NPRA needs to be thorough, experts say


MALAYSIA’S position in the race to procure Covid-19 vaccines is falling short due to global supply issues and lengthy approval process, but experts said it is necessary to ensure that the vaccines are safe and effective.

Malaysian Integrated Medical Professionals Association president Dr Muhamad Hazizi Muhamad Hasani said the National Pharmaceutical Regulatory Agency (NPRA), the agency tasked to approve every vaccine in the country, needs to be careful in ensuring the safety and efficacy of the vaccines given to the people.

“For example, Sputnik V from Russia is being delayed because although it has been administered in several countries, it has yet to obtain approval from the European Union’s European Medicines Agency.

“CanSino Biologics vaccine is also under the provision of the NPRA and should be approved soon after a few more detailed assessments,” he told The Malaysian Reserve (TMR).

He said the Janssen vaccines by Johnson & Johnson on the other hand, although it has been approved by the US Food and Drug Administration, is still being negotiated by the government.

“It was reported that our government is quite reluctant to get the agreement done if the stock given to Malaysia is too low and too late (by the end of 2021).

“That is why we are currently pushing our National Covid-19 Immunisation Programme with the three vaccines that we have, namely Comirnaty by Pfizer IncBioNTech SE (US), Sinovac by Sinovac Biotech Ltd (China) and AstraZeneca by Oxford-AstraZeneca plc (UK-Sweden),” said Dr Muhamad Hazizi.

To date, Malaysia received 828,000 doses of the expected 1,387,200 doses of AstraZeneca vaccine provided by the Covax Facility or Covid-19 Vaccine Allocation Plan.

The 559,200 doses of AstraZeneca vaccines that arrived last week followed the April 21st Covax shipment of 268,800 doses to Kuala Lumpur.

Currently, more than 10 million people have registered for vaccination, of which more than 1.5 million have been vaccinated.

To achieve herd immunity and confidence in the economy to be in full swing, more people need to be inoculated as soon as possible.

Malaysian Public Health Physicians’ Association president Datuk Dr Zainal Ariffin Omar told TMR he observed many in the country that have registered for inoculation with MySejahtera since February, but still no feedback on their appointment for the first dose.

The government had opened up the AstraZeneca opt-in vaccination programme to those 60 years old and above on Sunday. The inoculation process for this category will begin on June 7.

Meanwhile, Pantai Hospital Kuala Lumpur internal medicine specialist Dr Helmy Haja Mydin said the main factor has been the supply, which is a global issue.

“Having said that, we are due to receive more vaccines over the next few months, so one would expect the rollout to increase,” he noted.

Dr Muhamad Hazizi said several factors also come into play such as the initial problem with low acceptance based on the registration, as well as issues with the shipment where some vaccines did not arrive as scheduled, thus slowing down the vaccination drive.

“Besides that, because Phase 2 involves citizens above 60 years old and those with comorbidities (chronic medical illness), the vaccination team needs to be careful in assessing the recipients in terms of any possibility of serious side effects and life-threatening allergic reaction,” he added.