Pune: Covishield Maker Serum Institute of India (SII) Owner and Chief Executive Officer (CEO) Adar Poonawalla on Saturday rejected the need for ‘Marketing Authorization Application’ and said that 15 of the 27 European Union member countries (EU) had already done the agreed covishield List of Pre-Qualification (WHO) World Health Organization or Emergency Use (EUL).
“A total of 15 of the 27 European Union member countries (EU) have approved the covishield including Germany, Switzerland, the Netherlands.
But Italy, France, and some others have not agreed.
We do not make any application to those who have agreed.
Europe, USA, and Everyone must admit that this vaccine (covishield) is of good quality because it has approved, “said Poonawalla.
In the European Union (EU), there are two main routes for vaccine authorization: centralized routes and national routes.
Whereas the majority of innovative new drugs are evaluated by EMA and authorized by the European Commission, the Supervisory Board of each country can also allow authorization to vaccines in their jurisdiction.
The covishield vaccine, produced under the transfer of technology from Oxford / Astrazeneca, is currently not among the official vaccines under EMA.
The lack of authorization for the covishield creates obstacles for Indian travelers.
Ema in a press meeting on July 15 said that it had not received any application from SII for the Covishield authorization almost two weeks after the EU introduced the Covid Digital EU certificate that allowed 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.
Referring to that, Poonawalla said, “The marketing authorization application was made when the manufacturer intends to sell its vaccines in the country.
We cannot register because we do not sell Covisheilds in Europe.
Europe doesn’t even want to sell and we don’t even have a license from AstraZeneca to do that .
We have no plans to export our vaccines.
So the question of us placing the application does not appear at all.
“Poonawalla said that Astra-Zeneca 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.
Asked about efforts to overcome the current concern about the trip to the EU, Poonawalla said, “We have written to all countries.
We have spoken with all our diplomats.
Our foreign office has taken it.
We have taken it.
We have taken it directly with the country This country, AstraZeneca, and also with WHO.
Efforts have produced results in the form of 15 European Union countries recognize Covishielgy based on the prequalification.
“Fifteen countries have confirmed that they will receive tourists who have received Jab Covisheild.
It includes Austria, Belgium, Bulgaria, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Malta, Netherlands, Slovenia, Spain, Sweden and Switzerland, he said.
A WHO Prequalification, or an emergency use listing (EUL), is given after assessing the quality, security, and efficacy of the Covid-19 vaccine and allows the state to accelerate their own regulation agreements.
“If the vaccine is approved by WHO, it must be a good passport certificate for the trip,” said Poonawalla.
So far, EMA only approved only those who were vaccinated by one of the four vaccines – Comirnaty of Pfizer / Biontech, Modern Spavax, Vaxzervia by AstraZeneca-Oxford, and Johnson & Johnson’s Janssen – for free travel restrictions in the EU during a pandemic.
That means people who are vaccinated with covishield will be subject to quarantine protocols such as those enforced by individual member countries, and can even be blocked to enter several others.