Context

The Government must make COVID-19 data including that for vaccine regulatory approvals and policy available.

Kay decisions

• On December 25, the Prime Minister of India announced two key decisions.
• Vaccination of children: All children in the 15-17 age bracket will be eligible to receive COVID-19 vaccines from January 3, 2022.
• Third shot: All health-care workers, frontline workers and the people aged 60 years and above (with co-morbidities and on the advice of a medical doctor) can get a third shot, or ‘precaution dose’.
•  The eligibility for the precaution dose will be on the completion of nine months or 39 weeks after the second dose.
• Teenage children whose birth year is 2007 or before will be eligible for COVID-19 vaccines.
• Children will receive Covaxin, the reason being (according to the note) it is the only emergency use listed (EUL) World Health Organization vaccine available for use in this age group in India.

Issues with the decision

• Lack of scientific evidence: The decision is said to be based on ‘advice of the scientific community’.
• A few members of the National Technical Advisory Group on Immunisation (NTAGI) in India,  have written or spoken publicly about not having enough scientific evidence to administer booster doses and vaccinate children in India.
• Successive national and State-level sero-surveys have reported that a majority of children in India had got natural infection, while staying at home and thus developed antibodies.
• The studies have shown that children rarely develop moderate to severe COVID-19 disease.
• Targeted vaccination approach not adopted: Most public health and vaccine experts favour a ‘targeted vaccination approach’ by prioritising high-risk children for COVID-19 vaccination.
• However, such an approach is likely to face an operational challenge in the identification of the eligible children.
• Consultation cost:  A majority of the elderly have one or other comorbidities. Of the 14 crore elderly population in India, an estimated 7 to 10 crore people could have co-morbidities.
•  If they have to seek advice from a physician, in order to get vaccinated, this essentially means that there would be up to 10 crore of medical consultations, which would come at a cost —  all of which is avoidable.

Suggestions

• Do away with prescription: The conditionality of comorbidities and the need for advice/prescription by a doctor for ‘the precaution shot’ in the elderly should be done away with.
• Third dose to all immunocompromised adults: There is scientific evidence and consensus on administering the third dose for immunocompromised adults.
• The Indian government should urgently consider administering a third dose for all immunocompromised adults, irrespective of age.
• Third dose on a different vaccine platform: Studies have found that a heterologous prime-boost approach — third shot on a different vaccine platform — is a better approach.
• Identify policy questions: Various pending policy questions on COVID-19 vaccine need to be identified urgently.
• The technical expert should be given complete access to COVID-19 data for analysis and to find answers to those scientific and policy questions.
• Vaccine supply and stock management: Vaccination for teenage children, exclusively with Covaxin (which means 15 crore doses for this sub-group) has other implications.
• Covaxin will also be needed for people coming for their first shot, returning for their second shot, and then for their ‘precaution dose’ if a third shot of the same vaccine is allowed.
• Focus on primary vaccination: The precaution dose and vaccination for children should not divert attention from the task of primary vaccination, which continues to be an unfinished task in India; 46 crore doses are still needed for the first and second shots.
• Make data public: It is time the Union and State governments in India make COVID-19 data — this includes clinical outcomes, testing, genomic sequencing as well as vaccination — available in the public domain.
• This would help in formulating and updating COVID-19 policy and strategies and also assess the impact of ‘precaution dose’ as well as vaccination of children.

Conclusion

The Indian government urgently needs to make COVID-19 data available, including the one used for regulatory approvals of vaccines and for vaccine policy decisions. This will bring transparency in decision making and increase the trust of the citizen in the process.

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