Moderna’s Covid-19 vaccine is 7th to be approved in Malaysia

 

The Drug Control Authority (DCA) has granted conditional approval for the Moderna vaccine against Covid-19 to be used in Malaysia, making it the seventh Covid-19 vaccine to be approved in the country.

Health Ministry director-general Dr Noor Hisham Abdullah said the DCA approved the vaccine - also known as mRNA-1273 or Spikevax - during a meeting today.

“The Health Ministry wishes to inform that this conditional approval requires the quality, safety, and efficacy of the product to be monitored based on the latest data from time to time.

“This is to ensure the benefit-over-risk ratio of vaccine products remains positive,” he said in a statement today.

The DCA approval is for Moderna vaccines manufactured by Rovi Pharma Industrial Services in Spain. Zuellig Pharma Sdn Bhd is the local product registration holder.

The Moderna vaccine is an mRNA vaccine similar to the Pfizer-BioNTech vaccine.

Like its Pfizer competitor, it is also a two-dose vaccine and had shown similarly high efficacy against Covid-19 in trials.

Against the Delta variant that is now prevalent in Malaysia, laboratory studies predicted a reduced but still highly effective protection.

There is not yet real-world data on the vaccine’s effect after full vaccination.

Nevertheless, a Canadian study found that after 14 days with just a single dose, the vaccine offered 72 percent protection against Covid-19 symptoms and 96 percent protection against hospitalisation or death.

The study did not have enough data to estimate the effect of two doses and has yet to be formally vetted by other experts.

Unlike most other Covid-19 vaccines approved by the DCA, the Moderna vaccine is likely destined solely for the private market rather than being used in the National Covid-19 Immunisation Programme (NIP).

NIP coordinating minister Khairy Jamaluddin had told a May 19 press conference that the vaccine is too expensive to be used in the programme.

Earlier today, the Health Ministry said it held discussions with Moderna since late last year, and a formal offer was made on Dec 6 for enough vaccines to inoculate 10 percent of Malaysia's population. Delivery for the vaccines was scheduled for the third and fourth quarters of this year.

It said the Special Committee on Ensuring Access to Covid-19 Vaccine Supply (JKJAV) ultimately decided to procure other vaccines due to the later delivery date, in order to expedite the NIP.

Apart from the Moderna vaccine, the only other approved Covid-19 vaccine that is used solely in the private market is the Sinopharm-BIBP vaccine.

The Sinovac vaccine would also be used in the private market as it is being phased out of the NIP since the company has delivered all of the government’s orders.

The JKJAV is expected to discuss guidelines for the private vaccine market tomorrow, including the issue of price.

Apart from the vaccines mentioned above, the other Covid-19 vaccines approved by the DCA to date are those developed by Oxford-AstraZeneca, CanSino Biologics, and Johnson & Johnson. - Mkini