The U.S. Department of Health and Human Services (HHS) and U.S. Department of Defense (DoD) inked two separate agreements to facilitate commercial-scale manufacturing of an investigational anti-viral antibody treatment and an investigational COVID-19 vaccine, according to news releases.
The agreements are as follows:
· $1.6 billion contract with Novavax, Gaithersburg, MD, for the company’s COVID-19 investigational vaccine. The vaccine candidate – NVX‑CoV2373 – consists of a stable, prefusion protein made using its proprietary nanoparticle technology.
· $450,000 contract with Regeneron, Tarrytown, NY, for its COVID-19 investigational anti-viral antibody treatment. REGN-COV2 is an investigational double antibody cocktail for the treatment and prevention of COVID-19, according to Regeneron.
The contract with Novavax also includes financial support for late-stage development and a Phase 3 clinical trial, with up to 30,000 subjects, beginning in the fall of 2020, the company said in a press release. By funding the manufacturing projects, the federal government will own the doses that result from these efforts, which the government estimates will be 100 million doses of the Novavax vaccine and between 70,000 and 300,000 doses of Regeneron’s treatment.
In both cases, the manufacturing demonstration projects will take place while clinical trials are underway, shaving months off the traditional product development timeline, according to HHS. The deal with Novavax builds on an agreement that DoD and Novavax announced in June. Under that $70 million agreement, the company is manufacturing components of the vaccine in the United States and delivering 10 million doses of NVX‑CoV2373 that could be used in Phase 2/3 clinical trials or under emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA).
NVX‑CoV2373 relies on a stable, prefusion protein antigen made using the company’s proprietary nanoparticle technology and includes Novavax’s proprietary Matrix‑M adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies to enhance immune responses and stimulate high levels of neutralizing antibodies. Antigen stimulates the body’s immune response against the virus, and adjuvant enhances the immune response, reduces the amount of antigen required per dose, and improves the chances of delivering an effective vaccine that can be manufactured at scale, according to HHS and DoD.
Meanwhile, Regeneron said its Phase 3 trial will evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient, such as the patient's housemate, while it has also moved into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the cocktail's ability to treat hospitalized and ambulatory patients with COVID-19. As part of the manufacturing demonstration projects, the doses of the medicines and vaccines will be packaged and ready to ship if clinical trials are successful and FDA grants an EUA or approves them.
The FDA can issue EUAs to facilitate the availability of an unapproved product only after several statutory requirements are met. For investigational vaccines or treatments being developed to prevent or treat COVID-19, an assessment will be made on a case-by-case basis depending on the clinical trial data and the total scientific evidence available. An EUA is different that an FDA approval, and additional analysis is required for the FDA to license a vaccine.
