THERE is an urgent need for a proper system for public reporting and access to adverse drug reactions records in light of the recent incident of adverse reactions to vaccines reported in Kajang Prison.
In October last year, Kajang Prison authorities wrote to the Hulu Langat health office, highlighting 18 cases of adverse reactions to Covid-19 vaccines, including two deaths, among inmates vaccinated.
The prison director had written to the district health office to get its view on the need to give prisoners booster doses.
A letter by Hulu Langat health officer Dr Zailiza Suli that went viral revealed the adverse effects suffered by the affected inmates as follows: three cases of cardiovascular-related issues, four involving temporary paralysis, three of distant abscesses (sores with pus far from the inoculation point), and six of lung infections.
The viral letter says 15 inmates were given Pfizer shots, and three were given CanSino jabs.
Dr Zailiza noted in the letter that the death rate from AEFI (adverse effects following immunisation) – one fatality per 1,391 inmates – is a worrying ratio. She recommended that further studies be carried out before mandating additional or booster vaccine shots to these inmates.
On January 4, the Malaysian Muslim Consumer Association (PPIM) urged the Health Ministry (MoH) for answers about the reported AEFI and general safety of vaccines in view of Dr Zailiza’s leaked letter.
On the same date, the MoH said it was investigating the matter. National Pharmaceutical Regulatory Agency (NPRA) director Dr Roshayati Mohamad Sani said in a statement: “The Health Ministry is continuously monitoring the safe usage of all vaccines, including Covid-19 vaccines, through the NPRA by monitoring AEFI reports.”
Dr Roshayati in her statement said all reports stated in the letter that went viral have been received by the NPRA and are being investigated.
Till today, we have not heard of the results of the investigations.
It took a viral letter to shake the complacency of the health authorities to take note of the deaths and adverse events. This should not be the case.
This is not the only reported incident of adverse events. On Wednesday, Perlis mufti Datuk Mohd Asri Zainul Abidin was reported in Berita Harian as saying that his father had a stroke after getting the third booster jab.
He called on the MoH to postpone the third booster dose drive, which is feared to carry serious adverse health events. The authorities, he said, need to reassess the safety and necessity of the third vaccine dose for certain groups of people.
According to him, many people have approached him to relate the side effects they, their friends or their families have experienced.
“Some have claimed that deaths have occurred after the third dose, but these are villagers with no means of channelling official complaints to the authorities,” he said.
Reconsider frequent booster jabs
Repeated Covid-19 booster jabs are unsustainable, World Health Organisation (WHO) experts recently said.
On January 12, a WHO expert group created to assess the performance of Covid-19 vaccines said a vaccination strategy of repeated booster doses of existing vaccines against new coronavirus variants is not an effective way to deal with the pandemic. The current vaccines need to be reworked to ensure they are effective against infection and disease by variants of concern, including Omicron and future variants, they said.
In Malaysia, a public health expert also voiced his objection towards the frequent administration of Covid-19 vaccine booster shots without strong evidence that initial vaccination is ineffective against infection or severe disease.
“In my opinion, the decision for further booster doses because of waning immunological parameters – from a small fraction of the population – must be corroborated with epidemiological evidence that the vaccine and other public health measures are no longer working. We cannot be boosted after every few months,” Prof Dr Lokman Hakim Sulaiman pro-vice-chancellor of research at International Medical University told Code Blue on Thursday.
CAP’s recommendations are as follows:
1. Malaysia should set up a more transparent reporting system like the Vaccine Adverse Event Reporting System (VAERS) in the United States or the Yellow Card scheme in the United Kingdom, to which the public can report side effects and view reports of adverse events others have experienced. Currently, Malaysians can report adverse events to the authorities, but there is no public access to the reports.
In the US, anyone can submit a report to VAERS, including parents, patients, healthcare professionals and vaccine manufacturers. VAERS reports are monitored carefully by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). All adverse events reported to VAERS are made available to the public online.
In the UK, there is a specific website set up under the Yellow Card scheme, where the public can report suspected side effects from medicines, vaccines or medical devices relating to Covid-19 treatment.
The scheme relies on the voluntary reporting of suspected adverse incidents by healthcare professionals and members of the public (patients, users, or carers). The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation.
In the European Union, the European Medicines Agency (EMA) monitors the safety of Covid-19 vaccines authorised for use “extremely carefully”. This enables the detection of any rare side effects that may emerge once millions of people are vaccinated. The latest information on the safety of each vaccine, including the number of cases of suspected side effects, is given in the vaccine’s monthly safety update, which is easily accessible to the public online.
2. Our health authorities must take adverse events seriously, investigate them and perform autopsies on people who have died from suspected adverse events, to find out the real cause of deaths.
According to German pathologist Peter Schirmacher of the University of Heidelberg, whose group studied 40 people who had died within two weeks of vaccination, he concluded that around 30% to 40% of the total did indeed die from the vaccine. He believes that the overall deaths following vaccination are underreported.
We are using these experimental vaccines that are approved by emergency regulations, thus the need for investigations into adverse events and deaths due to these experimental vaccines are even more crucial than ever to protect ourselves.
3. Instead of using only experimental vaccines, we should also be looking at the available alternative treatments that are safer, cheaper, and efficacious. These treatments have been used in many countries and showed positive results.
Countries with high vaccine rates such as the US, the UK, and Israel are suffering from high infection rates. Covid-19 infections in the US have reached one million daily. Vaccination has not lowered infection rates although they are effective in reducing hospitalisations and deaths. – The Vibes, January 22, 2022
Mohideen Abdul Kader is president of Consumers’ Association of Penang
