KUALA LUMPUR, July 7 — No individual countries in the European Union (EU) have yet to deny entry to travellers who received AstraZeneca Covid-19 vaccines produced in facilities that are not approved by the European Medicines Agency (EMA), said Ong Kian Ming.
The former deputy minister of international trade and industry, in a statement today, said that individual EU member nations have not announced different travel policies between the Vaxzevria brand of AstraZeneca produced by EMA-approved facilities in the EU and UK and the AstraZeneca versions produced in other countries, like South Korea, Thailand, or Japan.
Citing Germany’s Paul Ehrlich Institute (the Federal Institute for Vaccines and Biomedicines), Ong said the country still lists Malaysia’s AstraZeneca vaccine as equivalent to EU-authorised vaccines which are authorised abroad (original or licensed productions).
The DAP lawmaker said Malaysians should not overreact to the matter, claiming that EMA’s “non-recognition” is not a restriction for those vaccinated with AstraZeneca in Malaysia 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 regard to international travel to and from EU countries,” he said, referring to Malaysia’s drug regulator, the National Pharmaceutical Regulatory Agency (NPRA).
The European Commission (EC) confirmed with CodeBlue on July 3 that individual EU nations will ultimately decide on whether to permit entry to travellers inoculated with Covid-19 vaccines not approved by EU’s drug regulator. The EU’s “green pass” currently only recognises four vaccines approved by the EMA: Vaxzevria, Pfizer-BioNTech, Moderna, and Johnson & Johnson.
Stefan de Keersmaecker, EC spokesman for public health, food safety, and transport, said entry into the EU for non-essential travel “should” be allowed to people fully vaccinated with one of the coronavirus vaccines approved in the EU, even if the vaccines were not produced in EMA-approved facilities.
Pascal H Grégoire, ambassador of Belgium to Malaysia, also reiterated the EC’s position when he said that a non-EU vaccination certificate may be recognised as equivalent to the EU’s Digital Covid Certificate, in response to a tweet by political analyst Bridget Welsh.
Welsh branded as “racist” and “stupid” the EU’s decision not to recognise AstraZeneca shots manufactured in Asia, saying this could cost Europe millions in business and tourism and “seriously undermine its credibility among allies in Asia”.
The EU Digital Covid Certificate, which came into force July 1, is digital proof that a person has either been vaccinated against Covid-19, received a negative test result, or recovered from Covid-19.
The EU’s “green pass” only recognises the Vaxzevria brand of the AstraZeneca vaccine produced in the EU and the UK that has been approved by the EMA, besides the Pfizer, Moderna, and Johnson & Johnson shots that received EU-wide marketing authorisation.
Ong said 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.
“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),” he said.
Ong said in Germany, there are indicators which have been publicly published which categorised countries into “Areas of Variant of Concern” (effectively a travel ban list), “High Incidence Areas” — of which Malaysia entered into starting on June 14 — and “Base Risk Areas”.
For the UK, which is no longer in the EU, and is likely the most visited country nearing Europe by Malaysians, according to Ong, the main challenge is to ensure that Malaysia does not fall into the list of “red” countries and territories, which would mean that Malaysians will not be allowed to travel to the UK regardless of vaccination status.
Malaysia is currently on the “amber” list, which means that those travelling from Malaysia will have to take a Covid-19 test before travelling to England, quarantine in a hotel or at home for 10 days, and pay for 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,” Ong said.
The majority of supplies of the AstraZeneca vaccine being used in the EU is manufactured in Belgium and in the US, according to the BBC.
Ong 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 AstraZeneca 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,” he said.
This does not mean that AstraZeneca vaccines from production facilities not recognised by the EMA are less safe, Ong said.
He noted that Malaysia’s NPRA has not yet recognised Moderna’s vaccine, but the shot is already being widely used in many countries including Singapore. The NPRA did not authorise Moderna because no application to register for the vaccine for use in Malaysia has been made yet; the Malaysian government has decided not to procure Moderna.
Malaysia’s direct procurement of 6.4 million AstraZeneca doses are produced by Thailand’s Siam Bioscience, while Malaysia’s request of 1.39 million AstraZeneca doses through the global COVAX Facility backed by the United Nations are manufactured by South Korea’s SK Bioscience. Malaysia recently received a contribution from the Japanese government of a million AstraZeneca doses produced in Japan.
Besides AstraZeneca, Malaysia has also rolled out Covid-19 vaccines by Pfizer and Sinovac. Sinovac has received WHO approval for emergency use.