The US Food and Drug Administration on Wednesday, after a round of voting, announced that the new version of children's medicine Prevnar should be considered both effective and safe for administration in children and infants to treat "pneumococcal illnesses".
After some experts expressed concerns over the fact that clinical tests' data was not enough to determine if the new version was more effective than the original one, the FDA advisory board voted, and the drug won the agency's approval, 10-1.
Marketed as the Prevnar 13, the new drug has increased strains of "streptococcus pneumoniae bacteria", the root cause of conditions such as ear infections, pneumonia and meningitis in children. The advised series for administration to children is - four doses at the age of two, four and six months, and four doses between the ages of 12 and 15 months.
The original drug, marketed as Prevnar, was first introduced in 2000, and has since proved to be a much helpful vaccine to help children fight against pneumococcal diseases. As has been confirmed by official data shared by Pfizer, between 1998 and 2007, the drug reduced the number of such cases by nearly 76%.
After approval for use in children, Prevnar 13 is now being tested for potential use in adults. Post the announcement of the FDA approval, Pfizer shares surged by 1.4% on the NY Stock Exchange to trade at a new high of $18.19.
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