Shu Yuelong, director of the Chinese National Influenza Centre, said the first mutated strain of the (A)H1N1 virus was detected in June in a case imported from Britain and a similar strain was detected three months later in the eastern province of Zhejiang.

The mutation detected recently was an isolated case and the cases were not connected, Shu said.

Scientists fear that mutations in flu viruses could cause more virulent and deadly pandemic flu.

The World Health Organisation said Friday that a mutation had been found in samples of the swine flu virus taken following the first two deaths from the pandemic in Norway.

It said a similar mutation had been observed in Brazil, China, Japan, Mexico, Ukraine, and the United States, as early as April.

However, it stressed that the mutation did not appear to cause a more contagious or more dangerous form of A(H1N1) influenza and that some similar cases observed elsewhere had been mild.

China has reported 53 deaths out of nearly 70,000 confirmed swine flu cases but last week ordered more accurate reporting of fatalities after a medical expert said deaths were being deliberately underplayed.

Source : Konaxis

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.

Source : Konaxis

“The country has set up a green channel between the World Health Organization (WHO) and the Chinese drug makers. As soon as the WHO releases the vaccine strain, drug companies will be informed and will start manufacturing as soon as they can,” said Yin Hongzhang.

“If we can get the strain before early June, our drug companies will have produced the vaccine by July, under current conditions,” Yin said. He explained that through the green channel, drug companies save up to one month, compared with normal procedures for developing vaccines.

According to Yin, China will manufacture the vaccine in line with WHO protocols to ensure the high-level of safety required for this kind of product.

Last week, WHO said that drug companies wouldn’t be able to make an A/H1N1 vaccine until mid-July at the earliest as the virus was growing slowly in labs, making it difficult for scientists to get the key ingredient for a vaccine.

Yin added that aside from the slow growth of the key ingredient, the WHO was not sure yet whether to categorize the A/H1N1 flu as seasonal or pandemic, which was a problem for drug makers.

Seasonal flu occurs annually in predictable patterns, allowing people to develop resistance, while pandemic flu is rare, meaning that it’s hard for people to develop resistance. In the latter case, vaccine doses need to be higher to be effective.

Still according to Yin, China has 11 drug companies that can produce seasonal flu vaccines but only one that can make pandemic flu vaccines.

“Compared with a 1.3-billion population, our current vaccine producing ability is far from enough,” said Yin.

He added that if the A/H1N1 influenza was confirmed as pandemic, the country would first prioritize vaccine supplies for medical staff.

The A/H1N1 vaccine would produce antibodies within two weeks after it is injected into the human body. Then, it would take another 45 days to two months to take full effect, which would normally last for more than one year.

The Chinese mainland has joined over 40 counties worldwide with confirmed A/H1N1 flu cases.

Source : Konaxis