Prevnar 13 Vaccine with 6 Additional Strains of Bacteria: Pfizer's next Lipitor?

Pfizer got double good news Wednesday after the FDA approved Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the company's 13-valent pneumococcal conjugate vaccine. It is the updated version of Prevnar and protects against six additional strains of bacteria.

The same day, the CDC's Advisory Committee on Immunization Practices (ACIP) recommended the use of Prevnar 13 for healthy children between the ages of 2 and 59 months. ACIP also recommended that children who have started their immunization series with Prevnar should complete the series by switching to Prevnar 13 at any point in the schedule.

Prevnar 13 is indicated for active immunization of children 6 weeks through 5 years of age for the prevention of invasive disease--including sepsis, bloodstream infections and meningitis--caused by 13 Streptococcus pneumoniae.

The L.A. Times notes that Prevnar was the world's top-selling vaccine in 2008 with sales of $2.7 billion and was considered a key product in Pfizer's decision to purchase its rival Wyeth. And Matthew Herper of Forbes' health blog predicts that the vaccine could be Pfizer's top seller after Lipitor loses patent protection.

Pfizer expects to start selling Prevnar 13 in the U.S. during the first quarter. Already approved for infants and young children in 38 other countries, Prevnar 13 is also being studied in global Phase III clinical trials in adults, with regulatory submissions expected later in the year, according to a Pfizer statement. Earlier this year, the company said that Prevnar 13 sales in adults older than 50 could account for $1.5 billion in sales.

Pfizer's stock jumped 1.5 percent to $17.94 yesterday following the approval, according the Financial Times.

- see Pfizer's statement about the FDA approval
- check out the CDC announcement
- read the FT's coverage
- read the Forbes' blog post
- check out the L.A. Times' review

Related Articles:
FDA approves Pfizer's new megablockbuster vax
Pfizer seeks $1.5B adult market for Prevnar 13
FDA panel says yes to updated Prevnar

via fiercevaccines.com

Posted via web from NJCVC's posterous

Prevnar 13 Vaccine with 6 Additional Strains of Bacteria: Pfizer's next Lipitor?

Subscribe to the NJCVC feed via email - Get NJ Vaccination News and Updates in your inbox!

Subscribe to NJ Coalition for Vaccination Choice by Email

Posted via email from NJCVC's posterous

Subscribe to the NJCVC feed via email - Get NJ Vaccination News and Updates in your inbox!

The Coalition for Vaccine Safety Calls for Congressional Hearings on Federal Agencies' Failure to Provide Adequate Safety Research

WASHINGTON, Feb 24, 2010 /PRNewswire via COMTEX/ ----CASE NOT CLOSED ON GOVERNMENT VACCINE SAFETY CLAIMS

In a letter to the Chairmen and Ranking Members of House and Senate Committees charged with oversight of the Department of Health and Human Services (HHS), the Coalition for Vaccine Safety (CVS) is calling for hearings to investigate HHS, the Centers for Disease Control (CDC) and other government agencies for failure to fully address issues of vaccine safety as intended by the Mandate for Safer Vaccines in the 1986 National Childhood Vaccine Injury Compensation Act.

With the federal government claiming "case closed" on possible damage to children caused by compulsory vaccines, too much evidence exists and too many unanswered questions remain, according to the letter. Key concerns are: insufficient and flawed data knowingly and willing used by government entities to reach conclusions that science dictates simply cannot be reached; conflicts of interest of individuals and government agencies involved in vaccine safety research; and ignored statements from experts regarding the un-answered question of a link between thimerosal (mercury) in vaccines and autism.

"The question has not been answered." (former Chairman of the National Institute of Health (NIH) Dr. Bernadine Healy)

"[T]here's been grossly insufficient investment in research on the safety of immunization." (former head of the American Academy of Pediatrics, Dr. Louis Cooper)

"Yet the study had significant weaknesses and they knew it." (former Congressman David Weldon, MD, R-FL in reference to a CDC study regarding thimerosal and autism)

"[T]he committee cannot rule out, based on the epidemiological evidence, the possibility that vaccines contribute to autism in some small subset or very unusual circumstances." (The Institute of Medicine's (IOM) 2004 report on thimerosal and autism)

The Coalition for Vaccine Safety urges Congress to view the claims of HHS and the Centers for Disease Control (CDC) that vaccines are safe with a jaundiced eye. The existing evidence on vaccine safety is grossly insufficient and fails to meet the requirements of public confidence. In fact, significant evidence points to suppression of science that could prove or disprove vaccine safety. This suppression may be due to potential liability and financial conflicts of interest involving individuals and organizations responsible for scientific studies and vaccine safety policies. Furthermore, "HHS has blatantly disregarded laws passed by Congress requiring it to properly and thoroughly study vaccine safety," reads the letter.

The letter also notes pending National Vaccine Injury Compensation Program decisions at stake, "An important additional reason for Congress to act now is that the Court of Federal Claims is likely to release its Omnibus Autism Proceeding 'test cases' on the possible link between the mercury-containing preservative thimerosal and autism soon. Suppression of science or significant conflicts of interest contaminating the research that undergirds the Court's determinations creates an urgent need for Congress to act."

In light of the growing number of questions and concerns regarding vaccine safety, it is imperative that the U.S. government rely on the best, most thorough and rigorous science possible. The Department of Health and Human Services is legally and ethically bound to do everything reasonably possible to ensure the safety of vaccines.

The letter can be found at http://www.coaltionforvaccinesafety.org Recipients are:

Senator Tom Harkin (D-IA), Chairman, Senate Health, Education, Labor and Pensions Committee, Senator Michael Enzi (R-WY), Ranking Member, Cong. Frank Pallone (D-NJ) Chairman, Health Subcommittee of the House Energy and Commerce Committee and Cong. Nathan Deal (R-GA), Ranking Member.

For more information, contact Cheri Jacobus at (202) 547-7358 cherijacobus@aol.com

or Pamela Felice at 404-394-2857 pfelice@safeminds.org

SOURCE Coalition for Vaccine Safety

Copyright (C) 2010 PR Newswire. All rights reserved

via foxbusiness.com

Posted via web from NJCVC's posterous

The Coalition for Vaccine Safety Calls for Congressional Hearings on Federal Agencies' Failure to Provide Adequate Safety Research

H1N1 Flu Is a False Pandemic, Health Expert Claims

H1N1 Flu Is a False Pandemic, Health Expert Claims

Monday, January 11, 2010

A leading health expert said the swine flu scare was a "false pandemic" led by drug companies that stood to make billions from vaccines, The Sun reported Monday.

Wolfgang Wodarg, head of health at the Council of Europe

, claimed major firms organized a "campaign of panic" to put pressure on the World Health Organization (WHO) to declare a pandemic.

He believes it is "one of the greatest medicine scandals of the century," and he has called for an inquiry.

An emergency debate on the issue will be held by the Council of Europe later this month.

The Council of Europe covers 47 European countries and seeks to develop common and democratic principles between the nations.

Wodarg said, "It's just a normal kind of flu. It does not cause a tenth of deaths caused by the classic seasonal flu

.

"The great campaign of panic we have seen provided a golden opportunity for representatives from labs who knew they would hit the jackpot in the case of a pandemic being declared.

"We want to clarify everything that brought about this massive operation of disinformation. We want to know who made decisions, on the basis of what evidence, and precisely how the influence of the pharmaceutical

industry came to bear on the decision-making."

He added: "A group of people in the WHO is associated very closely with the pharmaceutical industry."

The WHO recently reaffirmed its stance that the pandemic is not over. However, the number of swine flu deaths is dramatically lower than expected.

In an interview with France's L'Humanite Sunday, Wodarg also raised concerns about swine flu vaccines.

"The vaccines were developed too quickly. Some ingredients were insufficiently tested," he said.

"But there is worse to come. The vaccine developed by Novartis was produced in a bioreactor from cancerous cells

, a technique that had never been used until now.

"This was not necessary. It has also led to a considerable mismanagement of public money.

"The time has come at last for us to make demands on governments. The purpose of the inquiry is to prevent more false alarms of this type in the future."

"We must make sure people can rely on the analysis and the expertise of national and international public institutions. The latter are now discredited, because millions of people have been vaccinated with products with inherent possible health risks."

Click here to read more from The Sun.

via foxnews.com

Posted via web from NJCVC's posterous

H1N1 Flu Is a False Pandemic, Health Expert Claims

FDA selects pandemic H1N1 for 2010-11 seasonal flu vaccine

FDA selects pandemic H1N1 for 2010-11 seasonal flu vaccine

Robert Roos  News Editor

Feb 22, 2010 (CIDRAP News) %u2013 The US Food and Drug Administration's (FDA's) vaccines committee voted today to follow the World Health Organization's advice and fold the pandemic H1N1 influenza vaccine into the seasonal flu vaccine for next season.

The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend that the pandemic virus become the influenza A/H1N1 component of the 2010-11 vaccine, according to FDA spokeswoman Shelly Burgess. Barring major surprises, that means there will be just one flu vaccine next fall instead of the two vaccines%u2014pandemic and seasonal%u2014that were made for the current flu season.

The committee also went along with the WHO's recommendation last week to switch the A/H3N2 component of the trivalent (three-strain) vaccine from the Brisbane strain to a 2009 Perth strain, Burgess reported.

In addition, the VRBPAC voted to keep the influenza B strain used in the 2009-10 vaccine, a 2008 Brisbane strain, as the WHO had advised, she said.

The WHO and FDA normally pick flu strains for the Northern Hemisphere in February because it takes months to develop vaccine viruses based on the circulating strains, grow large quantities of them in chicken eggs, and formulate them into vaccines. Most flu vaccines are still produced by the decades-old egg-based method.

The committee recommendation comes as pandemic H1N1 cases continue to decline and seasonal flu strains are scarce in much of the Northern Hemisphere, though some type B activity has been reported in China. Pandemic flu strains typically continue to be predominant in the first few years after their emergence, experts say.

The strains chosen by the FDA panel today, according to Burgess, are:

• For the H1N1 component, an A/California7/2009-like virus (the pandemic strain), which replaces A/Brisbane/59/2007
• For H3N2, an A/Perth/16/2009-like virus (an example is A/Wisconsin/15/2009), which replaces A/Brisbane/10/2007
• For type B, a Brisbane/60/2008-like strain (the same as last year)

These are the same three strains the WHO picked last September for the 2010 Southern Hemisphere flu season, which typically begins in May.

CLS Ltd., an Australian vaccine company, is currently producing trivalent vaccine for the Southern Hemisphere's season. Bill Cracknell, who is director of the company's influenza operations and attended the VRBPAC meeting, said today that CSL hasn't had any major production glitches but that yields of the three flu strains have not been great.

"It's been less than spectacular," he told CIDRAP News, but added that he doesn't expect problems making the vaccine for the Northern Hemisphere season.

Cracknell said CSL is using a Wisconsin strain, part of the Perth family, for the H3N2 component, but will switch to another related strain for Northern Hemisphere production in the hope of getting better yields.

He said the VRBPAC meeting brought no surprises. "I guess the whole meeting proceeded really as you would've expected it to, coming out of a season in which one strain knocked everything else's socks off," he commented.

Dr. Nancy Cox, director of the Centers for Disease Control and Prevention's Influenza Division, told the committee that the previous H1N1 strain "most likely poses a low risk in the forthcoming Northern Hemisphere season," according to a Bloomberg News report published today.

The WHO announced its flu vaccine recommendation Feb 18, after a 4-day meeting of experts from the agency's collaborating laboratories and national regulatory authorities. The VRBPAC routinely follows the WHO advice on the strains to put in the vaccine.

See also:

Feb 18 CIDRAP News story "WHO picks pandemic strain for next seasonal flu vaccine"

Sep 23, 2009, CIDRAP News story "WHO picks novel H1N1 for 2010 southern hemisphere flu vaccine"

via cidrap.umn.edu

Posted via web from NJCVC's posterous

FDA selects pandemic H1N1 for 2010-11 seasonal flu vaccine

New Jersey First to Mandate H1N1 to Children

We just received word that the 2010/2011 seasonal flu vaccine will contain the new H1N1 flu strain as one of its three strains. You can read more about the article here: lifehealthchoices.com

Posted via web from NJCVC's posterous

New Jersey First to Mandate H1N1 to Children

Please help set up meetings with newly elected legislators for this session.

IF YOU LIVE IN THESE DISTRICTS...

WE NEED YOUR HELP!

These are the newly elected legislators for this session.  Please make an appointment for Coalition leaders to meet with these new reps to get them signed on to our bills!  Consider this URGENT please!  Be a nudge!  Keep calling until we get in the door!

Contact: Maureen,  md1stnoharm@aol.com  with any information on legislative meetings.

To send an e-mail, find your legislator at:  http://www.njleg.state.nj.us/members/legsearch.asp

DISTRICT 3: Assemblywoman Celeste M. Riley, D./ 856-455-1011/ 14 East Commerce St., 3rd Floor/ Bridgeton, 08302

DISTRICT 4: Assemblyman Domenick C. DiCicco Jr., R./ by electronic mail only/ no contact info available

DISTRICT 5: Senator Donald Norcross, D./ 856-742-7600/ Brooklawn Shopping Plaza, Rt. 130 South & Browning Rd./Brooklawn, 08030

Assemblyman Angel Fuentes, D./ address and phone same as above.

Assemblyman Gilbert L. "Whip" Wilson, D./ address and phone same as above.

DISTRICT 9: Assemblywoman DiAnne Gove, R./ 609-693-6700/ 620 West Lacey Rd./Forked River, 08731

DISTRICT 19: Assemblyman Craig J. Coughlin, D./ 732-855-7441/ 569 Rahway Ave./Woodbridge, 07095

DISTRICT 23: Assemblyman John DiMaio, R./ 908-684-9550/ 1001 County Rte. 517, Suite 3/Hackettstown 07840

Assemblyman Erik Peterson, R./ 908-237-4694/ 23 Royal Rd. Suite 201/ Flemington 08822

DISTRICT 25: Assemblyman Anthony M. Bucco, R./by electronic mail only/ no contact information available.

DISTRICT 31: Assemblyman Charles S. Mainor, D./ 201-536-7851/ 485-7 Martin Luther King Jr. Dr., Jersey City 07304-2305

DISTRICT 39: Assemblyman Robert Schroeder, R./ 201-391-3673/ 123 Broadway, 2nd Floor/ Woodcliff Lake 07677

Posted via email from NJCVC's posterous

Please help set up meetings with newly elected legislators for this session.