H1N!1 Gone!

Goodbye swine flu! Epidemic seems to be over

Excerpt:

Is the U.S. swine flu epidemic over? Federal health officials won't go so far as to say that, but on Friday they reported for the fourth week in a row that no states had widespread flu activity.

U.S. cases have been declining since October. An official with the Centers for Disease Control and Prevention says swine flu cases are still occurring and are likely to continue a while longer at some level.

But another expert said a future large wave of cases now seems very unlikely.

Comment: Sure glad I bothered to get the shot! ?

H1N1 shot available at Atlanta airport

Seen today at the Atlanta airport. H1N1 shots available (I was in the C terminal) for $ 22.

I was in a rush so I did not get one

Vaccine production: a billion chicken eggs

How the H1N1 vaccine is made

Excerpt:

The most striking feature of the H1N1 flu vaccine manufacturing process is the 1,200,000,000 chicken eggs required to make the 3 billion doses of vaccine that may be required worldwide. There are entire chicken farms in the US and around the world dedicated to producing eggs for the purpose of incubating influenza viruses for use in vaccines. No wonder it takes six months from start to finish. But we'll get to that in a minute.

The most commonly used process for manufacturing an influenza vaccine was developed in the 1940s -- one of its co-inventors was Jonas Salk, who would go on to develop the polio vaccine -- and has remained basically unchanged since then. The process is coordinated by the World Health Organization and begins with the detection of a new virus (or rather one that differs significantly from those already going around); in this instance, the Pandemic H1N1/09 virus. Once the pandemic strain has been identified and isolated, it is mixed with a standard laboratory virus through a technique called genetic reassortment, the purpose of which is to create a hybrid virus (also called the "reference virus strain") with the pandemic strain's surface antigens and the lab strain's core components (which allows the virus to grow really well in chicken eggs). Then the hybrid is tested to make sure that it grows well, is safe, and produces the proper antigen response. This takes about six to nine weeks.

Comment: Still awaiting the opportunity to have the shot!

H1N1 vaccine: adjuvants, thimerosal, and chicken eggs

Why You Can't Get the Swine Flu Vaccine

Excerpt:

Though the swine flu is widespread in 46 states many Americans are still waiting to get their vaccines. The Obama administration blames the shortage on manufacturing delays at the five firms making these products. But production issues only explain part of the shortfall. Also to blame are a series of policy decisions that reflect our extreme caution when it comes to these products.

From a regulatory standpoint, vaccines are unique in many ways. Since we distribute them widely to otherwise healthy people, they deserve careful oversight. But right now we are shunning new, superior vaccine science by being overly cautious.

On Saturday, when President Obama declared the outbreak a national emergency, he enabled the suspension of federal rules in order to speed the distribution of treatments. Yet less than half the projected vaccine has been actually shipped. Supply is far below the government's estimate of 40 million ready vaccines by November.

The first fateful policy decision, made last spring, was to forgo vaccine additives—called adjuvants—that activate the immune system and make shots more potent. Adjuvants allow a smaller supply of vaccine stock to be stretched across more doses. These adjuvants are included in H1N1 vaccines world-wide, but not in the U.S.

Why do adjuvants matter? An adjuvanted H1N1 vaccine being used in Europe contains 3.75 micrograms of vaccine stock. The same vaccine in the U.S., without the adjuvant, requires 15 micrograms of vaccine for equal potency. If we used adjuvants, we could have had four times the number of shots with the same raw material.

The second cautious decision was to require that the H1N1 vaccine be a single shot. The government demanded single-dose syringes because they contain smaller amounts of thimerosal than multi-dose vials. This mercury-containing vaccine preservative continues to stir concern it can trigger childhood autism, even though this has been firmly disproven.

The third policy decision was to stick for too long with a proven, but slow process for making flu shots that uses chicken eggs to grow the raw vaccine material. Shots can be made much faster using mammalian cells to grow vaccine, and this process is already being used in Europe. The cell-based vaccines are unlikely to be approved in the U.S. Our precaution when it comes to vaccines means we don't easily embrace novel technologies, even if the Europeans would part with some of their limited supply.

Comment: Interesting!

H1N1 vaccine bottlenecks

H1N1 vaccine production running weeks behind

Excerpt:

The federal government originally promised 120 million doses of swine flu vaccine by now. Only 13 million have come through.

As nervous Americans clamor for the vaccine, production is running several weeks behind schedule, and health officials blame the pressure on pharmaceutical companies to crank it out along with the ordinary flu vaccine, and a slow and antiquated process that relies on millions of chicken eggs.

There have been other bottlenecks, too: Factories that put the precious liquid into syringes have become backed up. And the government itself ran into a delay in developing the tests required to assess each batch before it is cleared for use.

In depth article on egg based vaccine production: Egg-Based Production of Influenza Vaccine: 30 Years of Commercial Experience

H1N1 vaccine: low yield and FDA footdragging behind delays

Vaccine Output Falls Short - Less Than Half of Expected Supply Is Delivered

Excerpt:

The U.S. has purchased H1N1 vaccines from Sanofi-Aventis SA, Novartis AG, CSL Ltd., GlaxoSmithKline PLC and and MedImmune, which is a unit of AstraZeneca PLC.

The process has been slower than usually seen with seasonal vaccines. Viruses for both vaccines go through a purification process after being grown in eggs.

One problem is that Glaxo, which has contracted to provide 7.6 million doses of vaccine to the U.S., has yet to get Food and Drug Administration approval for its vaccine.

A Glaxo spokeswoman said she couldn't speculate on the timing of approval. The FDA declined to comment.

Novartis, which contracted to make 90 million vaccine doses for the U.S., saw a yield just one-fifth of what was expected after working with the first H1N1 "seed" virus to grow the vaccine. Novartis and other manufacturers are now working with another seed virus that they hope will yield better results.

Novartis officials said they expect to be able to produce 90 million to 120 million doses by year end, suggesting the U.S. likely won't get its entire order filled until the first part of next year, as the company is also supplying vaccine to other countries.

The head of Novartis's vaccine business, Andrin Oswald, said the low yield was the main reason for production delays. But he also said the U.S. request for a greater amount of its vaccine order in single-dose syringes was slowing the process.

Comment: Is there a way to develop the vaccine without eggs?

Question: Do you intend to get the H1N1 shot?

CDC: H1N1 flu vaccine to be ready by early October

Excerpt:

The H1N1 flu vaccine will be available earlier than had been expected, the director of the nation's top disease agency told CNN on Monday.

"We think the first doses of some of the vaccine forms should be available in about three weeks," said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention.

Previously, the CDC had been predicting the vaccine would not be available before middle or late October.

Frieden said that the vaccines appear to confer protection from the virus eight to 10 days after they are administered.

The news about the vaccine against H1N1, also called swine flu, comes a week after researchers concluded that a single injection would suffice to protect against the virus.

Health officials are urging that pregnant women, school-age children and anyone with underlying health conditions, like diabetes, heart disease or lung disease, get the swine flu shot.

Comment: Both Kathee and I had our regular flu shots this weekend. Question for readers: Do you intend to get the H1N1 shot this year? Why or why not? I'll go first: yes as soon as it is available. Why? better safe than sorry. I appreciate your views and comments.