Gaithersburg-Based Novavax Initiates Pediatric Expansion for Phase 3 Clinical Trial of COVID-19 Vaccine
Per Novavax:
Novavax, a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated a pediatric expansion of its Phase 3 clinical trial for NVX-CoV2373, the company’s recombinant protein vaccine candidate against COVID-19.
The additional arm of the ongoing PREVENT-19 pivotal trial will evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 3,000 adolescents aged 12-17 across up to 75 sites in the United States.
Participants will randomly receive either the vaccine candidate or placebo in two doses, administered 21 days apart. Two-thirds of volunteers will receive intramuscular injections of the vaccine and one-third will receive placebo. A blinded crossover is planned to take place six months after the initial set of vaccinations to ensure that all trial participants receive active vaccine. Participants will be monitored for safety for up to two years following the final dose.
“Through the expansion of our PREVENT-19 clinical trial, we hope to build upon the encouraging safety and efficacy data generated to-date in adults for our vaccine candidate and to play a significant global role in offering vaccination to as many people as possible across age groups to end the suffering caused by the pandemic,” said Gregory M. Glenn, M.D., President, Research and Development, Novavax.
Dr. Glenn will share an update regarding this arm of the PREVENT-19 trial during the 21st annual World Vaccine Congress taking place online, May 4-6. He will participate in two sessions during the congress, including a presentation and a panel discussion. Details are as follows:
Morning Plenary:
Date: Tuesday, May 4
Time: 9:10am – 10:40am EST
Title: Safety, efficacy, and uptake of COVID-19 vaccines
Moderator: Jakob Cramer, M.D., Head of Clinical Development, CEPI
Afternoon Session: COVID-19: Vaccine Response & Approaches
Date: Tuesday, May 4
Time: 3:30pm – 3:45pm EST
Title: Novavax COVID-19 Program Update
To register, please visit the World Vaccine Congress website here. Dr. Glenn’s presentation slides will be posted to the company’s website following the presentation here.
Gaithersburg-Based Novavax Reaches Agreement to Provide 1.1 Billion Doses of Covid Vaccine Candidate Globally
Per Novavax:
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced a Memorandum of Understanding (MOU) with Gavi, the Vaccine Alliance (Gavi), to provide 1.1 billion cumulative doses of NVX-CoV2373, Novavax’ recombinant protein-based COVID-19 vaccine candidate, for the COVAX Facility. The vaccine doses will be manufactured and distributed globally by Novavax and Serum Institute of India (SII), the latter under an existing agreement between Gavi and SII. NVX-CoV2373 is being studied in two ongoing pivotal Phase 3 clinical trials: in the United States and Mexico, as well as in the United Kingdom (U.K.), for the prevention of COVID-19. Novavax has previously reported positive interim efficacy results from its U.K. trial.
COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, which is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, and the World Health Organization (WHO), who are working in partnership with developed and developing country vaccine manufacturers, UNICEF, the World Bank, civil society organisations and others to guarantee fair and equitable access to the vaccine for every country in the world. COVAX currently includes more than 190 participating economies.
“We are proud to partner with all the COVAX collaborators and Serum Institute of India to provide global public health leadership and ensure that all countries have broad access to NVX-CoV2373,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “Novavax will play a critical role in the worldwide effort to provide access to safe and effective vaccines to end the pandemic.”
Gavi leads the design and implementation of the COVAX Facility and will work with Novavax to finalize an advance purchase agreement (APA) for vaccine supply and global distribution allocation via the COVAX Facility and its partners.
“This agreement brings the COVAX Facility one step closer to its goal of supplying vaccines globally and ending the acute phase of the pandemic,” said Dr. Seth Berkley, CEO of Gavi. “It helps us close in on our goal of delivering two billion doses in 2021 and increases the range of vaccines available to us as we build a portfolio suitable for all settings and contexts.”
CEPI has provided critical support to Novavax, including the commitment of approximately $400 million to advance early clinical development and manufacturing scale-up in multiple facilities around the globe. Novavax has created a global supply network to ensure there can be adequate and equitable supply of NVX-CoV2373 across the globe. Consistent with its mission to increase global manufacturing capacity and ensure broad, equitable supply distribution, Novavax licensed its NVX-CoV2373 technology to SII with no upfront, milestone or technology transfer payments. With this strategic partnership in place, Novavax and SII are jointly committed to deliver 1.1 billion doses to the COVAX Facility. For supply of NVX-CoV2373 to COVAX, Novavax is expected to supply doses primarily to high-income countries (HICs), with SII providing the majority of supply for low-, middle, and upper-middle-income countries, (LMICs, UMICs), utilizing a tiered pricing schedule.
“With this MOU in place, the vaccine candidate developed by our partners at Novavax is poised to play a significant role in combatting COVID-19 around the world,” said Dr. Richard Hatchett, CEO of CEPI. “CEPI’s investments in this vaccine have been pivotal to enabling equitable access to a significant volume of this vaccine through COVAX.”
“We are pleased to deepen our partnership with Novavax and COVAX to increase the doses of vaccine available to benefit humanity,” said Adar Poonawalla, Chief Executive Officer, Serum Institute of India.” This global collaboration is vital to ensure that the largest possible amount of vaccine is available to reach individuals across the broadest segment of countries.
NVX-CoV2373 was the first vaccine to demonstrate clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the United Kingdom and South Africa. NVX-CoV2373 can neither cause COVID-19 nor can it replicate. It is shipped in a ready-to-use liquid formulation. Because it is stable at 2°C to 8°C (refrigerated), existing vaccine supply chain channels can be used for its distribution.
Gaithersburg-Based Novavax Releases Covid Vaccine Trial Data
Novavax conducted a 15,000-person trial in the United Kingdom, and their early analysis suggests 90 percent efficacy after a two-dose regimen. The two vaccines that have received FDA Emergency Use Authorization (EUA), Pfizer and Moderna, have 95 percent and 94 percent efficacy after two doses, respectively. Unlike Pfizer and Moderna’s vaccines, which require varying levels of freezer storage, the Novavax vaccine is stable long-term in the refrigerator.
Less promising news comes from Novavax’s small trial in South Africa. Their vaccine is much less effective against the B.1.351 Covid mutation running rampant in the country; Pfizer and Moderna’s vaccines are also less effective against this variant.
Earlier this year, Novavax was one of six companies to receive a grant ($1.6 billion) from Operation Warp Speed, a federal initiative to speed up the development and production process. If the FDA grants EUA, Novavax is expected to provide 100 million doses to the US and hundreds of millions abroad.
By Prayag Gordy
