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Caroline Boyce

Rapidly Produced Flu Vaccine Wins F.D.A. Approval January 17, 2013

Filed under: Family,Health and Fitness — Caroline Boyce @ 2:32 pm
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I want to share this as I found this article to be very interesting since I am one of those who cannot take the vaccine due to being cultured in eggs.

By  Andrew Pollack 

Published: January 16, 2013 

SOURCES: Chicago Department of Public Health, Medical Director Dr. Julie Morita

Copyright © 2013 Chicago Tribune Company, LLC

vaccination generic500A new type of flu vaccine won regulatory approval on Wednesday, and its manufacturer said that limited supplies are expected to be available this winter.

The vaccine, developed by a small company called Protein Sciences, is made with a process that does not require the virus to be grown in chicken eggs, as is now generally done. That means a vaccine could be ready weeks earlier in the event of a pandemic.

“This approval represents a technological advance in the manufacturing of an influenza vaccine,” Dr. Karen Midthun, a senior official at the Food and Drug Administration, said in a statement announcing the agency’s approval of the product, which is called Flublok.

The approval comes during one of the more severe flu seasons in recent years, with many Americans rushing to find diminishing supplies of vaccine and spot shortages being reported.

Manon Cox, the chief executive of Protein Sciences, said the company could have about 150,000 doses ready to distribute later this flu season. That is a relatively small amount, but it could be particularly helpful for people who do not get flu shots now because they are allergic to eggs.

A spokeswoman for the F.D.A. said the timing of the approval was unrelated to the current flu season.

Most flu vaccines are made by growing the virus in chicken eggs, then inactivating or killing it, a long process.

Flublok, by contrast, consists only of a protein — hemagglutinin — from the virus. The protein is made by putting the gene for hemagglutinin into a virus that infects insect cells. Those cells, from the fall armyworm, are grown in culture and churn out the protein. Neither eggs nor the live virus are used, though viral genetic information is needed.

While new for flu, such protein-based vaccines are used to prevent some other diseases.

Protein Sciences, a privately held company in Meriden, Conn., first applied for approval nearly five years ago. It was turned down twice, in part because of the novelty of using insect cells. “Every time we were asked to do more and more studies to prove that this cell substrate was safe,” Ms. Cox said.

The company was close to bankruptcy in 2009 when it received a federal contract worth tens of millions of dollars to help develop its vaccine.

The vaccine is approved only for adults 18 to 49 years old. In a clinical trial, Flublok was about 44.6 percent effective against all influenza strains, not just the three contained in the vaccine, the F.D.A. said. As with current vaccines, Flublok will need to change each year to match the flu strains in circulation.

10 flu myths

photoFor those of you just tuning in (or hiding under a rock): We’re in the middle of a particularly horrible flu season. Here are 10 things you might be hearing about the flu, that are, well, just wrong.

By Ellen Jean Hirst, Chicago Tribune reporter  — January 17, 2013

I waited too long. It isn’t worth it anymore for me to get the flu shot.

Flu season still has many a week to thrive. It typically lasts from December through March. Getting a flu shot now will protect you for the rest of the season.

I already had the flu this season, so I don’t need a flu shot.

If you’ve had the flu, you’ll be protected from that strain, but several other strains abound. The flu shot protects against three.

My kid stayed home sick with the flu today, so I got a flu shot.

The flu vaccine doesn’t protect you same-day. It takes two weeks to reach maximum effectiveness for the season.

I didn’t get the flu shot, because it could give me the flu.

The flu shot does not give you the flu. The vaccine has a dead — inactive — virus, so it can’t make you sick.

I hate needles. I’m too scared to get the flu shot.

Needle-fearing healthy folks ages 2 to 50 can get a nasal spray vaccine, which has a weakened virus. The virus is so weak that you can’t get sick from it either.

If I wear a scarf or a mask, I probably won’t get the flu.

This generally will not prevent you from getting the flu. Though it’s recommended that you don’t touch your face too much, wearing a mask or scarf usually won’t prevent the flu.

I had the flu, but I feel better today. I must not be contagious anymore.

You are contagious up to seven days after the start of your flu illness. You also are contagious 24 hours before you show symptoms.

I got the vaccine, so I won’t get the flu.

You could still get the flu even if you’ve had the vaccine. You’re a lot less likely to get it, though.

I’m pregnant, so I can’t get the flu vaccine.

Pregnant women, especially, should get the flu shot.

I got the flu vaccine, so I don’t need to do anything else.

You should still be washing your hands, using hand sanitizer, coughing into an elbow, drinking plenty of fluids, getting enough sleep, eating healthfully and exercising regularly. And even then you might get it.


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