Biotechnology company Novavax Inc. today announced positive results from its two-stage pivotal study evaluating the safety and immunogenicity (immune response) of the company’s 2009 A/H1N1 virus-like particle (VLP) pandemic influenza vaccine. In response to the results, shares of Novavax rose 12 percent to $2.60 in mid-day trading.
The results were consistent with preliminary results that demonstrated that the vaccine was well tolerated and immunogenic at all three dose levels tested.
The study is being conducted at the Mexican Institute of Social Security (IMSS), the largest medical and research center in Latin America, by Novavax and Avimex Laboratories of Mexico. The two are working collaboratively to support registration of the vaccine in Mexico and other countries.
Dr. Rahul Singhvi, president and CEO of Novavax, said the results meet U.S. and European regulations, leading the company file for regulatory approval in Mexico.
“The success of Novavax’s 2009 H1N1 VLP pandemic influenza vaccine in the Mexico pivotal study clearly demonstrates the desirable tolerability and immunogenicity profile of our vaccine candidate in the largest clinical trial conducted by the company to date. We are highly encouraged by these results as the data meet the immunogenicity criteria of both the United States and European regulatory authorities. These data enable potential emergency use of the vaccine in pandemic situations and could be supportive in other countries in addition to Mexico. Based on these positive data, we have filed for regulatory approval of our H1N1 VLP pandemic influenza vaccine candidate in Mexico,” Dr. Singhvi stated in the press release. “The substantial safety dataset and strong immunogenicity signal from this large study provide us confidence as we plan phase III studies of our seasonal trivalent influenza VLP vaccine, pending results from the ongoing phase IIa trial in older volunteers and discussions with the U.S. Food and Drug Administration (FDA).”
The Stage A study was comprised of 1,000 healthy volunteers aged 18 to 64 years old , all of which were vaccinated with two doses of either 5 mcg, 15 mcg or 45 mcg of Novavax’s 2009 A/H1N1 VLP pandemic influenza vaccine or a placebo. The vaccine was reportedly well tolerated at all three dose levels and exhibited no systemic side effects and mostly mild local site reactions, similar to placebo.