The Food and Drug Administration said it has approved four vaccines against the 2009 H1N1 influenza virus, popularly known as swine flu, which caused the World Health Organization to declare a global flu pandemic this summer. Expected within the next four weeks, the vaccines were manufactured by CSL, MedImmune, Novartis Vaccines and Diagnostics, and Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group. According to the FDA, all four companies made the vaccines using the same processes, which the agency said have a long record of producing safe seasonal flu vaccines.
“The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines,” Jesse Goodman, FDA's acting chief scientist, said in a news release.
People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated, the FDA said. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines, with the most common side effect for the injected vaccine being soreness in the area where the vaccine was injected. For the nasal spray vaccine, common side effects are runny nose, nasal congestion or sore throat, and fever in children 2 to 6 years old.
Last week, Goodman joined HHS Secretary Kathleen Sebelius and experts from the National Institutes of Health and Centers for Disease Control and Prevention to announce
preliminary results of the clinical trials for the vaccines, which showed the 2009 H1N1 vaccines induced a robust immune response in most healthy adults eight to 10 days after a single dose. Clinical studies about the optimal dosage for children are ongoing and “findings are expected in the near future,” the FDA said.
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