PETALING JAYA: We should not over-react to the European Medicines Agency (EMA) having not yet recognised the Astra-Zeneca (AZ) vaccine produced in non-EU countries, Bangi MP Dr Ong Kian Ming said today.
“I must admit that I, like many other Malaysians, had a very negative reaction upon reading news reports that the EMA does not ‘recognise’ the AZ vaccines that were recently donated to Malaysia by Japan,” he said in a statement today.
“But upon further study, I realised that this was a gross over-reaction and that I had failed to educate myself on this issue.”
Firstly, the EMA is not supposed to recognise any vaccines that are produced outside the EU which are not meant for the EU market, he pointed out.
“Most of the supplies of the AZ vaccine which are being used in the EU are manufactured in Belgium as well as in the United States,” the Assistant Political Education Director for DAP said.
“Like any pharmaceutical regulator, the EMA would only be concerned about the manufacturing process at the facilities where the vaccines are being made. It would not be concerned with the AZ manufacturing facilities in Japan which were producing mostly for the domestic market and also in India (via the Serum Institute) which were producing for the domestic market as well as for the low to mid income countries as part of the Covax supply agreements.”
Secondly, the fact that EMA did not recognise these AZ vaccines from these production facilities does not mean that these vaccines are somehow “less safe”, Ong said.
“For example, the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia has not yet recognised the Covid-19 vaccine currently being produced by Moderna but this vaccine is already being widely used in many countries including in Singapore
“Thirdly, the EMA ‘non-recognition’ is not a restriction (as far as I know) for Malaysians who have taken the AZ vaccine to travel to Europe. I needed to be reminded that the EMA is a government agency just like the NPRA with a specific mandate and set of responsibilities.
“The EMA does not decide the rules with regards to international travel to and from EU countries. When it comes to travel to and within the European Union (EU), a European Commission spokesman said that travellers who are fully vaccinated with vaccines authorized in the EU should be allowed entry for non-essential travel even if these vaccines were not “produced in facilities covered by the marketing authorisation in the EU.
Ong said fourthly, the travel policy with regards to Malaysia travelling to the EU is still governed by the rules and policies of individual countries.
For most EU countries, the indicators which are of concern are the number and variant of Covid-19 cases and the rate of spread in the country from which an individual is travelling from.
“What this means is that we should be more concerned about increasing the vaccination rate domestically as part of the larger strategy of containing the Covid-19 virus so that we are not put on any ‘banned list’ of any country meaning that our citizens or those who are residing in Malaysia are banned from travelling to a country in the EU (or anywhere else, for that matter).
“In Germany, for example, there are indicators[4] which have been publicly published which categorized countries into ‘Areas of Variant of Concern’ (effectively a ban travel list), ‘High Incidence Areas’ (of which Malaysia entered into starting on June 14 and ‘Base Risk Areas’,” Ong added.
Within individual EU countries, Ong said he is not aware of any country which has announced a differentiated treatment for individuals who have been vaccinated with the AZ vaccines produced in facilities which are recognized by the EMA (VAXZEVRIA) versus AZ vaccines produced in facilities which are not recognised by the EMA (COVISHIELD).
“For the United Kingdom, which is no longer in the European Union, and is probably the most visited European country by Malaysians, the main challenge for us is to ensure that our country doesn’t fall into the list of ‘red’ countries and territories which means that Malaysians cannot travel to the UK regardless of vaccination status.
“We are currently in the ‘amber’ list which means that we have to take a Covid-19 test before travelling to England, quarantine in a hotel or at home for 10 days and pay for a Covid-19 tests in Day 2 and Day 8 of the quarantine. Instead of focusing on vaccine recognition, we should instead work towards achieving the status of a ‘green’ country where we have to take a Covid-19 test before travelling to the UK and have another test on day two of our visit. No home or hotel quarantine is required unless the Covid-19 test result is positive.”
