Laboratory tests on China’s domestically-developed A(H1N1) flu vaccine started on Monday (Jun 22).
The vaccines are expected to be available for sale in September after undergoing 14 days of laboratory based safety tests and two months of clinical tests from July, according to Fan Bei, deputy general manager of Hualan Biological Engineering Inc., based in Henan Provinc, one of the 11 drug companies expected to produce the vaccine. .
The company reported having produced a first batch of 90,000 doses, and that it would be able to make 600,000 doses a day once it was approved.
"As the vaccines still need to go through several tests, we did not produce at full capacity, " Fan said.
The clinical tests shall be conducted according to a plan submitted by the firm and was approved by the State Food and Drug Administration (SFDA), but Fan would not release the details of the plan.
The company received the flu strain samples "NYMCX-179A" from the World Health Organization (WHO) lab on June 3.
China has 11 drug firms that are qualified to produce flu vaccines. Another drug company, Sinovac Biotech Co. Ltd., announced that it had started development of A/H1N1 flu vaccines on June 15.
China has reported hundreds of A/H1N1 flu cases. Epidemiologists have warned of a "very high" risk of outbreak in densely populated communities.
The head of the biology production department under the State Food and Drug Administration, Yin Hongzhang, ensured the vaccines, which could be directly injected into the high-risk population, would be ready by October 1. But he added that the experiments on the vaccine's safety and effectiveness are necessary before batch production.
Yin Hongzhang also predicted in case of a global epidemic, China's annual vaccine production capacity is expected to reach 360 million from all the eleven domestic drug companies if they are approved for the batch production of A(H1N1) vaccines after testing.
