Vaccine Development Needs a Booster Shot

Article excerpt

Byline: Henry I. Miller, M.D., SPECIAL TO THE WASHINGTON TIMES

Every year in this country influenza kills tens of thousands and hospitalizes about a quarter-million.

In epidemic years, the numbers can be astronomical, even when there is enough vaccine to go around. This year there isn't: The supply was cut in half last week when one of only two companies that make flu shots for use in the United States abruptly announced its 48 million doses were unavailable because of possible contamination problems.

Flu vaccine should be an attractive product for manufacturers - it is used every year, recommended for virtually everyone, and extremely safe. But like virtually all other vaccines, it isn't profitable. And that has so discouraged vaccine development that supplies of many lifesaving vaccines are in jeopardy.

The fundamental problem is government policies discourage companies from investing aggressively to develop new vaccines. Innovation has suffered, and producers have abandoned the field in droves, leaving only four major producers and a few dozen products. There are only two producers of injectable flu vaccine, for example: Chiron, unable to supply any product this year because of alleged contamination; and Aventis Pasteur, whose 54 million doses will be all that's available. (In addition, there will be another 2 million doses of FluMist, an inhalable nasal vaccine.)

This is not the first time we have had dangerous shortages of several essential vaccines. Some school systems have been forced to waive immunization requirements because there aren't enough vaccines available.

Vaccination to prevent viral and bacterial diseases is modern medicine's most cost-effective intervention. Although their social value is high, their economic value to pharmaceutical companies is low because of vaccines' low return on investment and the manufacturers' exposure to legal liability.

There are short- and long-term remedies that must be undertaken immediately.

In the short-term, there should be Centers for Disease Control and Food and Drug Administration clinical tests to see if the injectable vaccine is effective when diluted. If, as previous evidence suggests, the vaccine is still effective when diluted by a factor of 2, that would make available another 54 million doses. We could have those results within a month. That would, in effect, make a dire threat to public health disappear.

Second, the FDA should make it clear that though the labeling for FluMist, the nasal vaccine, indicates it is intended for recipients aged 5 to 49 years, it will likely also be effective in those younger or older. (The labeling reflects the relatively narrow patient population in whom preapproval clinical trials were performed. …