AstraZeneca COVID-19 vaccine safe for use in Malaysia - Dr Adham

He said the AstraZeneca COVID-19 vaccine safety data, obtained from clinical studies as of Nov 4, 2020 involving 12,000 volunteers, showed that no serious side effects were reported.

The usual side effects frequently reported were soreness at the site of inoculation, lethargy, headaches, and others classified as mild or moderate onsets.

"Data also showed that post-vaccination effects were significantly reduced after the second dose was administered," he said in a statement regarding the safety status of the AstraZeneca COVID-19 vaccine, which was approved for registration by the Drug Control Authority (DCA) on March 2.

According to him the clinical studies also concluded that there were no safety issues concerning its effects on the blood's profile and contents, including blood clotting, after receiving the vaccine jab.

Dr Adham said AstraZeneca Sdn Bhd had also held a meeting with the National Pharmaceutical Regulatory Division (NPRA) on March 17 to explain the actual situation regarding the safety issue of the AstraZeneca COVID-19 vaccine, especially relating to blood clots (thromboembolic events).

According to the company, a total of 17 million people had received the AstraZeneca COVID-19 vaccine in the European Union (EU) and the United Kingdom (UK) as of March 8, with 15 cases of deep vein thrombosis (DVT) and 22 cases of pulmonary embolism reported from among the recipients.

Dr Adham said the company had conducted detailed studies of all the cases and concluded that there was no solid evidence that could link the vaccine to the risk of thromboembolic events.

"The total number of thromboembolic event cases reported was also far lower compared to the average expected cases in that population size and the conclusion was also supported by the European Medicines Agency (EMA).

"Therefore, it is concluded that the AstraZeneca COVID-19 vaccine is safe for use," he said.

Dr Adham said the Ministry of Health was committed to carrying out continuous monitoring to ensure the quality, safety and effectiveness of the COVID-19 vaccines are always guaranteed.

Recipients can report adverse effects following COVID-19 vaccine jabs through health personnel, directly to the NPRA website at www.npra.gov.my or through the MySejahtera application for mild adverse effects, he said.

On March 15, National COVID-19 Immunisation Programme Coordinating Minister Khairy Jamaluddin said Malaysia would proceed with the purchase and acquisition of AstraZeneca COVID-19 vaccines as there has been no evidence that the vaccine causes blood clots.

The Science, Technology and Innovation Minister said AstraZeneca had informed Malaysia on the side effects of the vaccine and so far, there has been no data to indicate any direct link between the vaccine and reports of blood clots in people, which had resulted in deaths in a few countries.

Several countries such as Denmark, Norway, Iceland and Thailand have reportedly paused the rollout of AstraZeneca's vaccine following reports of blood clots occurring in several individuals after being vaccinated.