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PUNE: Covishield maker Serum Institute of India’s (SII) owner and chief executive officer (CEO) Adar Poonawalla on Saturday dismissed the need for ‘marketing authorisation application’ and said that 15 of the 27 member countries of the European Union (EU) have already approved Covishield based on World Health Organisation’s (WHO) pre-qualification or emergency use listing (EUL).
“A total of 15 of the 27 member countries of the European Union (EU) have already approved Covishield including Germany, Switzerland, Netherlands. But Italy, France, and few others have not approved it. We did not make any application to those who have approved it. Europe, the US, and everyone have to acknowledge that this vaccine (Covishield) is of good quality because WHO has approved it,” Poonawalla said.
In the European Union (EU), there are two main routes for authorizing vaccines: a centralized route and a national route.
While the majority of new, innovative medicines are evaluated by EMA and authorized by the European Commission, regulatory bodies of every country can also allow authorization to the vaccine within their jurisdiction.
Covishield vaccine, manufactured under technology transfer from Oxford/AstraZeneca, is currently not among the authorized vaccines under the EMA. The lack of authorization for Covishield is creating hurdles for Indian travellers.
The EMA in a press meeting on July 15 said that it had not received any application from the SII for authorization of Covishield almost a fortnight after the EU introduced the EU Digital Covid Certificate that makes intra-EU travel possible.
“For the Covid-19 vaccine Covishield to be evaluated for use in the EU, the developer needs to submit a formal marketing authorization application to EMA, which to date has not been received,” the EMA said at a press meeting.
Referring to it, Poonawalla said, “Marketing authorization application is made when a manufacturer intends to sell its vaccine in that country. We can not apply because we are not selling Covisheild in Europe. Europe is not even our territory where we intend to sell and we don’t even have the license from AstraZeneca to do that. We have no plans to even export our vaccine. So the question of us putting an application does not arise at all.”
Poonawalla said that Astra-Zeneca is working with the EMA to get approval in other EU countries. “We have no local standing to deal with them (EMA). AstraZeneca is dealing with them,” he said.
Asked about the efforts to address the current concerns about the travel to the EU, Poonawalla said, “We have already written to all the countries. We have talked to all our diplomats. Our foreign offices have taken it up. We have taken it up directly with these countries, the AstraZeneca, and also with the WHO. The efforts have already yielded results in the form of 15 EU countries acknowledging Covishield based on WHO’s prequalification.”
Fifteen countries have confirmed they will accept travellers who have received the Covisheild jab. These include Austria, Belgium, Bulgaria, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Malta, Netherlands, Slovenia, Spain, Sweden, and Switzerland, he said.
A WHO prequalification, or emergency use listing (EUL), is given after assessing the quality, safety, and efficacy of Covid-19 vaccines and it allows countries to expedite their own regulatory approvals.
“If the vaccine is approved by the WHO it should be a good passport certificate for the travel,” Poonawalla said.
So far, the EMA has approved only those vaccinated by either of the four vaccines – Comirnaty of Pfizer/BioNTech, Moderna’s Spikevax, Vaxzervria by AstraZeneca-Oxford, and Johnson & Johnson’s Janssen – for restriction-free travel within the EU during the pandemic.
That means people vaccinated with Covishield will be subject to quarantine protocols as enforced by individual member countries, and may even be blocked from entering some others.
“A total of 15 of the 27 member countries of the European Union (EU) have already approved Covishield including Germany, Switzerland, Netherlands. But Italy, France, and few others have not approved it. We did not make any application to those who have approved it. Europe, the US, and everyone have to acknowledge that this vaccine (Covishield) is of good quality because WHO has approved it,” Poonawalla said.
In the European Union (EU), there are two main routes for authorizing vaccines: a centralized route and a national route.
While the majority of new, innovative medicines are evaluated by EMA and authorized by the European Commission, regulatory bodies of every country can also allow authorization to the vaccine within their jurisdiction.
Covishield vaccine, manufactured under technology transfer from Oxford/AstraZeneca, is currently not among the authorized vaccines under the EMA. The lack of authorization for Covishield is creating hurdles for Indian travellers.
The EMA in a press meeting on July 15 said that it had not received any application from the SII for authorization of Covishield almost a fortnight after the EU introduced the EU Digital Covid Certificate that makes intra-EU travel possible.
“For the Covid-19 vaccine Covishield to be evaluated for use in the EU, the developer needs to submit a formal marketing authorization application to EMA, which to date has not been received,” the EMA said at a press meeting.
Referring to it, Poonawalla said, “Marketing authorization application is made when a manufacturer intends to sell its vaccine in that country. We can not apply because we are not selling Covisheild in Europe. Europe is not even our territory where we intend to sell and we don’t even have the license from AstraZeneca to do that. We have no plans to even export our vaccine. So the question of us putting an application does not arise at all.”
Poonawalla said that Astra-Zeneca is working with the EMA to get approval in other EU countries. “We have no local standing to deal with them (EMA). AstraZeneca is dealing with them,” he said.
Asked about the efforts to address the current concerns about the travel to the EU, Poonawalla said, “We have already written to all the countries. We have talked to all our diplomats. Our foreign offices have taken it up. We have taken it up directly with these countries, the AstraZeneca, and also with the WHO. The efforts have already yielded results in the form of 15 EU countries acknowledging Covishield based on WHO’s prequalification.”
Fifteen countries have confirmed they will accept travellers who have received the Covisheild jab. These include Austria, Belgium, Bulgaria, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Malta, Netherlands, Slovenia, Spain, Sweden, and Switzerland, he said.
A WHO prequalification, or emergency use listing (EUL), is given after assessing the quality, safety, and efficacy of Covid-19 vaccines and it allows countries to expedite their own regulatory approvals.
“If the vaccine is approved by the WHO it should be a good passport certificate for the travel,” Poonawalla said.
So far, the EMA has approved only those vaccinated by either of the four vaccines – Comirnaty of Pfizer/BioNTech, Moderna’s Spikevax, Vaxzervria by AstraZeneca-Oxford, and Johnson & Johnson’s Janssen – for restriction-free travel within the EU during the pandemic.
That means people vaccinated with Covishield will be subject to quarantine protocols as enforced by individual member countries, and may even be blocked from entering some others.
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