Sunday, October 25, 2009

The CDC Continues to Misinform: Which Came First, the Chicken Egg Or the Vaccine? (Update)

Given the latest news on the H1N1 virus and Obama calling the outbreak a national emergency, a few things should raise questions with reporters in the media, but they really aren't.

The big question is; why is the CDC continuing with its misinformation on how the vaccine is developed and the mutation of the virus?

First, to the virus mutating; it is as was pointed out in this thread.

Meanwhile, the CDC has stated:


Virologists received a bit of a scare this week when researchers at the Adolfo Lutz Bacteriological Institute in Sao Paulo, Brazil, reported that they had isolated a mutated H1N1 virus from a patient who had recovered.

But academic researchers and scientists at the CDC discounted the report, noting that there were no changes in the portions of the virus that would alter its ability to spread or its pathogenicity.



But wait, what are investors concerned about?

Containing The Mutating H1N1 Flu Virus:

(NASDAQ:NVAX), (NYSE:AZN), (NYSE:NVS), (NYSE:SNY)


BioMedReports.com, the news portal covering the biomedical sector that delivers financial and investment intelligence to a community of highly informed investors has initiated a special report on news of the mutation of the H1N1 Flu virus and it examines which companies may be able to help.

The new strain of influenza appears to have mutated to become more infectious for humans, the online edition of science magazine Nature reported, referencing research by a team including Professor Yoshihiro Kawaoka of Tokyo University's Institute of Medical Science.

Dr. Kawaoka is very well known for the breakthrough of artificially-made influenza, as well as for remodeling ebola virus into a safe one which increases only in particular cells.

Although the new strain of Influenza identified this year that spread widely from Mexico seems to have converged, the next one is said to be coming in already without a sound; the mutant virus.

Companies with both existing and new products for treating the swine flu are covered in the special report.

They include:

Novavax, Inc. (NASDAQ:NVAX)
AstraZeneca PLC (NYSE:AZN)
Novartis AG (NYSE:NVS)
Sanofi-Aventis SA (NYSE:SNY)


I posted the story on the mutation here.

And I posted about GlaxoSmithKline and their delay on a H1N1 vaccine even though they had the first contracts to supply the vaccine.

Now they are a few months from distribution of a vaccine, while labs listed above will be distributing a H1N1 vaccine in July. This would indicate Glaxo IS working on a new strain.

The fact that the H1N1 virus is mutating, but the CDC is denying that it is and the World Health Organization has denied that the H1N1 virus was man-made, when stories now show that its origin came from Russian scientists should make one pause and ask why are these organizations not telling the truth.


As for how the vaccine is developed? Most labs use a cell-based technology which include companies like Novartis and Sanofi.

Vaccine maker Novartis said Friday it has completed production of its first batch of H1N1 influenza vaccine weeks ahead of schedule, allowing the company to move forward with testing. GlaxoSmithKline is still working on its swine flu shot.

Novartis, a Swiss company that is building a manufacturing operation in Holly Springs, says its cell-based manufacturing technology allows it to produce a vaccine in a matter of weeks. The traditional method of growing the virus strain in eggs takes months. Novartis is developing the vaccine in Germany.

“The speed advantages of our cell-based production approach and our unwavering commitment to address this public health emergency have resulted in our ability to provide the fastest possible response to this outbreak,” Dr. Andrin Oswald, CEO of Novartis Vaccines and Diagnostics, said in a written statement.


(...)

With the first clinical trial of its cell culture-based seasonal influenza vaccine commencing in the US, Sanofi Pasteur has demonstrated the production scale potential of a cell line in a successful bioreactor run of 20,000L.


And as I pointed out previously, GlaxoSmithKline uses the cell-based production.

For more than 30 years, vaccines have been produced inside chicken eggs. GlaxoSmithKline and other companies are researching ways to avoid the lengthy egg process by growing vaccines in cell-based or tissue-based cultures. However, Garnier said he was "cynical" about reaching landmark developments in tissue-based vaccine production.

(emphasis added)



As for the CDC and it comments on how the vaccine is produced?

Dr. Thomas R. Frieden, director of the U.S. Centers for Disease Control and Prevention, told a news conference Friday, "We have already had millions of cases of pandemic influenza in the United States, and the numbers continue to increase."

At the same time, he said, production delays continue to hamper distribution of the H1N1 swine flu vaccine.

The vaccine is growing more slowly in egg-based cultures than manufacturers had anticipated, resulting in fewer available doses at this time, Frieden explained
.

(emphasis added)



So the question is why does the CDC continue to misinform the public? Could news that the virus is mutating cause distrust in a vaccine that may be obsolete in fighting a mutating virus?

Or would investors like Warren Buffett stand to lose their investment in companies like Sanofi if the earlier production of the vaccine was found to be useless against a mutating strain?

Sanofi gets $190 million Swine Flu vaccine order from U.S.

Armed with a $190 million order from the U.S. Department of Health and Human Services, Sanofi Pasteur could begin production of a swine flu vaccine at one of its two Swiftwater facilities as soon as next month.

Announcing the news Monday, Sanofi noted the order was issued under an existing pandemic stockpile contract with the U.S.

News comes just two weeks after the U.S. Food and Drug Administration issued a license for Sanofi's new, $150 million, 140,000-square-foot vaccine manufacturing plant at Swiftwater. That's where initial work would begin, while an existing plant at the complex continues work on seasonal flu vaccine. Ultimately, both could produce the new vaccine.



(Emphasis added)

That is the production of the swine flu vaccine as soon as next month in June. Just previously posted on this site, in an article on May 20th, Sanofi was waiting to get the seed strain. And it would take at least until September to begin production.

So how is it that a company can go from 6 days ago not having a seed strain to producing the vaccine next month?


Lot's of questions that the news media is not asking.

Update:

This was a concern that was stated on this site...

As I stated awhile back on a previous thread, why would governments contract with a company that would use a process that is, (when compared to other companies) months behind in developing a vaccine?

The fact is, Glaxo doesn't, it uses cell-based technology too.

So don't be too surprised to see news in the fall that the virus is spreading faster and the severity is getting stronger and a new vaccine is being developed...
Swine flu vaccines discarded

NAIROBI, Kenya, Oct 23 - The World Health Organisation (WHO) says that scientists have discarded a first set of vaccines that had been developed for the prevention of H1N1 influenza virus commonly known as swine flu.

WHO Country Director Dr David Okello said on Friday that this was because of the dilemma there was a possibility of the highly contagious virus mutating into a more severe form.

“The scientists have moved to the second level because of the dilemma we are all facing,” Dr Okello said.

He said if the virus mutated, the people who are developing the vaccine would have to advance their technologies to address the problem.

“There will be a continuous re-checking of the vaccines even after development. Probably we will get a first phase of the vaccine and then a second phase and so on depending on the nature of the virus,” the WHO representative said.

He said the international health body was working closely with the manufacturers and expects the issue of mutation to be addressed.

He assured that Kenya was on the priority list to access the vaccine once it was available and clarified that the vaccine was yet to be released contrary to reports in a section of the press that a vaccine was already in the country.


Related threads:

Is There a Stronger Mutating H1N1 Virus in Brazil?

Osaka Fails to Report Tamiflu Resistant H1N1 Virus Mutation

Swine flu resistance testing to grow after US case

The Mutating Virus: A/Sao Paulo/1454/2009(H1N1)

4 comments:

Anonymous said...

The only commercially avaialbe cell based H1N1 vaccine is Baxter' s H1N1 vaccine. Novartis has a plant in Germen producing cell-based flu vaccine but H1N1 vaccine supplied to Europe and US is made in Italy and UK, which are cell-based. Novartis' cell based H1N1 vaccine is for pilot clinical study only. Sanofi and GSK is trying /establishing plant use cell culture technich but all current product is egg-based.

Tom said...

The government paid Novartis 481 million for their cell-based vaccines.

WASHINGTON, Jan. 15 (UPI) -- The U.S. government said it has awarded a $487 million contract to Novartis Vaccines and Diagnostics for cell-based flu vaccines.

That goes beyond "pilot program" as you state.

Moreover, in their own press release, the following is stated.

http://www.novartis.com/newsroom/media-releases/en/2009/1322241.shtml

Novartis successfully demonstrates capabilities of cell-based technology for production of A(H1N1) vaccine
First results achieved with A(H1N1) wild type strain shows significant time savings of cell-based production over egg-based manufacturing approach confirming its value in pandemic situations.
Based on this success Novartis expects to be able to achieve rapid production and scale up of influenza A(H1N1) vaccine manufacture with reassortant seed.
More than thirty governments have made influenza A(H1N1) vaccine supply requests to Novartis for cell-based and egg-based antigen and MF59®.

(...)

"The speed advantages of our cell-based production approach and our unwavering commitment to address this public health emergency have resulted in our ability to provide the fastest possible response to this outbreak," said Dr. Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. "This achievement is also a testament to the technical skills and innovation of Novartis Vaccines and Diagnostics people and our partners. I believe it highlights our reputation as a leader in influenza vaccine research, development and production."
Based on this success with the wild type, Novartis expects to be able to achieve rapid scale up of influenza A(H1N1) vaccine manufacture with reassortant seed which was provided by the Centers for Disease Control and Prevention (CDC) on May 27th. The company plans to start clinical trials with that vaccine in July and expects licensure in the fall of 2009.

(...)

The US Department of Health and Human Service's $289 million order in May 2009[1] with Novartis was the largest of the US government's commitments to influenza A(H1N1) vaccine ingredients.


As stated, it was the largest commitment to purchasing the vaccine which is not a "pilot program".

And you contradicted yourself in that the cell-based technology is available but then state it is a "pilot program".

There was a larger sum (921 million) then the 481 million given to Novartis to build the facility in the U.S.

However, the facilities overseas were supplying the vaccine as you noted.

gandolph said...

For a look at the number of confirmed swine flu cases (as reported by the CDC & WHO), in the US & the world, check out: http://www.peterdolph.com/2009/10/how-many-swine-flu-cases-are-there.html

Alan said...

"CDC Encourages Flu Shots, Dispels Fears" Read it at http://wp.me/pC3Xj-8c