KUALA LUMPUR: Malaysia is confident with the careful consideration conducted by the National Pharmaceutical Regulatory Agency (NPRA) which has given conditional approval for the use of AstraZeneca’s Covid-19 vaccine in the country.
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Health Minister Datuk Seri Dr Adham Baba said the government has received conditional approval by the NPRA to acquire the vaccine developed by the British-Swedish firm with Oxford University.
The assurance from Dr Adham came in the wake of a decision by the Danish government and a number of European countries to suspend the use of the vaccine after several patients in Denmark developed blood clots after receiving the jabs.
“Malaysia is confident with the deliberation by the NPRA in issuing the (conditional) approval which has certainly taken into consideration important matters which is the safety, quality and the effectiveness of the vaccine (by AstraZeneca),” he told the New Straits Times.
Dr Adham said the ministry took note on the report published by the European Medicines Agency (EMA) on March 11 over the cases in Denmark.
He said there was no indication that the vaccine caused these conditions, which are not listed as the vaccine’s side effects.
The ministry’ Pharmaceutical Services Programme in a statement said although the Covid-19 vaccine by AstraZeneca has been granted conditional registration by the Drug Control Authority (DCA) Malaysia, it is not yet available for use in the National Covid-19 Immunisation Program.
“Even though there is no clear indication that the event can be linked to the vaccine, the NPRA will continue to monitor the safety of the Covid-19 Vaccine.
“Further update on the outcome of the EMA assessment will be communicated and regulatory action will be taken if necessary.”
The EMA in a statement on its website said that the agency is aware of the decision by the Danish Health Authority to pause the use of the AstraZeneca vaccine in its vaccination campaign and a precautionary measure pending full investigation into reports of blood clots in people after receiving the jab, including one case in Denmark where a person died.
“The position of EMA’s safety committee PRAC (Pharmacovigilance Risk Assessment Committee) is that the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing.
“PRAC is already reviewing all cases of thromboembolic events, and other conditions related to blood clots, reported post-vaccination with Covid-19 Vaccine AstraZeneca.
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“The number of thromboembolic events in vaccinated people is no higher than the number seen in the general population.
“As of March 10, 30 cases of thromboembolic events had been reported among close to five million people vaccinated with Covid-19 Vaccine AstraZeneca in the European Economic Area,” the agency said, adding that it would further communicate as the assessment progresses.
Universiti Putra Malaysia’s epidemiology and biostatistics expert, Associate Professor Dr Malina Osman, said it would be relatively too early to make any conclusion on the use of the available Covid-19 vaccines at this time.
“I believe NPRA will scrutinise all related safety issues on this vaccine further.
“As the vaccine will be available in two or three months time, perhaps during the time when the vaccine has already become available, we will have more data and information.
“To conclude at this time, I think will be relatively too early,” she said.
Apart from Denmark, Norway and Iceland have also temporarily suspended the use of AstraZeneca’s Covid-19 vaccine.
Four other European countries – Estonia, Latvia, Lithuania and Luxemburg – have also suspended the use of vaccines from the same batch.
Meanwhile, Thailand became the first country in the South East Asia region to delay the rollout of AstraZeneca’s Covid-19 vaccine.
Health authorities in the Philippines, however, saw no reason to halt the usage of the vaccine. Australia would also continue with the roll-out of the AstraZeneca vaccine.
Health director-general Tan Sri Dr Noor Hisham Abdullah had on March 2 announced that the DCA had granted conditional approval to three Covid-19 vaccine products, including the one developed by AstraZeneca, to be used in the country.
It was reported that the AstraZeneca vaccines are scheduled to be delivered this month after being greenlit by the NPRA.- NST