Mumbai: Serum Institute of India It will not seek separate marketing approval from Europe’s regulator for its COVID-19 vaccine, Covishield, as its partner Astra Zeneca has asked to consider SII as an alternative manufacturing site. There is a requirement associated with the jab to be accepted as part of a ‘green pass’ for EU travel.
UK pharmaceutical company AstraZeneca, which developed the vaccine with Oxford University, has asked the regulator european medical agency (EMA) to add SII as ‘an alternative manufacturing site’ on approval granted for its vaccine, Vaxjeveria.
So far, 17 of the 27 EU countries have accepted CoveShield for quarantine-free travel. Sources told TOI that the SII-manufactured Covishield is similar to the one made by its licensee AstraZeneca and used in Europe, so a separate approval is not required. He added that the company need not apply for a marketing license as it will not be marketing Covishield in Europe.
The request made by the UK firm to the EMA in May is pending, and is being processed. An AstraZeneca spokesperson told TOI, “We have requested the addition of SII as an alternative manufacturing site on the Vaxzeveria license. Apart from AstraZeneca, Pfizer, Moderna and Johnson & Johnson vaccines have received EMA authorization and are ‘Vaccine passports’. This comes amid the issues and travel restrictions being faced by many students flying to study in the EU and those looking to travel for work .
The European Union’s Digital Covid Certificate or ‘Green Pass’ came into effect from 1 July. Under this, people taking vaccines authorized by the EMA will be exempted from travel restrictions within the European Union. Individual Member-States may also accept vaccines that have been authorized nationally or have been approved by WHO.
Experts say EU member states are encouraged to accept WHO-authorized vaccines. It may be noted that SII’s Coveshield was authorized by WHO earlier this year.
(with inputs from Indrani Bagchi)
UK pharmaceutical company AstraZeneca, which developed the vaccine with Oxford University, has asked the regulator european medical agency (EMA) to add SII as ‘an alternative manufacturing site’ on approval granted for its vaccine, Vaxjeveria.
So far, 17 of the 27 EU countries have accepted CoveShield for quarantine-free travel. Sources told TOI that the SII-manufactured Covishield is similar to the one made by its licensee AstraZeneca and used in Europe, so a separate approval is not required. He added that the company need not apply for a marketing license as it will not be marketing Covishield in Europe.
The request made by the UK firm to the EMA in May is pending, and is being processed. An AstraZeneca spokesperson told TOI, “We have requested the addition of SII as an alternative manufacturing site on the Vaxzeveria license. Apart from AstraZeneca, Pfizer, Moderna and Johnson & Johnson vaccines have received EMA authorization and are ‘Vaccine passports’. This comes amid the issues and travel restrictions being faced by many students flying to study in the EU and those looking to travel for work .
The European Union’s Digital Covid Certificate or ‘Green Pass’ came into effect from 1 July. Under this, people taking vaccines authorized by the EMA will be exempted from travel restrictions within the European Union. Individual Member-States may also accept vaccines that have been authorized nationally or have been approved by WHO.
Experts say EU member states are encouraged to accept WHO-authorized vaccines. It may be noted that SII’s Coveshield was authorized by WHO earlier this year.
(with inputs from Indrani Bagchi)
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