Low- and middle-income countries banking on doses of AstraZeneca’s COVID-19 vaccine from Serum Institute of India may have to wait a bit longer, the Indian shot maker’s CEO said over the weekend. The same goes for Europe, where officials have reportedly considered importing supplies from the world's largest vaccine maker by doses.
Serum Institute has been told to prioritize supplies for India first as the country hustles to vaccinate 300 million people, or a fifth of its population, by August. The move could signal delays for other countries waiting on orders of AstraZeneca’s adenovirus shot, which Serum Institute is cranking out on license under the name Covishield.
Taking to Twitter, chief executive Adar Poonawalla urged patience, noting that Serum Institute was doing the best it could to juggle India’s “huge needs” with those of other countries.
Dear countries & governments, as you await #COVISHIELD supplies, I humbly request you to please be patient, @SerumInstIndia has been directed to prioritise the huge needs of India and along with that balance the needs of the rest of the world. We are trying our best.— Adar Poonawalla (@adarpoonawalla) February 21, 2021
Aside from direct agreements with countries like Saudi Arabia and South Africa, Serum Institute has pledged to supply 240 million AstraZeneca doses to the World Health Organization’s equitable distribution scheme Covax during the first half of the year. In August, it signed on to produce up to 1 billion doses of Novavax’s shot hopeful, NVX-CoV2372, too.
But after AstraZeneca's scale-up in Europe got off to a rocky start, officials there have been considering importing doses from Serum Institute, Reuters reported last week. U.K. inspectors confirmed they were auditing the company's manufacturing operations, which could clear the way for AstraZeneca to import India-made shots to the U.K. and EU.
The European Medicines Agency could then use that British audit for its own Serum Institute approval, the regulator told Reuters. Sites would still need final EMA clearance to export vaccines to the EU, however.
AstraZeneca, for its part, recently suggested it could source doses from facilities outside the bloc, Reuters reported, citing two EU officials—one of whom singled out Serum Institute specifically as a potential supplier. The company is now meeting weekly with the European Union to patch up deliveries.
Serum Institute boasts an overall capacity of 1.5 billion vaccine doses per year. The company currently tackles production at the 42-acre Poonawalla Bio-Technology Park in its home city of Pune. Meanwhile, CEO Poonawalla has set up a new company, Serum Institute Life Sciences, which is building a “pandemic-level” production plant in the city, with planned capacity for 1 billion doses, Forbes reported in October.
The company didn't immediately reply to Fierce Pharma's request for comment.
A week before AstraZeneca's shot bagged an emergency authorization in Europe, AZ revealed manufacturing shortfalls at a Belgian facility that it said would squeeze deliveries in the first quarter. Originally set to deliver 80 million doses during that period, AZ said it would only be able to send 31 million. The company has since brought its first-quarter delivery forecast up to 40 million doses.
“We will be supplying tens of millions of doses in February and March to the European Union as we continue to ramp up production volumes,” an AZ spokesperson told Fierce Pharma at the time.
In early February, AstraZeneca teamed up with German CDMO IDT Biologika to look at ways to speed delivery of finished doses to the bloc. Aside from tackling Europe’s “immediate vaccination needs,” the partners are plotting combined investments in an IDT facility in Dessau, Germany, that should have capacity for “tens of millions” of AstraZeneca doses per month once the project wraps next year.
Meanwhile, the Seneffe, Belgium, facility blamed for AstraZeneca’s supply shortfalls has “drastically” increased production capacity, Reuters reported last week, citing EU industry commissioner Thierry Breton. Thermo Fisher bought the site from Novasep in January.