Merck herpes zosta vaccines have a production hiccup - HMP Gardasil vaccine is delayed for use in older women.

When we posted on Wednesday, May 31, 2006 about Merck Zostavax shingles vaccine could be a US$1 Bn. seller we were more concerned about finding a happy home for investment funds.

Big Pharma rides on blockbuster drugs that a (relatively) few people need to take forever, statins, anti - diabetic drugs,retrovirals or medication that is used on enormous populations eg vaccines. Zostavax seemed a likely candidate and so it has proved .

When we wrote about "an important tool that can help prevent an illness that affects many older Americans and often results in significant chronic pain" we didn't then , but do now know what it means.

If you are over 60 or you have family who are give this serious consideration and see your doctor. Shingles is fucking painful... and it lasts. BTW shingles is not a one off, it can re-occur.

The bad news is that Merck are having production problems. They make a product called bulk varicella which goes into both Zostavax (annual sales approx US$230 Mn.) and a chicken pox vaccine for children Varivax both of which afford protection from the herpes zosta virus.

Difficulties with less potent batches have resulted in production delays as manufacturing changes require approval before vaccine production recommences so they have given priority to Varivax after a national program since 2006 suggested a second dose for children which doubled sales to a robust US$855 Mn. out of total vaccine sales last year of approximately US$3 Bn.

Merck have also hit problems with their preparation for protection for Human Papilloma Virus, the cause of most cervical cancers. Whilst the Merck vaccine Gardasil has approval from the FDA for the age range from 9-26 they have not yet approved extending use to the 27-45 age range. Merck said it also failed to win FDA approval to expand Gardasil to protect against more strains of the Human Papilloma Virus that causes cervical cancer (currently acts against types 6, 11, 16, 18) . The company for now is dropping plans to pursue that expansion. There is also a potential to expand usage into males who can transmit the virus to their partners.

In the US Gardasil typically costs US$120 per dose, which means it costs US$400 to US$500 for the three-shot series plus physicians' charges. (Net Doctor details for use in UK)

Global sales of Gardasil rose 7 percent in the first quarter to $390 million. Cowen and Co has predicted annual sales of the vaccine would reach $1.9 billion in 2008 and jump to $3 billion by 2012.

Merck shares have fallen 37 % this year, principally due to setbacks to its cholesterol franchise and delays on introducing a new drug.


***** Zostavox vaccine is not currently available in the UK. A frozen formulation of the vaccine was granted a marketing authorisation (MA) in the EU in May 2006 for the prevention of shingles in individuals aged 60 years or older; a variation to the MA has been filed with the European Medicines Agency for a refrigerated formulation, but a final decision on approval has not yet been made. Zostavax is the first and only vaccine registered in Europe for this indication.

PS : Monday : An enquiry at a pharmacy today produced this response "Yes we do provide Zostavax although the product is currently on a manufactures backorder, with no release date, and we are now out of stock."