Tens of thousands of healthy hen eggs delivered every day to a nine-year-old Chinese company in Beijing have caught the attention of Indian drug manufacturers now racing to develop a vaccine to the H1N1 pandemic.
As winter nears and Indian health officials brace for an upsurge in swine flu, the Beijing eggs are being used to develop the world’s first H1N1 vaccine that over three lakh Chinese residents have already received. Australia, the US and the UK have also begun stockpiling and distributing H1N1 vaccines made by global drug makers.
A bored guard barely glanced at the taxi before letting this correspondent inside the complex of brown and cream buildings nestled in a biotech industry park off a highway leading to the Great Wall of China.
The dusty ping-pong tables were deserted. The scientific staff were at their busiest, checking each egg before injecting it with the new flu virus that raced across the world since May and left thousands of travellers quarantined across China during the peak of the scare.
The virus multiplies while the eggs incubate for three days. It is extracted and inactivated to make a single-dose H1N1 vaccine called PANFLU.1. It has been developed within weeks, faster than any global competitor.
Sinovac started work on the vaccine in June and announced the results of clinical trials mid-August.
“We have received a long list of requests for this vaccine from the world over, including India,” Helen Yang, head of investor relations at Sinovac Biotech, told HT. “We’ve also received requests from several India pharma companies to work with us.”
This vaccine is made the same way as Sinovac’s seasonal flu vaccine against the annual winter outbreaks of flu. The seasonal flu strain is replaced with the H1N1 strain. Yang said Sinovac has entered an agreement with two Indian drug makers and is awaiting approvals to export the made-in-China seasonal flu vaccine and Hepatitis-A vaccine to India.
In India, where the H1N1 virus has killed 420 people from 12,969 cases till Tuesday night — compared with two deaths from over 26,300 cases in China — a vaccine won’t be ready until next year. In China, the government is stockpiling millions of doses for a mass inoculation programme — including primary and middle school students in Beijing — that began with one lakh participants of the October 1 60th anniversary military parade and floats.
The vaccine production began in June when Sinovac received the H1N1 virus strain from the US soon after the outbreak was declared as a pandemic or fast-spreading worldwide virus.
“We had finished all the preparation work before the virus strain arrived,”Sinovac CEO Weidong Yin told HT. “We initiated the vaccine development without even a one-second delay.’’
In July, Sinovac began clinical trials of the 0.5 ml dose on 1,600 volunteers between 3 and 60 years old. Results were released in mid-August, raising doubts from some Chinese experts.
By mid-October, over three lakh Chinese residents had received the free single-dose vaccine. The Chinese media said 150 of them reported minor adverse reactions including fever, vomiting and local inflammation.
“I felt relieved and less anxious about swine flu after I was vaccinated,” a Tsinghua University student (22) who was vaccinated before participating in the parade, said. Requesting anonymity because he was not authorised to discuss the process with the media, he said he had to submit a week’s record of his daily temperature to the university after receiving his shot. He did not report abnormal reactions.
A single-dose vaccine is preferable to help vaccinate more people during epidemics when the flu spreads faster than the limited vaccine production capacity of drug makers.
“The vaccine is safe and effective with one dose, with minimal and minor side effects,” said Vivian Tan, spokesperson of the World Health Organisation in Beijing. “However, as in the case of all new vaccines, it is critical to keep monitoring the safety and efficacy of the H1N1 vaccine when it is administered on a massive scale.”
Sinovac is now conducting trials for an H1N1 vaccine for people older than 60 years. Some scientists have criticised the rushed trials and the efficacy of a single dose as against two doses.
SARS expert Zhong Nanshan told the State-run Xinhua agency in September that more time is needed before the vaccine can be proved reliable.
“The vaccine should be put into mass use only after it has been proved safe through tests in many pilot places,” he was quoted saying.
“We admit that the vaccine has some potential risks, as any vaccine inoculation is not 100 per cent safe,” Zeng Guang, an expert in epidemic disease research at the Chinese Centre for Disease Control and Prevention, also told Xinhua in the September report. “But we believe it is safer for Chinese people to have the inoculation rather than be vulnerable to the disease.”
Sinovac’s Yang insisted the results were ‘very good’. Chinese regulatory agencies put approvals on fast track and eight Chinese manufacturers received a licence to produce the vaccine.