KUALA LUMPUR: The Health Ministry has given its assurances that the AstraZeneca vaccine, which was registered by the country's 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 which were reported include pain at the injection area, fatigue, and headache that were classified as mild and moderate.
"The data also found that the side effects reduced during the injection of the second dose, compared to 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 today.
Dr Adham said the vaccine's registration holder, AstraZeneca Sdn Bhd, met with the National Pharmaceutical Regulatory Agency (NPRA) on March 17 to explain the situation involving safety concerns of the vaccine, especially on the blood clotting side effects (thromboembolic events) recently reported in Europe.
"According to the company, as of March 8, a total of 17,000 individuals have received the AstraZeneca vaccine in the European Union (EU) and the United Kingdom.
"Of the total number of vaccine recipients, 15 deep vein thrombosis (DVT) 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 was also far lower than the average expected cases for that population size.
"The European Medicines Agency (EMA) also supported this conclusion. The AstraZeneca vaccine is, therefore, safe to be used," he said.
Dr Adham also reaffirmed the ministry's commitment to conducting regular monitoring to ensure that the safety, quality and efficacy of the Covid-19 vaccines are 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 (WHO) and global health experts have reiterated that no evidence has been found to link the vaccine to blood clots and the immunisation programmes in Europe have resumed.