The trial is being conducted in partnership with the UK Government’s Vaccines Taskforce; and will enroll and immunize up to 10,000 individuals aged 18 to 84 with the two dose vaccine over the next four to six weeks in the UK.
The US vaccine developer will publish its UK study protocol in the next few days: mirroring moves from AstraZeneca, Moderna, J&J and Pfizer to do the same for their Phase 3 COVID-19 vaccine trials.
Novavax is targeting global production of 2 billion doses a year and is scaling up manufacturing capacity to meet this goal in mid-2021.
The Phase 3 study
Novavax’s COVID-19 vaccine candidate, NVX‑CoV2373, is engineered from the genetic sequence of SARS‑CoV‑2. It uses Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein, and contains Novavax’s saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
The vaccine can be stored at 2°C to 8°C: allowing distribution in standard vaccine channels.
As part of the vaccine’s Phase 1/2 clinical trial, the Phase 1 element showed that NVX‑CoV2373 was ‘generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.’
In August, Novavax launched two Phase 2 studies: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the US and Australia.
The UK Phase 3 clinical trial is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of the vaccine. Half the participants will receive two intramuscular injections of vaccine comprising 5 µg of protein antigen with 50 µg Matrix‑M adjuvant, administered 21 days apart, while half of the trial participants will receive placebo.
The trial aims to have at least 25% of participants over the age of 65, as well as prioritizing groups most affected by COVID-19, including racial and ethnic minorities.
Up to 400 participants will also receive a licensed seasonal influenza vaccine as part of a co-administration sub-study.
Scaling global production capacity
Novavax’s supply agreements for its COVID-19 vaccine candidate include 100 million doses for the US and 60 million doses for the UK. In July it was awarded $1.6bn from the US’ Operation Warp Speed.
A deal signed with the Serum Institute of India this month to manufacture 1 billion doses of NVX-CoV2373 takes Novavax's global production capacity up to 2 billion doses a year.
The antigen component of NVX-CoV2373 is being manufactured at Novavax CZ in the Czech Republic (formerly Praha Vaccines); Biofabri in Spain; FUJIFILM Diosynth Biotechnologies (FDB) in the US; FDB in the UK; SIIPL in India; SK Bioscience in the Republic of Korea and Takeda Pharmaceutical Company in Japan.
Novavax’s Matrix-M adjuvant is being manufactured at Novavax AB in Sweden; and AGC Biologics in the US/Denmark; while PolyPeptide Group will manufacture two key intermediaries used in Matrix-M in the US/Sweden.
