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Pharma leaders warn vaccine manufacturing doesn’t turn on a dime

Executives caution manufacturing buildup may be slow for first vaccines, push back on IP pool

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Don’t expect global manufacturing capacity to rapidly fill in for the first few COVID-19 vaccines to market, according to Paul Stoffels. The J&J vice chairman and CSO said it could take over a year for a manufacturing facility to switch over to produce a different type of vaccine.

Speaking at a press conference hosted by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Stoffels and three other executives of pharmas developing COVID-19 vaccines also rejected the need for an IP pool for COVID-19 products. The rebuke comes a day before WHO’s planned launch of a voluntary platform to openly share data, knowledge and IP for candidates to prevent and treat the novel coronavirus.

Joining Stoffels were Emma Walmsley, CEO of GlaxoSmithKline plc (LSE:GSK; NYSE:GSK); Albert Bourla, chairman and CEO of Pfizer Inc. (NYSE:PFE); Pascal Soriot, CEO of AstraZeneca plc (LSE:AZN; NYSE:AZN); and IFPMA Director General Thomas Cueni.

Stoffels highlighted how companies are committing the next 6-12 months to prepare at-risk manufacturing facilities to produce mass volumes of vaccine based on a specific technology. Switching those facilities over to a different type of vaccine can’t be done quickly, he cautioned.

“You can’t switch technologies overnight,” Stoffels said. “The capacity that everyone is building and making sure they have billions or hundreds of millions of doses, you can’t switch that out overnight.”

He added that global supply would likely require five to 10 separate COVID-19 vaccines.

At least 12 vaccines based on five different modalities are in the clinic, with at least another 127 in preclinical development, according to BioCentury’s COVID-19 Resource Center.

Switching between two vaccines of the same modality, especially mRNA, would be easier than changing between the modalities.

The Johnson & Johnson (NYSE:JNJ) CSO suggested that it would be more feasible to divert fill-finish capacity toward a newly available vaccine.

Stoffels, along with Bourla and Soriot, flagged availability of vials as a rate-limiting step in fill-finish capacity for COVID-19 vaccines.

All three said they were in discussions with regulators and national governments about supplying vaccines in vials containing five or 10 doses as a way to lower the demand for vials.

“The challenge is not so much to make the vaccine, but to fill the vials,” Soriot said. “There’s not enough vials in the world, so like everybody else we are looking at five doses per vial or 10 doses per vial so we can produce more doses with the limited number of glass vials that can be accessed.”

Pool players?

All four executives pushed back on the need for an IP pool.

“At this point in time it is nonsense,” Bourla said. “There’s a giant effort happening to find a solution to this pandemic. And the risks we are taking are bigger, and chances [of success] are still not very good.”

With “billions” being invested in pursuit of a vaccine and hundreds of biotechs working toward a solution, Bourla said, “To have a discussion that -- keep in mind if you discover it -- ‘we are going to take your IP,’ I think is dangerous.”

IFPMA’s Cueni also sees an IP pool as unnecessary. He pointed out that biopharma companies are already engaging in equitable access principles and voluntary licensing schemes to make therapeutics or vaccines broadly available.

IP is fundamental to the biopharma industry, Walmsley said, adding that the sector’s ability to mobilize now against COVID-19 “is because of the investments in science and research that’s been made with that support.”

“There isn’t enormous evidence that IP is a barrier to access” to vaccines, she said.

First proposed by the government of Costa Rica in March, the WHO announced two weeks ago that it would launch the voluntary IP pool to share data and IP for COVID-19 treatments and vaccines to better promote non-exclusive voluntary licensing.

Timelines

All four executives provided updates on their companies’ vaccine programs, while in a separate announcement GSK said it expects to produce one billion doses of its pandemic adjuvant in 2021.

GSK said that hundreds of millions of doses of the AS03 adjuvant are already earmarked for the vaccine the company is developing in partnership with Sanofi (Euronext:SAN; NASDAQ:SNY). The company has seven active partnerships for its adjuvant to be used with a COVID-19 vaccine, meaning the majority of the 2021 capacity could be allocated across those programs. In early February, GSK partnered with Coalition for Epidemic Preparedness Innovations to make its adjuvant available to any of CEPI’s funded programs (see “As COVID-19 Vaccines Progress”).

Bourla reiterated that Pfizer and partner BioNTech SE (NASDAQ:BNTX) expect that their BNT162 COVID-19 vaccine could be available by the end of October. Phase I data are expected next month, and the companies plan to rapidly move into a Phase II/III program in up to 30,000 healthy volunteers.

Soriot said data are coming soon from a Phase I/II trial of AZD1222 that completed last week. Oxford University, with which AZ is partnered, has already started screening individuals for a U.K. Phase III trial of the vaccine. The pharma is planning to start a 30,000 patient U.S. Phase III trial in July, according to the AZ CEO.

Stoffels said J&J continues to expect to start clinical testing of its Ad26 SARS-CoV-2 vaccine in September. The pharma hopes to quickly move to Phase III testing, where it plans to run two trials of its vaccine. The company may need to enroll patients in the Southern hemisphere if that’s where there’s more active outbreaks

J&J said in late March that it was moving to rapidly scale up its manufacturing capacity via a partnership with HHS, with the goal of supplying globally more than one billion doses of its vaccine annually. The initiative is part of a planned $1 billion investment by the company and HHS to co-fund vaccine R&D and clinical testing against COVID-19 (see “J&J Looks to Dramatically Scale Up Vaccine Manufacturing”).

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