Pentacel and Kinrix, two new combination vaccines that immunize infants and children against multiple diseases with fewer injections, received federal approval this week and will be available for distribution to U.S. health care providers by this summer.
Kinrix is produced by GlaxoSmithKline, a UK company with operations and research and development sites throughout Philadelphia, Upper Merion and King of Prussia. Likewise, Pentacel has a Pennsylvania connection, as it is the product of Sanofi Pasteur of Swiftwater. It is a division of Sanofi Aventis Group, a French company that creates vaccines protecting against infectious diseases.
The two vaccines were approved by the Advisory Committee on Immunization Practices, which voted to recommend adding both combination vaccines to the federal government's Vaccines for Children program. The program which provides free vaccinations for all children, regardless of ability to pay.
For the 6 weeks to 4-5 year (before the fifth birthday) age group, the FDA has approved Pentacel, a five-in-one vaccine manufactured by Sanofi Aventis, to protect infants and children against diptheria, tetanus, pertussis (also known as whooping cough), polio and Haemophilius influenzae type b (Hib).
It is administered as a four-dose series, one-a-time at 2, 4, 6 and 15-18 months of age. It is the first four-dose combination vaccine licensed in the U.S. that includes both poliovirus (IPV) and Hib vaccine antigens.
For children 4 to 6 years of age, GlaxoSmithKline will release Kinrix, a four-in-one booster vaccine that uses only one shot and is geared for use to protect against diptheria, tetanus, pertussis and polio. Kinrix is recommended for use by children who have already taken Infanrix or Pediarix vaccines.
Infanrix covers DPT, diphtheria, tetanus, and pertussis (whooping cough).
Pediarix is a multiple vaccine that covers DPT, hepatitis B and polio, and has had over 30 million doses used in younger children since 2003.
Clinical studies into Pentacel and Phase III trials into the safety of Kinrix have shown that the new combination vaccines offer similar safety benefits as previous vaccines.
Both vaccines seek to remedy the problem of multiple doctor visits where young children, their parents and their doctor must deal with the stress of frequent needle jabbing. The U.S. Centers for Disease Control and Prevention (CDC) currently recommend up to 23 single shots by the time a child reaches 18 months of age.
Using combination vaccines "reduces the number of shots by 6 shots in the first year of life, with the same degree of efficacy and no[ne or fewer] side effects," said Dr. Gary Emmett, professor of pediatrics at Jefferson University Hospital and member of the Board of Health in the city of Philadelphia.
Fewer shots can also have a positive effect on the child's health.
"When I started practicing, we gave DTP, which had almost 200 separate antigens in it, " said Dr. Emmett. "Now we give DTaP, which is more refined and has less than 30 antigens, so even though... the [earlier ones] were effective, they gave more side effects. Now we have less sore arms, less fevers, making the [children and the] pediatricians happy."
Combination vaccines can also help to fulfill both school and CDC immunization requirements, says Jennifer Armstrong, a GlaxoSmithKline spokewoman, while also creating less need to experience painful finger or arm pricks, especially when young children are involved.
"Four- to six-year-olds are a particularly challenging group," said Ms. Armstrong. "They are old enough to [know what's coming and] say no right off the bat."
Heather J. Chin can be reached at hchin@thebulletin.us
©The Evening Bulletin 2008
Kinrix is produced by GlaxoSmithKline, a UK company with operations and research and development sites throughout Philadelphia, Upper Merion and King of Prussia. Likewise, Pentacel has a Pennsylvania connection, as it is the product of Sanofi Pasteur of Swiftwater. It is a division of Sanofi Aventis Group, a French company that creates vaccines protecting against infectious diseases.
The two vaccines were approved by the Advisory Committee on Immunization Practices, which voted to recommend adding both combination vaccines to the federal government's Vaccines for Children program. The program which provides free vaccinations for all children, regardless of ability to pay.
For the 6 weeks to 4-5 year (before the fifth birthday) age group, the FDA has approved Pentacel, a five-in-one vaccine manufactured by Sanofi Aventis, to protect infants and children against diptheria, tetanus, pertussis (also known as whooping cough), polio and Haemophilius influenzae type b (Hib).
It is administered as a four-dose series, one-a-time at 2, 4, 6 and 15-18 months of age. It is the first four-dose combination vaccine licensed in the U.S. that includes both poliovirus (IPV) and Hib vaccine antigens.
For children 4 to 6 years of age, GlaxoSmithKline will release Kinrix, a four-in-one booster vaccine that uses only one shot and is geared for use to protect against diptheria, tetanus, pertussis and polio. Kinrix is recommended for use by children who have already taken Infanrix or Pediarix vaccines.
Infanrix covers DPT, diphtheria, tetanus, and pertussis (whooping cough).
Pediarix is a multiple vaccine that covers DPT, hepatitis B and polio, and has had over 30 million doses used in younger children since 2003.
Clinical studies into Pentacel and Phase III trials into the safety of Kinrix have shown that the new combination vaccines offer similar safety benefits as previous vaccines.
Both vaccines seek to remedy the problem of multiple doctor visits where young children, their parents and their doctor must deal with the stress of frequent needle jabbing. The U.S. Centers for Disease Control and Prevention (CDC) currently recommend up to 23 single shots by the time a child reaches 18 months of age.
Using combination vaccines "reduces the number of shots by 6 shots in the first year of life, with the same degree of efficacy and no[ne or fewer] side effects," said Dr. Gary Emmett, professor of pediatrics at Jefferson University Hospital and member of the Board of Health in the city of Philadelphia.
Fewer shots can also have a positive effect on the child's health.
"When I started practicing, we gave DTP, which had almost 200 separate antigens in it, " said Dr. Emmett. "Now we give DTaP, which is more refined and has less than 30 antigens, so even though... the [earlier ones] were effective, they gave more side effects. Now we have less sore arms, less fevers, making the [children and the] pediatricians happy."
Combination vaccines can also help to fulfill both school and CDC immunization requirements, says Jennifer Armstrong, a GlaxoSmithKline spokewoman, while also creating less need to experience painful finger or arm pricks, especially when young children are involved.
"Four- to six-year-olds are a particularly challenging group," said Ms. Armstrong. "They are old enough to [know what's coming and] say no right off the bat."
Heather J. Chin can be reached at hchin@thebulletin.us
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