as per the protocol approved by experts in the field.

Having found no serious adverse events in the trials mentioned above, pediatric vaccination was initiated gradually, i.e. starting with the oldest pediatric age, i.e. say 15 to 18 years old, the Center said.

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He said all such decisions were made periodically by the Subject Matter Expert Committee (SEC), which included experts from various domain specialties and that decision-making was based on expert advice.

Arguments that children are less susceptible to Covid and therefore should not be vaccinated are surprising coming from someone claiming to be an expert. All pediatric vaccines are always preventive in nature and are administered in a way that avoids any possible infection and eliminates any potential risk of infection, he said.

The government also told the high court that there is growing scientific evidence regarding prolonged clinical symptoms (known as “long COVID”) which are still being studied scientifically. He said that all global agencies such as World Health Organization (WHO), UNICEF, CDC (Centers for Disease Control), USA categorically recommend pediatric vaccination in line with global scientific consensus in favor of pediatric vaccination to date.

The Center said that no country in the world has faced such an unprecedented crisis facing humanity due to the COVID-19 outbreak for about 100 years.

He said that on March 13 this year, a total of over 180 crore doses of COVID-19 vaccines were administered in the country and 77,314 adverse events or 0.004% were reported.

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

He said severe AEFIs are events such as high fever of 102 degrees and above and anaphylaxis, a serious, life-threatening allergic reaction that must be treated clinically.

The Center said severe AEFIs are those that can result in death, hospitalization, persistent or significant disability, and a cluster event.

In addition, free medical treatment is provided to beneficiaries who suffer from AEFI in all public health institutions. States/UTs were asked to identify at least one AEFI management center in each block, he said.

On the issue raised in the plea regarding the disclosure of separate clinical trial data, the Center stated that, by the very nature of the subject matter, there is confidentiality attached to certain parts of the clinical trial process that do not may be compromised under the law.

He stated that with respect to raw or segregated data generated at trial sites, said data is always requested and reviewed prior to granting emergency use approval or final approval by the statutory committee of experts in the field and by the approval authority.

The advocacy asked for instructions to make public the separate clinical trial data for vaccines that are administered in India under the Emergency Use Authorization granted by the Comptroller General of Medicines of India.

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NDTV – Dettol has been working for a clean and healthy India since 2014 through the Banega Swachh India initiative, which is led by campaign ambassador Amitabh Bachchan. The campaign aims to highlight the interconnectedness of humans and the environment, and of humans to each other, with a focus on One Health, One Planet, One Future – Leaving No One Behind. It emphasizes the need to care for and consider the health of everyone in India – especially vulnerable communities – the LGBTQ population, indigenous peoples, various Indian tribes, ethnic and linguistic minorities, people with disabilities, migrants, geographically distant populations, gender and sexual minorities. As a result of the current COVID-19 pandemic, the need for WASH (water, sanitation and hygiene) is reaffirmed as hand washing is one of the ways to prevent coronavirus infection and other diseases. The campaign will continue to raise awareness on the same topic while focusing on the importance of nutrition and health care for women and children, the fight against malnutrition, mental well-being, self-care, science and health, adolescent health and gender awareness. Along with the health of people, the campaign realized the need to also take care of the health of the ecosystem. Our environment is fragile due to human activity, which not only overexploits available resources, but also generates immense pollution due to the use and extraction of these resources. The imbalance has also resulted in an immense loss of biodiversity which has caused one of the greatest threats to human survival – climate change. It has now been described as a “code red for humanity”. The campaign will continue to cover issues such as air pollution, waste management, plastic bans, manual garbage collectors and sanitation workers and menstrual hygiene. Banega Swasth India will also pursue the dream of Swasth Bharat, the campaign believes that only a clean Swachh or India where toilets are used and Open Defecation (ODF) status is achieved under the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like Diahorrea and the country can become a Swasth or a healthy India.

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