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Around 10 pm on December 25, 2021, Prime Minister Narendra Modi announced in a televised address that the Union health ministry would roll out COVID-19 vaccines for young adults aged 15-18 years as well as booster doses frontline and healthcare workers and the elderly (if they have a doctor’s certificate).
Since the government didn’t avail officials to elaborate on the decision at the late hour, here are 10 questions the Union health ministry and Prime Minister Modi should answer if the announcement is to make more sense.
1. On December 24, vaccination drive chief Vinod K. Paul, Indian Council of Medical Research chief Balram Bhargava and Union health secretary Rajesh Bhushan had said in a presser that their decisions are guided by science and that there isn’t any scientific basis yet to necessitate paediatric vaccination. Are we to believe the science changed substantially between December 24 evening and December 25 night? If so, what exactly changed?
2. Which vaccines will frontline workers, healthcare workers and the elderly receive as booster doses? What will the rationale be for these decisions considering the Paul-Bhargava-Bhushan triumvirate admitted on December 24 that there haven’t been studies thus far about Covaxin’s efficacy or its benefit as a booster dose – both against the omicron variant?
Addendum: Why has the emergency-approval for the Covavax vaccine, filed by Serum Institute, been delayed? Covovax was developed by Novavax and CEPI, and Novavax transferred the technology to Serum. This question arises because a) the WHO has already listed Covovax on its emergency-use vaccines roster, b) there has been a study from England saying the Covovax-equivalent there has been found to safely boost two doses of the AstraZeneca vaccine, and c) India is already exporting Covovax.
3. Did the Indian government wait to change its policy on vaccinating teenagers until the drug regulator had approved Covaxin for this age group? Because the government had approved Zydus Cadila’s ZyCoV-D for teenagers in August and the evidence for the need to vaccinate children hasn’t changed substantially since.
4. More worryingly, did the Indian government change its policy on vaccinating teenagers only because the drug regulator had approved Covaxin for this age group (considering the evidence at the moment on the need to vaccinate minors is iffy and debatable)? Put another way, if the regulator hadn’t approved Covaxin – no matter how unlikely such rejection – would government officials have continued to say they’re still unconvinced of the need to vaccinate children?
5. Covaxin maker Bharat Biotech has said it has formulated the vaccine such that the same dose works for those aged 15-18 years and for those older. How will this change the company’s manufacturing and supply calculi? Will existing stock start being diverted to vaccinate teenagers from January 3, 2022?
Also read: In May, Remdesivir From Zydus Cadila Made Patients Sicker: Report
6. Bharat Biotech reportedly submitted data from phase 2/3 trials for Covaxin for those aged 15-18 years, conducted in India, to the Drug Controller General. Is this data in the public domain, for independent verification? Or must we wait until tens of thousands of teenagers have been vaccinated before we’re offered a preprint paper?
Addendum: What about the deliberations of the National Technical Advisory Group on Immunisation, of the National Expert Group on Vaccine Administration for COVID-19 and of the Subject Expert Committee – all of which should have pointed the way for the drug regulator’s decision?
7. The one other vaccine the drug regulator has approved for use among those aged 12-18 years is ZyCoV-D, made by Zydus Cadila. The phase 3 trial data for this product isn’t available in the public domain either. Why?
8. Why must elderly citizens get a doctor’s certificate in order to receive booster doses while teenagers straightforwardly qualify for primary doses when the scientific evidence is ordered the other way: that SARS-CoV-2’s effects become worse the older you are, especially if you’re 60+, whereas the prevalence of disease, mild or severe, has been very low among minors? Remember that the vaccines’ primary outcome is preventing severe disease, and transmission can be cut by better designing and enforcing COVID-appropriate behaviour.
9. How will informed consent work with people aged younger than 18 years? This isn’t as simple as the buck stopping with their parents. For example, what happens when parents are opposed to a vaccine but their child wants one, or vice versa? Or when one parent is in favour of vaccination but the other is against? The UK uses a test called the Gillick competence to arbitrate such cases. The test stipulates: “the parental right to determine whether or not their minor child below the age of sixteen will have medical treatment terminates if and when the child achieves sufficient understanding and intelligence to understand fully what is proposed.”
10. Why is the prime minister making announcements about expanding the vaccination programme that are at odds with what representatives of the epidemiology and vaccination enterprises have been saying? And why is the prime minister making announcements related to healthcare at all instead of more informed officials who can answer questions from journalists and independent experts? (We may know the answer, but we must still ask.)
With inputs from Banjot Kaur.