MALAYSIANS should not be unduly worried about taking COVID-19 vaccines developed using new technology as it was tested thoroughly.
“The concerns regarding the safety of the new technology are genuine but it is a calculated risk.
“Even though this is the first time that the messenger RNA (mRNA) has been used to produce a vaccine, this technology has been meticulously researched in the last three decades.
“Therefore, scientists have enough experience to use this technology. The views of highly respected virologists in the country concerning safety of the vaccines should be respected,” Malaysian Pharmacists Society (MPS) president Amrahi Buang told FocusM.
In an opinion editorial last week, Parti Sosialis Malaysia (PSM) chairperson Dr Jeyakumar Devaraj urged the Government to exercise caution when using COVID-19 vaccines developed using the mRNA technology as much is yet to be known about it.
For example, Jeyakumar said the modernistic vaccines induce more killer lymphocytes, hence causing the destruction of some of the subject’s cells.
“Do the developers of these vaccine know for sure that their phospholipid capsules do not slip into nerve cells or into kidney cells? These are tissues that are not particularly capable of re-generating themselves if they are damaged,” the PSM leader was reported saying.
Jeyakumar, a veteran pulmonologist, said that the indemnity clauses indicated by the producing pharmaceutical companies itself should trigger alarm bells for the purchasing nations.
Instead, Jeyakumar suggested for the Government to consider using COVID-19 vaccines developed using the old technology instead such as the CoronaVac, the Zhifei vaccine and Novavax.
Touching on the expert’s concerns, Amrahi said the new technology vaccines have gone through the same steps as any other vaccine development programme, notably from laboratory work to animal studies and finally, human studies.
“At the end of these studies, the efficacy of the vaccines is more than 90% which is excellent,” he opined.
In terms of regulatory oversight, Amrahi said new pharmaceutical products entering Malaysia will be vetted by the National Pharmaceutical Regulatory Agency (NPRA).
He added the Pfizer-BioNtech’s vaccine dossier has been submitted to NPRA and the registration for its emergency use will take between three- to four-months.
“During this period, NPRA will also receive reports from the vaccine’s use in the UK and the US. This window should be used to monitor the safety of the vaccine worldwide,” Amrahi remarked.
On ethics, the MPS leader said the pharmaceutical industry is heavily regulated with the latter required to report any case of adverse event following immunisation (AEFI).
“Whether these AEFI is related to the vaccines will be ascertained. For example, now the vaccine will not be given to any individual who has a previous history of allergy.
“The present situation is the fourth stage involving large population and closely monitored by all stakeholders especially the safety aspect.
“This is called pharmacovigilance. All AEFI cases must be reported to the regulatory agency and the company concerned,” he pointed out.
On the indemnity clause, Amrahi added: “Since we don’t have the actual details of the agreement, it is difficult to comment. If there is a case then let the lawyer and judge do their work.” – Dec 28, 2020
