The list of companies taking vaccines against the virus that causes Covid-19 into late-stage testing added another member Thursday as a smaller, U.S.-based firm launched a Phase III trial in the U.K.
Gaithersburg, Maryland-based Novavax said it had started the Phase III study of its vaccine candidate, NVX-CoV2373, under a partnership with the U.K. goverment’s vaccine task force. The study is expected to enroll up to 10,000 volunteers aged 18-84.
Shares of Novavax (Nasdaq: NVAX) were up 5.1% pre-market on the Nasdaq on Friday following the news, by nearly 5% when markets opened and by more than 11% in mid-day trading.
“With a high level of SARS-CoV-2 transmission observed and expected to continue in the U.K., we are optimistic that this pivotal Phase III clinical trial will enroll quickly and provide a near-term view of NVX-CoV2373’s efficacy,” Novavax president for research and development Gregory Glenn said in a statement. “The data from this trial is expected support regulatory submissions for licensure in the U.K., E.U. and other countries.”
The company published Phase I data on the vaccine earlier this month from its Phase I/II study, in The New England Journal of Medicine. The data, on adults aged 18-59, showed that the vaccine produced antibody responses numerically superior to those seen in sera from recovered Covid-19 patients. There were no severe or serious adverse events, with the majority of events being mild and unrelated to the vaccine. That study included 83 participants who received the vaccine with adjuvant, 25 without adjuvant and 23 who received placebo.
The news came just a day after another vaccine maker, Johnson & Johnson, announced the launch of the global Phase III study of its vaccine against SARS-CoV-2, JNJ-78436735, also known as Ad26.COV2.S, in 60,000 healthy volunteers. It had also submitted Phase I/IIa data on the vaccine to the preprint server medRxiv.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Unlike the vaccines produced by Novavax, Moderna, Pfizer and BioNTech, J&J’s uses only a single shot, whereas the others include both a priming and booster shot, administered several weeks apart.
Photo: Bill Oxford, Getty Images
