Novavax is starting a phase 3 trial of its pandemic vaccine hopeful NVX-CoV2373 in 10,000 adults over the next month.
The biotech, one of many biopharmas in the latter stages of testing for a COVID-19 vaccine but certainly the smallest in terms of company size compared to the likes of Pfizer and AstraZeneca, is using its recombinant protein nanoparticle tech in the hope its two-dose shot can create both efficacy and safety. It's using a lower dose for the U.K. trial.
Novavax uses insect cells to grow synthesized pieces of the spike protein of the virus, while also using an adjuvant that increases the production of neutralizing antibodies.
The company, which has been handed a $1.6 billion Warp Speed handout, has a targeted 30,000-patient test in the U.S., with the federal government already preordering 100 million doses. The U.K. has a similar deal, recently agreeing to buy up 60 million doses of NVX-CoV2373.
Following Moderna, Pfizer/BioNTech and AstraZeneca’s unusual decision to publish the normally secret trial protocols, Novavax said its U.K. study protocol would also be released “in the coming days.”
It did publish some details, including that its U.K. test will see “at least 25 percent of participants over the age of 65” enrolled as well as its plan to prioritize groups that are most affected by COVID-19, “including racial and ethnic minorities.”
The trial has two primary endpoints: The first is first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least a week after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.
The second is first occurrence of PCR-confirmed symptomatic moderate or severe COVID-19 with onset at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.
“An interim analysis will be performed when 67% of the desired number of these cases has been reached,” the company added.
Like several other European countries, including Spain and France, the U.K. has seen a major surge in cases since the start of September, with deaths and hospitalizations also creeping up. While bad news for the country, which is increasing social restrictions amid this surge, it’s good news for vaccine developers, as there is more virus around.
“With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic that this pivotal Phase 3 clinical trial will enroll quickly and provide a near-term view of NVX-CoV2373’s efficacy,” said Gregory Glenn, M.D., president of R&D at Novavax.
“The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries. We are grateful for the support of the UK Government, including from its Department of Health and Social Care and National Institute for Health Research, to advance this important research.”
At the start of August, Novavax posted the first human data from its COVID-19 vaccine: The early results, from the phase 1 part of a phase 1/2 study, show that two dose levels of the recombinant vaccine triggered an immune response similar to those in patients who had recovered from the disease.
The biotech was up around 8% premarket Friday morning on the news.