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Put out the data, boost the dose of transparency

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

December 29, 2021 12:02 am | Updated 07:46 am IST

COVID-19 Vaccine Certificate Icon. Vaccination Document. Vector Illustration

COVID-19 Vaccine Certificate Icon. Vaccination Document. Vector Illustration

On December 25, the Prime Minister of India announced two key decisions . First, all children in the 15-17 age bracket will be eligible to receive COVID-19 vaccines from January 3, 2022. Second, 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 policy decision was followed by a note that was released on December 27, outlining operational details. The eligibility for the precaution dose will be on the completion of nine months or 39 weeks after the second dose. The note did not mention which vaccine would be administered as the precaution 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.

Opinion or evidence

The decision is said to be based on ‘advice of the scientific community’. However, it was not clear whether that advice was based on opinion or ‘the scientific evidence’. If media reports are to be believed, in the fourth week of December, the COVID-19 vaccine sub-group of the National Technical Advisory Group on Immunisation (NTAGI) in India, which was supposed to review the data on the scientific evidence on the booster shot and vaccination of children, had postponed the meeting for a later date. A few members of NTAGI have written or spoken publicly about not having enough scientific evidence to administer booster doses and vaccinate children in India. The term ‘precaution dose’ is being considered as tacit acknowledgement of insufficient evidence. What else explains not calling it a ‘booster dose’?

 

These two decisions make nearly 7.5 crore children eligible for the primary vaccination and three crore health-care and frontline workers and 10 crore of the elderly suitable for the precaution shot. The individuals will become eligible for the precaution dose on the rolling basis, and on day one of the roll-out (January 10, 2022) approximately one crore health-care and frontline workers and 14 lakh of the 60-plus population will be eligible. Thereafter, every subsequent day, approximately 3,00,000 to 4,00,000 individuals will be added for the precaution dose.

Vaccinating children

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. The emergence of the Omicron variant of COVID-19 has not altered the risk in children. It is in this backdrop that the benefits of vaccinating children are limited, and they are considered lower in the order of priority for COVID-19 vaccination.

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. The alternative is ‘vaccinating all children in a small age-subgroup’ with the advantage of administrative simplicity. The Government has opted for the second approach.

 

As per a note released on December 27, persons aged 60 years and above with comorbidities, on doctor’s advice, will be provided with the precaution dose. This makes vaccination a two-step process: first seeking consultation and then getting vaccinated. This additional step could prove an access barrier and people may defer the vaccination decision. For COVID-19, all the elderly are at higher risk. Therefore, it does not make practical sense in picking specific health conditions for precaution dose.

There is another key concern. 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 — indirect (travel time and opportunity cost for individuals and an avoidable burden on the health-care system) and direct cost (if attended in the private sector), all of which is avoidable.

Making it work

Now that a policy decision has been made, there need to be a few considerations taken into account in order to make its implementation effective. First, 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. If the conditionality of comorbidity needs to be retained due to any scientific evidence — which the Government has used in decision making — then it should be a self-declaration only, without the need for a doctor’s advice.

Editorial | More, and for more: On COVID-19 vaccines for children and boosters for the aged

Second, 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, studies have found that a heterologous prime-boost approach — third shot on a different vaccine platform — is a better approach. Among all the options, while mRNA-based vaccines have the best boosting effect, the drawback is that they are not available in India. However, Covovax (as Novovax’s recombinant protein nanoparticle-based vaccine is called in India) has received EUL from the World Health Organization and is being produced in India. Another protein-based vaccine, Corbevax, is being developed by Biological E Ltd. in India. The manufacturer of Corbevax has submitted trial data on a rolling basis to the Central Drugs Standard Control Organisation (CDSCO) in India. The Indian government has already made an ‘advance purchase agreement’ with the manufacturer for Corbevax. On December 28, Covovax and Corbevax were approved in India for restricted use in an emergency situation (https://bit.ly/3Hhb055). A recent study in The Lancet has reported that the use of a protein-based vaccine as third dose, would have a better boosting effect than the third shot of the same vaccine on viral-vectored or inactivated vaccine platforms. With approval for emergency use of two additional vaccines, India should consider administering an approved protein-based vaccine as the precaution dose.

Fourth, 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. Additional studies with primary data collection should be urgently commissioned for those policy issues which can not be answered by existing data. This is the only way to ensure that future COVID-19 vaccination decisions are based upon scientific evidence and not just the ‘assumptions’, ‘opinion’ or ‘advice’.

 

Fifth, 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. This should be an urgent reminder for a review of vaccine supply and better vaccine stock management.

Finally, 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.

Data for decision making

It was not that the booster dose or vaccination of children might have never been required. The discourse before the policy announcement on December 25 was more nuanced, was about the right time (when to start), the right interval (between second dose and the booster) and selecting the right vaccine (with proven benefit as booster). This was getting delayed partly due to the unavailability of COVID-19 related data to synthesise evidence and arrive at an informed decision.

 

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.

It is also time that once technical and regulatory decisions are made, the relevant scientific evidence should be made available in the public domain. 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.

Dr. Chandrakant Lahariya, a physician-epidemiologist, is a public policy and health systems specialist based in New Delhi

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