Industry Blog

Vaccinations.

In England alone 400,000 health and social care workers have been given the vaccine against swine flu.

The Health Department claims that there has been and estimated 387,000 people vaccinated and the number of doses given to the priority groups in 3.7 Million which also includes pregnant woman, 132,000 of them and finally including 214,000 children in good health aged 6 months to 5 years old.

Pharmaceutical companies have been shipping the vaccine out.

Pharmaceutical company GlaxoSmithKline to donate 50 million doses of swine flu vaccine to WHO

Pharmaceutical company GlaxoSmithKline will donate 50 million doses of H1N1 vaccine to the World Health Organization (WHO). APA reports that the related agreement was signed in Geneva.

WHO Director-General Margaret Chan said WHO will work to see that these vaccines are distributed to those who need them.

GlaxoSmithKline expects to prepare the first shipments of vaccine to the WHO by the end of November. WHO has prepared a list of 95 developing countries that are slated for receiving vaccines from GSM, and it intends to cover 10 percent of the population in these countries.

Source: APA.Az

Cadila to apply for swine flu vaccine clinical trials.

With an aim to launch vaccine for Influenza H1N1 A Virus (swine flu) in India, Cadila Pharmaceutical will seek the government’s nod in two days for initiating clinical trials in this regard.

Cadila Pharmaceutical Ltd (CPL) had set up a joint venture ‘CPL Biologicals Pvt Ltd’ with the US-based vaccine maker Novavax for manufacturing and developing a host of vaccines, including for swine flu, in India.

“The joint venture is going to file the application with the Drug Controller General of India (DCGI) in the next two days for phase-I clinical trials for swine flu vaccine,” CPL Chairman and Managing Director, Mr I A Modi told PTI.

Modi expressed confidence that Cadila would be the first Indian pharma company to launch the swine flu vaccine in India by December. “If we get the permission of DCGI soon, then with the advanced technology available from our partner, (we) would be able to launch it in India by December this year,” Mr Modi said.

With its existing facility, Cipla can produce up to one million doses of the vaccine per month, which can be scaled up to two million doses, Mr Modi said. “Novavax has already received permission for clinical trials from the US Federal Drug Administratio n and if we get it soon, we can simultaneously start the trials,” he added. - PTI.

www.thehindubusinessline.com

Swine flu vaccines will cost €80m

THE SWINE flu pandemic will lead to one of the biggest vaccination programmes in the history of the State.

In the coming months, everyone in the country will be offered two doses of a vaccine which is still being developed by the pharmaceutical giants charged with bringing it to the market.

The vaccine the world is waiting for has not been developed yet but Dr Patrick Doorley, the HSE’s national director of population health, said he is certain there will be one. “First of all you have to identify the exact nature of the virus. That is why we did not have a vaccine before this happened. The big companies have all got the seeds now. We will have a vaccine. These companies are well used to making them,” he said.

In total, 7.7 million vaccines will be bought from three foreign pharmaceutical companies – GlaxoSmith-Kline, Baxter Healthcare and Allphar Services – at a combined cost of around €80 million.

There will be enough to immunise 3.85 million people, though the plan is to immunise everybody. There have been around 150 confirmed cases, but no deaths, to date in Ireland.

www.irishtimes.com

Vaccine Market to Drive Future Pharmaceutical Growth

The worldwide vaccine market has undergone a rapid transformation phase over the last few years. In the present scenario, major pharmaceutical players are eyeing vaccine market for their growth. The global vaccine sales grew at a CAGR of around 28% during 2005-2008, reveals our new research report “Global Vaccine Market Forecast to 2012”.

According to the report, the leading pharmaceutical companies such as Sanofi Aventis, Glaxo Smith Kline, Merck and Wyeth made significant investments in R&D that brought the major turnaround in the market and the market size surpassed US$ 20 Billion in 2008. Also, the introduction of cancer and rotavirus vaccines helped the global vaccine market to boost significantly.

emailwire.com

Flu vaccine available in October

There is no indication the A(H1N1) virus has mutated in Thailand and a vaccine is expected to be available in October, Public Health Minister Witthaya Kaewparadai said on Tuesday.

He was confident the swine flu outbreak could still be contained.

People with flu-like symptoms should visit hospitals quickly if the symptoms do not subside in two days, he said.

A vaccine against the A(H1N1) virus  should be available by October, and the government would initially import 12 million doses at a cost of about two million baht.

The Government Pharmaceutical Organisation and Silpakorn University would also jointly research a vaccine for use against the virus.

The Bureau of Epidemiology said that cases of human-to-human transmission could be expected to increase this month. People should take precautions by washing their hands regularly and wearing face masks in public places.

bangkokpost.com

Britain pledges £485 Million to global vaccine project.

Britain will invest almost $500 million in an international scheme to encourage pharmaceutical firms to develop vaccines against some of the common diseases which plague poorer nations.

The Advance Market Commitment, a pilot project launched on the sidelines of the G8 finance ministers meeting this weekend, guarantees to buy vaccines at fixed prices once they have been developed, giving drug companies an incentive to produce them.

 

“The UK is pleased to support this initiative … which should ensure a sustainable and affordable supply of vaccines well into the future,” said British finance minister Alistair Darling.

 

Britain, Italy, Canada, Russia, Norway and the Bill and Melinda Gates Foundation are investing a total of $1.5 billion in the project, which is being run by the World Bank, UNICEF, the World Health Organization and the international vaccine agency GAVI alliance.

 

Pharmaceutical firms who sign up will be tasked with developing vaccines to fight pneumococcal diseases, which claim up to 1.6 million lives each year — most of them children.

 

Firms that participate will also make legally binding commitments to supply the vaccines at lower and sustainable prices after the donor funds are spent.

 

The AMC scheme aims to prevent more than 7 million deaths by 2030.

AstraZeneca: Nasal Flu Vaccine submitted for European Approval

An recent article on Pharmaceutical Business Review states that MedImmune, the global biologics unit of AstraZeneca, has submitted a Marketing Authorisation Application (MAA) for its nasal spray live-attenuated seasonal influenza vaccine (LAIV) with the European Medicines Agency (EMEA). The vaccine is already marketed in the US under the brand name FluMist. The proposed indication in the MAA is for prevention of seasonal influenza and is based on data from 73 global clinical and US post-marketing studies of more than 141,000 subjects ranging in age from seven weeks to 97 years and conducted in 38 countries. However, MedImmune has not communicated the age range it is seeking approval for with the EMEA.

LAIV is a trivalent seasonal influenza vaccine which was first approved in the US in 2003 for use in individuals aged five to 49 years of age. In September 2007, the age range of the vaccine was extended by the FDA for use in children aged two to five years. However, this still only represents a small proportion of the key target population for seasonal influenza vaccination. The lack of approval in the elderly, the target group showing the highest seasonal flu vaccine coverage rates, has restricted the overall commercial potential of the vaccine, which only achieved sales of $53m in 2007.

The seasonal influenza vaccine market is a highly competitive field which is becoming increasingly commoditized as a result of the increasing number of available vaccines. Due to its intranasal mode of administration and very good efficacy in this age group, FluMist’s largest opportunity lies in the infant segment. However, it is questionable whether the cost-conscious European payers will opt to introduce FluMist readily following its European approval, if AstraZeneca decides to pursue a similar strategy as in the US, where the vaccine is marketed at a premium price compared to conventional seasonal influenza drugs.

In addition, seasonal flu vaccination in most European countries is currently largely restricted to the elderly population and does not cover the age group of two to 49 year olds, for which LAIV is approved in the US. Unless LAIV is approved for a wider age group than in the US, Datamonitor expects the overall commercial opportunity for the product in Europe to be limited.
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