KUALA LUMPUR, March 3 — The use of CoronaVac Suspension for Injection COVID-19 Vaccine (Vero Cell), Inactivated produced by Sinovac Life Sciences Co Ltd, China and Pharmaniaga Lifescience Sdn Bhd, Malaysia for children aged five to 11 is allowed.
Health director-general Tan Sri Dr Noor Hisham Abdullah announced the conditional registration approval was agreed by the Drug Control Authority (DCA) in its 370th meeting today.
He said it is the second COVID-19 vaccine approved for children aged five to 11 as the Comirnaty vaccine was approved for the group on Jan 6.
“CoronaVac was earlier approved for conditional use for individuals aged 12 and above,” he said in a statement today.
Meanwhile, Dr Noor Hisham said the meeting also agreed to give conditional approval for the Paxlovid (PF-07321332 150mg Film-Coated Tablets) and Ritonavir 100mg Film-Coated Tablets) for the use of COVID-19 treatment among adults aged 18 and above who do not need oxygen therapy and high-risk to get bad symptoms
However, he said Paxlovid produced by Pfizer Manufacturing Deutschland GmbH, Germany and Pfizer Ireland Pharmaceuticals, Ireland is not aimed at being used as a substitute for COVID-19 vaccination and public health action especially on standard operating procedure (SOP) compliance.
“The Health Ministry (MOH) wishes to announce that the conditional approval registration still requires quality, safety and efficacy information of the vaccine product and the anti-virus will be continuously monitored and evaluated by the National Pharmaceutical Regulatory Agency (NPRA) based on the latest data from time to time.
“This is to ensure the comparison of benefit over risk for the vaccine to remain positive,” he said.
He also said MOH would continue to be committed to improve people’s access to medicine for the purpose of treatment or prevention of COVID-19 in the country by ensuring it is evaluated based on quality, safety and efficacy.