The Health Ministry has affirmed that AstraZeneca’s Covid-19 vaccine is safe after several countries briefly suspended the use of the vaccine to investigate a possible link to a rare blood-clotting disorder.
Health Minister Dr Adham Baba said AstraZeneca representatives in Malaysia had met the National Pharmaceutical Regulatory Agency (NPRA) last week to explain the situation.
Based on company data, there had been 15 incidents of deep vein thrombosis and 22 cases of pulmonary embolism reported in the European Union and the UK, out of 17 million people vaccinated.
Adham said the company reviewed all cases and found no concrete evidence to suggest the vaccines had caused the thromboembolic events.
“The number of thromboembolic events reported is also far lower compared to the average number of expected cases given the size of the population.
“The conclusion is also supported by the European Medicines Agency (EMA). Therefore, it is surmised that AstraZeneca’s Covid-19 vaccine is safe to use,” he said in a statement today.
The minister also noted that in AstraZeneca’s clinical trial up to Nov 4, data on about 12,000 trial volunteers showed no sign of severe adverse events following vaccination. Most side effects were of mild or moderate severity and were usually milder for the second dose than the first dose.
“The clinical trial also concluded there are no safety issues relating to blood profile and content (including blood clots) after receiving this vaccine,” he said.
Earlier this month, several countries - predominantly in Europe - suspended the use of AstraZeneca's vaccine in their vaccination drives following several reports of unusual blood clots among vaccinated people.
After the EMA reviewed the matter, it said it cannot definitively rule out a link between the vaccine and the blood clots, but affirmed that the benefits of receiving the vaccine still outweighed any potential risk.
It also noted that the threat of Covid-19 is still widespread, and the disease can also lead to potentially fatal blood clotting disorders.
The World Health Organisation has likewise reaffirmed its support for the vaccine.
Most EU countries have lifted the suspension of AstraZeneca’s vaccine following the EMA review.
Malaysia’s Drug Control Authority (DCA) had previously granted conditional approval for the vaccine on March 2.
Before the vaccine can be used in Malaysia, however, additional approval is still required for the facility in Thailand that would produce the doses destined for Malaysia.
For now, the only Covid-19 vaccines being used in Malaysia are those co-developed by Pfizer and BioNTech, and those developed and manufactured by Sinovac in China. Sinovac vaccines bottled in Malaysia have yet to receive DCA approval.
As of yesterday, 481,989 Covid-19 vaccine doses have been administered in Malaysia – 430,368 people have received at least one dose, and 51,621 have received both doses.
Malaysia aims to complete the first phase of its vaccination campaign in April, where 500,000 frontliners such as healthcare workers, security personnel, and lawmakers would be immunised against the disease.
Subsequent phases would see at least 23.6 million people vaccinated by February next year, though its coordinating minister Khairy Jamaluddin said the goal may be reached by the end of this year if vaccine deliveries are received on schedule. - Mkini
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