Pfizer vaccine nod for 12-year-olds and above

Comirnaty was earlier approved for conditional registration on June 8 for active immunisation of individuals aged 18 and above


THE Drug Control Authority (DCA) of Malaysia has approved Pfizer Inc-BioNTech SE’s Comirnaty vaccine for those aged 12 and above.

Health DG Tan Sri Dr Noor Hisham Abdullah (picture) said Comirnaty was earlier approved for conditional registration on June 8 for active immunisation of individuals aged 18 and above.

“Even though the additional indications were approved, the Health Ministry (MoH) is of the view that the priority of vaccination is still for high-risk groups in line with the existing policy set under the National Covid-19 Immunisation Programme (NCIP).

“The approval of this conditional registration requires 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,” he said in a statement yesterday.

Dr Noor Hisham said this is to ensure that the comparison of benefit over risk for the vaccine products remains positive.

“The MoH will always improve the level of public health in combating the Covid-19 pandemic through the procurement of vaccine supplies that have been evaluated in terms of quality, safety and effectiveness by the National Pharmaceutical Regulatory Division and approved by the DCA,” he added.

He noted that the government is also committed to ensuring that Malaysians achieve herd immunity in line with the NCIP target.

Additionally, Dr Noor Hisham announced yesterday that the DCA had given the conditional registration for the emergency use of the CanSino Biologics Inc and Johnson & Johnson (J&J) vaccines.

He said for the two vaccine products, individuals receiving them only require one dose.

The two vaccines, “Convidecia Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)” produced by CanSino in China, and “Janssen Covid-19 Vaccine” manufactured by J&J were given Emergency Use Listing by the World Health Organisation (WHO).

Dr Noor Hisham said the “Janssen Covid-19 Vaccine” was obtained by the government through the COVAX (Covid-19 Vaccines Global Access) facility and is implemented through a recognition mechanism based on WHO EUL approval.

Separately, the government of Japan announced yesterday that it will provide AstraZeneca plc vaccines manufactured in Japan to Malaysia, Indonesia, the Philippines and Thailand from July.

Its Foreign Minister Motegi Toshimitsu said the Embassy of Japan in Malaysia will continue to work closely with Malaysia to provide the vaccine in the country.

“This will be another symbol of friendship between Japan and Malaysia,” he said in a statement.

Meanwhile, the MoH yesterday reported a total of 5,419 new Covid-19 cases, of which 5,413 were local cases and six were import cases.

Selangor once again topped the daily cases at 1,996, followed by Sarawak (718) and Kuala Lumpur (650).

This has brought the current active cases in the country to 70,112 and the total confirmed cases to 667,876.

A total of 19 new Covid-19 clusters were identified yesterday, of which 14 were linked to workplaces, four community clusters and one high-risk group cluster.

Among the active cases yesterday, 922 were placed in the intensive care unit, while 450 patients were put on ventilators.

There were also 101 new deaths reported nationwide yesterday, increasing the overall Covid-19 death toll to 4,069.

As for recovery, a total of 6,831 patients were discharged, increasing the total recovered cases in the country to 593,695, which equals 88.9% of total cases.