ʻITʼS SAFEʼ
WITH concern persisting over the AstraZeneca vaccine following suspensions abroad and criticism over its trial data, the Health Ministry assures Malaysians that no adverse side effects have been reported in 12,000 volunteers.
THE Health Ministry has given its assurance that the AstraZeneca vaccine, which was registered by the Drug Control Authority on March 2, is safe for use.
Health Minister Datuk Seri Dr Adham Baba said the data obtained from the clinical trial of the AstraZeneca vaccine, which involved some 12,000 volunteers, found no adverse side effects being reported.
“The most common side effects reported include pain at the injection area, fatigue and headache, which were classified as mild and moderate.
“The data also found that the side effects were reduced after the injection of the second dose, compared with the first dose.
“The clinical trial also concluded that no safety issues involving effects on blood profiles and content (including blood clotting) occurred after the vaccine was administered,” he said in a statement yesterday.
Dr Adham said the vaccine’s registration holder, AstraZeneca Sdn Bhd, met the National Pharmaceutical Regulatory Agency (NPRA) on March 17 to explain the situation involving safety concerns of the AstraZeneca vaccine, especially on the blood clotting side effects (thromboembolic events).
“According to the company, up to March 8, a total of 17,000 individuals have received the AstraZeneca vaccine in the European Union and the United Kingdom.
“Of the total number of vaccine recipients, 15 deep vein thrombosis cases and 22 pulmonary embolism cases have been reported.
“The company conducted a detailed evaluation of all the cases and concluded that no strong evidence was found to attribute the thromboembolic event cases as resulting from the AstraZeneca vaccine.
“The thromboembolic cases reported were also far lower than the average expected cases for
that population size.
“The European Medicines Agency also supported this conclusion. The AstraZeneca vaccine is, therefore, safe to be used.”
Dr Adham also reaffirmed the ministry’s commitment to conduct regular monitoring to ensure that the safety, quality and efficacy of the Covid-19 vaccines were guaranteed.
On March 11, Denmark became the first country to suspend the use of the AstraZeneca vaccine as a precautionary measure due to concerns of blood clots in vaccine recipients.
Several European countries, including France, Italy and Germany, followed suit to halt the use of AstraZeneca shots on March 17 over similar fears.
However, the World Health Organisation and global health experts had reiterated that no evidence had been found to link the vaccine to blood clots.
Dr Adham said 481,989 individuals had been vaccinated via the National Covid-19 Immunisation Programme up to Tuesday.
Of the total, 430,368 had received the first dose of the vaccine, while 51,621 individuals had completed the full vaccination regimen, he said.
Based on the infographic he shared on his Twitter account yesterday, three states recorded the highest number of individuals who had received the first dose of the vaccine, namely Selangor at 58,552 recipients, Perak (49,451) and Sabah (41,125).
This was followed by Kuala Lumpur (37,254), Sarawak (36,103), Pahang (33,317), Johor (31,451), Penang (30,394), Kedah (26,293), Kelantan (19,734), Terengganu (19,698), Negri Sembilan (19,639), Melaka (10,875), Perlis (9,526), Putrajaya (4,612) and Labuan (2,344), he said.
Three states recorded the highest number of individuals who had completed the two doses of the vaccine, namely Sarawak (10,166), Pahang (5,793) and Perak (5,337).
It was followed by Kuala Lumpur (4,894), Kelantan (4,647), Johor (3,271), Kedah (3,138), Terengganu (2,406), Selangor (2,174), Negri Sembilan (1,802), Penang (1,721), Sabah (1,525), Melaka (1,443), Labuan (1,276), Perlis (1,037) and Putrajaya (991).
The immunisation exercise, launched on Feb 24, aims to immunise, free of charge, everyone in the country, locals and foreigners alike, against Covid-19.