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GENERAL

AstraZeneca, CoronaVac receive conditional approval as booster dose - Health DG

17/11/2021 06:54 PM

KUALA LUMPUR, Nov 17 -- The 366th Drug Control Authority (DCA) meeting today agreed to give conditional approval for the use of AstraZeneca and CoronaVac vaccines as COVID-19 booster dose to 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 the booster dose for AstraZeneca vaccine would be given six months after receiving the first two doses of the vaccine.

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

"The dispensing of the booster dose for both vaccines is for certain target groups determined by the COVID-19 Immunisation Task Force-Booster (CITF-B) and it would be announced periodically,” he said.

According to Dr Noor Hisham, during the meeting today, DCA also gave conditional approval registration  for AstraZeneca Solution for Injection vaccine from the third manufacturer, SK Bioscience Co. Ltd of South Korea and the holder of the registration for the vaccine 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 was 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 the risk of the vaccine remained positive, said Dr Noor Hisham. 

He said the Health Ministry (MOH) 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 (NPRA) and approved by DCA.

-- BERNAMA


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