Malaysia

AstraZeneca, CoronaVac receive conditional approval as booster dose: health DG

Applies for individuals aged 18 and above after receiving first two shots

Updated 4 years ago · Published on 18 Nov 2021 6:54AM

AstraZeneca, CoronaVac receive conditional approval as booster dose: health DG
Health Director-General Tan Sri Dr Noor Hisham Abdullah says the dispensing of booster doses are for certain target groups determined by the Covid-19 Immunisation Task Force-Booster and will be announced periodically. – Bernama pic, November 18, 2021

KUALA LUMPUR – The 366th Drug Control Authority (DCA) meeting agreed to give conditional approval for the use of AstraZeneca and CoronaVac vaccines as Covid-19 booster doses for individuals aged 18 and above after receiving the primary series of vaccination from the same type (homologous).

Health Director-General Tan Sri Dr Noor Hisham Abdullah in a statement said booster doses for the AstraZeneca vaccine will be given six months after receiving the first two doses of the vaccine.

For the CoronaVac vaccine, the booster dose will be given after three to six months from the first two doses.

“The dispensing of the booster dose for both vaccines are for certain target groups determined by the Covid-19 Immunisation Task Force-Booster and will be announced periodically,” he said.

According to Dr Noor Hisham, during the meeting today, DCA also gave conditional approval registration for the AstraZeneca Solution for Injection vaccine from the third manufacturer, SK Bioscience Co Ltd of South Korea. The holder of the vaccine’s registration is AstraZeneca Sdn Bhd.

He said DCA had earlier given conditional registration approval for the first manufacturer, which is AstraZeneca Nijmegen B.V. Netherlands, while the second manufacturer is Siam Bioscience Co Ltd Thailand.

He said the conditional registration approval requires information on the quality, safety and effectiveness of the vaccine, which is monitored and evaluated based on the latest data from time to time.

It is also to ensure the benefit over risk of the vaccine remaines positive, said Dr Noor Hisham.

He said the Health Ministry is always committed to improving access to Covid-19 vaccines in Malaysia by ensuring it is evaluated in terms of quality, safety and effectiveness by the National Pharmaceutical Regulatory Agency and approved by DCA. – Bernama, November 18, 2021

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