Vaccine makers seek funds to stay ready

Drug manufacturer Acambis Inc. has delivered 182.5 million doses of smallpox vaccine to a federal stockpile, enough for every American who might need one.

But Acambis has requested $30 million from the federal government to keep its Canton factory ready to produce additional doses, citing the uncertain shelf life of the vaccine and potential overseas demand for it in an emergency.

''Even if you have a stockpile of 200,000 bullets, if you go to war, suddenly you would need more bullets. This is the same idea," said Gordon Cameron, chief executive of Acambis, a British company whose US headquarters are in Cambridge.

Since 2000 the company has filled vaccine orders worth $480 million, but its production line is now idle. Planners at the US Department of Health and Human Services say they won't make a decision on the request for more funding until this summer.

Large pharmaceutical companies have shied away from the vaccine business because the potential for profit is uncertain. That has provided room for specialized players like Acambis, BioPort Corp. of Michigan, which makes an anthrax vaccine, and BioPort's California rival, VaxGen Inc. While smaller companies are interested in vaccine development, their financial resources are limited. BioPort and VaxGen also have sought federal funds to keep their production facilities for vaccines on standby.

The concept is known as ''warm base." Some biodefense analysts and drug industry executives say it is crucial to the nation's safety. ''You can't just, at the flip of a switch, turn some plant into making any kind of vaccine," said Brad Smith, a fellow at the University of Pittsburgh's Center for Biosecurity.

Jerome Donlon, chief scientist in the Health and Human Services' office of public health emergency preparedness, said that before deciding whether to buy more vaccine from Acambis, the agency wants to know whether orders from foreign governments would be sufficient to keep the company's production line at the ready.

''The concept of the warm base is to keep operations functional," Donlon said. ''If they're doing that with other clients, the US government doesn't have to duplicate that."

Acambis says it has received orders from 13 countries, but not enough to keep its production line at the ready. The Acambis funding issue is one of several facing federal officials who want to convince more drug makers to produce biodefense vaccines and medicines.

BioPort manufactures an anthrax vaccine that was approved for use 35 years ago. Last year it signed a $245 million Department of Defense contract to supply vaccine for military personnel and has been negotiating with Donlon's office to supply at least five million doses for civilian use.

''Five million doses doesn't sustain us for long," said Kim Brennan Root, a BioPort spokeswoman. ''A way of truly getting at the warm base would be to have a long-term licensed technology in production."

The government's reluctance to move forward with an order for additional doses from BioPort has drawn criticism from US Senator Charles Grassley, an Iowa Republican.

The agency also awarded an $878 million contract to VaxGen to produce 75 million doses of an experimental anthrax as well as a $69 million contract that includes a provision to keep VaxGen's manufacturing base ready in case orders from other countries don't materialize.

Supplies of vaccines, antibiotics, chemical antidotes, and other medicines are overseen by the Strategic National Stockpile, which is controlled by the Centers for Disease Control.

For years, the federal government has tried to recruit drug companies to participate in the effort to create and stockpile vaccines. Increasing the number of suppliers reduces the chance of a single commercial mishap leading to shortages. For example, manufacturing problems last year at Chiron Corp. led British authorities to suspend the company's license, cutting off nearly half of the supply of influenza vaccine anticipated for US distribution.

A bill signed last year by President Bush provided $5.6 billion to pay for private companies to develop and purchase additional vaccines and treatments. But many industry executives say more incentives are needed.

Only a few biodefense drugs, such as Bayer Corp.'s antibiotic Cipro, have found significant commercial markets. Cipro was widely prescribed to treat the 2001 mail-borne outbreaks of anthrax.

Before the terrorist attacks of 2001, many drug manufacturers were not interested in biodefense. Smallpox, which in recent years has resurfaced as a public health threat, by 1977 had been eradicated. The viral disease can cause blindness and scarring and has a 30 percent fatality rate.

The primary vaccine used to protect against smallpox was Wyeth Laboratories Inc.'s Dryvax. It was made from dried calf lymph, the clear whitish fluid that forms a key part of mammals' immune systems. But Dyrvax had side effects -- including one death for every million vaccinations -- and its use ended once the disease was declared eliminated.

The Acambis vaccine, which does not yet have a brand name, is similar to Dryvax but more refined. It hasn't yet been cleared for human use by the FDA, but the company plans to apply for final approval later this year.

The case for increasing the stockpile was illustrated during a January bioterrorism training exercise at the Pittsburgh biosecurity center. Senior US and foreign officials played the parts of world leaders struggling to contain a smallpox outbreak in Europe, where some countries don't have enough vaccine. During the exercise, the shortfall led to an economic crisis when some countries closed their borders while they contemplated whether to share vaccine supplies.

Acambis executives cite the exercise in their campaign to generate more vaccine orders. The chance of an overseas smallpox outbreak was also mentioned in a letter of support for Acambis's request, sent in January to Health and Human Services by Senator Edward M. Kennedy and the rest of the Massachusetts congressional delegation.

''We have to recognize that in the event of some kind of outbreak, it becomes a global event," said Acambis' Cameron." People will be looking all over the world for vaccine, and if there's a single dose of vaccine dispatched by the US, that reduces the stockpile for the US by one."

Ross Kerber can be reached at kerber@globe.com.