Make public pharmacovigilance report on COVID-19 vaccines

THE Government should make its pharmacovigilance report available to the public, so as to alleviate any concerns the public may have over the efficacy of the COVID-19 vaccines.

“As we all know, the Government kickstarted the National COVID-19 Immunisation Programme (PICK) on Feb 24, where Prime Minister Tan Sri Muhyiddin Yassin was administered the Pfizer-BioNTech vaccine. After that, the vaccines were given to 223,923 individuals under the first phase.

“But until today, the Government has yet to release its pharmacovigilance report on the vaccines. The question is, who is responsible to collect data and report the matter to the authorities?” Malaysian Pharmacists Society (MPS) president Amrahi Buang asked FocusM.

Earlier today, the Malaysia Health Coalition (MHC) urged the Government to be transparent on the PICK programme in order to ensure more people register to get themselves inoculated.

For now, only about 12% of the public have registered to get themselves vaccinated for COVID-19.

“It’s time for the Government to act on it, not just talk about improving vaccine confidence among Malaysians and foreigners staying here.

“The approach must be multilingual, multiplatform and multipronged, involving community leaders of all backgrounds.

“Plus, there must be a proactive effort to improve overall science and health literacy by communicating facts in accessible terms. Higher science literacy is helpful in fighting pseudoscience, fake products and products with misleading claims,” MHC was reported saying.

Elaborating, Amrahi said that COVID-19 Vaccine Supply Special Committee (JKJAV) would have embarked on pharmacovigilance, particularly on adverse event following immunisation (AEFI).

With that, he said the Government should periodically reveal its findings every week if there are any AEFI cases, like what Canada and South Korea are doing.

“If there are adverse effects following immunisation, the Government should halt the programme for the time being.

“The AEFI report is important as it would convince the public on the safety and efficacy of the COVID-19 vaccines. This is not to create anxiety among the rakyat but to ensure they remain confident of the programme,” he opined.

Rope in community pharmacists, let us help

As the world is undergoing phases of mass vaccination programmes, Amrahi reiterated the need for National Pharmaceutical Regulatory Agency (NPRA) to monitor the pharmacovigilance process.

In reality, he said that NPRA already has a system to gather data and report AEFI issues, adding it was requirement for such cases to be reported immediately for follow ups.

“NPRA is the centre of pharmacovigilance to report adverse drug reaction (ADR), including vaccines, under the purview of the World Health Organization (WHO).

“Plus, NPRA is also part of an international network called the Global Vaccine Safety Initiative under the WHO.

“Through the network, all AEFI cases will be screened thoroughly by the Malaysian Adverse Drug Reaction Advisory Committee (MADRAC), under the Malaysian Drug Control Authority (PKBD), before being sent to the WHO,” Amrahi stated.

He added that under a programme called ConSERF, the public themselves can report AEFI cases to MADRAC, which will then probe the cases and decide whether it was caused by the vaccines or not.

Citing the “lot release” mechanism under the Global Vaccine Safety Initiative (GVSI), Amrahi said the system was  designed to create confidence among the public.

“For example, the Government itself had returned 585 vials of Pfizer-BioNTech vaccines after it was found defective and needed to be replaced, under the ‘lot release’ mechanism,” he said.

On related matter, Amrahi urged JKJAV to allow community pharmacists to get involved directly in the PICK, so that the mass vaccination programme can be hastened and raise awareness of the public on the importance of getting inoculated.

“Community pharmacists can also embark on pharmacovigilance and speed up the vaccination programme. We can register ourselves in the MySejahtera application for better scrutiny. – March 13, 2021.

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