ANY analysis on the raw data of the effectiveness of COVID-19 vaccines which include the fatalities among vaccinated population released by the Health Ministry (MOH) on online hosting service GitHub must use the standard scientific methodology and framework as well as be peer-reviewed, said Pharmaniaga Bhd.
“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,” it said in a statement on Monday (Sept 13).
The statement followed a news portal that had recently published an unverified analysis claiming that there have been 10.11 vaccine breakthrough deaths for every 100,000 people vaccinated with Sinovac, 3.47 for Pfizer recipients and 0.91 deaths per 100,000 for AstraZeneca.
“The release of the raw data to the public must be guided with a thorough explanation by the authorities to avoid misinterpretation and speculation,” said Pharmaniaga group managing director Datuk Zulkarnain Md Eusope.
“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.”
According to Zulkarnain, 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.”
Zulkarnain went on to point out that the online news report did not provide a clear picture of the purported data and somehow had reflected an insufficient engagement with subject-matter experts such as scientists and researchers, as it should be scientifically analysed, peer-reviewed and accepted by a panel of experts.
He was echoing a news report by New Straits Times on Sept 12, 2021 whereby Universiti Putra Malaysia epidemiologist and biostatistician Associate Professor Dr Malina Osman said that the unverified analysis by the online news portal could be misleading.
According to Malina, if 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, this could threaten to undo all the hard work put into making the (vaccination) drive a success.
Furthermore, if MOH did not explain the data, it could also be manipulated by anti-vaxxers, she added.
Meanwhile, Zulkarnain noted that the analysis of raw data on vaccination status and deaths reported with complete or 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,” he added. – Sept 13, 2021