FDA reviews update to Pfizer vaccine for kids

November 16, 2009 By MATTHEW PERRONE , AP Business Writer

(AP) -- Federal health officials on Monday questioned whether to approve an updated version of Pfizer's best-selling anti-infection vaccine for children, despite company studies that failed to meet certain goals.

The Prevnar 13 vaccine reduces risk of infection by 13 varieties of pneumococcal disease, which causes ear infections, and . The new version of the vaccine protects against six more varieties of the disease.

But reviewers said that company studies failed to meet the preselected goals for three types of the disease, according to documents posted online.

The missed goals were statistical measures for vaccine response selected by the FDA. However, since no other vaccine fights the same of the disease as Prevnar, the FDA said the significance of the missed goals "may not be clear."

Dr. Emilio Emini, Pfizer's chief of vaccine research, said the missed goals were due to statistical groupings of patients in the study, not a flaw with the vaccine itself.

Pfizer's briefing documents note that the World Health Organization's vaccine guidelines say meeting the study goals in question is "desirable, but not an absolute requirement."

The FDA will ask a panel of outside vaccine experts to weigh in on the results at a meeting Wednesday. The agency is expected to make its decision on the vaccine by Dec. 30. The FDA is not required to follow the group's advice, though it usually does.

Pfizer acquired Prevnar from Wyeth, as part of a $68 billion buyout that closed last month. Prevnar's $2.7 billion in sales last year trailed only those of the antidepressant Effexor for Wyeth.

Wyeth applied for approval of Prevnar 13 in March and was granted a priority review from the FDA, which indicates the agency sees the product as a public health priority.

Pfizer has said the new vaccine will save lives in the U.S. and in developing countries.

"The public health imperative for this vaccine is clearly there," Emini said. "Pneumococcal disease is the number one cause of vaccine-preventable death in world."

New York-based is seeking FDA approval to market the vaccine for infants and young children and has tested it in more than 7,000 youngsters in 13 major studies.

Prevnar has been on the market for more than nine years and is on sale in 95 countries. More than 235 million doses have been distributed, according to the company.

The requires a series of four injections, generally given at 2, 4 and 6 months old and then between 12 and 15 months old.

Prevnar 13 also recently received a positive review from a committee of European regulators, setting the stage for approval across the European Union.

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Related Stories

Recommended for you

Drug for spinal muscular atrophy prompts ethical dilemmas, bioethicists say

December 11, 2017
When the Food and Drug Administration approved the first drug for people with spinal muscular atrophy a year ago, clinicians finally had hope for improving the lives of patients with the rare debilitating muscular disease. ...

FDA's program to speed up drug approval shaved nearly a year off the process

December 7, 2017
Speeding the pace at which potentially lifesaving drugs are brought to market was a rallying cry for Donald Trump as a candidate, and is a stated priority of his Food and Drug Administration commissioner, Dr. Scott Gottlieb. ...

Dangers of commonly prescribed painkillers highlighted in study

December 6, 2017
Commonly prescribed painkillers need to be given for shorter periods of time to reduce the risk of obesity and sleep deprivation, a new study has revealed.

Viagra goes generic: Pfizer to launch own little white pill

December 6, 2017
The little blue pill that's helped millions of men in the bedroom is turning white. Drugmaker Pfizer is launching its own cheaper generic version of Viagra rather than lose most sales when the impotence pill gets its first ...

Surgery-related opioid doses can drop dramatically without affecting patients' pain

December 6, 2017
Some surgeons might be able to prescribe a third of opioid painkiller pills that they currently give patients, and not affect their level of post-surgery pain control, a new study suggests.

Four-fold jump in deaths in opioid-driven hospitalizations

December 4, 2017
People who end up in the hospital due to an opioid-related condition are four times more likely to die now than they were in 2000, according to research led by Harvard Medical School and published in the December issue of ...

1 comment

Adjust slider to filter visible comments by rank

Display comments: newest first

brant
not rated yet Nov 16, 2009
For these vaccine studies to really be effective wouldnt you have to infect a bunch of kids to see if they get infected??

Do you think they would allow that???

I tell you what. I would never put this stuff in my kids!!! The vaccine load is high enough as it is for young developing bodies.

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.