RE: Chiron Recalls, Withdraws Measles Vaccine

March 16, 2006

Does it contain thimersol?

Sincerely, <

From: "Holly Bortfeld" <maximom@...>Reply-EOHarm To: <EOHarm >Subject: Chiron Recalls, Withdraws Measles VaccineDate: Thu, 16 Mar 2006 16:02:00 -0500

Chiron Recalls, Withdraws Measles Vaccine

Email this StoryMar 16, 12:10 PM (ET)

EMERYVILLE, Calif. (AP) - The biotech company linked to recent flu shot shortages said Thursday that it was recalling and withdrawing a measles, mumps and rubella vaccine it supplies to developing countries and Italy because of a higher rate of adverse effects than similar vaccines.

Chiron Corp. (CHIR) said about 5 million doses of the Morupar vaccine were distributed to developing countries in 2005, and about 450,000 doses were distributed in Italy.

The company said the side-effects included fever, allergic reactions and glandular swelling, which occurred just after inoculation.

Chiron said in a statement the reactions do not indicate any long-term risk and that the recall and withdrawal were a precaution.

The recall does not affect its other vaccines, Chiron said.

Emeryville-based Chiron set off a public health panic in 2004 when it failed to deliver half the nation's expected 100 million flu shots after British regulators discovered contaminated vaccine at its Liverpool, England, manufacturing plant.

Last fall, Chiron Corp. again said it wouldn't be shipping as many flu shots as it initially had hoped, saying production delays and decreased output occurred after it made repairs at its Liverpool plant.

Chiron has said it delivered 13 million flu vaccine shots in 2005, well below the 18 million to 26 million doses it had initially planned to make.

Chiron said it will work closely with the World Health Organization to conduct a risk-benefit analysis to see if the measles, mumps and rubella vaccine should be rereleased in limited quantities.

The recall prompted the company to lower its fourth-quarter results by 3 cents per share.

The company revised its earnings to $138 million, or 68 cents per share, from $144 million, or 71 cents a share, for the fourth-quarter, and to $180 million, or 94 cents per share, from $187 million, or 97 cents a share, for the year. Chiron reported results in late January.

The Morupar vaccine booked $10 million in sales for 2005. Chiron wrote off about $6 million of Morupar inventory for 2005 and recorded $1.7 million of reserves for anticipated product returns.

Shares of Chiron fell 6 cents to $45.64 in midday trading on the Nasdaq Stock Market.

The Federal Trade Commission has approved the company's acceptance of a $45-per-share buyout offer from Swiss drug maker Novartis AG. (NVS)

Novartis already owns 44 percent of Chiron and has offered $5.1 billion in cash for the rest of the stock. The two companies hope to close the deal in the first half of this year, but four shareholders owning a combined 17.5 percent of the company oppose the deal as too cheap.

One of those shareholders, ValueAct Capital, said Wednesday it will call for the ouster of Chiron Chief Executive Pien if he backs Novartis' bid and the shareholders turn it down.

"If Pien is going 'on the road' to argue for the appropriateness of the Novartis offer, we can only conclude that our confidence in him has been betrayed, and that he has chosen not to accept responsibility for maximizing shareholder value," ValueAct partner G. Mason Morfit wrote in a letter to Pien and the Chiron board.

March 17, 2006

Poking around on the Internet, I could not find any mention of the Morupar vaccine containing thimerosal, but I did find some information that the Urabe strain of mumps vaccine may have been used in this vaccine. Could this be the cause of the adverse effects? Aasa I found this at the JABS Foum (link at: http://72.14.207.104/search?q=cache:oYFgisHG5wYJ:jabs.org.uk/pages/message_board.asp+morupar+jabs+forum & hl=en & gl=ca & ct=clnk & cd=1 ) However, we do learn that the Morupar MMR vaccine which contains the Urabe strain linked to neurological reactions, while banned in most Western countries, is still sold widely in Latin America and other third world countries.

------------------------------------------------------------------------------------------------------There is also this review to consider, from the Cochrane Review (which is available at: http://72.14.207.104/search?q=cache:XJnMljKOtEMJ:cochrane.bireme.br/cochrane/show.php%3Fdb%3D%26mfn%3D%26id%3D_ID_CD004407%26lang%3Den%26dblang%3D+morupar+urabe+strain & hl=en & gl=ca & ct=clnk & cd=1 ) Vaccines for measles mumps and rubella in children [protocol] Bianco E, Price D, Jefferson T, Demicheli V This protocol should be cited as: Bianco E, Price D, Jefferson T, Demicheli V.

Vaccines for measles mumps and rubella in children (Protocol for a Cochrane Review). In: The Cochrane Library, Issue 1, 2005. Oxford: Update Software. Background Mumps, measles and rubella are serious diseases that can lead to potentially fatal illness, disability and/or death. Measles, mumps and rubella are particularly prevalent in developing countries where vaccination programmes are inconsistent and the mortality rate from disease is high. In developed countries, however, mumps, measles and rubella are now rare, due to large-scale vaccination programmes. The single component live attenuated vaccines of measles, mumps, and rubella have been licensed in the USA since the 1960s (Plotkin 1999 a; Plotkin 1999 b; Redd 1999). Single vaccines have been shown to be highly effective at reducing the morbidity and mortality associated with these childhood illnesses. Nevertheless, no country in the world recommends that measles, mumps, and rubella be given as three separate vaccines. Combined live attenuated measles, mumps and rubella (MMR) vaccine was introduced in the United States in the 1970s, (Schwarz 1975; Redd 1999). MMR is included in the World Health Organisation's "Expanded Programme on

Immunisation" and it is used in over 30 European countries, USA, Canada, Australia and New Zealand. In total, over 90 countries around the world use MMR. Accepted recommendations are that the first dose should be administered on or after the first birthday and the second dose of MMR at least 28 days later. In many European countries the second dose is administered at 4 to 10 years of age. Vaccination with MMR provides significant improvement in the efficiency of paediatric immunisation through the administration of three vaccines in a single injection, reducing costs while increasing immunisation coverage against the three diseases (Makino 1990). The incidence of measles, mumps, and rubella worldwide has been significantly reduced by MMR vaccination (WHO 1999). The component of monovalent vaccine containing measles, mumps and rubella viruses and subsequently combined MMR vaccine are described below (Makino 1990; Plotkin 1999 . Numerous attenuated measles vaccines, mostly derived from the Edmonston strain, are currently produced worldwide. Four vaccines containing non-Edmonston derived strains are also in use including Leningrad-16, Shanghai-191, CAM-70 and TD97. In most cases, the virus is cultured in chick embryo cells however, a few vaccines are attenuated in human diploid cells. The majority of

vaccines contain small doses of antibiotics (e.g. 25 g of neomycin per dose), but some do not. Sorbitol and gelatin are used as stabilizers (Schwarz 1975). More than ten mumps vaccine strains (Jeryl Lynn, Urabe, Hoshino, Rubini, Leningrad-3, L-Zagreb, Miyahara, Torii, NK M-46, S-12 and RIT 4385), have been used throughout the world (Redd 1999). The Jeryl Lynn strain is used in many countries. Most vaccines contain 25 g of neomycin per dose. Several manufacturers in Japan and Europe produce a live mumps vaccine containing the Urabe Am9 virus strain, however, concerns about vaccine-associated meningitis prompted several countries to stop using MMR with mumps Urabe strain. Often, the viruses are cultured in chick embryo fibroblasts (such as for the Jeryl Lynn and Urabe strain containing vaccines), but, quail and human embryo fibroblasts are also used for some vaccines. Most rubella vaccines used throughout the world contain the RA 27/3 virus strain (Plotkin 1965). The only exceptions are vaccines produced in Japan which use different virus strains (Matsuba, DCRB 19, Takahashi, and TO- 336) all

produced using rabbit kidney cells and Matsuura produced on quail embryo fibroblasts. The RA 27/3 strain is used most often because of consistent immunogenicity, induction of resistance to reinfection, and low rate of side effects (Plotkin 1973). The live virus produces viraemia and pharyngeal excretion, but both are of low magnitude and are non-communicable (Plotkin 1999 a). At least five MMR vaccines are known to us: (1) Triviraten Berna vaccine is live containing 1000 TCID50 (50% tissue culture infectious doses) of Edmonston-Zagreb (EZ 19) measles strain, 5000 TCID50 of Rubini mumps strain, and 1000 TCID50 of Wistar RA 27/3 rubella strain propagated on human diploid cells. The product contains lactose 14 mg, human albumin 8.8 mg, sodium bicarbonate 0.3 mg, medium 199 5.7 mg, and distilled water as a solvent. (2) M-M-R by Merck is a live virus vaccine. It is a sterile lyophilised preparation of 1000 TCID50 Enders' attenuated Edmonston measles strain and propagated in chick embryo cell culture; mumps 20000 TCID50 Jeryl Lynn strain propagated in chick embryo cell culture; and rubella 1000 TCID50 Wistar RA 27/3 propagated on human diploid lung fibroblasts. The growth medium is medium 199 5.7 mg as stabilizer and neomycin. (3) Morupar by Chiron is a live virus vaccine. It contains sterile

lyophilised preparation of 1000 TCID50 of Schwarz measles strain propagated in chick embryo cell culture; 1000 TCID50 Wistar RA 27/3 rubella strain propagated on human diploid lung fibroblasts; and 5000 TCID50 Urabe AM 9 mumps propagated in chick embryo cell culture with neomycin as stabilizer. (4) Priorix vaccine Glaxo Kline Beecham (GSK), is a lyophilised mixed preparation of the attenuated Schwarz measles CCID50 (50% cell culture infective dose) strain, RIT 4385 mumps CCID50 (derived from Jeryl Lynn strain) and CCID50 Wistar RA 27/3 rubella strain of viruses, separately obtained by propagation either in chick embryo tissue cultures (mumps

and measles) or MRC5 human diploid cells (rubella). The vaccine also contains residual amounts of neomycin (25 g). (5) Trimovax by Pasteur-Merieux Serums and Vaccines contains live virus: Schwarz measles strain, 1000 TCID50; Urabe Am 9 mumps strain, 5000 TCID50; Wistar RA 27/3 rubella strain, 1000TCID50. Despite its worldwide use, no systematic reviews of the effectiveness and safety of MMR are available. Objectives To assess the absolute effectives of MMR vaccine in children. To assess the occurrence of common, rare, short and long-term adverse event outcomes following exposure to MMR in children. Criteria for considering

studies for this review Types of studies Study designs included: Effectiveness: we will include any study of randomized controlled trial (RCT) and controlled clinical trial (CCT) designs (see Appendix 1 in the Methods section) Safety: we will include all comparative prospective or retrospective studies (see Appendix 1 in the Methods section). Types of participants Healthy individuals aged up to 15 years of age Types of intervention Vaccination with any combined MMR vaccine given independently, in any dose, preparation or time schedule, compared with do-nothing or placebo. Types of outcome measures (1) Clinical cases (measles, mumps, rubella). (2) Number and type of adverse events (classified as local and systemic) observed following MMR vaccination. (3) Systemic adverse events - including fever, rash, vomiting, diarrhoea and more generalised and

severe signs including all the potential adverse events which have been hypothesised so far (thrombocytopenic purpura, parotitis, joint and limb symptoms, Crohn's disease, ulcerative colitis, autism, aseptic meningitis). (4) Local adverse events - including soreness and redness at the site of inoculation. Search strategy for identification of studies For effectiveness: We will search the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Acute Respiratory Infections (ARI) Group trials register to identify randomized and quasi-randomized controlled trials identified through electronic databases and handsearches. We will search MEDLINE 1966 to the present using the Cochrane highly sensitive search strategy, parts one and two (e 2003 a) in combination with the following search terms: # 1 explode 'Vaccines-Combined' / all subheadings # 2 explode 'Vaccines-Attenuated' / all subheadings # 3 #1 or #2 # 4 trivalen* or combin* or simultan* or tripl* or trebl* # 5 vaccin* or immuni* or inoculat* # 6 # 4 and # 5 # 7 # 3 or # 6 # 8 explode 'Measles-' / all subheadings # 9 explode 'Mumps-' / all subheadings # 10 explode 'Rubella-' / all subheadings # 11 measles or mumps or rubella # 12 #8 or #9 or #10 or #11 # 13 #7 and #12 # 14 explode 'Measles-Vaccine' #15 explode 'Mumps-Vaccine' #16 explode 'Rubella-Vaccine' #17 explode 'Measles-Mumps-Rubella-Vaccine' / all subheadings #18 measles mumps rubella or MMR #19 #14 or #15 or #16 or #17 or #18 #20 #13 or

#19 These subject terms will be adapted to search the other databases listed below. EMBASE will be searched from 1980 to present to identify controlled trials in combination with subject terms adapted for EMBASE. Biological Abstracts will be searched from 1985 to present. Science Citation Index will be searched from 1980 to present. We will also search the Cochrane Database of Systematic Reviews (CDSR) and NHS Database of Abstracts of Reviews of Effects (DARE) for published reviews. We will search bibliographies of all relevant articles obtained and assess any published reviews will be assessed for additional studies. We will also search the following sources for unpublished, prospectively registered trials http://www.clinicaltrials.gov/ and http://www.controlled-trials.com/ In addition we will contact vaccine manufacturers, companies that market vaccines, first or corresponding authors of studies evaluated and

researchers or experts in the field where appropriate, to identify any unpublished studies. For safety: We will search CENTRAL to identify reports of randomized and quasi-randomized controlled trials and published reviews in CDSR and DARE. The Cochrane Library will be searched to identify reports from the results of handsearching the journal Vaccine. We will also search MEDLINE from 1966 to present using the following search terms: Vaccines-Combined [mesh word (mh)] or Vaccines-Attenuated (mh) or ((trivalen*[text word (tw)] or combin* (tw) or simultan* (tw) or tripl* (tw) or trebl* (tw) and (vaccin* (tw) or immuni* (tw) or inoculat* (tw))) and measles (tw) and mumps (tw) and rubella (tw) or Measles-Vaccine(mh) and Mumps-Vaccine (mh) and Rubella-Vaccine (mh) or MMR [title, abstract (ti,ab)] or measles (tw) and mumps (tw) and rubella (tw) and (vaccin* (tw) or immuni* (tw) or inoculat* (tw) and adverse events [floating sub-heading (fs)] or chemically induced (fs) or complications (fs) or contraindications (fs) or toxicity (fs) or poisoning (fs) or drug effects (fs) or adverse (tw) near (effect* (tw) or event* (tw)) or side effect* (tw) or hypersensitiv* (tw) or sensitiv* (tw) or safe* (tw) or pharmacovigil* (tw) or explode Product-Surveillance-Postmarketing (mh) or Drug-Monitoring (mh) or Drug-Evaluation (mh) or explode Risk (mh) or Odds-Ratio (mh) or explode Causality (mh) or relative risk (tw) or risk (tw) or causation (tw) or causal (tw) or odds ratio (tw) or etiol* (tw) or aetiol* (tw) or etiology (fs) or epidemiology (fs) This filter will be adapted for searching the other databases listed below. EMBASE from 1980 to present. Biological Abstracts from 1985 to present. We will search

Science Citation Index from 1980 to present using search terms equivalent to the MEDLINE strategy (see above). We will assess bibliographies of all relevant articles and any published reviews for additional studies. Methods of the review Study Selection Two reviewers will independently apply the inclusion criteria to all identified and retrieved articles Quality assessment The reviewers will independently assess the methodological quality of the included studies. The quality of randomized and semi-randomized trials will be assessed using the criteria adapted from the Cochrane Reviewers' Handbook (e 2003 . Quality assessment of non-randomized studies will

be made in relation to the presence of potential confounders, which could make interpretation of the results difficult. However, because there is insufficient empirical evidence to demonstrate the validity of the non-randomised quality assessment screens, they will be used for the purposes of qualitative analysis only. We will evaluate the quality of case control (prospective and retrospective) and cohort studies using the appropriate Newcastle-Ottawa Scales (NOS) (Wells 2000). We will apply quality control assessment grids, based on those developed by The University of York, NHS Centre for Reviews and Dissemination (Khan 2001) to HCTs, interrupted time-series and case cross-over studies,

and ecological studies. For case-only design studies, we will use a classification and methodological quality checklist (unpublished) especially developed by CP Farrington and TO Jefferson adapted from a paper by CP Farrington (Farrington (in press)). Data extraction Two reviewers will independently perform data extraction using a data extraction form. We will contact authors in studies where data are insufficient or missing. Statistical Considerations We will first assess included studies for clinical homogeneity to see if the individual studies (within each design category) appear clinically similar. Homogeneity of the participants, intervention and outcomes will then be assessed

statistically (using the chi-square test), before deciding whether to combine the data from the individual studies within each design category. If significant heterogeneity is found, we will perform sensitivity analysis. Where studies are found to be homogenous, we will undertake a meta-analysis of these studies within each design category. We will analyse non-randomized evidence separately from randomized evidence. The study results will be described individually in the discussion section of the review and will not be combined. Primary and secondary outcomes will be presented as relative risk with their 95% confidence intervals. We will use a random effects model in case of significant heterogeneity (P < 0.1), and a fixed effect model if there is no significant heterogeneity. We will calculate the number-needed-to-treat to show the number of participants who should be vaccinated to prevent one case of measles, mumps and rubella. The number-needed-to-treat will

be calculated for high and low risk populations separately to account for the effect of the baseline risk. We will perform subgroup analysis when the data are available for type of vaccine administered, age of individuals, time schedule and specificity of outcome definitions. APPENDIX 1 (Based on: Jefferson 1999; Last 2001; Farrington (in press)) A case-control study is a prospective or retrospective epidemiological study usually used to investigate the causes of disease. Study participants who have experienced an adverse outcome or disease are compared with

participants who have not. Any differences in the presence or absence of hypothesised risk factors are noted. A cohort study is an epidemiological study where groups of individuals are identified who vary in their exposure to an intervention or hazard, and are then followed to assess outcomes. Association between exposure and outcome are then estimated. Cohort studies are best performed prospectively, but can also be undertaken retrospectively if suitable data records are available. An historical controlled trial (HCT) is a study with control subjects for whom data were collected at a time preceding that at which the data are gathered on the group being studied. Indirect comparisons are comparisons of the two or more index groups with a control (usually in randomly allocated groups). The comparisons are usually not contemporaneous and inference is made from the

comparisons to the general population. A randomised controlled trial (RCT) is any study on humans in which the individuals (or other experimental units) followed in the study were definitely or possibly assigned prospectively to one of two (or more) alternative forms of health care using random allocation. A controlled clinical trial (CCT) is any study on humans in which the individuals (or other experimental units) followed in the study were definitely or possibly assigned prospectively to one of two (or more) alternative forms of health care using some quasi-random method of allocation (such as alternation, date of birth or case record number). A time-series is a comparative design with controls in which measurements are made at different times, allowing trend detection and before and after exposure assessment. Case-only design studies: An ecological study is a study in which the units of analysis are populations or groups of people, rather than individuals. Inference is then made by observing the difference in incidence between populations of the event in question. A case-crossover study is a design in which exposures of cases during one period is compared to matched-pair analyses to their own exposure during a preceding period of similar length. Case-coverage design is a study comparing prevalence of exposure in cases with exposure in the reference population. No denominator data are required and the population coverage information is derived from summary statistics. When coverage information is derived from a population sample, the design is that of a case-base study. A self-controlled case series uses

cases as their own controls. The ages at vaccination are regarded as fixed and the age at adverse event is the random variable of interest within a pre-determined observation period. Acknowledgements Anne Eisinga, Dr CP Farrington, Letizia Giampaoli Potential conflict of interest References Additional references e 2003 a e M, Oxman AD. Optimal search strategy for RCTs. Cochrane Reviewers' Handbook 4.1.6 [updated January 2003]. Appendix 5c. The Cochrane Library 2003;(1). e 2003 b e M, Oxman AD. Cochrane Reviewers' Handbook 4.1.6 [updated January 2003]. The Cochrane Library 2003;(1). Farrington (in press Farrington CP. Control without separate controls: Evaluation of vaccine safety using case-only methods. Vaccine in press. Jefferson 1999 Jefferson TO, Demicheli V. Relation between experimental and non-experimental study designs.HB vaccines: a case study. Journal of Epidemiology and Community Health 1999;53:51-3. Khan 2001 Khan SK, ter Riet G, Popay J, Nixon J, Kleijnen J. Stage II Conducting the review: Phase 5: Study quality assessment. In: Khan SK, ter Riet G, Glanville J, Sowden AJ, Kleijnen J, editor(s). Undertaking Systematic Reviews of Research on Effectiveness. CRD's guidance for carrying out or commissioning reviews. CRD Report No 4. 2nd Edition. York: York: NHS Centre for Reviews and Dissemination, University

of York, 2001. Last 2001 Last J, editor. A dictionary of epidemiology. Oxford: Oxford University Press, 2001. Makino 1990 Makino S, Sasaki K, Nakayama T, Oka S, Urano T, Kimura M et al. A new combined trivalent live measles (AIK-C Strain), mumps (Hoshino Strain), and rubella (Takahashi strain) vaccine. American Journal of Diseases of Children 1990;144:905-10. Plotkin 1965 Plotkin SA, Cornfeld D, Ingalls TH. Studies of immunization with living rubella virus: Trials in children with a strain cultured from an aborted fetus. American Journal of Diseases of Children 1965;110:381-9. Plotkin 1973 Plotkin SA, Farquhar JD, Ogra PL. Immunologic properties of RA 27/3 rubella virus vaccine. JAMA 1973;225:585-90. Plotkin 1999 a Plotkin SA. Rubella vaccine. In: Plotkin SA, Orenstein WA, editor(s). Vaccines Philadelphia: WB Saunders, 1999:409-39. Plotkin 1999 b Plotkin SA, Wharton M. Mumps vaccine. In: Plotkin SA , Orenstein WA, editor(s). Vaccines Philadelphia: WB Saunders, 1999:267-92. Redd 1999 Redd SC, Markowitz LE, Katz SL. Measles vaccine. In: Plotkin SA, Orenstein WA,

editor(s). Vaccines Philadelphia: WB Saunders, 1999:222-6. Schwarz 1975 Schwarz A, JE, Ehrenkranz NJ, Ventura A, Schiff GM, Walters VW. Clinical evaluation of a new measles-mumps-rubella trivalent vaccine. American Journal of Diseases of Children 1975;129(12):1408-12. Wells 2000 Wells GA, Shea B, O'Connell D, J, Welch V, Losos M et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses 2000. URL: http://www.lri.ca/programs/ceu/oxford.htm . WHO 1999 World Health Organization. Measles: progress towards global control and regional elimination, 1998-1999. Weekly Epidemiol Records 1999;74:429-39. Cover sheet Vaccines for measles mumps and rubella in children Reviewer(s) Bianco E, Price D, Jefferson T, Demicheli V Contribution of Reviewer(s) Deirdre Price, Elvira Bianco, Vittorio Demicheli and Tom Jefferson designed the protocol and edited the manuscript. Issue protocol first published 2003 issue 3 Date of last minor amendment 12 March 2003 Date of last substantive amendment 12 March 2003 Most recent changes Information not supplied by reviewer Review expected to

be published in: Issue 3, 2004 Contact address Deirdre PriceRadcliffe InfirmaryWoodstock RoadOxfordOxonUKOX2 6HETelephone: Facsimile: E-mail: deirdre.price@... Cochrane Library number CD004407 Editorial group Cochrane Acute Respiratory Infections Group Editorial group code ARI Sources of support External sources of support European Union Programme for Improved Vaccine Safety Surveillance. EU Contract Number 1999/C64/14 EUROPEAN

UNION Internal sources of support Istituto Superiore di Sanita' ITALY Additional tables Additional tables are not available for this protocol Herman Fudenberg <nitrf@...> wrote: Does it contain thimersol? Sincerely, < From: "Holly Bortfeld" <maximom@...>Reply-EOHarm To: <EOHarm >Subject: Chiron Recalls, Withdraws Measles VaccineDate: Thu, 16

Mar 2006 16:02:00 -0500 Chiron Recalls, Withdraws Measles Vaccine Email this StoryMar 16, 12:10 PM (ET) EMERYVILLE, Calif. (AP) - The biotech company linked to recent flu shot shortages said Thursday that it was recalling and withdrawing a measles, mumps and rubella vaccine it supplies to developing countries and Italy because of a higher rate of adverse effects than similar vaccines. Chiron Corp. (CHIR) said about 5 million doses of the Morupar vaccine were distributed to developing countries in 2005, and about 450,000 doses were distributed in Italy. The company said the side-effects included fever, allergic reactions and glandular swelling, which occurred just after inoculation. Chiron said in a statement the reactions do not indicate any long-term risk and that the recall and withdrawal were a precaution. The recall does not affect its other vaccines, Chiron said. Emeryville-based Chiron set off a public health panic in 2004 when it failed to deliver half the nation's expected 100 million flu shots after British regulators discovered contaminated vaccine at its

Liverpool, England, manufacturing plant. Last fall, Chiron Corp. again said it wouldn't be shipping as many flu shots as it initially had hoped, saying production delays and decreased output occurred after it made repairs at its Liverpool plant. Chiron has said it delivered 13 million flu vaccine shots in 2005, well below the 18 million to 26 million doses it had initially planned to make. Chiron said it will work closely with the World Health Organization to conduct a risk-benefit analysis to see if the measles, mumps and rubella vaccine should be rereleased in limited quantities.

The recall prompted the company to lower its fourth-quarter results by 3 cents per share. The company revised its earnings to $138 million, or 68 cents per share, from $144 million, or 71 cents a share, for the fourth-quarter, and to $180 million, or 94 cents per share, from $187 million, or 97 cents a share, for the year. Chiron reported results in late January. The Morupar vaccine booked $10 million in sales for 2005. Chiron wrote off about $6 million of Morupar inventory for 2005 and recorded $1.7 million of reserves for anticipated product returns. Shares of Chiron fell 6 cents to $45.64 in midday trading on the Nasdaq Stock Market. The Federal Trade Commission has approved the company's acceptance of a $45-per-share buyout offer from Swiss drug maker Novartis AG. (NVS) Novartis already owns 44 percent of Chiron and has offered $5.1 billion in cash for the rest of the stock. The two companies hope to close the deal in the first half of this year, but four shareholders owning a combined 17.5 percent of the company oppose the deal as too cheap. One of those shareholders, ValueAct Capital, said Wednesday it will call for the ouster of Chiron Chief Executive Pien if he backs Novartis' bid and the shareholders turn it down. "If Pien is going 'on the road' to argue for the appropriateness of the Novartis offer, we can only conclude that our confidence in him has been betrayed, and that he has chosen not to accept responsibility for maximizing shareholder value," ValueAct partner G. Mason Morfit wrote in a letter to Pien and the Chiron board.

March 17, 2006

Do you have contact nethod with Rockville MD adverse vaccine reaction group?

Sincerely,

H.H. Fudenberg, M.D., D.D.G., I.O.M.

226 Edgewater Road

Inman, SC 29349

864-592-8076

nitrf@hotmailcom

From: "Herman Fudenberg" <nitrf@...>Reply-EOHarm To: EOHarm Subject: RE: Chiron Recalls, Withdraws Measles VaccineDate: Thu, 16 Mar 2006 17:38:34 -0500