Malaysia Only Ordering Covid Vaccines After Local Approval Amid Global Race

By CodeBlue | 16 November 2020

The evaluation of new drug products granted Priority Review, which can be granted during a pandemic, will take 120 working days starting from the date of approval of Priority Review, according to the National Pharmaceutical Regulatory Agency (NPRA).

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KUALA LUMPUR, Nov 16 — The Malaysian government will only place orders for a Covid-19 vaccine after local health regulators have verified its safety and effectiveness, Khairy Jamaluddin said today, as countries worldwide rush to pre-book doses.

The science, technology and innovation minister said the government was aiming to get access to a Covid-19 vaccine by the first or second quarter of 2021, depending on approval from the National Pharmaceutical Regulatory Agency (NPRA), under the Ministry of Health (MOH).

“NPRA will ensure that a vaccine passes tight conditions that have been set on aspects of safety and efficacy, based on data from clinical studies. Only after going through this stringent process will a vaccine be approved and a decision for orders be made,” Khairy told Kota Kinabalu MP Chan Foong Hin in the Dewan Rakyat today.

The DAP lawmaker had asked if the Ministry of Science, Technology and Innovation has made any orders to import coronavirus vaccines from pharmaceutical companies in China or the United Kingdom.

Khairy’s office told CodeBlue later that Malaysia would continue to negotiate for the best deals through a multi-pronged approach, when asked if the minister’s Parliament reply indicated that Malaysia has not made any deposit payments to secure Covid-19 vaccine supplies, either from the COVAX Facility or in separate agreements with pharmaceutical companies.

“We will make advance bookings, for example via COVAX and bilateral deals, but the full payment and delivery will only be made after the vaccines pass NPRA approval,” said Khairy’s office.

According to NPRA’s Drug Registration Guidance Document revised July 2020, a Priority Review may be granted for an application to register a new drug product in Malaysia in certain urgent circumstances, including pandemic situations in the interest of public health.

Companies should submit an application for Priority Review to the NPRA director once screening has been approved. The approval of Priority Review is subjected to the decision of the Drug Evaluation Committee Meeting upon submission of complete product registration documentation. NPRA’s guidance document did not state the timeline for obtaining Priority Review approval.

The evaluation of new drug products granted Priority Review will take 120 working days starting from the date of approval of Priority Review, according to the timeline stated in NPRA’s guidance document.

The government’s decision to only pre-order Covid-19 vaccines after local regulatory approval poses a serious risk of Malaysia trailing other nations in the global queue for a vaccine during the pandemic, as countries worldwide have already pre-booked supplies of various coronavirus vaccines, even before the release of results from Phase 3 trials. AFP reported last August that at least 5.7 billion doses have already been pre-ordered globally.

The Independent reported last Friday that Pfizer has already sold 82 per cent of its Covid-19 vaccine stocks to among the world’s wealthiest nations, just two days after the company issued a press release announcing that interim data from its Phase 3 trial showed its vaccine was 90 per cent effective in preventing symptomatic Covid-19 infection.

Pfizer and German partner BioNTech reportedly plan to manufacture 1.3 billion doses throughout next year, but most have already been pre-ordered by the United Kingdom, the US, the European Union (EU), and Japan that purchased hundreds of millions of doses between them.

Khairy also said today that Malaysia would secure access to Covid-19 vaccines from COVAX, a global vaccine access plan co-led by the World Health Organization (WHO), to cover 10 per cent of the population. The government is also working to get more doses to immunise another 60 per cent to achieve herd immunity, where 70 per cent of the Malaysian population will be vaccinated.

The minister said the Malaysian government has directly contacted eight of 11 manufacturers of Covid-19 vaccine candidates currently in Phase 3 clinical trials, while another two were contacted through the COVAX Facility.

“Several negotiations are in the final phase and an official announcement will be made when the negotiations are finalised soon. These negotiations comprise collaboration in all aspects of vaccine development, like R&D, scientists exchange, fill-and-finish development (technology transfer, logistics, cold chain), including vaccine purchase (finished product), as a guarantee of access to a vaccine supply for the country,” Khairy said.

“Detailed information cannot be announced because these are non-disclosure agreements.”

On Covid-19 vaccination priority, Khairy said the Special Committee On Access To Supply of Covid-19 Vaccines (JKJAV) — which was set up last October 14 as the main government committee to plan, implement, and monitor the Covid-19 vaccine procurement strategy — has decided to divide the immunisation priority targets into three phases:

  • First: frontliners comprising MOH staff and staff from non-MOH agencies like the police, the army, the Immigration Department, the Prisons Department and others.
  • Second: high-risk groups like individuals with comorbidities and the elderly.
  • Third: Other adult populations.

“Further details on these groups are being drafted and are expected to be announced as early as the first quarter of next year,” said Khairy.

Note at 11:30pm: The article included comments from Khairy’s office to CodeBlue, written in the fifth and sixth paragraphs.

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