3 | Pfizer to start pilot delivery program for its COVID-19 vaccine in four US states: Pfizer Inc has launched a pilot delivery program for its experimental COVID-19 vaccine in four U.S. states, as the U.S. drugmaker seeks to address distribution challenges facing its ultra-cold storage requirements. Pfizer’s vaccine, which was shown to be more than 90% effective in preventing COVID-19 based on initial data, must be shipped and stored at -70 degrees Celsius (minus 94°F), significantly below the standard for vaccines of 2-8 degrees Celsius (36-46°F).
US biotech company Novavax entered into an agreement with Gavi, the Vaccine Alliance, to provide 1.1 billion doses of Novavax COVID-19 vaccine 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.
Novavax had earlier licensed its COVID-19 vaccine technology to SII with no upfront, milestone, or technology transfer payments. SII will manufacture and distribute Novavax COVID-19 vaccine in the low-, middle, and upper-middle-income countries, (LMICs, UMICs), while Novavax will supply doses primarily to high-income countries (HICs).
COVAX has already signed up with SII for 240 million doses of AstraZeneca-Oxford University COVID-19 vaccine at $3 per dose. SII has earlier indicated that it would supply a total of 1.1 billion vaccines to COVAX, making it the biggest supplier of COVID-19 vaccines globally.
The Bill & Melinda Gates Foundation, via its Strategic Investment Fund, provided $300 million in funding for SII. Gates Foundation is a major donor of Gavi.
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.
COVAX is co-led by Gavi, the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI). The agency was formed to guarantee fair and equitable access to the vaccine for every country in the world. COVAX currently includes more than 190 participating economies.
CEPI has provided $400 million funding to Novavax to advance early clinical development and manufacturing scale-up in multiple facilities around the globe.
The Novavax COVID-19 vaccine called NVX-CoV2373 is being studied in two ongoing pivotal Phase 3 clinical trials in the United States and Mexico, as well as in the UK for the prevention of COVID-19.
Novavax has previously reported positive interim efficacy results from its U.K. trial.
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.
The vaccine will be shipped in a ready-to-use liquid formulation and is stable at 2°C to 8°C (refrigerated), existing vaccine supply chain channels can be used for its distribution.
“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,” Erck said.
“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,” Berkley said.
“We are pleased to deepen our partnership with Novavax and COVAX to increase the doses of vaccine available to benefit humanity,” said AdarPoonawalla, Chief Executive Officer, Serum Institute of India.