AstraZeneca to make COVID-19 vaccine with roots in Oxford’s CEPI-funded MERS project

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When the first therapies and vaccines for COVID-19 are approved, it is likely that they will be the result of responses to prior viral outbreaks and pandemic preparedness programs. Products that will be hailed as overnight successes are actually the result of R&D stretching back years and in some cases decades.

Most of the COVID-19 vaccines in the clinic and those slated to start trials by early summer are modified versions of vaccines originally developed for other coronaviruses or were made possible by investments in pandemic and biodefense platforms.

Similarly, other countermeasures now being deployed against COVID-19 were developed to combat Ebola, such as remdesivir from Gilead Sciences Inc. (NASDAQ:GILD) and early mAb therapies, which received funding from the U.S. Defense Advanced Research Projects Agency (see “DARPA’s Gambles”).

Thursday, AstraZeneca plc (LSE:AZN; NYSE:AZN) partnered with the University of Oxford and Vaccitech Ltd. to provide a global commercialization and distribution partner and another source of manufacturing capacity for Oxford’s COVID-19 vaccine, a countermeasure developed by the university’s Jenner Institute and Vaccitech Ltd. that has its roots in a MERS project funded in part by Coalition for Epidemic Preparedness Innovations.

The approach of building off existing technology with a track record in coronaviruses has put the Oxford program in the running to be first to receive emergency use authorization. The vaccine candidate, which began clinical testing last week, could be available for emergency use by September.

Optimizing for speed

The work Oxford put into its vaccine platform during MERS enabled it to hit the ground running for COVID-19.

Both coronavirus vaccines are based on the same recombinant adenovirus vector. The technology proved itself capable of inducing neutralizing antibodies against MERS in humans and has been shown to be safe in testing in 320 individuals, according to Oxford’s website.

The new vaccine uses the vector to deliver genetic sequences from SARS-CoV-2.

Oxford isn’t stopping at speedy vaccine design. Like other vaccine makers, it is ramping up manufacturing before efficacy is determined, to ensure it can meet as much demand as possible as quickly as possible.

Under a 2018 deal with Merck KGaA (Xetra:MRK), Oxford’s Jenner Institute had already improved its manufacturing process for adenovirus vaccines. According to Oxford, the partnership laid the foundation for large-scale vaccine production of the university’s COVID-19 vaccine candidate in two months, rather than the six months to a year it typically takes to develop a manufacturing process (see “Oxford Adds to Surge of Pandemic Deals”).

AstraZeneca is one of several companies that will contribute to manufacturing the vaccine at scale. In a sign of the urgency of the pandemic response, AZ and Oxford are proceeding with their deal prior to finalizing the partnership’s terms.

The partners have pledged to operate on a not-for-profit basis during the pandemic, with neither the university nor Vaccitech taking any royalties during the pandemic period, Vaccitech CEO Bill Enright told BioCentury.

The partners said the vaccine will be distributed globally, while “providing U.K. population with early access to new vaccine if trials are successful.”

It is the first U.K. vaccine partnership to be formed since the country launched its Vaccines Taskforce on April 17 to help find, test and deliver a new coronavirus vaccine (see “Public-private Groups Seek to Speed U.K.’s COVID-19 Vaccine Response”).

The partners said they will work to make the vaccine “available and accessible for low- and medium-income countries.”

Much of that help will come from the Serum Institute of India Pvt. Ltd., the world’s largest vaccine producer by volume, which has partnered with the Jenner Institute to produce up to 60 million doses this year of the ChAdOx1 vaccine (see “India Emerging as Major COVID-19 Vaccine Manufacturer”).

Enright said the expectation is the vaccine would also be made available in the U.S. He said they’ve already held a pre-IND meeting with FDA and are preparing an IND that would likely be under AZ’s responsibility.

The U.K. Phase I/II COV001 trial is enrolling more than 1,000 healthy volunteers, with Phase I data expected in May. Enright said Phase II/III testing in 5,000 individuals could then start as early as this summer.

Manufacturing coalition

AZ will be responsible for development and worldwide manufacturing of the vaccine.

The university had already launched a manufacturing consortium to provide capacity. The group includes the Vaccines Manufacturing and Innovation Centre; Pall Life Sciences, a unit of Danaher Corp. (NYSE:DHR); Cobra Biologics AB; Dutch CDMO Halix B.V.; Merck; and Oxford Biomedica plc (LSE:OXB).

Enright said any biologics manufacturing facility can be used to produce the viral vector, making AZ’s MedImmune unit a good fit as a commercial partner.

“Everybody is getting geared up to produce as many doses as we can,” Enright said. “The addition of AstraZeneca to that mix is great, because they obviously bring manufacturing firepower around the world.”

While Enright couldn’t estimate how many doses could be produced over the coming year, he said that AZ is “committed to getting a global supply as quickly as possible.”

Neither AZ or Oxford responded in time for publication to a question regarding manufacturing capacity for the vaccine.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus

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