CDC

CDC: Side effects not linked to Gardasil

Tracy Staton — Thu, 23 Oct 2008 10:37:32 -0400

Merck appears to be having a few difficulties marketing Gardasil--but now it may have one less. In their first post-marketing review of the human papillomavirus vaccine, U.S. health regulators conclude that reported side effects likely weren't caused by Gardasil. Data from that post-marketing safety study, along with stats from the vaccine adverse events reporting system, together showed that there was no increased risk of certain potential side effects, including Guillain-Barre Syndrome, stroke, blood clots, anaphylaxis, and more. "Based on all of the information we have today, CDC and FDA have determined that the HPV vaccine is safe to use and effective," the CDC said.

Meanwhile, BNet and the Pharma Marketing Blog have pointed out that Gardasil could end up as a victim of its own success. "As more girls get the shot, its remaining market declines--and thus Merck must target increasingly marginally profitable populations" BNet notes, commenting on the company's aim at 19-to-26-year-olds who have been less likely to get the shot thus far.

Why not simply target the three-quarters of teenagers who haven't been vaccinated against HPV yet? For one thing, Merck is hamstrung by marketing rules; it needs parental permissions to direct promotional mail and email to kids who aren't of age. And it has to do something to reverse the shot's 33 percent decline in sales.

- check out the side effects report in the WSJ
- read BNet's take
- see the post at the Marketing Blog

HPV vaccine makes inroads, CDC says

Tracy Staton — Fri, 10 Oct 2008 10:31:51 -0400

Merck's Gardasil has quickly taken hold among teenage girls, the CDC reports. According to the health agency's teen vaccine survey, at least one in four girls has received at least one dose of the human papillomavirus vaccine, which is designed to stave off four strains of the virus that's linked with cervical cancer and genital warts.

That's pretty quick uptake for a vaccine just approved in June 2006. "For a new vaccine, 25 percent coverage is really very good," the CDC's vaccine services chief said.

There are several hindrances to new immunizations, experts told the Wall Street Journal. For one thing, parents tend to be cautious about vaccine safety. Plus, in Gardasil's case, protection can be expensive. The three-shot course costs about $375, and it's unclear whether it offers lifetime immunity or will require boosting in the future. And because Gardasil protects against a sexually transmitted virus, some parents feel free to wait a year or two beyond the recommended administration age of 11 to 12 years, which could be inhibiting uptake numbers.

- see the CDC release
- check out the story in the New York Times
- see the WSJ's article

CDC backs wide use of Merck's Zostavax

Tracy Staton — Tue, 20 May 2008 09:45:08 -0400

TODAY'S SPOTLIGHT... CDC backs wide use of Merck's Zostavax
The Centers for Disease Control and Prevention is giving a boost to Merck's Zostavax vaccine. The public health agency is recommending that all adults 60 years and older should get the herpes zoster shot to prevent shingles, a painful and sometimes long-lasting disease. Complications of shingles, such a pneumonia and blindness, are more common among older folks. The CDC's advice comes after a long peer-review process, and its official stamp could prompt more doctors to give the vaccine--and, importantly, more private insurance companies to cover it. Release | Report

ALSO NOTED: Novo Nordisk creating 400 NJ jobs; Schering to sell off animal products;

Thu, 24 Apr 2008 06:59:50 -0400

> GlaxoSmithKline is acquiring Cambridge, MA-based Sirtris Pharmaceuticals for $720 million. GSK will pay $22.50 per share for the company. Report

> Novo Nordisk plans to expand its North American headquarters in New jersey, adding 400 jobs. Report

> Schering-Plough is selling 12 animal health products, including several vaccines, to Pfizer and the French animal health firm Virbac. Release

> Bayer's net income dropped by 73 percent for the first quarter--but before you have a heart attack, realize that last year's figure was inflated by the company's sale of its diagnostic business. Income from continuing operations rose 16 percent, to $1.2 billion, on $13.4 billion in revenues. Report

> ImClone Systems boosted revenues by 15 percent during the first quarter, to $162.6 million, on a 36 percent hike in Erbitux sales, but an $84 million charge took the bottom line into the red by $55.9 million. Report

> Fresenius Kabi offered to buy an additional 20 percent of the family-controlled Indian drug company Dabur Pharma; already Fresenius had agreed to buy the Burman family's 73.3 percent stake. Report

> Nicholas Piramal India saw fourth-quarter profits soar on a 19 percent increase in revenues. Report

> Theravance announced that it is cutting 40 percent of its workforce now that it has finished work on its antibiotic telavancin. Report

> The U.K.'s Acambis has won a $425 million contract to supply the CDC with its smallpox vaccine for 10 years. Report

And Finally... DTC advertising is poised for growth this year, just as regulators and activists are considering reforms. Report

France picks Gardasil over GSK upstart

Tue, 15 Jan 2008 06:59:58 -0500

Gardasil captured more territory for Merck and Sanofi-Aventis yesterday when French health officials recommended that vaccine against Human Papilloma Virus, or HPV. The French authority recommended that girls of 14 be vaccinated against four strains of the virus, which Gardasil does; its rival Cervarix, made by GlaxoSmithKline, protects against only two. Cervarix targets two HPV strains that cause cancer; Gardasil aims at two cancer strains and two that cause genital warts.

It's just one more victory for Gardasil, which made it to market first, and gained all the attendant early-bird advantages. Though Cervarix is approved in a multitude of countries, it's not for sale in the U.S.; the FDA recently asked GSK for more info about the product. But GSK has been so confident in its product that it launched a head-to-head study pitting Cervarix against Gardasil. Results are expected later this year.

- get the report from CNN Money
- read about the U.S. CDC's recent purchase of 10 million Gardasil doses
- here's GSK's release about its Cervarix vs. Gardasil study

SPOTLIGHT: CDC halts Hib boosters after Merck recall

Thu, 20 Dec 2007 06:59:52 -0500

In the wake of Merck's Hib vaccine recall, the CDC is telling docs to stop giving the booster shot that comes due for infants at 12 to 15 months. Sanofi Pasteur won't be able to make up the shortfall, at least not immediately, officials say; Merck recalled 1.2 million doses and shut down production, with new shipments delayed probably until the fourth quarter of 2008. Report

CDC: Plenty of flu vaccine to go around

Thu, 20 Sep 2007 06:59:56 -0400

You know flu season's coming up when the media starts chanting about flu vaccines and flu remedies. So break out the tissue and fluids, because three big flu stories hit the news today.

First, good news for soft-hearted parents of toddlers and for MedImmune, the maker of FluMist. The FDA approved the no-needle vaccine for use in kids as young as 2; previously, it could only be used in children 5 years and older. Cited by the FDA in spring for manufacturing problems, MedImmune recently announced that it had ironed out those wrinkles and was ready for the season.
Second, the CDC announced that flu vaccine is in plentiful supply this year. Some 132 million doses are expected to ship this year, about 10 million more than last year. This is big news after a couple of years of shortages that left many patients without their flu shots.
Finally, Roche got the E.U.'s OK for kiddie-sized capsules of its antiviral Tamiflu. Until now, the drug was available only in 75 mg capsules, too much for young kids. Only a powder for oral suspension was marketed for use in children, and that formula doesn't have the extended shelf life of capsules. This is important since governments have been stockpiling Tamiflu in preparation for a potential flu pandemic.

- see Roche's press release on Tamiflu
- check out MedImmune's release about FluMist
- read the Kansas City Star article on vaccine supplies