By Chioma Obinna

The African Union Commission and the Africa Centres for Disease Control and Prevention, Africa CDC, have raised concerns over the exemption of recipients of Covishield vaccine from the Digital COVID Certificate “Green Pass” recognition given by the EU to recipients of other COVID-19 vaccines.

The two bodies are worried that non-recognition of Covishield which is one of the dominant vaccines donated to many African countries through the COVAX facility, may jeopardise the ongoing vaccination programme in the continent.

The EU had come up with a Digital Covid Certificate that allows people who have received two doses of a COVID-19 vaccine approved by its medicines regulator, the European Medicines Agency, EMA, to travel freely within the union.

The pass only recognises AstraZeneca doses manufactured in Europe (branded Vaxzevria) and not those manufactured by the world’s largest vaccine manufacturer — the Serum Institute of India (SII) — which is branded Covishield.

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However, in a statement issued by the African Union Commission and the Africa CDC and tagged: “Covishield and the European Union (EU) Digital COVID Certificate “Green Pass”, expressed worry that 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 AU, Member States.

In their response, the AU and Africa CDC noted that 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, they lamented that the official information for EU Member States to issue vaccination certificates regardless of the COVID-19 vaccine type used, the granting of a “green pass” applies, only to vaccines that have received EU-wide marketing authorisation.

Still expressing concern, they said the new EU guidelines may discriminate against persons that were vaccinated with Covishield.

  “Thus, while the AstraZeneca vaccine (ChAdOx1_nCoV-19) produced and authorized in Europe (Vaxzervria) is included, the same formation of the vaccine (Covishield) produced under license by the Serum Institute of India (SII), is excluded.

Under such regulations, persons who received Covishield, despite being able to demonstrate proof of vaccination, would continue to be subject to public health restrictions, including limitations of movement and testing requirements, with considerable administrative and financial implications.”

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 Covidshield vaccine, alongside the versions of the AstraZeneca/Oxford COVID-19 vaccine produced by AstraZeneca-SKBio (Republic of Korea), was one of the first available candidates considered safe and efficacious through the World Health Organisation’s Emergency Use Listing (EUL) process.

Both candidates received approval as early as 15 February 2021 with the explicit goal of rolling it out through the COVAX Facility, providing access to lower-income countries, and making the global population safe from COVID-19.

They further urged the EU Commission to consider increasing mandatory access to those vaccines deemed suitable for global rollout through the EU-supported COVAX facility.

Meanwhile, the EMA in a report is insisting that only Covid-19 shot from AstraZeneca for which approval was requested — leading to its authorization in the EU.

“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,” the EMA said.

“This is because vaccines are biological products. 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 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.”

They urged the EU Commission, “to consider increasing mandatory access to those vaccines deemed suitable for global rollout through the EU-supported COVAX Facility.

Vanguard News Nigeria