The fallout from the loss of morethan half of this year's flu vaccinesupply is likely to be widespread,but some observers doubt that any realsolutions will be found soon, given theodious economic, political, regulatory,and legal climate in which vaccine makersare forced to operate. As usual,though, the public isn't getting an accurateportrait of the problem.
The big question:
The near-term cause of the crisis isclear—the shutdown by British regulatorsof a vaccine-making plant in Englandoperated by Chiron, one of two approvedmanufacturers of flu vaccine for the USmarket. How did weget to where there are only twoapproved manufacturers of the flu vaccine?It's quite clear that, if more companieswere making the vaccine, the loss ofone would not have caused the "crisis"that we are going through now.
Tighter manufacturing regulationsfrom the FDA are among the reasonswhy the number of flu vaccine makershas dropped from five to two over thepast 10 years. But stiffer regulations areonly part of the picture; also at work isthe price jawboning engaged in by thefederal government. One of the fewparts of Senator Hillary Rodham Clinton'smassive health care reform package thatmanaged to become law was a vaccine buyingprogram for children. The idea offree vaccines for kids may sound good,but for vaccine makers, governmentprice controls and forced discounts meanwading through reams of regulatorypaperwork and risking liability suits forpaltry business rewards.
Among the many other hurdles vaccinemakers face is the regulatory mentality.Making the flu vaccine currentlytakes up to 8 months and the vaccinelasts only 1 year, but getting approval fornewer techniques that would speed upthe process is difficult and expensive,given the mindset at the FDA. Itsbureaucrats often perceive that the risksof new methods are not worth the benefitthey would provide.
Some expect that the shortfall in theflu vaccine may also spawn a round ofliability suits that vaccine makers can illafford. Although the US Congress haspassed a liability-protection law for vaccinemanufacturers, aggressive tortlawyers are already searching for, andfinding, loopholes. Meanwhile, thethreat of a lawsuit that could wipe outone of the two remaining vaccine makersis a real one. Proponents of tort-liabilityprotection for vaccine makers alsopoint out that it's not only the flu vaccinesupply that's in jeopardy. There iscurrently only a single approved manufacturerfor vaccines for diseases likepolio, tetanus, diphtheria, measles, andmumps. Clearly, this is a blueprint for apotential health care disaster.
There's also ample evidence thatmedia hype has played a major part increating the crisis. If the immunizationrate this year were the same as last year,the total number of flu shots deliveredwould be around 43 million doses, anumber far lower than the 61 milliondoses of the vaccine now on hand. Themedia's typical herd mentality about theshortage has created unprecedenteddemand, even among those who havenever before received a flu shot. In fact,most healthy people have passed on flushots in past years and the vast majorityof them have never gotten the flu.
In stoking the flu shot panic amongconsumers, there's even more good newsthat the news media have managed toignore—health officials say that thisyear's flu strain is quite similar to lastyear's. That means those who got a flushot or had the flu last winter are likelyto still have a level of immunity thatoffers them some protection this year,without the benefit of another shot.