KUALA LUMPUR, July 2 — Malaysians vaccinated with AstraZeneca-Oxford’s Covid-19 vaccine may be barred from entering Europe, as the European Union’s (EU) Digital Covid Certificate — which came into force yesterday — only recognises EU-approved shots for free travel within the bloc.
While the European Medicines Agency (EMA) has approved the Covid-19 vaccine by AstraZeneca (branded Vaxzevria), besides Pfizer-BioNTech, Moderna, and Johnson & Johnson, the EU drug regulator’s approval does not cover AstraZeneca doses made by South Korea’s SK Bioscience or Thailand’s Siam Bioscience.
South Korea and Thailand produce AstraZeneca vaccines for Malaysia’s order from the global COVAX Facility and direct orders respectively.
“The only Covid-19 vaccine from AstraZeneca for which a marketing authorisation application was submitted to and evaluated by EMA, leading to its authorisation in the EU, is Vaxzevria (previously Covid-19 Vaccine AstraZeneca),” the EMA told CodeBlue today in a statement.
The EMA has only approved AstraZeneca vaccine manufacturing sites in the EU, the United States, the United Kingdom, and China.
But while South Korea’s SK Bioscience manufacturing site is listed in Vaxzevria’s product information as one of the manufacturers of the vaccine’s biological active substance, EMA said this simply means that “the active substance produced at this site can be used to manufacture Vaxzevria, the vaccine that is authorised in the EU”.
“This, however, does not automatically mean that the AstraZeneca vaccine SK-Bio is approved for use in the EU, even though it may be produced in the same site as the active substance for Vaxzevria (previously Covid-19 Vaccine AstraZeneca),” EMA told CodeBlue.
“It is important to note that in the context of a vaccine authorisation the company has to submit a list of manufacturing sites to EMA and it is EMA’s role to evaluate and potentially approve it. The benefits and risks of Covid-19 vaccines need to be properly assessed based on detailed information on manufacturing as well as on nonclinical data and well-designed clinical trials.”
Malaysia received yesterday a contribution from the Japanese government of a million doses of AstraZeneca’s coronavirus vaccine manufactured in Japan. Japan was not listed among the EMA-approved manufacturers for AstraZeneca.
Covishield, the AstraZeneca version produced by the Serum Institute of India that is the biggest Covid-19 vaccine supplier for low- and middle-income countries through COVAX, is also reportedly not recognised by the EU’s “green pass”. Health Policy Watch reported June 30 a European Commission spokesperson as saying that although travellers fully inoculated with vaccines authorised by the EU “should” be allowed entry, even if the shots were not produced in EMA-approved manufacturing sites, it is up to individual EU countries to decide on whether to do so.
While EU member states are obliged to issue vaccination certificates regardless of the type of Covid-19 vaccine taken by travellers, the European Commission only compels EU states to exempt free movement restrictions — like travel-related testing or 14-day quarantine — for travellers fully inoculated with vaccines that received EU-wide marketing authorisation.
“Member States have the option to also accept vaccination certificates issued in relation to vaccines that have been authorised at national level or by the World Health Organization (WHO),” states the European Commission’s FAQ on the EU Digital Covid Certificate.
The WHO has approved Sinovac’s Covid-19 vaccine, which is currently being rolled out in Malaysia.
When asked about the progress of approval for China’s Sinovac and Russia’s Sputnik V vaccines, the EMA said both shots are currently under rolling reviews.
“Rolling reviews will continue until sufficient evidence is available for formal marketing authorisation applications, which have not been received yet,” the EMA told CodeBlue.
“Please note that EMA will be in a better position to comment on possible timelines for an authorisation of the Sinovac and Sputnik V Covid-19 vaccines once a marketing authorisation application has been submitted to the Agency, allowing a better understanding of the robustness of the data available.”
Sinovac is the third Covid-19 vaccine used in Malaysia, besides Pfizer and AstraZeneca. Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has not yet approved the Sputnik V shot procured by the government.
The EMA told CodeBlue that it was not responsible for any decision regarding travelling into the EU and travelling conditions associated with Covid-19 vaccination, such as the EU Digital Covid Certificate, saying: “This is a matter for the European Commission and for individual Member States.”
CodeBlue has contacted Vaccine Minister Khairy Jamaluddin’s office for comment on whether Malaysia is engaging in talks with the EU to recognise the Covid-19 vaccines used by Malaysia.