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Novartis Receives Fast-Track Seasonal Flu Vaccine Approval

Posted by Jane Akre
Monday, November 30, 2009 10:43 AM EST
Category: Major Medical
Tags: Influenza, Flu, Swine Flu, H1N1, CDC, WHO

Seasonal flu shot has been fast-tracked by the FDA as made by Novartis.



IMAGE SOURCE: ©iStockphoto/ flu shot/ author: pressdigital

Novartis Flu Shot

A new flu vaccine has received a fast-track approval by the Food and Drug Administration (FDA).

Made by Novartis Vaccines, Agriflu is a one-time vaccine used to prevent seasonal influenza, not swine flu.

The FDA believes Novartis demonstrated that the vaccine induces levels of antibodies in the blood, reports CNN, but further study is needed.

Agriflu will be available in single-dose prefilled syringes for adults 18 and older. It is made in Siena, Italy with eggs and is available in Europe under a different brand name, Aggripal.

Novartis also produces Fluvirin, for seasonal influenza, not H1N1 or swine flu. 115 million doses of seasonal flu vaccine are distributed in the U.S. every year.

Swine Flu Update

U.S. health officials are seeing a number of serious bacterial infections among swine flu patients, many younger adults who are not normally vulnerable to bacterial infections.

“We are seeing an increase of serious pneumococcal infections around the country,” said Dr. Anne Schuchat of the CDC in a telephone briefing with reporters.

Patients and doctors need to keep an eye out for the infections and treat them quickly before the bacteria invades the blood and organs, creating a secondary infection, often seen among people who die from influenza.

Reuters reports that Denver showed 58 cases of serious Streptococcus pneumonia infections in October, when there might generally be about 20 cases. Many of those affected are under age 60.

The CDC estimates swine flu has infected at least 22 million Americans and killed 3,900 including those with secondary infections.

Seasonal Flu

Earlier this year, members of the public health community in Canada were buzzing about a series of studies in three Canadian provinces that seem to show people who got a seasonal flu shot last year were twice as likely to come down with the swine flu as those who didn’t.

Known as “the Canadian problem” by some scientists, word of the data spread through Canada and worldwide.

The World Health Organization (WHO) plans to go through the data to see if it is correct or flawed before it deters people from getting a seasonal flu shot.

Officials at the CDC are aware of the studies but reportedly have not found similar evidence in the U.S. 

Barbara Loe Fisher of the National Vaccine Information Center (NVIC) has urged that federal officials monitor the vaccination history of children who are sickened or die from swine flu to investigate the impact our increasing schedule of childhood vaccines has on chronic illness such as allergies and susceptibility to adverse effects from the flu vaccine. To date, no one is gathering that information.

According to a report in the British medical journal, The Lancet, the monitoring is important to separate normal disease rates from those caused by vaccines - such as 2,500 miscarriages that occur daily in the U.S. and 3,000 heart attacks.

No one really knows if they coincide with vaccinations. #

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