AstraZeneca has further bolstered its global manufacturing capacity for AZD1222, the COVID-19 vaccine it is co-developing with University of Oxford and its spinout company, by signing agreements to supply the vaccine in four of Europe’s largest countries—including Italy, where the pharma giant will support its production through a separate accord with Catalent.

Catalent said today its manufacturing facility in Anagni, Italy, will provide AstraZeneca with vial filling and packaging capacity, and help the pharma giant prepare for large-scale commercial supply of AZD1222, through an agreement whose value was not disclosed.

Catalent has agreed to prepare its Anagni facility to enable round-the-clock manufacturing schedules and supply hundreds of millions of doses of AZD1222 from August 2020, and potentially through to March 2022 should the vaccine win approval by regulatory agencies.

The 28,000 square-meter (305,000 square-foot) Anagni facility specializes in late-stage and commercial product launch, with capabilities in aseptic liquid filling for biologics and sterile products across multiple vial sizes. The site also provides comprehensive primary and secondary packaging solutions, including serialization, to support product launches for oral solids, sterile, and biologics products.

“Catalent has significant experience in the tech transfer and rapid scale-up of vaccine programs to meet demand,” Alessandro Maselli, Catalent president and COO, said in a statement. “Our manufacturing site in Anagni, Italy has served for many years as a primary launch facility for new medicines, and the plant’s skilled team will take great pride in preparing to manufacture this vaccine candidate for COVID-19 and ensuring that the product will be able to reach patients as quickly as possible if approved.”

By partnering with Catalent, AstraZeneca aims to accelerate a rapid scale-up of capacity over the coming months in order to support the dedicated production of AZD1222.

“Front runner” candidate

AZD1222 is among 19 “Front Runner” candidates among the 240+ COVID-19 therapeutics under study in GEN’s updated “COVID-19 Drug & Vaccine Candidate Tracker.”

AZD1222 (formerly ChAdOx1 nCoV-19) uses a replication-deficient simian viral vector based on a weakened version of the adenovirus containing the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, which primes the immune system to attack COVID-19 if it later infects the body. The recombinant adenovirus vector (ChAdOx1) is designed to generate a strong immune response from a single dose and to not replicate, in order to preclude causing an ongoing infection in the vaccinated individual.

AZD1222 has been developed by the University’s Jenner Institute in partnership with colleagues from the University’s Oxford Vaccine Group, with AstraZeneca having joined the university and its spinout company Vaccitech in April. Vaccitech has joint rights with the University to the platform technology behind the vaccine candidate.

AZD1222 is now under study in a Phase II/III trial (NCT04400838) that began last month and is set to enroll up to 10,260 health UK volunteer patients. The trial will evaluate the efficacy, safety and immunogenicity of the vaccine in four study groups:

  • Groups 1 and 2 are adults over the age of 56 and will participate in the study for 6 months with the option to come for an additional follow up visit at day 364.
  • Group 3 is children aged 5–12 years will participate in the study for 6 months with the option to come for an additional follow up visit at day 364.
  • Group 4 is adults over the age of 18 and will participate in the study for 3 months with the option to come for an additional follow up visit at day 182.

A Phase I/II trial, COV001 (NCT04324606), began in April. The single-blinded, randomized, multi-center study was designed to determine the efficacy, safety, and immunogenicity of the vaccine candidate in healthy adult volunteers aged 18–55 years across five trial centers in southern England. As of late May, more than 1,000 participants were immunized, and researchers were conducting follow-up studies on patients

Alliance’s first agreement

AstraZeneca’s manufacturing scale-up of AZD1222 will include Italy as well as other European nations, after the company inked the first agreement signed by the new Inclusive Vaccines Alliance (IVA), which was formed by Italy as well as France, Germany, and the Netherlands to secure COVID-19 vaccine doses as quickly as possible. AstraZeneca has agreed to supply the IVA with up to 400 million doses of AZD1222 to nations within the alliance at no profit, starting by the end of 2020.

“This agreement will ensure that hundreds of millions of Europeans have access to Oxford University’s vaccine following approval,” AstraZeneca CEO Pascal Soriot stated. “With our European supply chain due to begin production soon, we hope to make the vaccine available widely and rapidly. I would like to thank the governments of Germany, France, Italy and the Netherlands for their commitment and swift response.”

The agreements with the IVA and Catalent are the latest in a wave of manufacturing initiatives launched this month with the aim of ramping up AZD1222 production and distribution worldwide. On Thursday, the company agreed to use the molecule-to-market contract development and manufacturing (CDMO) services of Emergent BioSciences, through a collaboration valued at $87 million.

On June 8, AZD1222 gained additional production capacity when the Vaccines Manufacturing and Innovation Centre (VMIC)—a not-for-profit organization established to provide the UK’s first strategic vaccine development and advanced manufacturing capability—agreed to provide equipment for Oxford Biomedica to rapidly equip two new GMP manufacturing suites within Oxford Biomedica’s new 7,800 m2 (about 84,000-square-foot) Oxbox commercial manufacturing center in Oxford, U.K.

The additional capacity will allow the University of Oxford, AstraZeneca, and partners to help meet vaccine demand in the U.K. and Europe starting in the summer, Oxford Biomedica said, adding that the suites could also be used for other viral vector vaccine candidates.

Up to 2 billion doses

Earlier in June, AstraZeneca said it had come to terms with partners to produce up to 2 billion doses of AZD1222 per year, double the 1 billion dose goal it articulated a month earlier. The pharma and SII (formerly the Serum Institute of India) agreed to produce 1 billion of the doses for low- and middle-income countries, starting with 400 million doses by year’s end.

AstraZeneca will also receive a combined $750 million toward manufacturing and distributing 300 million doses by year’s end from two groups: $383 million from CEPI, the Coalition for Epidemic Preparedness, and $367 million from GAVI, The Vaccine Alliance.

The New York Times reported June 3 that AstraZeneca, the University of Oxford, and partners were among developers of five COVID-19 vaccines identified by President Donald Trump’s administration as most likely to produce a vaccine for the virus, citing unnamed “government officials.” According to the report, the five will receive additional government funding, assistance with clinical trials, and financial and logistical support for manufacturing through the administration’s Operation Warp Spegened initiative. A formal announcement is expected in coming weeks.

Last month, AstraZeneca received $1.2 billion from the Biomedical Advanced Research and Development Authority (BARDA) toward development, production, and delivery of AZD1222. The development and production work to be funded by BARDA will begin this fall, and will include a Phase III trial designed to recruit 30,000 participants, as well as another trial to evaluate the vaccine in children, according to the company.

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