Monday, November 16, 2009

FDA approves fifth vaccine to protect from H1N1 Swine Flu symptoms in adults

November 16, 7:52
New H1N1 Vaccine Approved to Protect from Swine Flu Symptoms

The Food and Drug Administration (FDA) announced November 16th that it has approved a fifth vaccine to protect against the 2009 H1N1 virus, produced by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC.

What is the New H1N1 Vaccine?

Like the four previously approved H1N1 swine flu vaccinations, the new vaccine for H1N1 is an Influenza A (H1N1) 2009 Monovalent Vaccine, and will be produced in the same manner as the company's seasonal flu vaccine; that is, an established and licensed manufacturing process based on cultures from eggs.

The new H1N1 vaccine will be produced in multi-dose vials, and will contains thimerosal as a preservative. Thimerosal is up to 50% ethyl mercury.

What Are the Side Effects of the New Swine Flu Shots?

According to the FDA press release, "Potential side effects of this H1N1 vaccine are expected to be similar to those of the seasonal and H1N1 flu vaccines. The most common side effect is soreness at the injection site. Others may include mild fever, body aches and fatigue for a few days after the inoculation. As with any medical product, unexpected or rare serious adverse events may occur. The FDA is collaborating with other government agencies to enhance adverse event safety monitoring during and after the H1N1 2009 vaccination program."

In addition, the package insert indicates a smaller chance of headache, myalgia, and swelling at the injection site. It also warns that if the patient has suffered from Guillain-Barre syndrome in the past, this vaccine should likely not be used; and that those who are immunocompromised (have a very weakened immune system) may see a poor immune system response and not receive the flu protection against H1N1 swine flu symptoms.

There is no information on the possible side effects from the thimerosal, however.

No comments:

Post a Comment