Problem With Potency
The Centers for Disease Control and Prevention (CDC) reports Tuesday that a swine flu prefilled syringe intended for infants is being voluntarily recalled.
Sanofi-Aventis makes the thimerosal-free vaccine and is voluntarily recalling four lots of the pediatric H1N1 swine flu vaccine because it may have dropped in potency by 12 percent at the time it was released.
There is no safety concern and the vaccine should work anyway, the CDC announced in its recall notice.
The vaccine is intended for infants between six and 35 months of age. About 800,000 doses were distributed to health care providers.
The CDC discovered the potency problem as part of a quality assurance testing program.
"While the antigen content of these lots is now below the specification limit for the product, CDC and FDA are in agreement that the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response among persons who have received the vaccine," the CDC said.
The vaccine was released about a month ago so has likely already been used, but the warning would cover any syringes still left on the shelves. Doctors can return any supplies they have left.
Dr. Anne Schuchat, director of the National Center or Immunization and Respiratory Diseases tells the New York Times, “We think children who got the vaccine are fully protected, assuming they got the two shots we recommend for that age.”
She says parents do not need to contact their doctor.
The Sanofi-Aventis infant vaccine is the only thimerosal-free version licensed for young children, with the exception of the nasal spray which contains a live swine flu virus. Pregnant women are not advised to receive the live virus.
Altogether about 75 million swine flu or H1N1 vaccines in various forms have been made available to the public from the Paris-based company, reports Bloomberg. After the company ships the vaccine it maintains a sample batch and continues to test for safety and potency. When the vaccine was first shipped the shots passed the test.
According to the CDC, the swine flu has killed about 10,000 Americans and hospitalized another 200,000 since it hit the U.S. in March. But how the CDC knows these numbers is a mystery since U.S, health officials stopped counting swine flu cases in July, reports CBS News.
The CDC instead relied on a patchwork gathering of data while hospitals reported illness that could be the swine flu or something else.
Vaccine doses with the following lot numbers are included in the recall:
0.25 ml pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25):
0.25 ml pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70):