Sinovac has received a revised Drug Supplementary Application Approval (SAA) for Panflu, company’s pandemic influenza vaccine, from SFDA, based on the phase-IIb clinical trial.
Under the revised approval, the age group eligible for use of the whole viron inactivated pandemic influenza vaccine was expanded to 18 years and above.
Sinovac has also received SAA to change the existing packaging of 0.5mL per vial of Panflu to 1mL per vial, enabling Sinovac to double its filling and packaging capacity.
Sinovac is currently focused on production of a vaccine against the new pandemic influenza strain, H1N1. This vaccine will be sold under the Panflu brand.
Weidong Yin, Chairman, President and CEO of Sinovac, said: Having received approval to administer our Panflu vaccines to individuals over the age of 60, Sinovac now has the ability to protect a much larger percentage of the Chinese population from pandemic influenza viruses. The revised approval is especially important, as the 60+ age group is often a high-risk group.”
“We also now have the ability to supply a greater number of vaccines, as the approval to increase the Panflu packaging to 1mL. We continue to expect to complete production of the first batch of H1N1 Panflu vaccine by the end of the July. With these revised approvals, Sinovac is better positioned to deliver on its first order from the Beijing government, as well as additional government orders we may receive in the future, he added.