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The Flu Vaccine Crisis: Did we miss a Red Flag?

VACCINES: AN ONLINE CONFERENCE

The Flu Vaccine Crisis: Did we miss a Red Flag?

By RFD Columnist, Dr. F. Edward Yazbak

Falmouth, Massachusetts, USA
tlautstudy@aol.com

The Centers for Disease Control and Prevention (CDC) acted responsibly when it was confronted by a serious flu vaccine shortage this fall, that resulted from the banning and withdrawal of several thousand doses of vaccine manufactured in a particular British plant, because of contamination with Serratia marcescens.

The question is “Could this year’s crisis have been prevented?”

Although 77% of the cultures identified by the CDC in the last flu season did not match the strains in the available vaccine, there were reassurances that vaccination would still provide cross-protective immunity and reduce the severity of the symptoms. An infectious disease specialist even claimed that “the available flu vaccine will prevent death”.

In that 2003-2004 flu season, the CDC published several reports on “flu deaths” in children under 18 to stress the importance of the pediatric vaccination program that had just been recommended. Two of those reports were discussed in HYPING VACCINES: AN INVESTIGATION (1), published on Red Flags on January 12, 2004.  

A last CDC report (2) was published on January 8, 2004 after submission of the above article. The following is from that January report: “Since October 2003, a total of 93 influenza-associated deaths among children aged <18 years have been reported to CDC. All patients had evidence of influenza virus infection detected by rapid antigen testing or other laboratory tests.

The date of death was reported for 92 of the 93 cases. The median age of the 93 children was 4 years (range: 4 weeks--17 years), with 55 (59%) children aged <5 years and 24 (26%) aged 6--23 months. Among the 92 children whose sex was reported, 41 (45%) were male. A total of 35 (38%) of the 93 children were reported to have had underlying chronic medical conditions and 41 (44%) were reported to have had no underlying conditions; the medical history was unknown for 17 (18%) children”…

 “Pneumonia was a reported complication in 25 of the 93 children. Invasive bacterial co-infections were reported in 15 children, including methicillin-resistant Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus sp., Haemophilus influenzae (type b and non-typable), Neisseria meningitidis, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Serratia marcescens.

Of the 45 children whose influenza vaccination status was reported, one child had evidence of adequate vaccination, whereas 33 (73%) were not vaccinated, and six children were partially vaccinated (i.e., they had received 1 of 2 doses); five children were reported as vaccinated, but the interval between vaccination and onset of illness was not documented.

Although the gender of the deceased and the date of death are important, they are not as critical as the vaccination status, missing in over 50% of cases and the past medical history, lacking in 18% of all deceased children described in the report. These deficiencies should have been investigated and published particularly in the year when routine pediatric flu vaccination was being recommended.

It is not known from the report whether the child (or children) who had a Serratia marcescens fatal secondary infection was (were) vaccinated and the origin of the vaccine they actually received. The isolation of such an unusual pathogen should have resulted in a detailed investigation of the case (s). If the child/children or adults who had evidence of super-infection with Serratia marcescens had received a vaccine that originated in the British plant in question and if that connection had been made last winter, may be the manufacturer could have been alerted and could have sterilized the process, thus  avoiding this year’s vaccine shortage and panic?

Serratia marcescens

Serratia are gram-negative bacteria. Serratia marcescens is the most pathogenic of the species. Rarely, other strains also cause disease.

S marcescens produces prodigiosin, a pink to red pigment. In the first half of the 20th century, S marcescens was used as a biological marker for studying microbial transmission. Since the 1960s, the organism has been recognized as an opportunistic human pathogen causing nosocomial septicemia, pneumonia, urinary tract, skin and soft tissue infections.  Outbreaks of Serratia marcescens meningitis have occurred in pediatric wards and nurseries. Overall, about 25% of the patients die; Mortality is obviously highest with meningitis and blood stream infection. (3)

Thimerosal

Thimerosal contains 49.6% Ethyl mercury by weight. It is assumed to be valuable in securing the sterility of multidose vaccine vials, in which the re-entry of needles may increase the risk of bacterial invasion. It is likely that the manufacturers’ real motive for adding it to vaccines for over 60 years was primarily to guarantee against production-related contamination. At least this time around, it seems to have failed.

To think that we have injected a mercury product into infants for decades is bad enough. To realize that may be it does not work is tragic.

Past problems

A report in the Kansas City Star (Monday November 8, 2004) states that US inspectors had been aware of contamination problems at the British plant manufacturing the flu vaccine destined for the U.S. market. A 1999 FDA report obtained by the Star reportedly showed that at least 21 batches of the vaccine for the 1999-2000 flu season had to be filtered more than once to make them sterile enough for distribution. The FDA provided the documents as part of a lawsuit by a woman who claims she was paralyzed by a vaccine manufactured at the plant. Chiron recently settled that case even though the company did not own the plant at the time. (4)

The 2004-2005 Flu season and its impact

Because of a slow start, no one yet knows for sure if this season’s vaccine will be effective against the strains that will be isolated. Otherwise there is plenty of information readily available from the CDC (5) and from news reports. It would truly be unfortunate if we “missed” the predominant strain again this year after scaring everyone half to death.

From Mythology to the NASDAQ

A Centaur has the body of a horse and the torso, head and arms of a man. According to Greek Mythology, the father of Centaurs was Centaurus, a shady character with a bad reputation. Some have claimed that he was the son of Apollo and Stilbe others that he was the son of Ixion. He gave birth to the race of Centaurs by mating with Magnesian mares.

Centaurs (Kentaurs) were usually wild, savage and lustful except for Chiron, the good, wise and immortal Centaur, who became the tutor of several Greek heroes including Achilles. Paintings of Chiron and Achilles abound. Apparently one day, a terrible fight erupted between Heracles and several drunken centaurs. Chiron who had wisely avoided the fight was accidentally wounded by Heracles and lived in terrible pain. (6)

Today’s Chiron (NASDAQ:CHIR) is also very wise and much wealthier than its namesake. The company because of its multiple acquisitions and business connections has become an international financial empire. (7)

Chiron participates in three healthcare markets: Vaccines, biopharmaceuticals and blood testing. In July 2003, Chiron acquired PowderJect Pharmaceuticals plc, a company based in Oxford, England that develops and commercializes vaccines.

In 2003, Chiron’s income from continuing operations was $220.3 million compared to $181.1 million for 2002. Total revenues were $1,766.4 million vs. $1,276.3 million in 2002 and product sales were $1,345.8 million compared to $914.1 million in 2002. Some of the total revenues reflected the benefit from the favorable Euro to U.S. dollar exchange rate that added approximately 8% to the total revenues and about 15% to the total 2003 vaccine revenues. Vaccine product sales accounted for 50% of total product revenues in 2003 up from 39% in 2002. PowderJect Pharmaceuticals total revenues in 2003 were $244.7 million with flu vaccine sales of $219.2 million for the year.

Thoughts to Ponder

As amazing as it seems, past and present problems and deficiencies are certain to guarantee a sensational success for future vaccination campaigns, even if this flu season is minor and the available vaccine has not targeted the predominant wild strains.

It is pretty certain that people will be lining up next year starting on the Fourth of July to receive their “flu shot”. Healthy adults and children, who “gave up their vaccination” this year to make it available to those who really needed it, will have plenty available next year and for certain, not too many people will fuss about a little mercury either.

References

  1. http://www.redflagsdaily.com/conferences/vaccines/2004_jan12.php
  2. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5253a4.htm
  3. http://www.emedicine.com/med/topic2103.htm
  4. http://www.wistv.com/global/story.asp?s=2535656&ClientType=Printable
  5. http://www.cdc.gov/flu/protect/vaccineshortage.htm
  6. http://edweb.sdsu.edu/people/bdodge/scaffold/GG/centaur.html
  7. http://biz.yahoo.com/e/040303/chir10-k.html

F. Edward Yazbak, MD, Falmouth, Massachusetts.

Personal Note
This is my first contribution since Nick left us. I still cannot believe that he will not be calling me to discuss it. Obviously, every time I access Red Flags, he will still be there, indeed a small consolation.

FEY

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