As India goes into overdrive to have indigenous H1N1 — or swine flu — vaccines ready by April 2010, there comes a warning from the US: not only does the new vaccine have the usual side effects associated with flu vaccines, it may also not provide good protection to most of the high-risk groups.
The packaging inserts for H1N1 vaccines on the US Food and Drug Administration (FDA) website say the vaccines can cause Guillain Barre Syndrome (GBS), a paralysing disorder. GBS was one of the side effects of the swine flu vaccine that reportedly killed 25 people in the US in 1976.
The USFDA website inserts — by manufacturers Novartis, CSL, Sanofi Pasteur and Med-Immune LLC — say the H1N1 vaccines are less effective in high-risk groups such as the elderly and those with HIV, cancer, or people who’ve had an organ transplant. Its safety and effectiveness in pregnant women, nursing mothers and children below 4 years has also not been established.
Manufacturers Novartis, Glaxo SmithKline, Baxter, and Sanofi Pasteur have agreed to do trials in India but are waiting for guarantee of purchase.
India has reported 10,233 cases of H1N1, and 315 deaths.