One out of three ain't bad? Out of a trio of Merck vaccine news today, one story was a clear thumbs-up for the company: Its RotaTeq vaccine [1] delayed the onset of the usual rotavirus season by about three months--from November to February--compared with the usual schedule. You'll recall that Rotateq was recommended for routine use in infants two years ago; now that's it's in use, the number of lab tests for the virus dropped by 37 percent from January to May 2008, and positive tests fell by 79 percent. The CDC says it's possible that widespread use of the vaccine is actually staving off the spread of rotavirus to unvaccinated kids, too.
And now for the bad news. First, the FDA said it's not ready to approve Merck's HPV vaccine Gardasil for use in older women. The company says the agency has "issues" that it will respond to next month. It could just be a temporary setback. Merck certainly hopes so; expanding the use of Gardasil first to older women and next to male carriers is a key growth strategy.
Second, the company is having a tough time getting a crucial ingredient for its Zostavax shot, Merck's anti-shingles product. The company will continue to accept orders, but shipments could be delayed by up to six weeks. The problems stem from a manufacturing problem at Merck that led to shortages of another varicella vaccine product last year.
- see Merck's release [2]
- read the Pharmalot item [3] on Rotateq
- check out the Gardasil news [4] at Seeking Alpha
- see the Wall Street Journal's story [5] on Zostavax
PLUS: Many Wall Street analysts greeted the FDA's decision to reject Merck's bid to expand the use of Gardasil to 27 to 45-year-old women with a yawn. Report [6]
ALSO: A U.S. advisory panel added GlaxoSmithKline's two-dose rotavirus vaccine to the recommended list for infants, where it will join Merck's three-dose product Rotateq. Report [7]
Related Articles:
France picks Gardasil over GSK upstart [8]
It's Merck v. Glaxo in vaccine battle [9]
FDA staffers raise Gardasil questions [10]
Links:
[1] http://www.fiercebioresearcher.com/vaccines/story/merck-s-rotavirus-vaccine-makes-big-impact/2008-06-26
[2] http://www.fiercebiotech.com/press-releases/merck-co-inc-receives-complete-response-letter-fda-use-gardasil-women-ages-27-through
[3] http://www.pharmalot.com/2008/06/merck-vaccine-delayed-onset-of-rotavirus-season/
[4] http://seekingalpha.com/article/82765-fda-delivers-one-two-punch-to-merck-eli-lilly
[5] http://online.wsj.com/article/SB121443178028504909.html?mod=googlenews_wsj
[6] http://www.fiercebioresearcher.com/vaccines/story/wall-street-shrugs-fda-s-gardasil-rejection/2008-06-26
[7] http://www.washingtonpost.com/wp-dyn/content/article/2008/06/25/AR2008062502074.html
[8] http://www.fiercepharma.com/story/france-picks-gardasil-over-gsk-upstart/2008-01-15?utm_medium=rss&utm_source=pharma_Gardasil&cmp-id=OTC-RSS-FP0
[9] http://www.fiercepharma.com/story/its-merck-v-glaxo-vaccine-battle/2007-10-04
[10] http://www.fiercebiotech.com/story/fda-staffers-raise-gardasil-questions/2006-05-18