Following up on last week’s post, it appears that the H1N1 flu vaccine is effective in older children, ages 10 to 17, based on preliminary results of an ongoing trial. This week, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that early results of clinical studies of the vaccine “look promising.” Read more »

The US Food and Drug Administration approved on Tuesday four H1N1 flu vaccines that demonstrated in clinical studies that a single dose produced a strong immune response in healthy adults after 8–10 days. Based on the manufacturers’ production schedules, things seem to be on track for vaccines to be available in four weeks.

But clinical trials of the vaccine are still underway on pregnant women and children, two groups that the Centers for Disease Control and Prevention (CDC) says are especially vulnerable to the H1N1 flu. Read more »

Have you ever considered getting a flu shot but quailed at the sight of the needle? Lots of people hate getting injections, but this delivery method is still the predominant technique for administering biological drugs. Rising demand for vaccines and other biologicals is one factor spurring manufacturers to seek alternative delivery methods that could one day rescue the needlephobic. Read more »

German authorities busted a counterfeit-drug ring yesterday selling fake Viagra (Pfizer, New York) via Internet pharmacy websites, according to an Agence France-Presse report. After a months-long investigation involving 60 customs officers, seven prosecutors and 25 tax investigators, raids in five cities produced 46,000 counterfeit Viagra tablets, frozen bank accounts in Austria, Switzerland, Spain, Belgium, France, and Turkey, four confiscated luxury vehicles, 15,000 euros ($21,000) in cash, and four people in police custody. Read more »

For the first time in 41 years, the world is at the start of an influenza pandemic.  The announcement regarding raising the H1N1 influenza pandemic level from Level 5 to Level 6 came today from from Dr. Margaret Chan, director general of the World Health Organization. Read more »

The United States Department of Health and Human Services (HHS) is trying to cover all of its bases as it seeks to stockpile a vaccine to fight influenza A (H1N1). GSK and Sanofi are first on the list of drugmakers that will work with HHS to meet its objectives. Research scientists are also preparing for possible drug-resistant strains by making progress toward a new type of drug that will be able to stop the spread of infection and possibly prevent initial infection. Read more »

In response to the swine-flu outbreak, the European Medicines Agency (EMEA) last week authorized the use of Tamiflu (oseltamivir) capsules up to two years after the drug’s prescribed expiration dates. EMEA’s Committee for Medicinal Products for Human Use (CHMP) specifically extended the shelf-life of Tamiflu 75 mg, 45 mg, and 30 mg hard capsules from 5 to 7 years. Read more »

As my colleague Maribel Rios discussed in her blog this week, the recent outbreak of swine flu gives us pause to consider our pandemic preparedness. The events of this past week also makes us more aware of the interrelationships and complexity of global public health, giving rise to an even broader question, has the pharmaceutical industry as a whole met its responsibility in effectuating global public health? Read more »

The almost overnight public concern and media attention over the swine flu outbreak has again turned the attention to pandemic preparedness. Officials continue to encourage preventive actions and precautions, noting that, as of yet, it is still unknown whether current vaccines and antivirals will have any effect against the strain responsible for this outbreak. It is also unknown whether those who received a vaccination during the 1976 US swine flu outbreak will have some protection against the current strain. Read more »