SHAH ALAM: Any analysis on the raw data of the effectiveness of COVID-19 vaccines which include the fatalities amongst vaccinated population released by Ministry of Health (MOH) on online hosting service GitHub recently must use the standard scientific methodology and framework, as well as peer-reviewed.

This is to ensure the interpretation of the data is accurate and avoid erroneous speculation, as well as risk of bias which can contribute to a bigger repercussion or causing more harm than benefit to the national vaccination efforts.

A news portal recently published an unverified analysis by claiming that there have been 10.11 vaccine breakthrough deaths for every 100,000 people vaccinated with Sinovac, 3.47 per 100,000 for Pfizer recipients and 0.91 deaths per 100,000 for AstraZeneca.

Pharmaniaga Berhad (Pharmaniaga) Group Managing Director Datuk Zulkarnain Md Eusope said the release of the raw data to the public must be guided with a thorough explanation by the authorities to avoid misinterpretation and speculation.

"In the current crisis, data is essential in measuring the effectiveness of the nation's COVID-19 vaccination programme, however speculation and misinterpreted data will cloud the waters, obscuring nuances within communities and create unnecessary confusion amongst the public. 

“Clinical data is highly time-dependent and require advanced statistical methods to avoid common pitfalls such as selection, length, immortal-time and competing risk bias. In the same way as data should be collected in a standardised way, data should also be analysed in a standardised way.

"The online news report clearly does not provide a clear picture of the purported data and somehow has reflected an insufficient engagement with subject-matter experts such as scientists and researchers, as it should be scientifically analysed, peerreviewed and accepted by a panel of experts," he said. 

Datuk Zulkarnain was echoing to a news report by the New Straits Times published on 12 September 2021, Universiti Putra Malaysia epidemiologist and biostatistician Associate Professor Dr Malina Osman was quoted as saying that the unverified analysis by the online news portal could be misleading.

"If the ministry (MOH) does not come out to state whether this interpretation as right or wrong and why while elaborating its context, parameters and the limits of the data, then this could threaten to undo all the hard work put into making the (vaccination) drive a success," she was quoted as saying in the report adding that if the MOH did not explain the data, it could also be manipulated by anti-vaxxers.

Datuk Zulkarnain said the analysis of raw data on vaccination status and deaths reported with complete/incomplete vaccination was without any scientific methodology and consideration of a causal association with other critical parameters related to death which are not available in the raw data. 

In this regard, the comparison was based on raw data of deaths listing from the health authorities, which has neither scientific rigour nor adequate background information to support comparison. 

Below are a few analytical biases in the unverified analysis by the online news portal:

a. Comparison of deaths after vaccination is made with deaths in unvaccinated populations with very different health-seeking behaviour and early access to health care facilities.

b. The status of healthy and comorbid subjects is not available to compare the meaningful incidence of death within each vaccine group.

Considering the above, Datuk Zulkarnain urged the authorities to provide a solid explanation as soon as possible to allay public fear as well as on vaccines’ safety and effectiveness or it can disrupt the Government’s upcoming mission to vaccinate children between 12 and 17 years old. 

“We believe the fight against the COVID-19 pandemic requires unity and coordinated responses that all parties must commit to fighting the pandemic and contribute to the nation’s overall well-being and livelihood,” he concluded.   Pharmaniaga is the leading pharmaceutical company of Boustead Holdings Berhad group of companies, and together with Lembaga Tabung Angkatan Tentera, are the major shareholders of the Company.