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PubMed2001

Platelet aggregation inhibition with glycoprotein IIb--IIIa inhibitors.

Inhibitors of the platelet receptor glycoprotein (GP) IIb--IIIa are a novel and potent class of antithrombotic drugs for the management of patients with non-ST-segment elevation acute coronary syndromes (ACS) and those undergoing percutaneous coronary intervention (PCI). Pharmacodynamic studies with three currently approved agents in this class (abciximab [ReoPro, Centocor, Inc., Malvern, Pennsylvania, and Eli Lilly & Company, Indianapolis, Indiana]; eptifibatide [INTEGRILIN, COR Therapeutics, Inc., South San Francisco, California, and Key Pharmaceuticals, Inc., Kenilworth, New Jersey]; and tirofiban HCI [Aggrastat, Merck & Co., Inc., Whitehouse Station, New Jersey]) all sought to identify dosing regimens that would establish and maintain >80 % inhibition of ex vivo platelet aggregation throughout the duration of intravenous infusion. Direct comparison of these prior studies is difficult, however, because the assays used different anticoagulants (sodium citrate [abciximab, tirofiban HCI] or D-phenylalanyl-L-prolyl-L-arginine chloromethyl ketone [PPACK] [eptifibatide]) and different concentrations of the platelet agonist adenosine diphosphate (ADP) (5 micromol [tirofiban HCI] or 20 micromol [abciximab, eptifibatide]). More recent work has attempted to overcome these limitations by using similar assay conditions for all GP IIb--IIIa inhibitors. These studies have indicated that the concentrations of all three agents required to provide the targeted effect for platelet inhibition are considerably higher in the presence of an anticoagulant that does not chelate calcium ions (e.g., heparin or PPACK) than in the presence of calcium-chelating anticoagulant (i.e., sodium citrate). Of the three currently approved GP IIb--IIIa inhibitors, eptifibatide is the only agent whose approved dosing is based on an ex vivo platelet aggregation assay that uses such an anticoagulant. Additionally, Kereiakes et al. have recently reported that the high levels of platelet inhibition (>80 %), using PPACK as an anticoagulant and ADP (20 micromol) as an agonist, are more consistently achieved with the approved dosing regimen of eptifibatide. The antiplatelet effect of abciximab showed more interpatient variability, whereas the median inhibition of ex vivo platelet aggregation with the approved dosing regimen for tirofiban HCl was <80 % at almost all time points during drug infusion.

Abciximab↗
PubMed1998

Acute encephalopathy followed by permanent brain injury or death associated with further attenuated measles vaccines: a review of claims submitted to the National Vaccine Injury Compensation Program.

OBJECTIVE: To determine if there is evidence for a causal relationship between acute encephalopathy followed by permanent brain injury or death associated with the administration of further attenuated measles vaccines (Attenuvax or Lirugen, Hoechst Marion Roussel, Kansas City, MO), mumps vaccine (Mumpsvax, Merck and Co, Inc, West Point, PA), or rubella vaccines (Meruvax or Meruvax II, Merck and Co, Inc, West Point, PA), combined measles and rubella vaccine (M-R-Vax or M-R-Vax II, Merck and Co, Inc, West Point, PA), or combined measles, mumps, and rubella vaccine (M-M-R or M-M-R II, Merck and Co, Inc, West Point, PA), the lead author reviewed claims submitted to the National Vaccine Injury Compensation Program. METHODS: The medical records of children who met the inclusion criteria of receiving the first dose of these vaccines between 1970 and 1993 and who developed such an encephalopathy with no determined cause within 15 days were identified and analyzed. RESULTS: A total of 48 children, ages 10 to 49 months, met the inclusion criteria after receiving measles vaccine, alone or in combination. Eight children died, and the remainder had mental regression and retardation, chronic seizures, motor and sensory deficits, and movement disorders. The onset of neurologic signs or symptoms occurred with a nonrandom, statistically significant distribution of cases on days 8 and 9. No cases were identified after the administration of monovalent mumps or rubella vaccine. CONCLUSIONS: This clustering suggests that a causal relationship between measles vaccine and encephalopathy may exist as a rare complication of measles immunization.

Acute Disease↗
PubMed1999

Availability of hepatitis B vaccine that does not contain thimerosal as a preservative.

On August 27, 1999, Merck Vaccine Division (Merck & Co., Inc., West Point, Pennsylvania) received approval from the Food and Drug Administration (FDA) of a supplement to Merck's license application to include the manufacture of single-antigen preservative-free hepatitis B vaccine (Recombivax HB, Pediatric); distribution is expected to begin September 13, 1999. In addition, SmithKline Beecham Biologicals (SmithKline Beecham, Philadelphia, Pennsylvania), expects to make single-antigen preservative-free hepatitis B vaccine (Engerix-B, Pediatric) available in the near future. Further product information will be provided when it becomes available. Product packaging and labels will indicate that these vaccines do not contain preservative.

Hepatitis B Vaccines↗
PubMed2000

Fat redistribution in indinavir-treated patients with HIV infection: A review of postmarketing cases.

CONTEXT: Fat redistribution (FR) occurring alone or in association with hyperlipidemia has been associated with protease inhibitors (PI) and nucleoside reverse transcriptase inhibitors (NRTIs); however, the relationship between FR features, relationship of FR to hyperlipidemia, and pathogenesis of FR is unknown. OBJECTIVE: To characterize the spectrum of FR, assess relationships among FR features, determine trends in occurrence of FR, and determine relationship of FR to hyperlipidemia. DESIGN: Review of postmarketing indinavir reports of FR in Merck & Co. Inc.'s database. SETTING AND PARTICIPANTS: 282 reports of FR among HIV-positive patients taking indinavir submitted through the passive postmarketing system to Merck through February 23, 1998. RESULTS: 282 FR reports were compared across 3 groups: fat accumulation (FA) only, FA with peripheral wasting (FA with PW), and peripheral wasting only (PWO). Of 282 reports, 56% (159 of 282) had FA only, 22% (63 of 282) had FA with PW, and 21% (60 of 282) had PWO. The proportions of reports of PWO was higher in men, whereas the proportion of reports of FA was higher in women. Blood lipids were provided in 93 of 282 reports; were elevated in 69 of 93, and were normal in 24 of 93 reports. Proportions of hyperlipidemia and hypertriglyceridemia reports were significantly higher in the PWO group versus FA only group (p =.024 and.003, respectively) and versus FA with/without PW groups (p =.038 and.005, respectively). Weight gain was more frequently reported in those with FA (100%) or FA with PW (68%), whereas weight loss was usually reported in those with PWO (83%). In all, 98% of patients reporting FR on indinavir for whom a concomitant drug history was available were also taking lamivudine, stavudine, or both. A higher proportion of patients reporting PWO (34 of 60; 56.7%) versus FA (42 of 159; 26.4%) only took both lamivudine and stavudine. CONCLUSIONS: Differences observed from analysis of cases in clinical features, gender, weight change, concomitant medications, and presence of hyperlipidemia among the three groups of FR cases reported to Merck suggests that PWO may be a distinct entity from other features of FR. The data suggest that certain antiretroviral combinations predispose HIV persons to development of FR.

Adipose Tissue↗
PubMed2005

Public-private partnerships in blindness prevention: reaching beyond the eye.

The control of river blindness (onchocerciasis) has been one of the major public health achievements of recent decades. Initially, vector control was used to stop transmission of the parasite Onchocerca volvulus by blackflies (Simulium) but the introduction of ivermectin (Mectizan) as a means of morbidity control enabled new strategies of distribution to be developed based on community directed treatment. The donation of Mectizan by Merck & Co. Inc. for onchocerciasis control in 1987 'as long as needed' was a public health landmark to be followed by a donation from GlaxoSmithKline of albendazole in 1997 for lymphatic filariasis to which Merck also responded by agreeing to extend their donation to include the coadministration of Mectizan and albendazole. Both the drugs, however, have wider impacts than those specific to filarial parasites and are effective against a range of intestinal parasites, whilst ivermectin has an important effect on ectoparasites. The wider benefits of the annual public health intervention-collateral benefits--therefore include deworming, improved nutritional status, increased growth, improved school performance and attendance, and improved haemoglobin status as a result of the impact of albendazole on hookworm, a major cause of anaemia. More recently, studies suggest that worm-free children have a significantly reduced frequency of malaria specific episodes of fever and Ascaris-infected children have a two-fold higher frequency of cerebral or severe malaria than those without Ascaris. These findings suggest that programmes based on annual interventions to control river blindness and lymphatic filariasis can contribute disproportionately more to a range of public health problems than has been hitherto recognized, thereby assisting in attaining the millennium development goal targets.

Blindness↗
PubMed1999

Reactogenicity and immunogenicity of a new live attenuated combined measles, mumps and rubella vaccine in healthy children.

OBJECTIVE: To compare the reactogenicity and immunogenicity of a novel live attenuated measles-mumps-rubella vaccine, SB MMR (Priorix; SmithKline Beecham Biologicals), with a widely used MMR vaccine, Merck MMR (M-M-R II; Merck & Co. Inc). METHODS: A total of 4702 healthy children, ages 9 to 24 months, were enrolled in 8 single blind, randomized, controlled trials. Reactogenicity (local and general solicited symptoms and all unsolicited symptoms) was assessed for up to 42 days postvaccination. Immunogenicity [seroconversion rates and geometric mean titers (GMT)] was assessed at 42 or 60 days postvaccination in 1912 subjects in 7 studies. In two studies the persistence of the antibodies at Month 12 postvaccination was assessed in 201 subjects. RESULTS: Local symptoms (pain on or immediately after injection; pain, redness and swelling within 4 days of injection) were reported less frequently after SB MMR than Merck MMR (P < 0.0001). General symptoms and all other events were similar between the two groups. Fever >39.5 degrees C was reported after 9.5 and 11.9% of the SB MMR and Merck MMR doses, respectively. At Days 42 to 60 postvaccination seroconversion rates for antimeasles antibodies were higher with SB MMR than with Merck MMR (98.7% vs. 96.9%, P < 0.031) but similar in both groups for anti-mumps and anti-rubella antibodies, GMTs being approximately 10% higher (P < 0.05) with Merck MMR than with SB MMR. At the Month 12 assessment the seropositivity rates and GMTs were similar in both groups. CONCLUSION: When administered as primary vaccination in children in the second year of life, the new SB MMR vaccine has been shown to be superior to a comparator vaccine in terms of local reactogenicity, with equivalent immunogenicity.

Analysis of Variance↗
PubMed2006

The human papillomavirus vaccines.

Genital human papillomavirus (HPV) infection is the most common sexually transmitted infection (STI) among sexually active couples. Its annual incidence is approximately 5.5 million. Overall, an estimated 75% of sexually active men and women have been exposed to HPV at some point in their lives. HPV-16 and -18 account for about 70% of cancers of the cervix, vagina and anus, and for about 30%-40% of cancers of the vulva, penis and orophaynx. Cancer of the cervix uteri is the second most cancer among women worldwide. Cancer of the penis is a rare cancer, accounting for less than 0.5% of cancers in men. Spontaneous clearance of HPV infection is accompanied by humoral and cellular immune response against virus-specific antigens. Two vaccines, prophylactic and therapeutic ones, are considered. Prophylactic vaccines use L1 and L2 capsid proteins to induce production of conformationally-specific antibodies. They block HPV infection. Lone L1 and L2 proteins self-assemble into a capsid that is identical to the complete virion. In this way, an antibody-mediated response is induced before the body actually comes into contact with the live virion. Therapeutic vaccines are being developed to protect HPV-positive persons against tumor development. For these vaccines, researchers are targeting the activity of the E6 and E7 oncoproteines.On June 8, 2006, the U.S. Food and Drug Administration (FDA) approved an HPV vaccine for clinical use. The HPV vaccine that has been approved is the quadrivalent vaccine that consists of recombinant viral-like particles (VLPs) of HPV 6, 11, 16, 18 mixed with an aluminum-containing adjuvant. It is manufactured by Merck & Co., Inc. and sold under the name of Gardasil?. The new vaccine is approved for use in females 9-26 years of age. The primary target population for vaccination should be females aged 11-12 years. However, vaccination can be given to girls as young as 9 years of age. Vaccination can receive women aged 13-26 years who have been sexually active. There are still no data on the vaccine efficacy in women older than 26, and currently no data to demonstrate the efficacy of vaccination in males; male subjects should not be vaccinated until such data become available. The vaccine is to be administered intramuscularly either into the deltoid muscle of the arm or the high anteriolateral area of the leg. Each patient receives three 0.5 mL doses given according to the following schedule: first dose is given at the elected date, second dose two months after the first dose, and third dose six months after the first dose. According to statements from Merck, the list price of the vaccine is 120 USD per dose. GlaxoSmithKline is now conducting a phase III trial of a bivalent (HPV 16, 18) vaccine, and it is going to be presented under the name of Cervarix. Similar results to those obtained with the quadrivalent HPV vaccine have been reported with the bivalent vaccine. It is expected to be released in June next year. Evaluation of the HPV vaccine efficiency in preventing dysplasia and cancer has been recommended as a globally accepted endpoint for population based studies.

Adolescent↗
PubMed1998

Aqueous humor flow in human eyes treated with dorzolamide and different doses of acetazolamide.

OBJECTIVE: To measure the effect of topically applied 2% dorzolamide hydrochloride (Trusopt, Merck & Co Inc, Whitehouse Station, NJ) and different doses of orally administered acetazolamide (Diamox, Lederle Ophthalmic Pharmaceuticals, Pearl River, NY), alone and in combination, on aqueous humor flow. DESIGN: A randomized, double-masked, placebo-controlled study of 20 human subjects was carried out. Aqueous humor flow was measured by clearance of topically applied fluorescein. Serum standard bicarbonate and serum acetazolamide levels were analyzed. RESULTS: Treatment with dorzolamide reduced aqueous flow by 17%, and a maximum dose of acetazolamide alone reduced flow by 29%. Increasing doses of acetazolamide alone gradually decreased flow, while small doses of acetazolamide did not suppress flow further when dorzolamide was already applied topically. Serum acetazolamide concentrations rose with increasing doses of acetazolamide. Serum standard bicarbonate levels were all in the normal range. CONCLUSIONS: Treatment with dorzolamide reduced aqueous humor flow statistically significantly (2.50 microL/min vs 3.00 microL/min; P=.001) compared with placebo, but less than a maximum dose ofacetazolamide. Small doses of acetazolamide added to dorzolamide treatment did not further enhance the decrease in flow. Since there was no metabolic acidosis as measured by plasma levels of standard bicarbonate, the decrease in aqueous flow could be attributed to the direct action of the carbonic anhydrase inhibitors on the carbonic anhydrase enzymes. It is concluded that the smaller effect of dorzolamide, as compared with acetazolamide, is due to insufficient inhibition of at least 1 of the 2 carbonic anhydrase isozymes involved in aqueous humor production.

Acetazolamide↗
PubMed2003

Short-term effect of dorzolamide hydrochloride on central corneal thickness in humans with cornea guttata.

OBJECTIVE: To investigate the short-term effect of dorzolamide hydrochloride, a topical carbonic anhydrase inhibitor, on central corneal thickness in patients with cornea guttata. DESIGN AND METHODS: In this randomized, placebo-controlled, double-masked, 3-drug crossover study, 20 patients with cornea guttata (mean endothelial cell count, 1321 cells/mm2) and 8 healthy control subjects (mean endothelial cell count, 2483 cells/mm2) were included. Study medications included 2% dorzolamide hydrochloride (Trusopt 2% eye drops; Merck & Co Inc, Whitehouse Station, NJ), 0.9% saline solution (saline placebo), and a solution identical to the carrier substance of dorzolamide in Trusopt (carrier placebo). The study drugs were applied 4 times per day for 1 day only. Central corneal thickness measurements were performed using partial coherence interferometry on every study day at baseline and after 24 hours of study medication treatment. MAIN OUTCOME MEASURES: Change in central corneal thickness. RESULTS: The mean thickening in central corneal thickness within 24 hours in eyes with cornea guttata treated with dorzolamide, saline placebo, and carrier placebo was 12.0 micro m (95% confidence interval [CI], 7.0-17.1 microm), 0.6 micro m (95% CI, -1.0 to 2.2 microm), and 1.3 micro m (95% CI, -0.1 to 2.6 microm), respectively. CONCLUSION: Application of dorzolamide for 1 day results in a slight but statistically significant thickening of central corneal thickness in patients with cornea guttata.

Administration, Topical↗
PubMed2005

Pregnancy outcomes after maternal exposure to simvastatin and lovastatin.

BACKGROUND: Our objective was to determine the frequency of adverse outcomes after maternal exposure to simvastatin and/or lovastatin during pregnancy in postmarketing experience. METHODS: We reviewed the Merck & Co., Inc. (West Point, PA) pharmacovigilance database for reports of exposure to simvastatin or lovastatin during pregnancy. The reports were classified as prospective (reported prior to pregnancy outcome) or retrospective (reported after pregnancy outcome) and were evaluated for timing of exposure, outcome, congenital anomalies, and other events. Outcome rates were calculated for prospective pregnancies. RESULTS: We identified 477 reports (386 prospective and 91 retrospective) with 225 prospective outcomes reported: 154 live born infants, 49 elective abortions, 18 spontaneous abortions, and 4 fetal deaths. Six congenital anomalies were reported: chromosomal translocation, trisomy 18, hypospadias, duodenal atresia, cleft lip, and skin tag. The rate of congenital anomalies (congenital anomalies/live births plus fetal deaths) was 3.8%, which is similar to the background population rate (3.2%; relative ratio, 1.21; 95% 1-sided upper confidence interval [CI], 2.02). There were 13 retrospective reports describing a range of congenital anomalies. No specific pattern of anomalies was identified in either the prospective or retrospective reports. Rates for other outcomes were similar to background rates. CONCLUSIONS: Although the number of reports was relatively small, there was no evidence of a notable increase in congenital anomalies in women exposed to simvastatin or lovastatin versus the general population. Greater reporting of congenital abnormalities in the retrospective cohort is not unexpected and may reflect a reporting bias. Drugs should be used during pregnancy only if the benefits outweigh the risks. Simvastatin and lovastatin remain contraindicated during pregnancy.

Abnormalities, Drug-Induced↗
PubMed2003

A five-year evaluation of reports of overdose with indinavir sulfate.

PURPOSE: To describe the adverse event profile for indinavir sulfate overdose. METHODS: Analysis of indinavir overdose reports in Merck & Co., Inc.'s safety database through the first 5 years following US licensure of indinavir. Reports were classified as acute (single high dose in excess of 2400 mg), chronic (multiple extra doses, not exceeding 2400 mg per dose), single extra dose (not exceeding 2400 mg) and dose not reported. RESULTS: Seventy-nine reports of indinavir overdose were reviewed (15 acute, 43 chronic, 13 single extra dose and 8 dose not reported). A total of 52/79 (66%) reports were associated with adverse events. For acute overdose reports with adverse events, indinavir doses ranged from 2.8 g to 48 g (median 6 g; mean 13 g); for acute overdose reports without adverse events, indinavir doses ranged from 4 g to 80 g (median 56 g; mean 45 g). Adverse events following acute and chronic exposures were similar; the most commonly reported adverse events included nausea, vomiting, abdominal pain and nephrolithiasis. Of the 52 patients with adverse events, 39 recovered, 6 had not recovered at the time of reporting and no information regarding outcome was provided in 7 reports. CONCLUSIONS: Overdose with indinavir was associated with adverse events in the majority of reports. These were most commonly gastrointestinal and renal events, and were generally consistent with the known safety profile of indinavir. The majority of patients recovered.

Adolescent↗
PubMed1994

Use of doxorubicin and dacarbazine for the management of unresectable intra-abdominal desmoid tumors in Gardner's syndrome.

PURPOSE: The aim of this study was to describe the natural history and management of surgically unresectable intra-abdominal desmoid tumors in two patients with Gardner's syndrome from two unrelated families, where each had failed on conventional therapy. METHODS: Two patients with Gardner's syndrome were placed on a chemotherapy regimen which included doxorubicin (90 mg/m2) and dacarbazine (900 mg/m2) in divided doses over four days of continuous infusion. Their progress on chemotherapy was assessed by abdominal computerized tomography and laparoscopy. RESULTS: The computerized abdominal tomography scans proved difficult to interpret because of adhesions and matted small bowel resulting from the patients original colectomies. These findings made it difficult to differentiate postoperative changes from residual desmoid tumor. Second-look laparotomy in such patients was contraindicated as this may predispose to further desmoid production. Laparoscopy disclosed a complete response to this chemotherapy. Nevertheless, we had an iatrogenic small bowel perforation in one of these patients. Each patient showed a complete response to chemotherapy. CONCLUSION: Surgical resection remains the first-line treatment of intraabdominal desmoid tumors. However, doxorubicin/dacarbazine chemotherapy on a clinical trial basis may be indicated in patients whose intra-abdominal desmoid is unresectable, or who have failed to respond to treatment with hormones (tamoxifen, Toremifene), steroids (prednisone), and nonsteroidal anti-inflammatory agents (Clinoril; Merck & Co., Inc., West Point, PA).

Adult↗
PubMed1998

Management of desmoid tumors in patients after ileal pouch-anal anastomosis for familial adenomatous polyposis.

PURPOSE: The aim of this study was to review the management of desmoid tumors in patients who have undergone ileal pouch-anal anastomosis for familial adenomatous polyposis and their outcome. METHODS: A retrospective review of case notes was undertaken in a series of 196 patients with familial adenomatous polyposis who had had an ileal pouch-anal anastomosis. Eleven patients were identified in whom desmoid tumor had developed (4 male; median age, 30 (range, 16-43) years). RESULTS: Desmoid tumors developed in the abdominal wall alone in 4 of 11 patients. Three enlarging tumors were resected with no subsequent recurrence. No patient received adjuvant treatment and pouch function remained stable at a median follow-up of eight years. Mesenteric desmoid tumors developed in seven patients; the pouch has been excised in two because of ischemia; two other patients have had defunctioning stomas created because of slow progression of their desmoid tumors. One patient had a single-lumen pouch excised and a new S-pouch inserted, with no subsequent recurrence of the desmoid tumor, and in two patients the mesenteric desmoid tumor has remained unchanged. All of these patients received long-term Clinoril (sulindac, Merck & Co., Inc., West Point, PA). Although there has been no significant deterioration in pouch function in patients in whom the pouch remains in situ, the pouch function was significantly worse compared with a control group of patients after ileal pouch-anal anastomosis for familial adenomatous polyposis in whom desmoid tumors did not develop. CONCLUSION: Desmoid tumors developed in 5.6 percent of 196 patients after ileal pouch-anal anastomosis for familial adenomatous polyposis. No patient with abdominal-wall desmoid tumor had a recurrence after local excision. By contrast, mesenteric desmoid tumors eventually resulted in pouch failure in four of seven affected patients.

Abdominal Muscles↗
PubMedDate not supplied

Comparative study of reactogenicity and immunogenicity of new and established measles, mumps and rubella vaccines in healthy children.

Concerns about the association of aseptic meningitis with measles-mumps-rubella (MMR) vaccines containing the Urabe Am 9 strain and the increasing worldwide demand for MMR vaccines, prompted the development of a new mumps vaccine strain (RIT 4385) by SmithKline Beecham Biologicals (SB) as part of a trivalent live attenuated MMR vaccine. The present study assessed the immunogenicity and reactogenicity of two lots of 'Priorix' with a widely used and established vaccine M-M-R II (Merck & Co. Inc.) as comparator vaccine. 255 healthy children, 12 to 24 months of age, were enrolled in a single-blind study and randomly allocated to receive a single dose of one of two lots of "Priorix" or M-M-R II vaccine. Vaccinees were followed up for six weeks post-vaccination for solicited and unsolicited symptoms. Immunogenicity was determined in pre- and 60 days post-vaccination sera using commercial immunoassays for measles, mumps and rubella antibodies. There were no significant differences in immune responses between groups for any of the three vaccine components. In initially seronegative subjects, the respective post-vaccination seroconversion rates for 'Priorix' lots 1 and 2, and M-M-R II were 100, 100 and 97.6% for measles antibodies, 91.7, 95.1 and 94% for mumps antibodies and 100, 100 and 100% for rubella antibodies, respectively. GMTs for the three groups were 3,076, 3,641 and 3,173 mIU/ml for measles antibodies, 934, 900 and 1,043 U/ml for mumps antibodies, and 86.4, 87.5 and 97.1 IU/ml for rubella antibodies, respectively. The incidence of local symptoms was significantly lower for both 'Priorix' lots (17.6 and 15.3% for lots 1 and 2, respectively) than for M-M-R II (37.6%). Fever > or = 38.1 degrees C during the six-week observation period occurred in approximately 25% of all subjects in all groups with no differences between the groups. No parotid/salivary gland swelling or signs of suspected meningism were reported, and there were no serious adverse events related to vaccination. The new MMR vaccine 'Priorix' containing the new RIT 4385 mumps strain was safe and had a significantly improved local tolerability profile over the comparator vaccine, M-M-R II, while eliciting an at least equivalent immune response.

Antibodies, Viral↗
PubMed2006

Building effective public-private partnerships: experiences and lessons from the African Comprehensive HIV/AIDS Partnerships (ACHAP).

This paper examines the processes for building highly collaborative public-private partnerships for public health, with a focus on the efforts to manage the complex relationships that underlie these partnerships. These processes are analyzed for the African Comprehensive HIV/AIDS Partnerships (ACHAP), a 5-year partnership (2001-2005) between the government of Botswana, Merck & Co., Inc. (and its company foundation), and the Bill & Melinda Gates Foundation. ACHAP is a highly collaborative initiative. The ACHAP office in Botswana engages intensively (on a daily basis) with the government of Botswana (an ACHAP partner and ACHAP's main grantee) to support HIV/AIDS control in that country, which had an adult prevalence of 38.5% HIV infection in 2000 when ACHAP was being established. The paper discusses the development of ACHAP in four stages: the creation of ACHAP, the first year, the second and third years, and the fourth year. Based on ACHAP's experiences over these four years, the paper identifies five lessons for managing relationships in highly collaborative public-private partnerships for public health.

Botswana↗
PubMed2006

Chapter 11: HPV vaccines: commercial research & development.

We are now in the fortunate position of having two highly promising human papillomavirus (HPV) vaccines in the pipeline. Amidst the excitement of anticipating what these vaccines may be able to offer, it is worth pausing to look back at how the vaccine development story unfolded from an industrial perspective, since without the massive commitment shown by manufacturers over the last decade, without any guarantee of success, there would be no such prospect. This chapter focuses on the two HPV prophylactic vaccines, produced independently by Merck & Co., Inc. and GlaxoSmithKline (GSK), that are in advanced clinical development, and it aims to provide an insight into the key considerations for initiating the programmes in a commercial context as well as some of the research and development hurdles that needed to be surmounted to bring them to the point where efficacy has been demonstrated and the licensing process is well underway.

History, 20th Century↗
PubMed1999

Uveitis associated with varicella virus vaccine.

PURPOSE: To report a case of uveitis associated with the live attenuated varicella virus vaccine (Varivax; Merck & Co, Inc, West Point, Pennsylvania) in a young, otherwise healthy girl. METHODS: The time of onset of uveitis in relation to vaccination and the number and the pattern of distribution of vesicles were noted. The patient received oral acyclovir and topical steroids and cycloplegic drops. RESULTS: The uveitis and vesicular rash improved significantly after 7 days of treatment. A literature review and communications with the drug's manufacturer disclosed no identifiable previous cases of uveitis associated with Varivax. CONCLUSIONS: Uveitis should be recognized as a possible adverse side effect of the varicella vaccine.

Acyclovir↗