US aims to speed influenza vaccine development
WASHINGTON, Mar 2 (Reuters) US health officials today issued guidelines to speed development of new vaccines to fight seasonal influenza as well as a feared avian flu pandemic that could circle the globe quickly.
The recommendations aim to encourage more companies to develop flu vaccines and to use new technologies that could shorten the time it takes to make immunizations once a new flu strain is identified, officials said.
The guidelines from the Food and Drug Administration should provide ''faster time frames, greater certainty and lower costs'' for manufacturers, said Dr. Janet Woodcock, FDA deputy commissioner for operations. In part, they outline what types of data the agency needs before approving new vaccines.
Flu vaccine is difficult to make using the current manufacturing process. The flu virus needs to be grown in special types of chicken eggs for months, and the United States has experienced periodic shortages in recent years.
Experts are worried the H5N1 avian flu strain that has infected birds in Asia, Europe and Africa could mutate into a form that spreads quickly among people and kills millions.
Having a vaccine would be crucial for minimizing harm.
Some companies are working on vaccines using new technologies involving cell cultures instead of eggs and using advanced genetic techniques to formulate the vaccines.
Both would be quicker and more reliable than current methods.
The new guidelines ''help clarify what are the fast pathways to get there,'' said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research.
For example, manufacturers may be able to win approval for a pandemic flu vaccine by changing the strain in an already approved seasonal flu shot. That process is simpler than the usual path for an entirely new vaccine, officials said.
The FDA also will consider new vaccines under ''accelerated approval'' rules that provide a faster route to market for important new products. Those rules ''can take one to two years off time of development and licensure of a product,'' Goodman said.
Companies also can test technology that will allow smaller amounts of flu vaccine to be used while still producing enough immunity to fight off an infection, Goodman said.
With the quicker approaches, ''we would like to see some enhanced post-approval monitoring'' for side effects, he added.
The FDA will take public comments on the guidelines for 90 days before finalizing them.
Health experts say the federal government must make it easier and more profitable for companies to make influenza vaccines. Only four companies currently make vaccine for the US market and recent years have seen several serious shortages of the supply.
Also today, Dr Julie Gerberding, head of the US Centers for Disease Control and Prevention, urged Congress to fully fund President George W Bush's 7.1 billion dollar request for pandemic influenza money.
Congress has approved 3.8 billion dollars of that.
''Part of the reason why we hoped to have full appropriation committed ... was to warrant to the manufacturers that we are serious,'' Gerberding told a hearing of the House Appropriations Committee.
Some of the money was meant to provide a guaranteed market so vaccine makers could be confident the government would buy up any unused vaccines they made.
REUTERS DH RAI0229