U.S. focus on Pfizer production could delay manufacturing of other COVID-19 vaccines, Serum Institute CEO warns

The U.S.' move to lock up raw materials and supplies for Pfizer's COVID-19 vaccine could spell trouble for manufacturers working on other shots around the globe. 

The world’s largest vaccine maker by volume, Serum Institute of India, sees bottlenecks ahead, thanks to a U.S. law blocking exports of certain materials needed to produce COVID-19 shots. The World Health Organization has also raised flags about a global shortage of raw materials used to turn out the pandemic vaccines, Bloomberg first reported

In January, the Biden administration said it would leverage the "full power" of the Defense Production Act to free up supplies for the production of coronavirus shots, including Pfizer's BioNTech-partnered mRNA vaccine Comirnaty. 

Now, the U.S. has blocked exports of certain materials like bags and filters, Serum Institute CEO Adar Poonawalla said during a World Bank panel discussion Thursday. WHO's chief scientist, Soumya Swaminathan, warned of shortfalls of vials, glass, plastic and stoppers, too. 

Serum Institute, producing shots on license for AstraZeneca and Novavax, has so far delivered 90 million doses of AZ and the University of Oxford's adenovirus-based shot to 51 countries, but supply shortfalls could scupper work on Novavax's vaccine, Poonawalla said.

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“The Novavax vaccine, which we’re a major manufacturer for, needs these items from the U.S.,” he said. "If we’re talking about building capacity all over the world, the sharing of these critical raw materials, which just can’t be replaced in a matter of six months or a year, is going to become a critical limiting factor.”

It's an issue Serum Institute could take to the Biden administration directly, Poonawalla said. "We're talking about having free global access to vaccines but if we can't get the raw materials out of the U.S.—that's going to be a serious limiting factor."

The company didn't immediately reply to Fierce Pharma's request for comment. 

Swaminathan echoed Poonawalla, stating, “This is where again you need global agreement and coordination not to do export bans.”

The issue of vaccine nationalism came to a head last month when the European Union, feuding with British drugmaker AstraZeneca over reduced shot deliveries, placed temporary controls on exports of vaccines produced in the bloc. Just this week, the Italian government—with EU support—blocked AstraZeneca’s request to ship some 250,000 doses from its Anagni, Italy plant to Australia, Reuters reported.

Meanwhile, WHO has spent months pushing wealthier nations to join its equitable vaccine distribution scheme COVAX, warning that when it comes to the pandemic, “whether we win or lose, we will do so together.” On February 10, the agency said that of the 128 million vaccine doses administered so far, more than three quarters of those were in just 10 countries that account for 60% of global GDP. At the same time, nearly 130 countries had yet to administer a single dose.

The “self-defeating” strategy could cost lives, give the virus time to mutate and evade vaccines, and undermine economic recovery efforts, WHO warned.

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Industry trade group PhRMA, for its part, acknowledged that “ending the pandemic and helping the nation return to normal are our top priorities.”

“We need to move forward recognizing the complexities and challenges of manufacturing medicines to prevent and treat COVID-19, while also avoiding unintended consequences that could disrupt the delivery of other life-saving medicines,” a PhRMA spokesperson said via email.

Pfizer's vaccine rollout hasn't been without its problems, though the company has made several upgrades to production since Comirnaty's authorization in December. Pfizer in November said it would deliver 50 million doses to the U.S. in 2020, down from a planned 100 million, thanks to slower-than-expected manufacturing scale-up and raw materials shortages. 

"Scaling up a vaccine at this pace is unprecedented, and we have made significant progress as we have moved forward in the unknown," a Pfizer spokesperson told Fierce Pharma at the time, adding, "scale-up of the raw material supply chain took longer than expected."

That same month, Pfizer said it could supply more than the 100 million doses it promised in its original contract with the U.S. government in the first half of 2021, provided U.S. officials pushed raw materials suppliers to quickly fulfill the company’s orders. CEO Albert Bourla suggested the U.S. leverage the Defense Production Act, and the Biden administration did just that earlier this year. 

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In the meantime, Pfizer and BioNTech have ratcheted up their vaccine output to a planned 2 billion doses by year-end. Stateside, the company has said it will more than double deliveries from 4 million to 5 million doses per week to more than 13 million a week starting in mid-March. The company says it's on track to deliver 120 million doses by the month's end. 

The company credited that boost to "significant investments" at its plants in Missouri, Massachusetts and Michigan, plus the addition of new lines at its McPherson, Kansas site, as well as a lipid production start in Groton, Connecticut.

Meanwhile, the FDA recently cleared the use of a bonus sixth dose in vials of Pfizer's vaccine. The regulator also approved the doubling of its batch size, increased yields from each batch, reduced cycle times and more, the company said in executive testimony prepared before a recent hearing with the House Energy and Commerce Committee's oversight arm.

Editor's note: This story has been updated with additional details from WHO and PhRMA.