Novavax has announced that it is to provide 1.1 billion cumulative doses of its COVID-19 vaccine, NVX-CoV2372, to the international vaccines-sharing facility COVAX.
The memorandum of understanding between Gavi, the Vaccine Alliance and Novavax for the vaccine doses was announced yesterday.
The doses of NVX-CoV-2373 for COVAX will be manufactured and distributed by Novavax and the Serum Institute of India (SII) – Novavax has licensed its technology for NVX-CoV2372 to the SII with no upfront, milestone or technology transfer payments.
While the SII will works to provide the majority of its supply of the vaccine to low-, middle- and upper-middle-income countries, Novavax is expected to primarily supply doses to high-income countries.
“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 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,” he added.
COVAX is the vaccine pillar of the WHO’s ACT Accelerator – a collaborative initiative co-led by Gavi, the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI) that is aiming to accelerate the development, production and equitable access to COVID-19 tests, treatments and vaccines.
CEPI committed approximately $400m to advance the early clinical development of Novavax’s COVID-19 vaccine, as well as manufacturing scale-up in multiple facilities across the globe.
In January, Novavax revealed that NVX-CoV2372 demonstrated an efficacy rate of 89.3% in a phase 3 clinical trial, also finding that the jab is effective against the UK variant.
The trial, conducted in partnership with the UK’s Vaccines Task Force, enrolled over 15,000 people aged 18 to 84.
The first interim analysis is based on 62 PCR-confirmed, symptomatic COVID-19 cases. Within this case number, 56 cases were observed in the placebo group versus six in the vaccinated group – resulting in a vaccine efficacy of 89.3%.
In addition, preliminary analysis found that the UK variant was detected in over 50% of the PCR-confirmed cases – with 32 cases being caused by the UK variant, 24 by the non-variant and six ‘unknown’.
A number of rolling reviews of the vaccine are currently being conducted by regulatory authorities across the globe, including with the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada.