FDA Approves Four 2009 H1N1 Vaccines

The U.S. Food and Drug Administration announced that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

“Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus,” Commissioner of Food and Drugs Margaret A. Hamburg, M.D., said this week. “This vaccine will help protect individuals from serious illness and death from influenza.”

The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines, FDA said.

”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,” said Jesse Goodman, M.D., FDA acting chief scientist, on Tuesday.

Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine, FDA said, adding that clinical studies underway will provide additional information about the optimal dose in children. The recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.

As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal. FDA noted that people with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated. The agency added that in the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.

For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects, according to FDA, may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and--in children 2 to 6 years old--fever.

FDA notes that, as with any medical product, unexpected or rare serious adverse events may occur. The agency said it is working closely with governmental and nongovernmental organizations to enhance the capacity for adverse event monitoring, information sharing, and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention.

Vaccines against three seasonal virus strains are already available and should be used, FDA said. However, they do not protect against the 2009 H1N1 virus. These latest four vaccines are designed to do that.

Industrial Hygiene Product Showcase

  • M-Power Defense System™ Impact 3 Glove

    M-Power Defense System™ Impact 3 Glove

    Sacrifice Nothing: Experience next level impact protection with the M-Power Defense System™ from Magid. Heavy-duty back-of-hand protection with a unique ventilated honeycomb design that offers extreme protection with 9 times more airflow and maximum flexibility. Try the unbeatable combination of lightweight Impact 3 protection and amplified grip! You can have it all. Try it FREE! 3

  • New Enhanced Sound Level Meter!

    New Enhanced Sound Level Meter!

    Casella Launches Its Enhanced 620 Sound Level Meter to Protect Workers from Noise-induced Hearing Loss. The new device offers significant upgrades such as time history profiling, voice notes and GPS. The new device offers significant upgrades over its predecessor, providing users with a greater understanding of noise in the workplace and easier, faster ways to record measurement data. 3

  • BAND V2 Wearable Heat Monitor/Alert

    BAND V2 Wearable Heat Monitor/Alert

    Need help with your heat program to meet the OSHA Heat-related Hazards NEP? The SlateSafety BAND V2 arm-worn monitor provides 24/7 connected real-time monitoring of heart rate, exertion levels, and core temperature. BAND V2 alerts workers and OH&S professionals before heat exposure injuries occur. Tough to withstand harsh environments, yet comfortable for workers and easy to use for you, BAND V2 can optimize work/rest cycles, promoting safety and productivity. Its powerful web-based platform and the new Go Mobile App helps you connect and protect workers from heat stress in real-time. Visit SKC at AIHce Booth 601 for a demo! 3

Featured

Webinars