Novavax Inc. is still awaiting U.S. regulators’ review of its Covid-19 vaccine. But the Gaithersburg company is not waiting to position that candidate for the future it’s betting on — including as a booster.
The biotech said Friday its protein-based vaccine, NVX-CoV2373, is involved two clinical trials to test its viability as a booster, including one in our backyard at the National Institutes of Health. That trial, as well as a study in the United Arab Emirates, aim to evaluate mixing and matching vaccine types for a third dose.
“Additional Covid-19 booster studies are important to support vaccine choice for individuals, health care providers and public health authorities," Dr. Filip Dubovsky, chief medical officer of Novavax, said in a statement.
The lineup includes a phase 1/2 study by the NIH’s National Institute of Allergy and Infectious Diseases to evaluate the shot in people immunized with a Covid vaccine approved or authorized by the Food and Drug Administration. Novavax’s vaccine will be given as a third dose to roughly 180 of those 1,130 adult participants, the rest of whom will receive one of the three Covid vaccines already greenlit by the FDA.
The study, held across 10 research sites, aims to evaluate the candidate’s safety, adverse reactions and ability to generate an immune response against the virus. It’s enrolling volunteers now and expects to report initial findings later this year and full results in 2023.
The vaccine is also being assessed in a phase 3 study in the UAE in patients already inoculated with the Covid vaccine from the China National Pharmaceutical Group Corp., known as Sinopharm. That trial is shooting to enroll about 1,000 adult participants at two sites in Abu Dhabi. Results are expected in the fourth quarter. It comes after the UAE’s Ministry of Health and Prevention approved Novavax’s vaccine for emergency use in December.
Related: Our cover story on Novavax’s dramatic transformation.
Novavax has long contended that its two-shot vaccine would also work well as a booster, but it’s still not authorized in the U.S. even for primary immunization. The biotech officially applied at the end of January after a dragged-out lead-up and multiple delays to its original timeline. It’s now waiting for the FDA’s review and, in addition, plans to seek full approval for that vaccine in the U.S. in the second half of 2022, Novavax CEO Stanley Erck said on a company earnings call earlier this month.
But outside of the U.S., Novavax has earned authorizations for its coronavirus vaccine with 12 regulatory agencies across 38 countries, with plans to sell its product under the Covovax brand in Bangladesh and India and under the Nuvaxovid brand in Canada, Singapore, New Zealand, Australia, South Korea and the United Kingdom, among others. It has also secured an emergency use listing from the World Health Organization, which gives it the possibility of reaching another 130 countries. The company intends for its vaccine to be used as a primary defense against the virus, and as a booster and in pediatric populations specifically.
And under those assumptions, the company is forecasting total revenue of $4 billion to $5 billion for this year, up significantly from the $1.15 billion it reported for 2021.
But the AP reported this week on delays in Novavax’s delivery of a quarter-million vaccine doses to COVAX, a coalition of international vaccine organizations working to provide equitable worldwide access to coronavirus vaccines. The delays to the shipments, from March to now April or May, highlight the inequity in the global pandemic response, according to the article. That’s after Novavax received $388 million from the Coalition for Epidemic Preparedness Innovations, which is among the organizations leading the initiative to get vaccines to poorer countries.
Novavax received Tuesday the first authorization of its Covid vaccine for adolescents ages 12 to 17 in India. The decision by the regulatory agency, the Drugs Controller General of India, referenced data from Novavax’s late-stage pediatric study in the U.S., the company said. The hope, Erck said in a statement, is that this sets the tone for more to come as “the first of many worldwide so that families have an additional choice built on a well-understood platform used in other vaccines for decades.”
Novavax’s (NASDAQ: NVAX) share price fluctuated Friday, opening at $81.38 before falling more than 6% to $76.04 early afternoon.
