As the European Union (EU) launches its Digital COVID Certificate today 1st July, many Nigerians and indeed Africans may face challenges travelling to the EU under this new “Green Pass” regime
This is due to the fact that the EU has not approved the AstraZeneca vaccine manufactured by the Serum Institute in India, known as Covishield even though it has been approved by the World Health Organisation (WHO)
The EU currently only recognizes the four following vaccines namely:
- the Pfizer-BioNTech vaccine is known as Comirnaty
- Oxford-AstraZeneca (AZ) is known as Vaxzevria
- Moderna is known as Spikevax
- Janssen (sometimes referred to as the Johnson & Johnson vaccine)
Note that though the AstraZeneca vaccine manufactured in Serum Institute in India (Covishield) is identical to that manufactured in Europe (Vaxzeria), the EU has not authorized Covishield
What is the EU Digital COVID Certificate?
An EU Digital COVID Certificate is a digital proof that a person has either
- been vaccinated against COVID-19;
- received a negative test result or
- recovered from COVID-19
It is expected that the certificate will make it easier for people to travel around the EU. It’s available in, and recognized by, all 27 EU member states – plus Switzerland, Iceland, Norway and Liechtenstein.
Key features of the certificate
- Digital and/or paper format
- with QR code
- free of charge
- in national language and English
- safe and secure
- valid in all EU countries
Covishield is being used in most African countries including Nigeria, via the COVAX vaccine programme. COVAX is co-led by Gavi, the Vaccine Alliance, the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI), working in partnership with UNICEF as well as the World Bank, civil society organisations, manufacturers, and others.
The COVAX scheme was set up to assist poorer countries in having faster access to the COVID-19 vaccines.
The COVAX Facility is expected to deliver around 90 million doses of COVID-19 vaccines to the African Region in the first quarter of 2021 and has committed to providing up to 600 million doses to the region by end-2021 to cover 20 per cent of the population.
Serum Institute head Adar Poonawalla said in a tweet Monday that people who have been administered the Covishield shot are “facing issues with travel to the EU.”
“I assure everyone, I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries,” Poonawalla added.
The European Medicines Agency (EMA) says that “In the EU, the vaccine called Covishield does not currently have a marketing authorization. Even though it may use an analogous production technology to Vaxzevria, Covishield as such is not currently approved under EU rules”
“This is because vaccines are biological products,” the agency stated. “Even tiny differences in the manufacturing conditions can result in differences in the final product, and EU law therefore requires the manufacturing sites and production process to be assessed and approved as part of the authorization process.”
The African Union Commission and the Africa Centres for Disease Control and Prevention (Africa CDC) issued a statement saying that they “noted with concern recent communications regarding the applicability of the EU Digital COVID Certificate “Green Pass” to different COVID-19 vaccines. The availability of such a Certificate, with its potential to significantly facilitate free safe movement across all EU Member States and certain associated countries, is a significant step forward. However, the current applicability guidelines put at risk the equitable treatment of persons having received their vaccines in countries profiting from the EU-supported COVAX Facility, including the majority of the African Union (AU) Member States.”
These developments are concerning given that the Covidshield vaccine has been the backbone of the EU-supported COVAX contributions to the AU Member States’ vaccination programmes.
Furthermore, given that the expressed goal for the Serum Institute of India production is to serve India and lower-income countries, the SII may not apply for EU-wide market authorisation, meaning that the inequalities in access to “Green Passes” created by this approach would persist indefinitely.
The EMA statement added: “Should we receive a marketing authorization application for Covishield or should any change to the approved manufacturing sites for Vaxzevria be approved, we would communicate about it.”
The EU told CNN in a statement Wednesday that the certificate was “not a prerequisite for travel into the European Union” and that “Member States could also allow entry for people vaccinated with vaccines having completed the WHO Emergency Use Listing process,” which includes Covishield. Travelers may also enter the EU by presenting a negative PCR test.
