WHO meets on production of swine flu vaccine

LONDON — As swine flu cases topped 6,600 worldwide, vaccine makers and other experts met Thursday at the World Health Organization in Geneva to discuss the tough decisions that must be made quickly to fight the evolving virus.

Pharmaceutical companies are ready to begin making a swine flu vaccine — but as the virus constantly mutates, questions abound: How much should be produced? How will it be distributed? Who should get it?

The expert group’s recommendations will be passed to WHO Director-General Margaret Chan, who is expected to issue advice to vaccine manufacturers and the World Health Assembly next week.

But some feel the main decision has already been made.

“It’s a foregone conclusion,” said David Fedson, a vaccines expert and former professor of medicine at the University of Virginia. “If we don’t invest in an H1N1 (swine flu) vaccine, then possibly we could have a reappearance of this virus in a mild, moderate, or catastrophic form and we would have absolutely nothing.”

Most flu vaccine companies can only make one vaccine at a time: seasonal flu vaccine or pandemic vaccine. Production takes months and it is impossible to switch halfway through if health officials make a mistake.

Vaccine makers can make limited amounts of both seasonal flu vaccine and pandemic vaccine — though not at the same time — but they cannot make massive quantities of both because that exceeds manufacturing capacity.

Seasonal flu kills up to 500,000 people a year. At the moment, health officials aren’t sure how deadly swine flu is, and whether they will need more seasonal flu vaccine or swine flu vaccine. And if the swine flu mutates, scientists aren’t sure how effective a vaccine made now from the current strain will remain.

WHO estimates that up to 2 billion doses of swine flu vaccine could be produced every year, though the first batches wouldn’t be available for four to six months.

The U.S. Centers for Disease Control and Prevention is currently working on a “seed stock” to make the vaccine, which should be ready in the next couple of weeks. That will be distributed to manufacturers worldwide so they can start producing the vaccine.

Until vaccine manufacturers get the seed stock, they won’t know how many doses of vaccine they can make or how long that would take. Sanofi Pasteur, the world’s biggest vaccine producer, said Thursday it is waiting for the green light from WHO before it starts making swine flu vaccine.

WHO is also negotiating with vaccine producers like GlaxoSmithKline PLC to save some of their swine flu vaccine for poorer nations. Many rich nations like Britain, Canada, Denmark, France, Switzerland and the United States signed deals with vaccine makers years ago to guarantee them pandemic vaccines as soon as they’re available.

As of Thursday, at least 33 countries reported more than 6,600 cases of swine flu worldwide, with 69 deaths. According to WHO’s pandemic alert level, the world is at phase 5 — out of a possible 6 — meaning that a global outbreak is “imminent.”

“It’s a no-brainer,” Fedson said of the decision to make swine flu vaccine. “All that’s being discussed now is the details of how to make sure you have enough seasonal flu vaccine and the logistics of making the switch to H1N1 vaccine production.”

North America has been the hardest-hit continent. The United States has reported 3,352 laboratory-confirmed cases of swine flu, including three deaths. Mexico has 2,656 cases and 64 deaths, while Canada has 389 cases with one death, according to WHO figures.

Mexico confirmed 374 more cases Thursday including four more deaths, but Health Secretary Jose Angel Cordova said the new cases show the virus is appearing less deadly. Mexico’s swine flu deaths now represent 2.4 percent of its confirmed cases, he said.

Spain and Britain have the most cases in Europe, at 100 and 78 respectively.

In Central America, Costa Rica has eight cases and one death and Panama has 29 cases.

Mexico pushing for homegrown swine flu vaccine

MEXICO CITY — Grappling with low supplies of swine flu vaccines, President Felipe Calderon persuaded drug makers this week to sell him 30 million doses, while 1,000 Mexicans lined up for an experimental vaccine they hope can speed up supplies.

Meanwhile, French drug maker Sanofi-Aventis announced plans to open a manufacturing plant in Mexico that will produce 25 million flu vaccine doses a year starting in 2012.

Officials are eager to get the plant off the ground, Mexican Health Secretary Jose Angel Cordova told reporters Thursday.

“There is a big commitment to this and we are working in a very coordinated manner,” he said.

If a community can vaccinate before the virus arrives, that can reduce the number of severe cases and fatalities, and it can slow the spread, because the flu has trouble establishing itself in a population.

After the first case of swine flu in the world was confirmed in Mexico last April, drug makers immediately began making vaccines to control a potential pandemic.

But most of those supplies were snapped up by the world’s wealthiest countries, including the United States, Canada and those in western Europe, which wanted to ensure they had enough doses should a pandemic emerge. Norway and Switzerland, for example, have about twice as much vaccine as they need.

The U.S. has contracted with vaccine makers to produce and distribute up to 100 million doses, with the ability to produce 150 million more should the need arise this flu season, according to the Centers for Disease Control.

The CDC’s goal is to provide vaccine to anyone who wants it, but right now the U.S. is only receiving half the supply it expected for October due to slow production, said Dr. Mark Mullican, a researcher at the Emory Vaccine Center in Decatur, Georgia.

In Mexico, where vaccine supplies are much lower, officials plan only to provide vaccine to high-risk groups, including health care workers, pregnant women, day care workers and 6-month-old to 23-month-old youngsters, said Dr. Diana Leticia Coronel, director of the infant and adolescent health program. A prescription will be required, she said.

For the past 30 years it has taken drug makers about six months to make a new vaccine, growing the virus inside chicken eggs. This week in Mexico a small company began testing swine flu vaccine cultivated in a new way: inside insect cells.

Dr. Rahul Singhvi, president and CEO of Novavax Inc., the company manufacturing the new vaccine, said: “We absolutely want to help Mexico in getting more vaccine. We want to save lives in Mexico.”

U.s experts praised the idea.

“In general, we need new technologies, such as the insect cell approach, that do not require egg-based growth of the vaccine, which is slow and has problems,” said Mullican, the Emory researcher.

Dr. Andrew Pekosz at Johns Hopkins University’s Bloomberg School of Public Health said the speedier technique could save lives. “The most important thing about these new technologies is the speed in which a vaccine can be generated,” he said.

Pekosz said the insect cell method of making vaccines doesn’t make it more dangerous. “The vaccine itself is purified away from the components of the insect cell,” he said.

While awaiting successful clinical trials, Mexican officials are moving forward, trying to buy what vaccine they can.

Cordova said Thursday that Sanofi Pasteur, a division of Sanofi-Aventis, has guaranteed to send 1 million doses by the end of November. Cordova said the doses will be used to vaccinate health care workers.

The company will provide 4 million more doses by the end of December and 15 million by the end of January, Cordova said. Sanofi Pasteur officials reached the agreement with Mexico’s president in a meeting Thursday morning.

Ten million additional doses will be manufactured by London-based GlaxoSmithKline, Cordova said.

A new wave of swine flu began to flare up in Mexico last month, and officials say it will continue into early 2010. As of Monday, Mexico has had 45,809 reported cases of swine flu and 271 deaths.

Associated Press Writer Catherine E. Shoichet contributed to this report.