RodISHI
Platinum Member
- Nov 29, 2008
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I found these news releases from Pfizer. I been trying to figure it out and I'm wondering if some experts on here can help me understand all this stuff.
FDA apparently approved this new drug for infants and children.
I have a few questions and probably will have more tomorrow. Does our government agencies actually promote specific products for use on the people? Who makes the call to promote these products?
I'm also having a hard time figuring out all these numbers on the amounts of childhood Pneumonia cases. From what I'm seeing here in this 2006 health report from CDC, I am not finding an overwhelming number of deaths caused by Pneumonia but this stuff needs deciphered by someone smarter than me.
http://www.cdc.gov/NCHS/data/nvsr/nvsr57/nvsr57_14.pdf
On,
Table 11. Death rate for 113 Selected Causes and Enterocolitis due to Clostridium difficile, by age...
(rates per 100,000 in specific age groups.......)
Pneumonia
all ages - 18.5 under 1 year 5.9 1 to 7 years 0.7 5 to 14 years 0.4
Figures for Pneumoconioses (dust and such) and chemicals figures are 0.3 for all ages. Pneumontis due to liquids (drowning) and solids are 5.6 for all ages.
From quick facts:
Population, 2008 estimate 304,059,724
Persons under 5 years old, percent, 2008 6.9%
Persons under 18 years old, percent, 2008 24.3%
Can anyone from this information for 2006 come up with a figure of how many children under age 14 actually died in 2006 from Pneumonia?
FDA apparently approved this new drug for infants and children.
February 24, 2010 11:22 AM Eastern Time
Pfizer Receives FDA Approval for Prevnar 13 for the Prevention of Invasive Pneumococcal Disease in Infants and Young Children
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSEFE) announced today that the United States Food and Drug Administration (FDA) has granted approval for Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the Companys 13-valent pneumococcal conjugate vaccine. Prevnar 13 is indicated for active immunization of children 6 weeks through 5 years of age for the prevention of invasive disease caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Prevnar 13 is also indicated for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A.
Invasive pneumococcal disease includes sepsis and bacteremia (bloodstream infections), meningitis (inflammation of the coverings of the brain and spinal cord), bacteremic pneumonia, and empyema (accumulation of pus in the cavity surrounding the lungs).
The approval of Prevnar 13 means that infants and young children in the United States will have access to a pneumococcal conjugate vaccine that provides coverage against 13 serotypes that could potentially result in life-threatening illnesses, says Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc. Together, these 13 serotypes are responsible for the majority of invasive pneumococcal disease in the United States. Notably, serotype 19A is now the most common invasive disease-causing serotype in young children.
Prevnar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) the first pneumococcal conjugate vaccine introduced in 2000 plus six additional serotypes (1, 3, 5, 6A, 7F, and 19A).
While the incidence of invasive pneumococcal disease caused by the serotypes in Prevnar has been substantially reduced since the introduction of the vaccine in 2000, invasive pneumococcal disease remains a serious health threat to infants and young children, adds Dr. Emini.
In connection with the approval by the FDA, the Company has agreed to certain post-marketing commitments involving conducting a study to further evaluate the safety profile of Prevnar 13, a study to evaluate the prevention of overall invasive pneumococcal disease and various studies to evaluate reduction in otitis media. The approval of Prevnar 13 is based on the review of 13 Phase III studies involving more than 7,000 infants and young children. Data from the Phase III trials support the safety and efficacy of Prevnar 13 for the prevention of invasive pneumococcal disease in infants and young children. Clinical trial data indicate that Prevnar 13 can be administered with all routine pediatric vaccines studied.
Prevnar 13 is recommended to be administered as a 4-dose series at 2, 4, 6, and 12 to 15 months of age. Children who have received one or more doses of Prevnar may complete the 4-dose immunization series with Prevnar 13. Children 15 months through 5 years of age who have received four doses of Prevnar may receive one dose of Prevnar 13 to elicit immune responses to the six additional serotypes. The immune responses induced by this Prevnar 13 transition schedule may result in lower antibody concentrations for the six additional serotypes (types 1, 3, 5, 6A, 7F, and 19A), compared to antibody concentrations following four doses of Prevnar 13 (given at 2, 4, 6, and 12 to 15 months). The clinical relevance of these lower antibody responses is not known.
This approval is a significant milestone for Pfizer and yet another expression of our mission to improve health and well-being at every stage of life, says Geno Germano, president and general manager, Specialty Care Business Unit, Pfizer Inc. Prevnar 13 is an important priority for the entire Pfizer organization as we continue to expand our presence in the vaccine category.
Prevnar 13 will be discussed today at the upcoming meeting of the Advisory Committee on Immunization Practices (ACIP) and the Company expects the vaccine to be introduced commercially in the United States in the first quarter of this year. In addition to its approval in the United States, Prevenar 13* (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), as it is known in most countries outside the United States, has been approved for use in infants and young children in 38 other countries. Further regulatory filings for Prevnar 13 for pediatric use are in advanced stages of review in various countries. Prevnar 13 is also being studied in global Phase III clinical trials in adults, with regulatory submissions expected later this year.
Pneumococcal Disease
According to a World Health Organization (WHO) 2002 estimate, pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than 5 years. Pneumococcal disease is complex and describes a group of illnesses, all caused by the bacterium S. pneumoniae. It includes invasive infections such as bacteremia/sepsis and meningitis, as well as non-invasive disease including acute otitis media.
Indication for Prevnar 13
Prevnar 13 is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the 6th birthday).
Prevnar 13 is indicated for active immunization for the prevention of invasive disease caused by 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).
Prevnar 13 is also indicated for the prevention of otitis media (ear infection) caused by 7 strains of Streptococcus pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F). No efficacy data for ear infections are available for strains 1, 3, 5, 6A, 7F, and 19A.
Important Safety Information for Prevnar 13
Prevnar 13 should not be given to anyone with a severe allergic reaction to any component of Prevnar 13, Prevnar or any diphtheria toxoid-containing vaccine.
Prevnar 13 may not protect all individuals receiving the vaccine. Protection against ear infections is expected to be less than that for invasive disease. Children with weakened immune systems may have a reduced immune response to Prevnar 13. A temporary pause of breathing following vaccination has been observed in some infants born prematurely.
The most common side effects are redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability, increased sleep, and decreased sleep. Any side effects associated with the vaccination should be reported to your childs health care provider.
Indication for Prevnar
Prevnar is indicated for active immunization of infants and toddlers against serious invasive disease caused by Streptococcus pneumoniae, including bacteremia (bloodstream infection) and meningitis (infection of the membranes surrounding the brain and spinal cord) caused by the seven serotypes in the vaccine. The seven serotypes (strains) of S. pneumoniae included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) were the strains that most commonly caused these serious diseases in children prior to the introduction of the vaccine. The routine schedule is 2, 4, 6, and 12-15 months of age.
Prevnar is also indicated for immunization of infants and toddlers against otitis media (ear infections) caused by the seven serotypes in the vaccine. Protection against ear infections is expected to be less than that for invasive disease.
As with any vaccine, Prevnar may not protect all individuals receiving the vaccine from serious invasive disease caused by S. pneumoniae. This vaccine should not be used for treatment of active infection.
Important Safety Information for Prevnar
In clinical studies, the most frequently reported adverse events included injection site reactions, fever (≥38ºC/100.4ºF), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.
Risks are associated with all vaccines, including Prevnar. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevnar does not protect 100 percent of children vaccinated. Immunization with Prevnar does not substitute for routine diphtheria immunization.
Pfizer Inc.: Working together for a healthier world
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the worlds best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the worlds leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at Pfizer.com | Pfizer: the world's largest research-based pharmaceutical company.
DISCLOSURE NOTICE: The information contained in this release is as of February 24, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information that involves substantial risks and uncertainties regarding a potential indication for Prevnar 13 for use in infants and young children in the various countries in which the Companys regulatory applications are pending; when Prevnar 13 is expected to be introduced commercially in the U.S. for that indication; the anticipated submission of regulatory applications in various countries in 2010 for a potential indication for Prevnar 13 for use in adults; and the potential benefits of Prevnar 13. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory applications will be submitted in various countries for a potential indication for Prevnar 13 for use in adults; whether and when the regulatory authorities in various jurisdictions will approve applications that have been or may be submitted for these potential indications and their decisions regarding labeling and other matters that could affect the availability or commercial potential of these indications; and competitive developments.
A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and in its reports on Form 10-Q and Form 8-K.
*Trademark
Contacts
Pfizer Inc.
Media:
Gwen Fisher, +1-484-865-5160
or
Investor:
Suzanne Harnett, +1-212-733-8009
Permalink: Pfizer Receives FDA Approval for Prevnar 13? for the Prevention of Invasive Pneumococcal Disease in Infants and Young Children
I have a few questions and probably will have more tomorrow. Does our government agencies actually promote specific products for use on the people? Who makes the call to promote these products?
February 24, 2010 01:33 PM Eastern Time
CDCs Advisory Committee On Immunization Practices Recommends Pfizers Prevnar 13 Vaccine For The Prevention Of Invasive Pneumococcal Disease In Infants And Young Children In The U.S.
Recommendations Include Primary Dosing Series and a Supplemental Dose for Children Fully Immunized with Prevnar®
NEW YORK--(BUSINESS WIRE)--Pfizer Inc (NYSEFE) announced today that the United States Centers for Disease Control and Prevention's (CDCs) Advisory Committee on Immunization Practices (ACIP) has recommended the use of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) for healthy children aged 2 months through 59 months for the prevention of invasive pneumococcal disease caused by the 13 pneumococcal serotypes included in the vaccine.
The ACIP's recommendations include the routine use of Prevnar 13 for infants and toddlers, as well as a supplemental dose for children through 59 months of age who have completed the 4-dose immunization series with Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). In addition, the ACIP recommended that children who have started their immunization series with Prevnar should complete the series by switching to Prevnar 13 at any point in the schedule.
Prevnar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevnar available in the United States since 2000 plus six additional serotypes (1, 3, 5, 6A, 7F, and 19A). Together, these 13 serotypes are responsible for the majority of remaining invasive pneumococcal disease in infants and young children in the United States. In particular, serotype 19A is now the most common cause of invasive pneumococcal disease among children younger than 5 years of age in the United States.
We are pleased that the Advisory Committee has recommended the use of Prevnar 13, with coverage for 13 important invasive disease-causing serotypes, in infants and young children in the United States, says Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc. The incidence of disease caused by serotypes not included in Prevnar has been increasing in children younger than 5 years of age in the United States, including 19A , the most common serotype.
The ACIPs recommendations for Prevnar 13 vaccination of healthy unimmunized children 2 months through 59 months of age are identical to those previously recommended by ACIP for Prevnar, with Prevnar 13 replacing Prevnar for all doses.
Highlights of the ACIP recommendations included the following:
* Prevnar 13 is administered as a 4-dose series at 2, 4, 6 and 12 through 15 months of age.
* Children who have begun their vaccination series with Prevnar should complete the series by switching to Prevnar 13 at any point in the schedule.
* A single supplemental dose of Prevnar 13 is recommended for children through 59 months of age who have completed the 4-dose immunization series with Prevnar.
Earlier today, the United States Food and Drug Administration (FDA) approved Prevnar 13 for active immunization of children 6 weeks through 5 years of age for the prevention of invasive disease caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13 is also indicated for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A.
In the United States, the Prevnar 13 product label recommends a 4-dose series at 2, 4, 6, and 12 to 15 months of age. Children who have received one or more doses of Prevnar may complete the 4-dose immunization series with Prevnar 13. Additionally, children 15 months through 5 years of age who have received four doses of Prevnar may receive one dose of Prevnar 13 to elicit immune responses to the six additional serotypes. The immune responses induced by this Prevnar 13 transition schedule may result in lower antibody concentrations for the six additional serotypes (types 1, 3, 5, 6A, 7F, and 19A), compared to antibody concentrations following four doses of Prevnar 13 (given at 2, 4, 6, and 12 to 15 months). The clinical relevance of these lower antibody responses is not known.
Pfizer expects Prevnar 13 to be introduced commercially in the United States in the first quarter of 2010. In addition to the approval of Prevnar 13 in the United States, Prevenar 13* (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), as it is known in most countries outside the United States, has been approved for use in infants and young children in 38 other countries. Further regulatory filings for Prevnar 13 for pediatric use are in advanced stages of review in various countries spanning six continents. Prevnar 13 is also being studied in global Phase III clinical trials in adults, with regulatory submissions expected later this year.
Pneumococcal Disease
According to a World Health Organization (WHO) 2002 estimate, pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than 5 years. Pneumococcal disease is complex and describes a group of illnesses, all caused by the bacterium S. pneumoniae. It affects infants and young children and includes invasive infections such as bacteremia/ sepsis and meningitis, as well as non-invasive disease including acute otitis media.
Indication for Prevnar 13
Prevnar 13 is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the 6th birthday).
Prevnar 13 is indicated for active immunization for the prevention of invasive disease caused by 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).
Prevnar 13 is also indicated for the prevention of otitis media (ear infection) caused by 7 strains of Streptococcus pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F). No efficacy data for ear infections are available for strains 1, 3, 5, 6A, 7F, and 19A.
Important Safety Information for Prevnar 13
Prevnar 13 should not be given to anyone with a severe allergic reaction to any component of Prevnar 13, Prevnar or any diphtheria toxoid-containing vaccine.
Prevnar 13 may not protect all individuals receiving the vaccine. Protection against ear infections is expected to be less than that for invasive disease. Children with weakened immune systems may have a reduced immune response to Prevnar 13. A temporary pause of breathing following vaccination has been observed in some infants born prematurely.
The most common side effects are redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability, increased sleep, and decreased sleep. Any side effects associated with the vaccination should be reported to your childs health care provider.
Indication for Prevnar
Prevnar is indicated for active immunization of infants and toddlers against serious invasive disease caused by S. pneumoniae, including bacteremia (bloodstream infection) and meningitis (infection of the membranes surrounding the brain and spinal cord) caused by the seven serotypes in the vaccine. The seven serotypes (strains) of S. pneumoniae included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) were the strains that most commonly caused these serious diseases in children prior to the introduction of the vaccine. The routine schedule is 2, 4, 6, and 12-15 months of age.
Prevnar is also indicated for immunization of infants and toddlers against otitis media (ear infections) caused by the seven serotypes in the vaccine. Protection against ear infections is expected to be less than that for invasive disease.
As with any vaccine, Prevnar may not protect all individuals receiving the vaccine from serious invasive disease caused by S. pneumoniae. This vaccine should not be used for treatment of active infection.
Important Safety Information for Prevnar
In clinical studies, the most frequently reported adverse events included injection site reactions, fever (≥38ºC/100.4ºF), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.
Risks are associated with all vaccines, including Prevnar. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevnar does not protect 100 percent of children vaccinated. Immunization with Prevnar does not substitute for routine diphtheria immunization.
Pfizer Inc: Working together for a healthier world
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the worlds best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the worlds leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at Pfizer.com | Pfizer: the world's largest research-based pharmaceutical company.
DISCLOSURE NOTICE: The information contained in this release is as of February 24, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information that involves substantial risks and uncertainties regarding a potential indication for Prevnar 13 for use in infants and young children in the various countries in which the Companys regulatory applications are pending; when Prevnar 13 is expected to be introduced commercially in the U.S. for that indication; the anticipated submission of regulatory applications in various countries in 2010 for a potential indication for Prevnar 13 for use in adults; and the potential benefits of Prevnar 13. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory applications will be submitted in various countries for a potential indication for Prevnar 13 for use in adults; whether and when the regulatory authorities in various jurisdictions will approve applications that have been or may be submitted for these potential indications and their decisions regarding labeling and other matters that could affect the availability or commercial potential of these indications; and competitive developments.
A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and in its reports on Form 10-Q and Form 8-K.
* Trademark
Contacts
Media:
Gwen Fisher, +1-484-865-5160
Investor:
Suzanne Harnett, +1-212-733-8009
Permalink: CDC?s Advisory Committee On Immunization Practices Recommends Pfizer?s Prevnar 13? Vaccine For The Prevention Of Invasive Pneumococcal Disease In Infants And Young Children In The U.S.
I'm also having a hard time figuring out all these numbers on the amounts of childhood Pneumonia cases. From what I'm seeing here in this 2006 health report from CDC, I am not finding an overwhelming number of deaths caused by Pneumonia but this stuff needs deciphered by someone smarter than me.
http://www.cdc.gov/NCHS/data/nvsr/nvsr57/nvsr57_14.pdf
On,
Table 11. Death rate for 113 Selected Causes and Enterocolitis due to Clostridium difficile, by age...
(rates per 100,000 in specific age groups.......)
Pneumonia
all ages - 18.5 under 1 year 5.9 1 to 7 years 0.7 5 to 14 years 0.4
Figures for Pneumoconioses (dust and such) and chemicals figures are 0.3 for all ages. Pneumontis due to liquids (drowning) and solids are 5.6 for all ages.
From quick facts:
Population, 2008 estimate 304,059,724
Persons under 5 years old, percent, 2008 6.9%
Persons under 18 years old, percent, 2008 24.3%
Can anyone from this information for 2006 come up with a figure of how many children under age 14 actually died in 2006 from Pneumonia?