By Rebecca Vesely, InsideBayArea, 9 Oct 2006
Although there is expected to be plenty of flu vaccine this year, some health providers say their shipments of a special mercury-free flu shot for children younger than 3 and pregnant women is delayed.
On July 1, California became the first state to require that flu vaccine given to pregnant women and children younger than 3 years old contain little or no thimerosal, a preservative that contains mercury that has been used in vaccines since the 1930s to prevent bacterial contamination.
The move was based on recommendations by the American Academy of Pediatrics and Public Health Service agencies made in 1999. Most other pediatric vaccines also no longer contain thimerosal as a precaution.
Only one manufacturer, Sanofi Pasteur, makes a flu vaccine for children that doesn't contain thimerosal. Three manufacturers — Novartis, GlaxoSmithKline and Sanofi Pasteur — produce a vaccine with trace amounts of thimerosal that can be administered to pregnant women.
Some health providers, including Kaiser Permanente, were told by Sanofi Pasteur this past week that their orders of the pediatric mercury-free vaccine would be delayed.
Kaiser Permanente Northern California expects to receive one-fifth of its order by the start of its flushot clinics on Oct. 14, or 19,000 doses. The health plan was told it will receive the rest of its total order of 103,000 doses by the middle of November, said Randy Bergen, a pediatric infectious disease physician at Kaiser Walnut Creek.
Right now, Kaiser officials plan to distribute what vaccine it has and ask members to call its flu shot hot line, at (800) KP-FLU11, to check availability of the pediatric vaccine as the flu season unfolds, Bergen said.
Flu shots are important for infants and toddlers because they lack previous exposure to the virus and so are at greater risk of falling ill, Bergen said. "It is worrisome as a pediatrician that I don't have the vaccine when we need it," he said.
Arthur Woo, program director of pharmacy services at Sutter Visiting Nurses Association and Hospice, said he has received less of the mercury-limited vaccine for pregnant women from Sanofi Pastuer than expected. But overall, the group has ordered more than 60,000 doses of flu vaccine and is encouraging people, especially the elderly and immune-compromised to get a flu shot.
Sanofi Pasteur expects to produce 8 million doses of mercury-free vaccine, said company spokeswoman Patty Tomsky, and has already begun sending it to distributors.
Tomsky said she had no knowledge of any shipment delays and emphasized that the Centers for Disease Control and Prevention recommends that people can get vaccinated as late as December and January.
But Kaiser's Bergen said that infants should get their flu shots early because they require two doses of the vaccine, one month apart.
The Alameda County Public Health Department received its order of mercury-free pediatric vaccine but is waiting on 600 doses for pregnant women.
The state Department of Health Services, which distributes its annual supply of flu vaccine to local health departments, ordered 15,000 doses special vaccine for pregnant women from Emeryville-based Chiron, which is now part of Novartis.
But Novartis on Sept. 18 told distributors it would not be producing its Fluvirin vaccine in single-dose pre-filled syringes without preservatives, as suitable for pregnant women under California's new law, said company spokeswoman Alison Marquiss.
Novartis is producing between 30 million and 35 million doses of its Fluvirin vaccine for older children and adults who are not pregnant, Marquiss said. That vaccine does contain thimerosal.
The state secured 15,000 doses of the special vaccine from GlaxoSmithKline, said a spokesman for the California Department of Health Services.
The California Medical Association is talking with its members to determine whether they are seeing delays in their orders, said association spokeswoman Karen Mikos.
The state Department of Health Services is also monitoring the situation, a spokesman said.
Overall, retailers are flush with flu vaccine this season and flu shot clinics are already under way. More than 100 million doses are expected to be available this season — a record, according to the Centers for Disease Control and Prevention.
Local drug stores and supermarkets do not carry the mercury-free vaccines required for infants and pregnant women, and most do not inoculate children. "People should check with their doctor or department of health for the mercury-free flu shots," said Jennifer Webber, spokeswoman for Safeway.
Patient advocacy groups such as the National Autism Association have pushed the Food and Drug Administration to more closely examine the link between thimerosal and autism and other disorders.
Kaiser's Bergen said given the choice between inoculating California children with flu vaccine containing thimerosal and having a shortage of thimerosal-free flu shots, he would choose the thimerosal vaccine.
"Children die of influenza every year," he said. "The risk of mercury exposure is theoretical. I'm going to go with the clear risk."
The latest snafus aren't the worst we've seen in the flu vaccine supply chain. In 2004, half the nation's flu vaccine supply went unfilled after Chiron experienced manufacturing problems at its plant in England and was unable to supply a single dose. Last year, supplies were delayed in what turned out to be a late and mild flu season.
"On a scale of best to worst it doesn't seem bad yet," Anthony Iton, Alameda County Health Officer, said.
Governor Arnold Schwarzenegger signed a bill on Sept. 28 that will require flu vaccine manufacturers and distributors to give more information about supply problems, and require providers to share information on inventories with health officials.
"We need transparency and we need better information," said Iton, who co-authored the bill, which was sponsored by Assemblywoman Wilma Chan, D-Oakland.
I read such news and I get sad. Am I the only one who sees the big picture?
First, creating a huge news wave that is saying that there are enough flu shots ready. Now there are delays. Not to mention that the shots which were announced as ready are actually imposing risks for the health.
Really. Using “people dying from influenza” argument to secure the profit for pharma corporations is just sad.
How many people are dying from AIDS? From tobacco? From alcohol abuse? From drug overdose?
Before falling completely for this hype, open your mind. Try to see the bigger picture. Who knows, maybe pharma corporations simply have flu shots which are due to expire. And all they need is to make sure that these are sold. To you. And yoru children. Under which sauce will it be sold, its up to politicians, PR departments and media.