Government should make available COVID-19 data, including vaccine regulatory approvals and policy
on 25th December, Prime Minister of India announced two major decisions, First, all the children 15-17 age group will be eligible to receive the COVID-19 vaccine From January 3, 2022. second, all health care workers, frontline workers and people 60 years of age and older (with co-morbidities and on the advice of a physician) can receive the third shot, or ‘Precautionary dose’, The policy decision was followed by a note, which was issued on December 27, outlining the operational details. The eligibility for a precautionary dose will be at the end of nine months or 39 weeks after the second dose. The note did not mention which vaccine would be administered as a precaution. Adolescent children who are born in 2007 or earlier will be eligible for COVID-19 vaccines. The reason children will get Covaxin (as of note) is because The Emergency Use Only Listed (EUL) World Health Organization vaccine is 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 on ‘scientific evidence’. According to media reports, in the fourth week of December, the Kovid-19 Vaccine Sub-Group of the National Technical Advisory Group on Immunization (NTAGI) in India was to review the data on scientific evidence. booster shots and vaccination of children, the meeting was postponed to a later date. Some members of the NTAGI have written or spoken publicly about the insufficient scientific evidence to provide booster doses and vaccinations to children in India. The term ‘precautionary dose’ is being treated as a tacit acknowledgment of insufficient evidence. What is the other explanation for not calling it a ‘booster dose’?
These two decisions make about 7.5 crore children eligible for primary immunization and three crore health care and frontline workers and 100 million elderly persons eligible for precaution. Individuals will become eligible for the precautionary dose on a rolling basis, and on the first day of the roll-out (January 10, 2022), around one crore health care and frontline workers and 1.4 million from a population of over 60 will be eligible. , Thereafter, every next day, around 3,00,000 to 4,00,000 persons would be added for the precautionary dose.
vaccination of children
Successive national and state-level sero-surveys have reported that most of the children in India contracted the natural infection during their stay at home and thus developed antibodies. Studies have shown that children rarely develop moderate to severe COVID-19 illness. The emergence of the Omicron variant of COVID-19 did not appear to change the risk in children. It is against this background that the benefits of vaccination to children are limited, and they are considered low in order of priority for COVID-19 vaccination.
Most public health and vaccine experts support a ‘targeted immunization approach’ by prioritizing high-risk children for COVID-19 vaccination. However, such an approach may face an operational challenge in the identification of eligible children. The alternative is to ‘vaccinate all children in the younger age-subgroup’ with the benefit of administrative simplicity. The government has adopted another method.
According to a note issued on December 27, persons aged 60 years and above with comorbidities will be provided with a precautionary dose on the advice of a doctor. This makes vaccination a two-stage process: first consultation and then vaccination. This extra step could prove to be an access barrier and people could defer vaccination decisions. For COVID-19, all elderly are at greater risk. Therefore, there is no practical sense in choosing specific health conditions for precautionary dosing.
There is another major concern. Most of the elderly have one or the other co-morbidities. Out of the 140 million elderly population in India, an estimated 7 to 10 crore people may have co-morbidities. If they have to consult a doctor for vaccination, it essentially means up to 10 crore medical consultations, which will come at a cost – indirect (travel time and opportunity cost for individuals) and an avoidable health care system. burden) and direct costs (if the private sector participates), all of which are avoidable.
make it work
Now that a policy decision has been taken, a few things need to be taken into account to make its implementation effective. Firstly, the need for a doctor’s prescription/prescription for co-morbid conditions and ‘precautionary pill’ in the elderly should be addressed. If there is a need to uphold the condition of comorbidity because of any scientific evidence – which the government has used in decision making – then it should only be a self-declaration without the need for a doctor’s advice.
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Second, there is scientific evidence and consensus on a third dose for immunocompromised adults. The Indian government should urgently consider a third dose for all immunocompromised adults, regardless of age.
Third, studies have found that a heterogeneous prime-boost approach — a third shot on a different vaccine platform — is a better approach. Of all the alternatives, while mRNA-based vaccines have the best promotion effect, the shortcoming is that they are not available in India. However, Kovovax (called Novovax’s recombinant protein nanoparticle-based vaccine in India) has received the EUL from the World Health Organization and is being produced in India. Another protein-based vaccine, Corbevax, is being developed in India by Biologic E Ltd. The manufacturer of Corbevax has submitted trial data on a rolling basis to the Central Drugs Standard Control Organization (CDSCO) in India. The Indian government has already entered into an ‘advance purchase agreement’ with the manufacturer of Corbevax. On 28 December, Covovax and Corbevax were approved in India for restricted use in an emergency (https://bit.ly/3Hhb055). a recent study the Lancet 20 have reported that the use of a protein-based vaccine as a third dose would have a better promoting effect than a third shot of the same vaccine on a viral-vector or inactivated vaccine platform. With approval for emergency use of two additional vaccines, India should consider giving an approved protein-based vaccine as a precautionary dose.
Fourth, the various pending policy questions on the COVID-19 vaccine need to be urgently identified. Technical experts should be given full access to COVID-19 data for analysis and to find answers to those scientific and policy questions. Additional studies should be initiated immediately with primary data collection for policy issues that cannot be answered by existing data. This is the only way to be sure that future COVID-19 vaccination decisions are based on scientific evidence and not just ‘assumptions’, ‘opinions’ or ‘advice’.
Fifth, vaccination for adolescent children, especially Covaxin (which means 150 million doses for this sub-group) has other implications. Covaxin will also be needed for people coming in for their first shot, for those returning for their second shot, and then for their ‘precautionary dose’ if a third shot of the same vaccine is allowed. This should be an immediate reminder to review vaccine supply and better vaccine stock management.
Finally, preventive dosing and immunization for children should not distract from the task of primary immunization, which is an incomplete task in India; For the first and second shots, 46 crore doses are needed now.
data for decision making
It was not that there would never have been a need for booster doses or vaccinations for children. The conversations before the policy announcement on 25 December were more nuanced, about the right timing (when to start), the right interval (between the second dose and the booster) and the right vaccine selection (with the proven benefits in the form of boosters). was in This was partly delayed due to non-availability of COVID-19 related data to synthesize the evidence and arrive at an informed decision.
The time has come for the central and state governments in India to make COVID-19 data – this includes clinical results, tests, genomic sequencing as well as vaccinations – available in the public domain. It will help formulate and update COVID-19 policy and strategies and assess the impact of ‘precautionary dosing’ as well as immunization of children.
It is also time that once technical and regulatory decisions are made, relevant scientific evidence should be made available in the public domain. The Indian government urgently needs to make available COVID-19 data, including data used for regulatory approvals of vaccines and for vaccine policy decisions. This will bring transparency in decision making and increase the confidence of citizens in the process.
Dr. Chandrakant Laharia, a physician-epidemiologist, is a public policy and health systems specialist based in New Delhi
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