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FDA OKs updated Prevnar, Pfizer says

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Prevnar vaccine has been talked about before on here so I'm posting this for those interested...




FDA OKs updated Prevnar, Pfizer says


Vaccine protects against 13 strains of infection, maker say


WASHINGTON - Pfizer said Wednesday the Food and Drug Administration has approved an updated version of its best-selling infection vaccine for infants and children.


Prevnar 13 is intended to reduce the risk of infection by 13 strains of pneumococcal disease in children 5 years old and younger. The disease causes ear infections, meningitis and pneumonia.


Prevnar 13 adds protection against six additional strains of bacterial infection compared with the current vaccine.


The vaccine, developed by Wyeth, is the first product to

win FDA approval since Pfizer acquired that company last year.


With sales of $2.7 billion in 2008, Prevnar was the

world's top-selling vaccine in 2008 and was considered a key product in Pfizer's

decision to purchase Wyeth for $68 billion.


The FDA was scheduled to make a decision on Prevnar by

last September, but extended its review twice since then.



from pneumococcal disease dropped dramatically after the original Prevnar was

released in 2000. However, infections began rising again in 2005 with the

development of new variants of the disease.


Dr. Emilio Emini, Pfizer's chief of vaccine research,

said the six new strains of pneumococcal disease covered by the vaccine account

for 70 to 75 percent of new infections in the U.S. When combined with the seven

types covered by the original vaccine, Emini says Prevnar 13 covers 90 to 95

percent of the causes of the disease in the U.S.


The vaccine also protects against two varieties of

pneumococcal disease that account for most cases in the developing world.


The World Health Organization has called the disease the

top vaccine-preventable cause of death in the world.


The vaccine requires a series of four injections,

generally given at 2, 4 and 6 months old and then between 12 and 15 months



To assure widescale use in the U.S., Prevnar 13 will need the recommendation of the Centers for Disease Control, which issues guidelines on vaccines to doctors and hospitals. About an hour after the Pfizer announcement, a CDC advisory panel on immunizations — meeting in Atlanta — voted to recommend that doctors start using Prevnar 13 to replace the older Prevnar vaccine.

Prevnar 13 will cost about $100 a dose. The company has already prepared 8.3 million doses and expects to start shipping them in mid-March, said Matt Garrett, a Pfizer vice president at the CDC meeting.<I itxtvisited="1">Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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You just HAD to go and post this didn't you! I have barely got my blood pressure under control since reading this a few days ago.


I happen to have a little saved info on hand in case I ever got the urge to go on a vax rant (which was almost triggered by a recent post regarding Hib/s pneum)


I'll leave some here, in case others want to wade thru it. Remeber there are something like 91 strains of s pneumonia. I probably should have posted the last one here, first.

The way many of these articles are written, they would have you believe that these additional strains were just discovered or something. You have to hunt to see that some have INCREASED (a few quite dramatically) in the wake of the 7 strain vaccine.







Prevnar generated $2.7 billion in sales in 2008. Analysts have estimated sales of Prevnar 13 will be between $5 and $6 billion in 2014-2015. No wonder Pfizer shares are up 1.3%.





Prevnar 13 - which Pfizer says will be launched within the next few weeks - will cost $108, 30% more than the current Prevnar 7 vaccine, which costs $83 a shot, but it protects against strains of the pneumococcus bacteria that the existing vaccine does not. This price increase accounts for much of the projected increases in sales of Prevnar.


Expected to help compensate for Lipitor


The vaccine expected to become Pfizer's top seller after its all-time mega blockbuster cholesterol-lowering drug Lipitor (atorvastatin) loses patent protection next year. Pfizer itself has estimated the new vaccine could add $1.5 billion sales to the Prevenar franchise.




Prevnar 13 covers -- you guessed it -- 13 different types of pneumococcal disease, six more than the original. In order to gain approval, Wyeth tested the new vaccine against the old version, but Prevnar 13 failed to show that it was as good as the original for three of the strains in some patients.


The FDA asked a panel of experts for their opinion on how important the failure was. But they shrugged it off at a meeting yesterday, voting 10-1 that the vaccine is safe and effective.


Now the ball is back in the FDA's hands. The agency doesn't have to follow the committee's advice, but I have a hard time imagining that it won't approve the vaccine, given such resounding support. The PDUFA date for the vaccine is Dec. 30, so perhaps an early Christmas present is in order.





Although they are nowhere as prevalent as pneumoccus was pre-Prevnar, they are becoming more common. Most worrisome is a strain called 19A. "It is now the most common cause of invasive, serious pneumococcal disease in children. It’s crept up slowly and it’s especially vicious because it’s multiply antibiotic resistant," says Schaffner. Pfizer is also studying Prevnar 13 to prevent pneumonia in adults, and expects to file an application with the FDA by the end of the year.




Prevnar, however, is losing its punch because strains not covered by the vaccine are filling the biological niche that the vaccine strains used to occupy, and they are causing disease. One strain in particular, called 19A, is big trouble. A new subtype of it caused ear infections in the nine Rochester children, ages 6 months to 18 months, that were resistant to all pediatric medications, said Dr. Michael Pichichero, a microbiologist at the University of Rochester Medical Center.

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