Override NPRA to speed up vaccine approvals, minister and DG told

Override NPRA to speed up vaccine approvals, minister and DG told

Lee Boon Chye says the pair should facilitate these approvals so Malaysia would be able to ramp up its vaccination efforts.

Dr Lee Boon Chye says that Sinopharm, for instance, has been approved by the WHO but Malaysia’s NPRA has been reluctant to approve it. (AP pic)
PETALING JAYA:
The health ministry has been told to override the National Pharmaceutical Regulatory Agency (NPRA) in the interests of speeding up vaccinations against Covid-19.

In a webinar hosted by the Wisdom Foundation, former deputy health minister Dr Lee Boon Chye said that given the worsening health crisis in Malaysia and the difficulties the country has experienced in vaccinating people with speed, drastic intervention is needed.

“To the minister and the director-general, please override NPRA now. This agency cannot be a hindrance to registration of vaccines that have been proven safe in other countries,” said Lee.

He questioned why Malaysia would not look to the US’ Food and Drug Administration or the World Health Organization for guidance on approvals, and felt that the NPRA would be “cocky” to think it was a better approval body.

Dzulkefly Ahmad says Malaysia cannot be acting like it has the luxury of time.

“You look at Sinopharm. This vaccine has been approved by the WHO, so why have we not done the same?”

This was echoed by former health minister Dzulkefly Ahmad, who served at the same time as Lee, and also wondered why approvals in the US or Europe could not be a catalyst for vaccine registration in Malaysia.

“These vaccines have all gone through stringent tests. Because we are in dire straits, we cannot be acting like we have the luxury of time.”

“We see emergency use authorisations being given in other countries because of this, especially for vaccines that are peer reviewed and have published research.”

He said that products like the Sputnik V vaccine, which Malaysia has a deal in place for, and the vaccine made by Moderna have both been researched and had results published in esteemed publications.

“These two in particular have been peer reviewed in established medical journals like the Lancet and the New Medical Journal of Medicine. You don’t doubt these vaccines any more.”

Lee said that emergency use authorisation, which typically relies on citing another regulatory agency’s approval to sanction a product’s use, can always be revoked if problems emerge with a particular product.

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