Pune: Owner and CEO of Covishield-Maker Serum Institute of India (SII), Adar Poonawalla, on Saturday rejected the need for ‘Marketing Authorization Application’ to the European Union (EU), said 16 of 27 member countries and Switzerland (not part of the EU) At present it has approved a vaccine based on whose pre-qualification or emergency use of emergency (EUL).
France on Saturday became the latest UE member country to approve the Covishield for traveling.
Poonawalla told TII, “with the addition of France, 16 of 27 European Union countries have approved the Covishield, including Germany, and the Netherlands.
Switzerland, who is not part of the EU, has also received it.
Slowly, every EU country.
Receive covishield.
But Italy and some others have not agreed.
We do not do any application to those who have agreed to it.
Europe, the US, and everyone must recognize that this vaccine (covishield) is good quality because of the good quality because of the good quality because it has approved it.
“In the EU, there are two main routes for vaccine authorization: centralized routes and national routes.
While most new and innovative drugs are evaluated by the European Medicine Agency (EMA), the supervisory body in each country can also independently ratify the use of vaccines in their jurisdiction.
Covishield, produced under the transfer of technology from Oxford / Astrazeneca, is currently not among the official vaccines under EMA.
The lack of authorization for this covishield has created obstacles for Indian travelers.
On July 15, EMA said it did not accept the application from SII for the Covishield authorization, almost two weeks after the EU introduced a Covid EU digital certificate, which allows intra-eu trips.
“For Covid-19 Covishield vaccines to be evaluated for use in the EU, developers need to submit the application of formal marketing authorization to EMA, which until now has not been received,” Ema said at the press meeting.
In its response, said Poonawalla, “Marketing authorization application was carried out when the manufacturer intended to sell its vaccine in the country.
We cannot register because we do not sell covishield in Europe.
Europe doesn’t even sell and we don’t even have a license from AstraZeneca to do that.
We Don’t have a plan to export our vaccine.
So the question of us who put the application not appear at all.
“Poonawalla said Astrazeneca worked with EMA to get approval in other EU countries.
“We don’t have a local position to deal with them (EMA).
Astrazeneca deals with them,” he said.
Regarding the efforts made to overcome concerns between those traveling to the EU, Poonawalla said, “We have written to all countries.
We have spoken with all our diplomats.
Our foreign offices have taken it.
We also take this problem directly with the state This country, AstraZeneca and also with WHO.
Efforts have produced results in the form of 16 EU countries recognize the covishield based on whose pre-qualifications.
“Sixteen countries of the European Union and Switzerland have confirmed that they will receive tourists who have received covishield.
This list includes Austria, France, Belgium, Bulgaria, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Malta, the Netherlands, Slovenia, Spain and Sweden, he said.
A pre-qualification, or emergency use listing (EUL), is given after assessing the quality, security, and efficacy of the Covid-19 vaccine.
This allows the state to accelerate the approval of their own rules.
“If the vaccine is approved by WHO, it must be a good passport certificate for traveling,” said Poonawalla.
So far, EMA only approved only those who were vaccinated by one of four vaccines – Comirnaty of Pfizer / Biontech, Spkevax, Vaxzervia by Astrazeneca-Oxford and Johnson & Johnson’s Janssen – for free travel restrictions in the EU during a pandemic.
This means that people who are vaccinated with covishield can be subject to quarantine protocols such as those enforced by individual member countries, and can even be blocked to enter several.