Monday Post

Europe is planning to facilitate easy entry for those vaccinated with jabs approved by European Medicine Agency (EMA). As per the latest report Covidshield, which is being manufactured by Serum Institute of India (SII) with AstraZeneca as a technology partner is not on the approved list, but the same vaccine manufactured by AstraZeneca under brand name Vaxzevria has been approved. It means that any person who is vaccinated with Covidshield will not be having an entry in Europe so easily, the person might have to face quartine or face no entry at the airport only.

The ministry of external affairs (MEA) has already the matter with the European Union (EU) drug regulator EMA and France which is reportedly one of the first European nations planning to facilitate entry for those vaccinated with EMA’s approved list of vaccines. Indian govt is carefully studying the EU’s current Green Pass directive, which appeared to be discriminatory and ad hoc. There have been informal talks on the matter with EU. Problem is that in India maximum people are vaccinated with Covidshield and this vaccine has been exported to so many other small countries of the third world. Now, this is becoming a political issue and the MEA will have to be involved in resolving the issue.

As of now, travel from India is restricted by most countries. But once these restrictions are removed, the absence of an Indian vaccine from the list of approved jabs will become a thorny issue. Non-incliusion of Covidshield will impact the travel plans of people in several countries. SII manufactured Covidshield vaccine has been widely distributed by World Health Organisation (WHO) co-sponsored Covax initiative and figures on the list of WHO-approved vaccines.

Experts who are familiar with the situation, feel that India will resolve the issue with EMA and European states to secure approval for Covidshiels as well as Bharat Biotech’s Covaxin.

India has also started using Russia’s Sputnik V, which has already applied for EMA approval, and it is under the rolling review process of EMA, which is the step prior to formal authorisation.

EMA, which is the agency of the EU responsible for the evaluation and supervision of medicines has so far approved only four Covid 19  vaccines- Pfizer, Moderna, Vaxzevria (Oxford AstraZeneca) and Janssen (Johnson & Johnson). Eu members that issue the Green Pass must accept these four vaccines. Individual countries have the freedom to grant entry to travellers who have taken other vaccines as well.

Now EMA has itself being the subject of some criticism among member countries. Italian PM last week suggested that there was a need for strengthening and may also for reform of EMA, to avoid a repeat of considerable confusion over the vaccination roll out. Presently there is a certain discrepancy in pronouncements over the safety of Covid 19 vaccines between EMA and the national medicines body.

Now the traveller information issued by the authorities of Schengen Zone, which includes EU countries plus several other non-EU European countries such as Norway and Switzerland. As the member states open borders for travel from non-EU countries for non-essential purposes, they also intend to issue EU Covid travel certificates to travellers from third countries intending to enter their territory. The commission also intends to accept certficatres issued in third countries, which are issued under the same conditions as the ones to EU. In order for the traveller to be able to get the vaccine, he/she should be vaccinated with one of the EU approved vaccines.

So it looks like there is confusion among EU member countries, plus they have to take care of non-EU countries which share the borders with member countries, otherwise, travel will become a big problem in Europe.

Now if EMA does not approve Covidshield, India may have to approach the member countries individually for getting the approval for Covidshield. and Covaxin. Now one question comes to my mind and that is “ if WHO has approved the vaccine and the same is not being approved by EMA, in that case, why WHO is not directing EMA to accept the same. Is EMA  above  WHO or the world body has lost its clout?

So let us wait and watch further development on this issue.

Waiting for your views and comments.

Anil Malik

Mumbai, India

28^th June 2021.