* H1N1 flu vaccine well-tolerated at all dose levels
* Shares up 16 percent (Adds analyst comment, updates share movement)
By Shailesh Kuber
BANGALORE, March 24 (Reuters) - Vaccine maker Novavax Inc (NVAX.O) reported positive results from the first phase of its two-stage pivotal study of H1N1 flu vaccine, sending its shares up as much as 16 percent.
The data showed safety and immunogenicity of the vaccine were consistent with preliminary results, the company said.
“It’s no surprise, but its always comforting that the final results confirm the preliminary data,” McNicoll, Lewis & Vlak analyst George Zavoico said by phone.
“The results show that the seroconversion and seroprotection rates are sufficient and exceed the recommended effectiveness criteria of regulatory authorities,” Zavoico said.
Seroconversion is the point at which the immune system is stimulated into developing antibodies, while seroprotection is the measure of clinical protection provided by the vaccine. The vaccine was well tolerated at all three dose levels of 5 micrograms (mcg), 15 mcg or 45 mcg -- and showed no systemic side effects, the company said.
These data confirmed that a single dose of 15 mcg was optimal to induce robust immune responses in broader age populations with a highly satisfactory safety profile, the company said.
Earlier this month, the company, which is conducting the study in partnership with Mexico’s Avimex Laboratories, completed enrollment of a cohort of over 3,500 volunteers in second phase of this study.
Shares of the company rose 11 percent to $2.60 in midday trade on Nasdaq. They touched a high of $2.72 earlier in the session. (Reporting by Shailesh Kuber in Bangalore; Editing by Ratul Ray Chaudhuri)