Serum Institute applies for EU nod through drugmaker AstraZeneca

Amid concern around visits to Europe by individuals who to­ok the jab of Serum Institute of India (SII), company sources have said SII has applied for marketing auth­ori­sation before the European Medicine Age­ncy (EMA) thro­ugh British drug­maker Astra­Zeneca, its vaccine partner.

So far, 287 million Covis­hield shots, single and double, have been given in India, and the company has exported close to 70 million doses.

SII Chief Executive Officer Adar Poonawalla said on Mon­day he had taken it up at the “highest levels”. If Euro­pean Union (EU) restriction on Covishield continues, at least a few hundred million people would face challenges entering or travelling within the EU me­mber states. 

“We have applied for marketing authorisation to the EMA through Astra­Zeneca. We will not sell the vaccine in the EU. But, since this is a technicality to ensure that those who got Covi­shield shots gain entry into the EU member countries, we have applied for marketing authorisation,” said a company source, adding that the issue should be resolved within a month or so.

The person added Covi­shield was recognised by the Medicines and Healthcare Pro­d­ucts Regulatory Agency of the UK, and SII has supplied this vaccine to the UK and Canada apart from low- and medium-income countries (LMICs).

SII did not wish to divulge more detail on the matter or whether it had applied through AstraZeneca. ANI quoted an EU official saying, “… as of yesterday, the EMA stated that it had not received a request for approval. It will examine any such request when received...”

Meanwhile, the African Union Commission and the Af­r­ica Centres for Disease Control and Prevention have urged the European Commission to consider increasing mandatory access to those vaccines dee­med suitable for a global roll-out through the EU-supported COVAX Facility.