KUALA LUMPUR, July 3 — The European Commission (EC) has confirmed that individual European Union (EU) nations will ultimately decide on whether to permit entry to travellers inoculated with Covid-19 vaccines not approved by EU’s drug regulator.
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 — AstraZeneca-Oxford, Pfizer-BioNTech, Moderna, and Johnson & Johnson.
“This does not mean that the vaccines have to be produced in facilities covered by the marketing authorisation in the EU,” Keersmaecker told CodeBlue in a statement today.
He also said EU countries could permit entry to travellers who received Covid-19 vaccines approved by the World Health Organization (WHO) for emergency use.
However, the spokesman for the EC — the executive body of the EU — maintained that it was up to individual EU countries to decide on whether to recognise the Covid-19 vaccination of international travellers with vaccines not authorised for use at their national level.
“First, where the national health system allows for it, Member States may issue an EU Digital Covid certificate on a case by case basis for persons vaccinated in a third country with a vaccine that has been authorised in the EU or that has been listed by the WHO for Emergency Use,” said Keersmaecker.
“It is for Member States to verify if the holder presents reliable proof of such a vaccination. Member States are, however, not required to issue certificates for a vaccine that is not authorised on their territory.”
The EC spokesman also said the EC may adopt “an equivalence decision” for a Covid-19 certificate issued outside the EU that would then be considered equivalent to EU Digital Covid Certificate (DCC) issued by EU countries.
“This is only possible when a third country’s certificates are interoperable with the DCC technical standards. When an EU Digital Covid Certificate, or a third-country certificate for which an equivalence decision on the interoperable framework has been issued, indicates vaccination with a vaccine that does not correspond to one centrally authorised in the EU, each Member State has the option to recognise it.”
CodeBlue broke the news yesterday about the European Medicines Agency (EMA) not approving AstraZeneca’s vaccine manufactured in South Korea, Thailand, and Japan, that could lead to travel restrictions for Malaysians vaccinated with AstraZeneca after the EU’s Covid Digital Certificate came into force July 1.
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.
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.
The EU Digital Covid Certificate, according to the EC’s website, is digital proof that a person has either been vaccinated against Covid-19, received a negative test result, or recovered from Covid-19.
Fully vaccinated people with the EU Digital Covid Certificate should be exempted from free movement restrictions like travel-related testing or 14-day quarantine when entering the EU.
Global outrage sparked in the past week over the EU’s “vaccine passport” not recognising Covishield, the AstraZeneca version produced in India, that is mainly used for low- and middle-income countries in the COVAX vaccine-sharing programme. The Hindu reported yesterday EU authorities as saying that they have yet to receive a request from Covishield manufacturer, the Serum Institute of India, for approval.
As of Friday, at least 10 European countries of the 27-member state EU bloc, have recognised Covishield, though The Hindu noted that it was not clear if Indians vaccinated with Covishield could travel from one country to another within the EU on the basis of “national” recognition of the vaccine, without EMA approval.