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ALACHUA ‒ A local biotech company, Ology Bioservices Inc., has been awarded a contract by the U.S. Army Contracting Command at Aberdeen Proving Ground, Maryland to produce COVID-19 vaccines once it is developed. The contract ceiling value is $106.3 million, of which $53.1 million was obligated at the time of award and the rest to come once a vaccine has been approved and production begins.

Ology Bioservices will manage the reservation of production capacity of approximately 186,840,000 doses of critical vaccines and therapeutics for COVID-19. This work is in support of the Operation Warp Speed response to the ongoing pandemic.

Operation Warp Speed (OWS) is a government program that aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

Protocols for the demonstration of safety and efficacy are being aligned, which will allow the trials to proceed more quickly, and the protocols for the trials will be overseen by the federal government, as opposed to traditional public-private partnerships, in which pharmaceutical companies decide on their own protocols.

Rather than eliminating steps from traditional development timelines, steps will proceed simultaneously, such as starting manufacturing of the vaccine at industrial scale well before the demonstration of vaccine efficacy and safety as happens normally.

“Along with producing vaccines and monoclonal antibodies to eventually combat the spread of COVID-19, the team at Ology Bioservices is very proud to support the fill and finishing network as needed by Operation Warp Speed,” said Peter H. Khoury, Ph.D., President and Chief Executive Officer of Ology Bioservices.

While the program will initiate once a vaccine is developed, most research for a vaccine is still in initial Phase 1 of 3 for clinical trials, and the January 2021 date for production is still uncertain. Vaccines typically require years of research and testing before reaching clinical tests, but scientists are racing to produce by next year under the government push for Operation Warp Speed.

Researchers are testing 36 vaccines in clinical trials on humans, and at least 90 preclinical vaccines are being tested in animals. Typically, the longest phase, is stage 3, because it involves waiting for up to a month to make sure it is permanently effective and not temporary. Many medical experts are concerned that rushing the Phase 3 trials could result in a vaccine that is not effective long term.

Last week, FDA Commissioner Stephen Hahn alarmed experts when he suggested the regulatory body could approve a vaccine before Phase 3 trials are complete. Many medical experts feel that approving a vaccine before Phase 3 trials are complete is not only unprecedented, but it’s also potentially unsafe. Experts have warned the Phase 3 process cannot be condensed because of the length of time needed to observe the effects of the inoculation’s safety and durability, which are governed by regulation. By getting the $53.1 million award now, Ology Bioservices can get prepared to begin immediate production once the vaccine is approved.

Ology Bioservices was founded as Nanotherapeutics in 1999 as an integrated biopharmaceutical company with a focus on development and manufacturing, as well as having expertise in preclinical and clinical development, formulation optimization, and of biopharmaceutical products, medical devices and to develop new drug delivery technologies and increase the efficacy of existing drugs.

Much of their research is funded by the Department of Defense (DoD) to come up with vaccines and countermeasures for epidemics like Malaria and Ebola as well as possible chemical and biological weapons that could be used against military troops.

In March 2013, the DoD awarded Nanotherapeutics, a contract to provide all the core services necessary to establish a Medical Countermeasures Advanced Development and Manufacturing (MCM ADM) facility dedicated to meet the specific needs of the DoD. The 10-year, $400 million-plus contract provided funding for the construction of a 183,000-square foot facility in Alachua as well as continued research and production.

In addition to government and DOD contracts, Ology Bio has also expanded into the commercial field with a grant from the Global Health Innovative Technology (GHIT) Fund to develop a vaccine candidate for combating Malaria. The DoD has also awarded an $8.4 million contract to Ology to manufacture an anti-Ebola monoclonal antibody.

In July 2020 they received a biologics contract development and manufacturing organization (CDMO), from the Department of Defense (DOD), through the Joint Science and Technology Office of the Defense Threat Reduction Agency (DTRA), for three biomanufacturing contracts with a combined value of more than $16 million. To date the company has been granted over $500 million in government contracts not including the new contract for COVID-19 vaccine manufacturing. The rest of the COVID award will be issued once a vaccine has been established and production can begin.

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