Three CEPI-funded vaccines secure additional manufacturing resources

AZ awarded first advanced market commitment for COVID-19 vaccine

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Three CEPI-funded vaccines secured additional manufacturing resources Thursday in a trio of announcements that included the first advanced market commitment from the ACT Accelerator to supply COVID-19 vaccines to low and middle-income countries at no cost.

AstraZeneca plc (LSE:AZN; NYSE:AZN) will receive $750 million from the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance, to support the manufacturing and distribution of 300 million doses of AZD1222 (formerly ChAdOx1 nCoV-19). The first doses of the vaccine, which the pharma licensed from the University of Oxford, will be delivered by year-end.

Thursday’s flurry of vaccine updates also saw CEPI close a COVID-19 vaccine manufacturing deal with The University of Queensland; Novavax Inc. (NASDAQ:NVAX) sign a $60 million contract with the U.S. Department of Defense; and the Bill & Melina Gates Foundation announce a five-year, $1.6 billion commitment to Gavi.

Under the deal with the international Access to COVID-19 Tools (ACT) Accelerator, which launched in April, AstraZeneca will work with the Serum Institute of India Pvt. Ltd. (SII) to supply 1 billion vaccine doses for low and middle-income countries. It plans to deliver 400 million doses by year-end.

In addition to CEPI and Gavi, ACT organizers include the Bill & Melinda Gates Foundation, Wellcome Trust, the WHO and other international organizations (see “World Leaders Commit to Collaborate”).

SII had initially reached an agreement with the University of Oxford’s Jenner Institute in April to produce 60 million doses of the vaccine (see “India Emerging as Major Vaccine Manufacturer”).

The ACT Accelerator partnership comes after the pharma closed vaccine deals with the U.K. and the U.S.

U.K. Business Secretary Alok Sharma said in May that the country will be the first to get access to AZD1222, with 30 million doses expected by September.

Days later, the Trump administration’s Operation Warp Speed pledged up to $1.2 billion AZ to support clinical development and manufacturing of AZD1222. The initiative plans to make 300 million doses of a safe and effective COVID-19 vaccine available for Americans by January (see “Operation Warp Speed Takes First Step”).

AstraZeneca did not respond in time for publication to questions regarding its manufacturing partners and whether the U.K. will be the first country to receive the vaccine.

The University of Oxford is enrolling about 10,000 adult volunteers to receive AZD1222 in a Phase II/III trial. The recombinant adenovirus vaccine encodes the SARS-CoV-2 spike protein.

Queensland aboard vaccine train

Also Thursday, CEPI closed a COVID-19 vaccine manufacturing deal with The University of Queensland.

The organization will share clinical development and manufacturing costs with CSL Ltd. (ASX:CSL); financial terms are undisclosed.

CSL’s Australian facility will be responsible for the initial phase of large-scale production. The company expects to produce 100 million doses by YE21, and plans to subcontract with global manufacturers to broaden geographical distribution of the vaccine and increase production.

A Phase I trial is slated to begin next month. If efficacious, the vaccine could be available in 2021; CEPI said 100% of its vaccine allocation would then be distributed through the ACT Accelerator.

Queensland’s vaccine uses synthetic proteins developed with its “molecular clamp” technology, which locks SARS-CoV-2 surface proteins in a form that the immune system can respond to more effectively.

Novavax signs U.S. contract

Under Novavax’s DoD contract, the company is eligible to receive up to $60 million to fund manufacturing of its COVID-19 vaccine; the deal stipulates the biotech must work with U.S.-based manufacturers.

Novavax will provide DoD with 10 million doses this year of NVX-CoV2373, which can be used in Phase II/III clinical trials or under an Emergency Use Authorization (EUA).

In March, Novavax secured manufacturing capacity with Maryland-based Emergent BioSolutions Inc. (NYSE:EBS). The CDMO closed a $628 million contract with HHS on Monday to provide manufacturing services to COVID-19 vaccine developers as part of Operation Warp Speed (see “Emergent Playing Key Role”).

Novavax has also partnered with AGC Biologics to manufacture Matrix-M; the CDMO is based in Washington state.

Last week, Novavax acquired a Czech biologics manufacturing facility. The company, which has received $388 million from CEPI, has committed to making NVX-CoV2373 globally accessible through the ACT Accelerator (see “CEPI Funding Fuels Novavax Vaccine Trial Start”).

The vaccine is a stable, prefusion protein that induces anti-SARS-CoV-2 spike antibodies and is made with the company’s recombinant protein nanoparticle technology.

Gates commits $1.6B

Also Thursday, the Bill & Melina Gates Foundation announced a five-year, $1.6 billion commitment to Gavi, a portion of which will go towards providing COVID-19 vaccines to low income countries. The Gates Foundation said it will also provide Gavi with an additional $50 million to purchase COVID-19 vaccines for lower income countries, bringing its total commitment to the initiative to $100 million.

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