News in brief - July 4, 2005

Chiron reduces number of projected flu vaccine doses - NSAID warnings from FDA - New pertussis vaccine OK'd by FDA - Tight glucose control saves the diabetic heart

Chiron reduces number of projected flu vaccine doses

Chiron Corp., the firm that was unable to deliver any of its expected influenza vaccine doses last year because of contamination problems, said last month that it had reduced the number of doses it plans to produce for the upcoming season.

According to a statement issued by the company, it expects to deliver between 18 million and 26 million doses, rather than the previously announced 25 million to 30 million doses. The reduction is being blamed on delays in ramping up to full production and the usual manufacturing issues associated with the complexity of this vaccine.

"While it remains possible that we will reach our previously announced range, the delays and other manufacturing issues have had an adverse impact on our ramp-up to full production. ... We are committed to our goal of supplying influenza vaccine in time for the upcoming season," said Chiron CEO Howard Pien.

The United Kingdom's Medicines and Healthcare Products Regulatory Agency restored the company's manufacturing license in March. The Food and Drug Administration is due to inspect the plant this month.

But while one manufacturer has reduced its projections, another has taken a step to enter the market. GlaxoSmithKline submitted its application to the FDA for approval of its vaccine in May.

NSAID warnings from FDA

The Food and Drug Administration has asked for labeling changes on all nonsteroidal anti-inflammatory drugs, for both prescription and over-the-counter products.

The agency is asking that manufacturers of all OTC NSAIDs, such as ibuprofen, include more specific information about the potential for gastrointestinal bleeding and cardiovascular risks associated with the popular pain relievers. The FDA exempts aspirin from the new recommendations, noting that it has been clearly shown that aspirin reduces the risk of serious adverse cardiovascular events in certain patients.

The agency is also asking that black-box warnings be carried by all prescription NSAIDs, including Celebrex (celecoxib0, the only COX-2 selective NSAID still on the market. The warnings should highlight the potential for increased risk of cardiovascular events as well as gastrointestinal bleeding associated with their use.

New pertussis vaccine OK'd by FDA

On June 10, the Food and Drug Administration approved the first booster vaccine that provides protection from pertussis for adults up to age 64 as well as adolescents. The vaccine, Adacel, also includes protection from tetanus and diphtheria.

The FDA approved a pertussis, diphtheria and tetanus booster, Boostrix, for adolescents in May.

Both vaccines are now available to combat the growing numbers of pertussis cases recently identified in teens and adults. Pertussis immunity from early childhood vaccinations wears off, leaving adults and adolescents susceptible to the disease, which they can then transmit to others.

Although not necessarily a serious illness in adolescents and adults, pertussis can be fatal in infants, particularly newborns who have not yet been fully vaccinated against pertussis.

Since 1980, the rates of reported pertussis cases have been increasing in adolescents and adults, as well as young infants. Adolescents and adults have been implicated as the source of pertussis infection for susceptible young infants and other family members, the FDA said.

Tight glucose control saves the diabetic heart

When patients with type 1 diabetes keep their blood sugar tightly controlled, the risk of cardiovascular disease is significantly reduced, says a study presented at the American Diabetes Assn. annual scientific sessions in San Diego last month.

This is the latest revelation from the Diabetes Control and Complications Trial, which already has revealed that when those with diabetes keep blood glucose as close to normal as possible, they are less likely to experience eye, nerve and kidney damage. These latest data revealed that 52 of the patients receiving usual care experienced 98 cardiovascular events. Only 31 of the patients receiving the intensive intervention experienced a total of 46 events.

"The longer we follow patients, the more we're impressed by the lasting benefits of tight glucose control," said Saul Genuth, MD, one of the authors and professor of medicine at Case Western Reserve University School of Medicine in Cleveland.