Safety Questions Over Swine Flu Vaccine

Finally, clinical trials are planned on humans for the swine flu vaccine. The vaccine is also expected to be distributed in Scotland shortly. Of concern: Distribution and dosing of the new <"">swine flu vaccine will likely occur in advance of complete human testing, reports the Herald.

The U.S. Centers for Disease Control and Prevention (CDC) describes the swine flu—the H1N1 virus—as a new virus first detected in the U.S. in April 2009 that is spreading from person-to-person worldwide, probably in much the same way that traditional seasonal influenza spreads. The CDC said that as of June 11, 2009, the World Health Organization (WHO) indicated that a pandemic of the new H1N1 flu was underway.

The vaccine testing, which will be taking place in Germany, will involve 128 adults who are healthy and between the ages of 18 and 60, said the Herald, which noted that the participants will be paid a small fee by GlaxoSmithKline (GSK). GSK is one of the two drug makers producing the inoculations. The participants will each receive a preliminary injection and a second dose 21 days later, reported the Herald, who explained that tests will be conducted to determine if the participants developed an immunity to the virus.

Meanwhile, the vaccine is expected to be ready by the middle of next month, said the Herald, and the European Medical Administration will likely license the drug—similar to approval in the U.S.—to ensure the United Kingdom will be prepared for the virus’s so-called “second wave,” said the Herald. The issue here is that GSK is not expected to complete its trials of the vaccine until a year from now, which means that human trials will only have been conducted on a small sampling of participants.

Many are concerned that the drugs to help prevent the swine flu could actually be more dangerous than the swine flu itself; of significant concern because those first being vaccinated will receive medicine that was not fully tested, said the Herald. According to the Herald, the British Neurological Surveillance Unit has stated its concerns regarding the swine flu vaccine and Guillain-Barre syndrome. Guillain-Barre is the nerve disease linked to the deaths of 25 people following the 1976 swine flu vaccinations in the U.S.

Worse, of the nurses questioned in a recent Nursing Times poll, one-third said they would not take the drug because of safety concerns, said the Herald. Worries over flu drugs and vaccines peaked recently, following reports of children in England who experienced adverse effects after taking Tamiflu, the anti-viral medication, said the Herald. In the U.S., the Food and Drug Administration (FDA) approved two antiviral drugs for treatment and prophylaxis of the 2009 H1N1 influenza virus: Tamiflu (oseltamivir phosphate) and Relenza (zanamivir).

In late 2006, the FDA alerted doctors and parents to watch for signs of bizarre behavior in children treated with Tamiflu after federal health officials noticed an increasing number of such cases overseas. There had been reports of 596 neuropsychiatric events, including 16 neuropsychiatric-related deaths among children and adults taking Tamiflu, according to documents posted online at the time on the FDA’s Website. Japan was also the origin of 81 Relenza reports and, according to Health Canada’s adverse reaction database, 27 people reported adverse reactions to Relenza, including one adult who died. One 14-year-old reported nightmares and another six-year-old temporarily lost consciousness. Another 96 people reported adverse reactions to Tamiflu, including 11 adults who died and nine who reported psychiatric problems.

In the UK, GSK is expected to make £60m from the swine flu vaccine.

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