FDA Approves Four Vaccines for 2009 H1N1 Influenza Virus

September 16, 2009

(ChattahBox) — The U.S. Food and Drug Administration announced today 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, keeping officials on track to begin a mass vaccination campaign by next month, Health Secretary Kathleen Sebelius said.

“I am pleased to report that today, the Food and Drug Administration (FDA) has approved applications for vaccine for the 2009 H1N1 virus for four of the (five) manufacturers of the US licensed seasonal influenza vaccine,” Sebelius told US lawmakers.

FDA Commissioner Margaret Hamburg welcomed the approval in a statement.

“Today’s approval is good news for our nation’s response to the 2009 H1N1 influenza virus,” she said. “This vaccine will help protect individuals from serious illness and death from influenza.”

The vaccine treatments are produced by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and Sanofi Pasteur Inc, and the FDA said all four firms use the same processes.

The US government has purchased 195 million doses of swine flu vaccine and will make shots against the influenza A(H1N1) virus available free of charge starting next month, Sebelius said, although providers might charge a fee to administer them.

“The large-scale 2009 H1N1 vaccine program will begin mid-October with small amounts of vaccine becoming available the first week of October,” she said.

The fifth US manufacturer was also expected to be licensed, she added.

Preliminary data from clinical studies showed the approved vaccines “induce a robust immune response in most healthy adults eight to 10 days after a single dose,” the FDA said, noting that clinical studies underway would determine the best dose for children.

Vaccination will be on a voluntary basis, with priority given to five groups deemed to be at particular risk from the novel swine flu virus.

The US Centers for Disease Control and Prevention (CDC) has recommended that pregnant women, people in contact with infants, medical personnel, people aged six months to 24 years and adults under the age of 65 with underlying medical conditions should be the first to get the shots.

That is about 160 million people in the United States — less than the 195 million doses of vaccine purchased by the government, only about one third of which are expected to be ready by October.

The vaccine will be available as either a flu shot made with dead A(H1N1) virus, or as a nasal spray made with live, weakened virus, Sebelius said.

Clinical trials are underway to determine if there is “any harm” in having a seasonal flu vaccine — which is already available — at the same time as the vaccine against influenza A(H1N1), Sebelius said.

For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects 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.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA 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 (see information on the seasonal flu). However, they do not protect against the 2009 H1N1 virus (see information on H1N1 flu).

Source: Life Sciences World


2 Responses to “FDA Approves Four Vaccines for 2009 H1N1 Influenza Virus”

  1. FDA Approves Four Vaccines for 2009 H1N1 Influenza Virus … « Swine Flu on September 17th, 2009 7:19 am

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  2. FDA Approves Four Vaccines for 2009 H1N1 Influenza Virus | Life Sciences Blog on September 19th, 2009 3:08 pm

    […] and Human Services, these agencies include the Centers for Disease Control and Prevention….Read the Full Story VN:F [1.6.3_896]Rating: 0 (from 0 votes) Related posts:FDA Approves Vaccines for 2009 H1N1 […]

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