FluMist Recommended for FDA Approval

Source: BioWorld Online. December 18, 2002. www.bioworld.com.

Carol A. Kemper, MD, FACP
An advisory panel has recommended FDA approval of FluMist, the first intranasal influenza vaccine, for people 5-49 years of age. In double-blind, placebo-controlled studies, FluMist, which contains live attenuated influenza A and B virus and is manufactured by MedImmune Inc., was 93% effective in preventing culture-proven influenza infection. Nonetheless, an earlier FDA Advisory Panel, which convened in July 2001, postponed recommendations for approval pending additional safety data.

Newer efficacy data reviewed by the committee demonstrates that the vaccine is sufficiently safe to justify approval, although an increased risk of asthma was observed in children aged 18-35 months. Hence, the recommendation to limit approval to children aged 5 and older—although the ability to administer an intranasal vaccine to younger children would have obvious advantages.

In addition, the panel requested additional vaccine efficacy data for patients aged 50 and older, as well as on shedding of vaccine virus from vaccine recipients. Viral shedding, such as during a sneeze, was found to occur in 80% of recipients and may be observed for up to 21 days following vaccination.

While transmission of vaccine virus was observed in day care attendees, the frequency and clinical significance of this occurrence is not yet known. Experts speculate that the vaccine may cost about $40.

Britain Extends Pet Travel to United States

Source: ProMED-mail post, November 19, 20, and 21, 2002; www.promedmail.org.

Great britain has announced the extension of the popular Pet Travel Scheme to the United States and Canada. This is the first time that cats and dogs from the United States with the appropriate certification will be allowed to enter the United Kingdom without 6 months of quarantine (although some pets may still be quarantined for 2-3 days until their ID and certification can be verified).

Since the Pet Travel Scheme was first introduced in February 2000, more than 75,000 cats and dogs from Europe and other designated countries have traveled to the United Kingdom. The plan is also being extended to several other countries, including New Zealand, Australia, and Japan. In order to qualify for entrance into the United Kingdom, eligible pets must meet all of the requirements, including a recent veterinary exam and certification of good health, current deworming, and microchip ID.

The United Kingdom has understandably been cautious in opening their country to foreign pets. The islands have been largely rabies-free for many years, although the European Bat Lyssavirus 2 was detected there in 2002. The last rabies-like neurologic illness occurred there in 1992, not including imported cases. Recently, an artist and ostensible bat-lover living in Scotland developed a severe neurologic illness, raising red flags in the United Kingdom, but preliminary studies were negative for rabies.

Nipah Confirmed in Bangladesh

Source: Eurosurveillance Weekly. September 19, 2002.

Investigators now believe that an outbreak of severe encephalitic-like illness that occurred in the remote village of Meherpur, Bangladesh, in April-May 2001 was due to Nipah virus or a closely related viral species. Twenty-eight adults, 9 of whom died, developed an acute, febrile neurologic illness, which was initially believed to be secondary to Japanese Encephalitis virus. Serological studies now point to Nipah as the culprit. A similar outbreak occurred in eastern India near the Bangladeshi border in early 2001. Although Nipah virus may result in subclinical infection, about 50% of the clinically apparent cases may be fatal.

The natural host of Nipah virus is believed to be certain species of the fruit bat, although the large outbreak that occurred in Malaysia in 1998-1999 was thought to be related to occupational exposure to pigs. The route of transmission to animal and humans is not known, but human-to-human transmission has not been documented. This outbreak fuels suspicions that Nipah may become more widespread in the future.