E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

 

Kathi Williams Note: NVIC president and co-founder, Barbara Loe Fisher is the consumer voting member on this committee. Despite the tragedy of losing her husband she made the courageous decision to attend this meeting. Barbara voted against the licensure of the vaccine and expressed concern that the study group was not large enough, did not include genetically diverse populations and the follow-up was only thirty days. Two of the pediatricians on the committee agreed with her that they too had concerns but said we really needed combination vaccines. They voted for licensure of the vaccine.  Please note the closeness of the vote, 6-5. Thank you Barbara, for representing the consumer even under the most difficult of circumstances.  The full transcript will be available on the internet soon.

 

http://biz.yahoo.com/rf/010307/n07469208_4.html

 

Wednesday March 7, 6:22 pm Eastern Time

U.S. panel doubts GlaxoSmithKline vaccine efficacy

(UPDATE: recasts; adds new information paragraphs 10-11, 13; edits)

By Lisa Richwine

BETHESDA, Md., March 7 (Reuters) - Drug giant GlaxoSmithKline Plc (quote from Yahoo! UK & Ireland: GSK.L) did not prove that a children’s vaccine to prevent five diseases was as effective as immunizing against the illnesses separately, a U.S. advisory panel narrowly voted on Wednesday.

By a 6-5 vote, with one abstention, the panel said company studies failed to show the vaccine could provide sufficient protection against all the diseases it was designed to prevent—diphtheria, tetanus, pertussis, hepatitis B and polio.

London-based GlaxoSmithKline, the world’s largest drug maker by sales, was hoping to secure the panel’s support for U.S. marketing of the vaccine, which would be the first in the United States to target five life-threatening diseases with one series of shots given at two, four and six months of age.

The product would reduce injections for the five diseases from nine to three, lessening pain for children and making immunization schedules more convenient for parents and doctors, the maker said. The company hopes to sell the vaccine under the name Infanrix DTPa-HepB-IPV.

The Food and Drug Administration (FDA) advisory committee did not vote on whether the vaccine was safe because there were “outstanding manufacturing issues that need to be addressed,” panel chairman Robert Daum said.

The FDA has final say on whether to approve the product for U.S. marketing, but the agency usually follows its panels’ advice.

Studies of more than 7,000 infants who received more than 20,000 doses of Infanrix DTPa-HepB-IPV showed the vaccine spurred an immune response at least as strong as that seen with individual vaccines, GlaxoSmithKline officials said.

But many panel members said the most relevant study was too small to clearly show that the combination vaccine worked as well as individual shots.

“As a pediatrician, I too appreciate the need for this vaccine, (but) I don’t think the data we have been presented is adequate to support efficacy at this time,” said Dr. Walter Faggett, a panel member.

Many panelists also expressed concern that 41 percent of infants given the combination vaccine developed fevers, compared with 29.6 percent of children who got separate shots. The company said most fevers disappeared within a few days and did not lead to serious health problems.

But panel members “want more information about what the consequences are for those increased rates of fevers,” Daum said.

GlaxoSmithKline spokeswoman Carmel Hogan said the company “remained confident in the safety and (effectiveness)” of the vaccine and would “work closely with the FDA to bring the vaccine to market as quickly as possible.”

Hogan said she could not provide details of the manufacturing issues Daum mentioned.

GlaxoSmithKline already sells a vaccine called Infanrix to prevent diphtheria, pertussis and tetanus.

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