Pune: Owner and CEO of Covishield-Maker Serum Institute of India (SII), Adar Poonawalla, on Saturday rejected the requirement of ‘marketing authorization application’ European Union (EU), 16 of the 27 member states and Switzerland (not part of the EU) have currently approved the vaccine based on the WHO’s pre-qualification or emergency use list (EUL).
France on Saturday became the latest EU member state to ratify coveshield for the journey.
Poonawalla told TOI, “With France joining, 16 of the 27 EU countries have already approved Kovishield, including Germany and the Netherlands. Switzerland, which is not a part of the EU, has also accepted it. It’s done. Slowly, every EU country is adopting Covishield. But Italy and some others haven’t approved it yet. We haven’t made any applications for those who approve it. Europe, America And everyone else has to accept that this vaccine (Kovshield) is of good quality because WHO has approved it.”
In the European Union, there are two main routes for authorizing vaccines: a centralized route and a national route. While most new and innovative drugs are evaluated by the European Medicines Agency (EMA), regulatory bodies in each country may also independently authorize the use of a vaccine in their jurisdiction.
Manufactured under transfer of technology from Covishield Oxford/AstraZeneca, is not currently among the vaccines authorized under the EMA. This lack of authorization for Covishield is creating hurdles for Indian travellers.
On 15 July, EMA said it had not received an application from SII for authorization of Covishield, almost a fortnight after the EU introduced the EU Digital COVID Certificate, which makes intra-EU travel possible.
“To evaluate the Covid-19 vaccine Covishield for use in the EU, the developer must submit a formal marketing authorization application to the EMA, which has not been received to date,” EMA said in a press meeting.
Poonawalla said in his response, “Marketing authorization application is made when a manufacturer intends to sell their vaccine in that country. We cannot apply because we are not selling Covishield in Europe. Europe is not even our region. , where we intend to sell and we do not even have a license from AstraZeneca to do so. We also have no plans to export the vaccine. So the question of us applying does not arise.”
Poonawalla said AstraZeneca is working with EMA to gain approval in other EU countries. “We don’t have any local conditions to deal with them (EMA). AstraZeneca is working with them,” he said.
About efforts to address concerns among those traveling to the EU, Poonawalla said, “We have already written to all countries. We have spoken to all our diplomats. Our foreign offices have taken it up.” We have also taken up this matter. Directly with these countries, also with AstraZeneca and WHO. The efforts have already yielded results with 16 EU countries accepting Covidshield based on WHO’s pre-qualification. Huh.”
Sixteen EU countries and Switzerland have confirmed that they will accept passengers who have received the Covishield. The list includes Austria, France, Belgium, Bulgaria, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Malta, the Netherlands, Slovenia, Spain and Sweden.
The WHO pre-qualification, or emergency use list (EUL), is given after assessing the quality, safety and efficacy of COVID-19 vaccines. This allows countries to accelerate their own regulatory approvals. “If the vaccine is approved by WHO, it should be a good passport certificate for travel,” Poonawalla said.
So far, the EMA has approved vaccination by only one of four vaccines for restriction-free travel within the EU during the pandemic – by Pfizer/BioNtech, Moderna’s SpikeVax, AstraZeneca-Oxford and Johnson & Johnson’s Jensen Vaxgerviria.
This means people vaccinated with CovShield may be subject to quarantine protocols enforced by individual member states, and some may even be blocked from entering.
France on Saturday became the latest EU member state to ratify coveshield for the journey.
Poonawalla told TOI, “With France joining, 16 of the 27 EU countries have already approved Kovishield, including Germany and the Netherlands. Switzerland, which is not a part of the EU, has also accepted it. It’s done. Slowly, every EU country is adopting Covishield. But Italy and some others haven’t approved it yet. We haven’t made any applications for those who approve it. Europe, America And everyone else has to accept that this vaccine (Kovshield) is of good quality because WHO has approved it.”
In the European Union, there are two main routes for authorizing vaccines: a centralized route and a national route. While most new and innovative drugs are evaluated by the European Medicines Agency (EMA), regulatory bodies in each country may also independently authorize the use of a vaccine in their jurisdiction.
Manufactured under transfer of technology from Covishield Oxford/AstraZeneca, is not currently among the vaccines authorized under the EMA. This lack of authorization for Covishield is creating hurdles for Indian travellers.
On 15 July, EMA said it had not received an application from SII for authorization of Covishield, almost a fortnight after the EU introduced the EU Digital COVID Certificate, which makes intra-EU travel possible.
“To evaluate the Covid-19 vaccine Covishield for use in the EU, the developer must submit a formal marketing authorization application to the EMA, which has not been received to date,” EMA said in a press meeting.
Poonawalla said in his response, “Marketing authorization application is made when a manufacturer intends to sell their vaccine in that country. We cannot apply because we are not selling Covishield in Europe. Europe is not even our region. , where we intend to sell and we do not even have a license from AstraZeneca to do so. We also have no plans to export the vaccine. So the question of us applying does not arise.”
Poonawalla said AstraZeneca is working with EMA to gain approval in other EU countries. “We don’t have any local conditions to deal with them (EMA). AstraZeneca is working with them,” he said.
About efforts to address concerns among those traveling to the EU, Poonawalla said, “We have already written to all countries. We have spoken to all our diplomats. Our foreign offices have taken it up.” We have also taken up this matter. Directly with these countries, also with AstraZeneca and WHO. The efforts have already yielded results with 16 EU countries accepting Covidshield based on WHO’s pre-qualification. Huh.”
Sixteen EU countries and Switzerland have confirmed that they will accept passengers who have received the Covishield. The list includes Austria, France, Belgium, Bulgaria, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Malta, the Netherlands, Slovenia, Spain and Sweden.
The WHO pre-qualification, or emergency use list (EUL), is given after assessing the quality, safety and efficacy of COVID-19 vaccines. This allows countries to accelerate their own regulatory approvals. “If the vaccine is approved by WHO, it should be a good passport certificate for travel,” Poonawalla said.
So far, the EMA has approved vaccination by only one of four vaccines for restriction-free travel within the EU during the pandemic – by Pfizer/BioNtech, Moderna’s SpikeVax, AstraZeneca-Oxford and Johnson & Johnson’s Jensen Vaxgerviria.
This means people vaccinated with CovShield may be subject to quarantine protocols enforced by individual member states, and some may even be blocked from entering.
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