VACCINE CONFIDENCE
Govt confident with consideration done by NPRA in approving Covid-19 jab, says Adham
MALAYSIA is to proceed with the procurement of the AstraZeneca vaccine, but will continue to monitor it as some countries suspend its use following reports of after-jab blood clots. Medical experts say it is too early to jump to conclusions and stress that vaccine benefits far outweigh the risks.
MALAYSIA is confident with the careful consideration taken by the National Pharmaceutical Regulatory Agency (NPRA), which has given conditional approval for the use of the AstraZeneca’s Covid-19 vaccine in the country.
Health Minister Datuk Seri Dr Adham Baba said the government had 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 taken into consideration important matters — the safety, quality and the effectiveness of the vaccine (by AstraZeneca),” he told the New Straits Times.
Dr Adham said the ministry took note of 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 were not listed as the vaccine’s side effects.
The ministry’s Pharmaceutical Services Programme in a statement said that although the Covid-19 vaccine by AstraZeneca had been granted conditional registration by the Drug Control Authority (DCA) Malaysia, it was not yet available for use in the National Covid-19 Immunisation Programme.
“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 was aware of the decision by the Danish Health Authority to pause the use of the AstraZeneca vaccine in its vaccination campaign as 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.
“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 progressed.
Universiti Putra Malaysia’s epidemiology and biostatistics expert Associate Professor Dr Malina Osman said it was too early to make any conclusion on the use of the available Covid-19 vaccines at this time.
“I believe NPRA will scrutinise further all related safety issues on this vaccine.
“As the vaccine will be available in two or three months’ time, 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 Luxembourg — have suspended the use of vaccines from the same batch.
Meanwhile, Thailand became the first country in the Southeast Asian region to delay the rollout of the AstraZeneca vaccine.
Health authorities in the Philippines, however, saw no reason to halt the usage of the vaccine. Australia would also continue with the rollout 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 following the green light from NPRA.