KUALA LUMPUR, June 15 — Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has approved Pfizer-BioNTech’s Covid-19 vaccine for use in children aged 12 years and above, after previously approving the shot for adults.
The Drug Control Authority (DCA) under the NPRA has also issued conditional registration for emergency use of two single-dose coronavirus vaccines by China’s CanSino Biologics and the United States’ Johnson & Johnson.
Johnson & Johnson’s Janssen vaccine has been approved by the World Health Organization’s (WHO) emergency use listing, which is a prerequisite for vaccine supply by the global COVAX Facility backed by the United Nations.
“Although these additional indications have been approved, the Ministry of Health is of the view that vaccination priority should still be for high-risk groups, in line with the existing policy set under the National Covid-19 Immunisation Program (PICK),” Health director-general Dr Noor Hisham mentioned in a press statement today, referring to NPRA’s approval for the Pfizer vaccine for children aged 12 years and older.
“MOH would like to inform that these conditional registrations require information on the quality, safety, and effectiveness of the vaccine product to be monitored and evaluated based on the latest data from time to time. It is to ensure that the comparison of benefit over risk for the vaccine products remains positive.”
As of June 8, only 20 per cent, or about 1.9 million, of the targeted 9.4 million high-risk individuals in Malaysia have been vaccinated with at least one dose of the coronavirus vaccine. Paediatrician Dr Musa Mohd Nordin wrote recently that there was no compelling argument to vaccinate healthy children against Covid-19, pointing out that the risk of a healthy American child and a healthy Malaysian child dying from Covid-19 was zero and 0.6 per million respectively.
“The DCA has approved single-dose vaccines CanSino and Johnson & Johnson as well as the use of Pfizer for 12 and above. This is a major development that will help get more jabs into arms as soon as possible,” Vaccine Minister Khairy Jamaluddin mentioned in a tweet today.
The government to date has ordered 44.8 million doses of the Pfizer vaccine — which cover 22.4 million people, or about 70 per cent of the Malaysian population on its two-dose regimen — as well as 3.5 million CanSino doses.
Nevertheless, Khairy is yet to reveal the order details of Johnson & Johnson’s vaccine from COVAX. He told a webinar last April that besides AstraZeneca’s vaccine, Malaysia will also be receiving Covid-19 vaccines from Johnson & Johnson and Novavax from the global COVAX vaccine sharing programme.
So far, the Malaysian government has ordered 6.4 million doses of AstraZeneca-Oxford’s vaccine from COVAX.
“CanSino has been registered by Solutions Biologics Sdn Bhd. They will also do the fill and finish in Malaysia apart from bringing in finished products from China,” Khairy’s science advisor Ghows Azzam mentioned in a tweet today.
The federal government had also ordered 6.4 million doses of Russia’s Sputnik V Covid-19 vaccine, which is yet to receive approval from the NPRA to be used in Malaysia.
Khairy previously told CodeBlue in March that Malaysia might lose 6.4 million pre-ordered doses of Russia’s Covid-19 vaccine to another country if it doesn’t get the approval from NPRA.