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HEALTH: Asian Countries Race to Produce Vaccine for H1N1 Virus

Marwaan Macan-Markar

BANGKOK, Sep 10 2009 (IPS) - The race to mass-produce vaccines for the lethal H1N1 virus has attracted contenders from Asia’s developing countries, confirming a noticeable expansion of a field that has been dominated by flu vaccine production centres in Europe and North America.

India and Thailand are among the countries working on such vaccine doses. The demand for immunisation measures comes at a time when public health authorities are warning that Asia, like other developing regions, is in dire need of vaccines to respond to the rapid spread of the Type A (H1N1) influenza pandemic.

“This is something new for these countries producing flu vaccines. But they have produced other vaccines,” says Dr Arun Thapa, coordinator for immunisation and vaccine development for the New Delhi-based South and East Asia office of the World Health Organisation (WHO). “India, Indonesia and Thailand responded to WHO’s request to help boost the vaccine supply.”

“All three countries have received the seed virus for vaccine production,” Dr Thapa said during a telephone interview from Kathmandu, Nepal’s capital, where the region’s public health experts are meeting this week to chart a response ahead of a possible winter surge in (H1N1) flu cases. “We expect this new vaccine to be ready in the first quarter of 2010. That is an optimistic scenario.”

The WHO, which has transferred technology and development funds to vaccine manufacturers in the three Asian countries, expects to have a “collective capacity of about 220 million doses annually, with a surge capacity that could reach 420 million vaccine doses annually,” states a press release by the Geneva-based health body.

Those numbers for Asia will also be boosted by another vaccine production centre – China. The region’s giant is reported to have moved ahead of India, Indonesia and Thailand, following an announcement early this month that experts from the country’s State Food and Drug Administration (SFDA) approved a vaccine candidate. It is expected to have vaccines for 65 million people by the end of the year.

“China is set to be the first country to mass-produce a vaccine against the A(H1N1) flu pandemic,” reported the state-owned ‘China Daily’ on its website at the beginning of September. “Only one shot is needed for inoculation.”

The vaccine, which was developed by the Beijing-based Sinovac, “would be appropriate for anyone aged three to 60,” the English-language publication revealed, quoting a vaccine expert from SFDA’s drug evaluation centre. “It is up to the international standard for safety and immunogenicity factors.”

Thailand, on the other hand, is still at the first phase of conducting clinical trials, said Dr Vichai Chokevivat, chairman of the Government Pharmaceutical Organisation (GPO), the state-owned entity that received funds and technology from the WHO for vaccine production. “We will be dividing 24 volunteers into two groups. One group will be give a low dose and the other a high dose.”

“We will move to the second phase, which will have 400 participants, after that. We will be testing the vaccines for efficacy and safety,” Dr Vichai told IPS. “The new vaccine should be available by December.”

This flu vaccine production initiative in the developing world began over the past three years, with six manufacturers joining the initial effort, followed, in May, by five more producers. They are located in countries such as Brazil and Mexico.

Yet the projected output is still far from meeting the number of vaccines the developing world will need, states the WHO following a recent assessment of the 25 H1N1 vaccine production centres across the world. The latter includes pharmaceutical giants Sanofi Aventis, GlaxoSmithKline and Novartis.

The WHO has requested vaccine manufacturers in the developed world to contribute at least 10 percent of their vaccine doses for people in the developing world. Two multinationals have reportedly responded to this WHO request: Sanofi, headquartered in France, has pledged to give 100 million doses and Britain-based GlaxoSmithKline has promised 50 million doses.

But just when those numbers can be reached still remains elusive, since the U.N. health agency notes that producing vaccines for an influenza virus takes time. “It takes approximately five to six months for the first supplies of approved vaccine to become available once a new strain of influenza virus with pandemic potential is identified and isolated,” said the WHO.

The WHO’s concern about vaccines for the developing world stems from countries in this poorer region having weak health systems to cope with a surge in the number of cases of this virus, which began in Mexico and rapidly spread through North America between March and April.

In June, the WHO declared that the world was facing a pandemic. It estimated, at one point, that close to two billion people – a third of the world’s population – could become infected with this new virus over the next two years.

This strain of the H1N1 influenza virus, also called swine-flue virus, has currently infected over 254,000 people, of whom 2,837 have died, according to the WHO. South and East Asia has recorded over 19,000 cases and 188 deaths.

The last flu pandemic was the 1968 ‘Hong Kong’ flu, which killed about one million people. The 1918 ‘Spanish’ flu pandemic, which killed over 50 million people around the world, began as a mild outbreak in the spring of that year and returned as a more virulent second wave during the winter.

The ordinary flu, on the other hand, kills about 250,000 to 500,000 every year. Close to 70 percent of the seasonal flu vaccines are produced in Europe and North America, “with further significant manufacturing capacity in Australia (and) Japan,” states the WHO.

Till the new vaccines are available in South and East Asia, patients have access to antiviral drugs when infected. Yet even that requires monitoring for “genetic mutation (of the virus) and drug resistance,” said Dr Samlee Plianbangchang, WHO’s South and East Asia regional director.