Misconceptions about Panvax H1N1 Addressed
CSL is committed to providing consumers and healthcare professionals with scientific, accurate information. Recently, there have been reported 'facts' about the Pandemic vaccine that are completely false. The inaccurate information sources include hoax emails and inaccurate blogs. For the most accurate information, CSL advises that consumers should seek advice from their healthcare professionals.
The following facts are provided in response to the misleading information being circulated.
MYTH: Experts believe the vaccine is several times more dangerous than the swine flu itself
FACT: There is no evidence that the vaccine is dangerous. It has undergone clinical trials and met the rigorous requirements for registration by Australia’s Therapeutic Goods Administration (TGA) and the US Food and Drug Administration (FDA).
The vaccine is identical to the seasonal flu vaccine apart from the flu strain used. CSL has been manufacturing seasonal influenza vaccines for over 40 years and the safety profile is well established.
The number of deaths associated with pandemic (H1N1) 2009 continues to increase, including a number of pregnant women. In addition, many thousands have been hospitalized with severe complications which is putting a large strain on intensive care units and other healthcare resources.
MYTH: Swine flu vaccines have not been thoroughly tested. Most medicines take about 6 years to develop and test.
FACT: New medicines do take several years to go through clinical trials. However pandemic influenza vaccines are not regarded by regulatory authorities as “new”. Pandemic vaccines are made using the same manufacturing process as for seasonal vaccines which have an extensive body of safety data. New flu vaccines are produced each year, the only change made to the vaccine is the flu strain used.
MYTH: Drug companies making the vaccine are so unsure of human safety they have applied for a special exemption to sidestep the drug testing protocols; and in Australia the vaccine is unregistered.
FACT: Panvax® H1N1 vaccine is registered in Australia and also in the US. Both regulatory authorities have evaluated the vaccine and declared it safe and effective. No protocols have been side stepped.
MYTH: The data sheet says the safety data for pregnant and lactating women are unknown.
FACT: The data sheet is a regulatory document and all statements must be supported by clinical trial data. No clinical trials have been conducted in pregnant women for flu vaccine. However it is widely accepted by regulatory authorities worldwide (ACIP, TGA, WHO) that the benefits of vaccinating pregnant women outweigh the risks. Pregnant women have been particularly affected by H1N1 influenza with deaths in Australia and many spending prolonged periods in ICU with severe respiratory disease.
MYTH: A possible side effect of the vaccine is Guillain-Barre Syndrome
FACT:The vaccine and the virus strain in the 1976 outbreak that some have associated with GBS are different from those used today. Studies on seasonal influenza vaccines subsequent to the 1976 vaccine have shown no or very minimal increased risk of GBS.
There is a far greater risk of GBS following an influenza-like illness than vaccination.
Approximately 1 in 100,000 adults develop GBS every year in the general population (regardless of whether they have received the vaccine).
MYTH: One of the ingredients is thimerosol (sic) which causes brain damage
FACT: The vaccine contains a small amount of thiomersal, a mercury-based preservative that has been used to ensure sterility in vaccines around the world for 60 years. The WHO Global Advisory Committee on Vaccine Safety Vaccines (GACSV) reviews the safety of thiomersal-containing vaccines on a regular basis and has concluded that there is currently no evidence of mercury toxicity in infants, children, adolescents or adults (including pregnant women) exposed to thiomersal in vaccines.Many well-conducted and thorough studies and reviews by expert panels in Europe and the US have shown that there is no evidence of developmental or neurologic abnormalities, such as autism, having resulted from the use of vaccines containing thiomersal.
Mercury occurs naturally in the environment and is present in some foods especially fish.
MYTH: Another ingredient is squalene
FACT: This is completely false. Panvax H1N1 vaccine does not contain any squalene whatsoever.