At the joint annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Diseases Society of America, being held in Washington D.C., Wyeth presented further data on its new version of the pneumoccocal vaccine, called Prevnar 13.
Wyeth´s vaccine Prevnar, given to infants and toddlers, is designed to protect against seven types of streptococcus pneumoniae, and the company´s new, expanded version Prevnar 13 targets the same seven strains plus six additional strains, including 19A, which had become resistant to most antibiotics since the introduction of Prevnar.
Some of the details of the study were as follows:
· 604 infants in Germany received either Prevnar 13 or Prevnar 7 (the current vaccine) at ages 2, 3 and 4 months.
· Infants were then assessed one month after receiving the vaccinations to see how well they produced antibodies to the strains of bacteria included in each vaccine
· Results suggests Prevnar 13 will be as effective as the current Prevnar in the same seven strains
· One measure showed the new vaccine offered slightly less protection to one strain of bacteria, 6B, than the current vaccine
· Both vaccines showed a lower rate of antibody response to the 6B strain compared with all the other strains covered by the vaccines
· The full four-dose series of the vaccine needs to be completed to boost the immune reaction to 6B based on previous research, given to babies between 12 and 15 months of age
· Side effects of the vaccine included redness and swelling at the injection site, fever, irritability, restless sleep and decreased appetite
Wyeth said it expects to complete its U.S. filing for pediatric use of the vaccine in the first quarter of 2009, with other pediatric global filings expected at the same time.
The FDA has granted the vaccine "fast-track" status, and could complete its review of the vaccine within six months of receiving the final piece of the vaccine approval application.
In the first nine months of 2008, Prevnar generated over $ 2.11 billion dollars for Wyeth.
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