Navigation Links
Large Recall of Children's Swine Flu Vaccine

About 800,000 doses have lower strength than needed for protection, CDC says,,

TUESDAY, Dec. 15 (HealthDay News) -- Almost 800,000 children's doses of H1N1 swine flu vaccine have been recalled by manufacturer Sanofi Pasteur Inc. because they have lost some potency, federal health officials said Tuesday.

According to the U.S. Centers for Disease Control and Prevention, the company's routine testing of the vaccine for children aged 6 months to almost 3 years found that four batches had lower than required potency levels. "This means that doses from these four vaccine lots no longer meet the manufacturer's specifications for potency," according to the CDC.

"This is not a safety problem; it's an issue of efficacy," said infectious disease expert Dr. Marc Siegel, an associate professor of medicine at New York University, in New York City.

Siegel said this recall is good news because it means the vaccine is being tested after it is shipped. "I am happy to see them testing this, because one of the things that happens is once a vaccine gets to market it kind of gets forgotten," he said.

Specifically, the recalled doses are in single shot pre-filled syringes, and do not contain the preservative thimerosal. To be protected from swine flu, children under 10 need two shots spaced about a month apart.

"I don't think this is a coincidence that this is occurring in the single-dose syringes," Siegel said. "This process is very labor-intensive. The more intensive the process, the more likely we will see variation in efficacy."

Although the manufacturer is asking that unused doses be returned, the vaccine itself is safe. "There are no safety concerns with these lots of H1N1 vaccine. All lots successfully passed pre-release testing for purity, potency and safety," the CDC said.

Since the potency of the recalled vaccine is only "slightly" below the required range of potency, children who have received vaccine from these lots do not need to be revaccinated.

Siegel agreed that the small drop in potency is not enough to require another vaccination. "The children that received this vaccine are very likely to have a significant amount of immunity, because the immune response as tested in studies was profound," he said.

The CDC points out that for children aged 6 months and older, vaccine in multi-dose vials is available. Vaccine in multi-dose vials has not had this drop in potency and "meets all standards of safety, purity and potency."

Like all multi-dose vials of vaccines, these vials contain thimerosal to prevent contamination after the vial is opened. The standard dose from these vials is the same as for the pre-filled syringes.

In addition, for children aged 2 and older, the H1N1 vaccine is also available as a nasal spray called Flumist.

Since early October, about 95 million doses of swine flu vaccine have been distributed in the United States.

More information

For more information on the H1N1 flu, visit

SOURCES: Marc Siegel, M.D., associate professor, medicine, New York University, New York City; Dec. 15, 2009, statement, U.S. Centers for Disease Control and Prevention

Copyright©2009 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Anthem Blue Cross Wins Third Largest Medicaid Managed Care Contract Renewal in the Country
2. University of Michigan Health System Receives $15 Million Gift, The Largest Ever for Womens Health
3. Unanimous Vote Creates Largest RN Union in U.S. History
4. The Countrys Largest Cooking Magazine Announces The Comfort Food Diet Cookbook
5. The WFH receives the largest humanitarian aid donation in its history - Donation represents more than 40 million international units to the WFH
6. Kansas City Prepares for Largest Free Health Clinic
7. Intriguing Scientific Results from World's Largest Intention Healing Project: DreamHealer
8. Intriguing Scientific Results from Worlds Largest Intention Healing Project: DreamHealer
9. Baylor Sammons Cancer Center Joins One of Nations Largest Cancer Clinical Trials Groups
10. Small and Large Animal Veterinarians Actively Texting, E-mailing for Business and Personal Reasons
11. First ever large-scale study of ketamine users published
Post Your Comments:
(Date:11/30/2015)... , ... November 30, 2015 , ... RoamRight, a leading ... with Public Television’s Travel With Kids to promote family vacations around ... family as they explore international destinations and educate families about the people and places ...
(Date:11/30/2015)... ... November 30, 2015 , ... Advocare Orthopedic ... orthopedic care. Led by John Vitolo, M.D., the center offers their patients ... team at Advocare Orthopedic & Sports Medicine is ready to help their patients ...
(Date:11/30/2015)... ... November 30, 2015 , ... International telepathology consultations ... and KingMed Diagnostics researchers. Their review of more than 1,500 ... UPMC pathologists resulted in significantly altered treatment plans for more than half of ...
(Date:11/30/2015)... ... November 30, 2015 , ... The American Society for Clinical Pathology (ASCP) announced ... Day 2015. On Nov. 30, ASCP shared its “Give a minute. Get tested. Find ... and the importance of getting tested for HIV. , ASCP has asked members to ...
(Date:11/30/2015)... ... ... An inventor from Charlottesville, Va., is concerned about the need for peace and ... due to loud noises," she said, "so I decided that there needs to be ... radio waves and microwaves." , The baby BABY MUFF prevents loud noises, radio waves ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... Texas , Nov. 30, 2015  Hanger, Inc. ... amendment and restatement of the terms of its previously ... Solicitation") relating to its $200,000,000 aggregate principal amount 7⅛% ... other things, (i) the consent fees payable pursuant to ... on the Notes and (iii) the expiration date of ...
(Date:11/30/2015)... NAMUR , Belgium , Nov. 30, ... life sciences company focused on developing blood-based diagnostic tests for ... announced the Company will present at the LD Micro Conference, ... Los Angeles, CA. Attending from VolitionRx will ... and Scott Powell , Vice President of Investor Relations. ...
(Date:11/30/2015)... , November 30, 2015 PFE ... at up to 10 G protein-coupled receptor (GPCR) targets ... to research and develop potential new medicines directed at ... multiple therapeutic areas. --> Heptares Therapeutics ("Heptares"), ... and wholly-owned subsidiary of Sosei Group Corporation ("Sosei"; TSE ...
Breaking Medicine Technology: