LONDON: The Indonesian government policy to exclude the elderly (aged 60 years and above) in the first phase of the free COVID-19 vaccination program could hinder the vaccine’s impact in lowering mortality rates.
The government has prioritised early-stage vaccination for health workers, civil servants and citizens aged 18 to 59.
The CoronaVac vaccines from Chinese company Sinovac will not be used to vaccinate elderly citizens aged 60 nd above.
Considering the enormous COVID-19 mortality rates in Indonesia, the highest in Southeast Asia and dominated by those in the 60 years and above age bracket (45 per cent of the total confirmed deaths from COVID-19), this policy is problematic.
In addition, this policy is inconsistent with Indonesia's prioritisation of recipients to be vaccinated announced by the government on Jan 4.
This guide also incorporates the technical recommendation from the World Health Organization (WHO) to prioritise health workers in the first phase of vaccination, and then civil servants and those aged 60 and above in the second phase (estimated to be January to April 2021).
This, according to the government, will provide indirect protection across age groups.
The government also claimed data isn’t available yet on CoronaVac vaccine safety for senior citizens.
Furthermore, the National Agency of Drug and Food Control (BPOM) so far has only authorised CoronaVac vaccines for citizens aged 18 to 59 years old.
But these claims are questionable.
CORONAVAC DEEMED SAFE FOR ELDERLY
In September 2020, Sinovac released preliminary results of their phase 1 and 2 clinical trials in China for healthy people aged 60 years and above.
The same vaccine is currently being tested in a phase 3 clinical trial in Bandung, Indonesia.
The preliminary results indicated that the CoronaVac vaccine showed good immunogenicity (ability to trigger immunity) against the virus that causes COVID-19.
The vaccine was deemed safe to use for healthy people aged 60 and above. There were no serious adverse effects related to the vaccine in clinical trial volunteers.
Turkey, one of Sinovac phase 3 clinical trial sites, granted emergency use authorisation for CoronaVac, targeting health workers and those above 65 in its early phase of vaccine roll-out. Turkey’s President Recep Tayyip Erdogan, 66, was the first recipient of the CoronaVac vaccine.
Empirical evidence regarding CoronaVac vaccine safety and efficacy from a trial involving elderly in Brazil has also been circulating.
Unfortunately, the data (from China and Brazil) were not considered in the evaluation by the National Agency of Drug and Food Control (BPOM) of Indonesia.
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NO RELIABLE EVIDENCE ON VACCINES REDUCING RISK OF TRANSMISSION
Based on clinical trials results of various COVID-19 vaccines that have been released, current vaccines are proven to reduce the risk of symptomatic COVID-19 with varying levels of efficacy.
But, these trials have not answered precisely how efficacious these vaccines are in reducing the risk of transmission or infection.
The phase 3 CoronaVac clinical trial protocol in Brazil, for example, stated that the primary endpoints are: One, the efficacy in reducing the risk of symptomatic COVID-19 cases; and two, the safety of the vaccine in adults (aged 18 to 59) and the elderly (aged 60 and above).
Recently, preliminary results from the phase 3 clinical trial in Brazil showed 50.39 per cent efficacy in lowering the incidence rate of symptomatic COVID-19 (with 95 per cent confidence interval: 35 to 62 per cent).
There is no reliable evidence from the trial on the efficacy against the transmission of the virus.
A MORE COMPREHENSIVE EVALUATION NEEDED
Data on CoronaVac vaccine safety and efficacy for those aged 60 and above are available to be further evaluated by the BPOM.
Kusnandi Rusmil, principal investigator of the CoronaVac Vaccine clinical trial research team in Indonesia, stated that data regarding vaccine safety on the elderly can be obtained from clinical trials in other countries.
BPOM has the right and obligation to request such data for further assessment so that recommendations for CoronaVac vaccine use in Indonesia can potentially be extended to the elderly population immediately.
BPOM should immediately consider preliminary clinical trial results from every location, testing the CoronaVac vaccine in a more comprehensive and detailed manner. This data can provide evidence regarding vaccine efficacy and safety in the elderly.
The differences between sample size and characteristics in every clinical trial location might affect efficacy and safety results and should be evaluated proportionally, based on the overall clinical trial data across locations.
Amid the high mortality rate in the elderly group due to COVID-19, overwhelmed healthcare facilities in various cities, and limited vaccines availability, the government should prioritise elderly in the first phase of the vaccination roll-out.
By prioritising vaccination for elderly, Indonesia may optimally reduce the hospital burden and COVID-19 deaths amidst a limited vaccine supply during the first vaccination phase.
Bimandra Djaafara is a PhD student in infectious disease epidemiology at the Imperial College London.
Fahrin Ramadan Andiwijaya is Research Assistant at Universitas Mataram.
Fiona Verisqa is a PhD candidate in Biomaterials and Tissue Engineering at UCL.
Ihsan Fadilah is NIHR Fellow at the Department of Biostatistics and Health Informatics, King's College London.
Kartika Saraswati is a DPhil student in Clinical Medicine at the University of Oxford.
Nursidah Abdullah is a MSc student in Public Health and Health Promotion at Swansea University.
Rizka Maulida is a PhD student at the Centre for Diet and Activity Research (CEDAR) at the University of Cambridge.
This commentary first appeared on The Conversation.