EMA did not clear Indian version of AstraZeneca vaccine: how does this affect Argentines who applied it

This morning we learned that European Medicines Agency (EMA) had not authorized the Indian version AstraZeneca COVID-19 vaccine, Covishield. Due to “possible differences” with the original, the producing laboratory must apply for an authorization to be included in the list of sera approved for the European Union (EU) vaccination passport..

The Covishield vaccine is a variant of Vaxzevria manufactured by AstraZeneca and Oxford, which is produced at the Serum Institute in India from a collaboration agreement as part of a technology transfer from the Anglo-Swedish laboratory and the British university . And it is one of those that several emerging countries have received within the framework of aid from the COVAX mechanism.

The Global Access Fund for COVID-19 Vaccines (COVID-19 Vaccines Global Access, COVAX) is an alliance promoted by public and private actors with the supposed aim of guaranteeing equitable access to vaccines developed against COVID-19. Currently, 190 countries are part of this alliance.

The initiative is led by the Global Alliance for Vaccines and Immunization (GAVI), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO), and Argentina received 580,000 Covishield vaccines through this route.

“The doses of Covishield came when AstraZeneca struggled to fulfill the contract”, they said to Infobae of the Ministry of Health of the Nation.

And concerning the decision of the EMA known today, the infectious disease doctor Roberto Debbag (MN 60253) analyzed before the consultation of this environment: “The manufacturing process carried out in India is exactly the same as that carried out by the AstraZeneca laboratory. The non-authorization may be related to the fact that the European agency does not have the plant pre-classified, but I don’t think that has to do with the vaccine itself ”.

“It’s a matter of regulatory process, not because the vaccine is different”, I consider.

According to the EU, the drug made in India by the Serum Institute, the world’s largest vaccine manufacturer by volume, has been excluded from the list for requiring independent marketing application in Europe, despite the fact that its Vaxzevria homologous formula is similar in composition.

“Even though it uses production technology similar to that of Vaxzevria (AstraZeneca’s immunizer), Covishield as such is currently not approved to EU standards,” said the EMA. in a statement to the news agency AFP.

“That is why vaccines are biological products. Even small differences in manufacturing conditions can lead to differences in the final product, and EU law requires manufacturing sites and production processes to be assessed and approved as part of the authorization process ”, he added.

“Regarding a possible authorization for Covishield, as of yesterday, the EMA indicated that it had not received a request for approval“On the side of the production company, they added to the agency Efe official EU sources.

Covishield is to date the main formula used in India for its vaccination campaign, with more than 280 million doses administered in the first six months of the program.

The WHO, which had already given its agreement to Covishield, regretted that some countries rejected the wording. “It’s a real shame because AstraZeneca-Covishield is the exact same vaccine as AstraZeneca-Vaxzevria, which is accepted as proof of vaccination”said Richard Mihigo of the WHO regional office for Africa.

“The only thing AstraZeneca-Covishield is manufactured and distributed in other parts of the world outside of Europe,” he added.

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