FDA Said RotaTeq Did Not Contain PCV1 Pig Virus DNA Snips Seven Weeks Ago
FOUND SAFE: 14 Year Old African American Male With Autism Missing in N. Hollywood, CA

TODAY: FDA Public Meeting To Discuss DNA From PCV1 in Rotavirus Vaccines

Rotateq-logo Vaccines and Related Biological Products Advisory Committee Meeting Announcement FDA Site for Full Meeting Details (Note, the announcement does not appear to have been updated to include the findings announced yesterday of both PCV1 and PCV2 in Merck's RotaTeq.)

Webcast Open To Public Register HERE

May 7, 2010 from 8:00 a.m. to approximately 4:30 p.m. Hilton Hotel DC North/Gaithersburg
620 Perry Pkwy, Gaithersburg, Maryland 20877

Agenda

On May 7, 2010, in the morning, the committee will review and discuss available data regarding the unexpected finding of DNA originating from porcine circovirus type 1 (PCV 1) in Rotarix, a U.S. licensed vaccine manufactured by GlaxoSmithKline and indicated for the prevention of rotavirus gastroenteritis in infants. The committee will discuss what additional steps should be considered to address this finding. In the afternoon, the committee will discuss and make recommendations on the use of advanced analytical detection methods not currently applied for the characterization of cell substrates, viral seeds, and other biological materials used in the production of viral vaccines for human use.

Meeting Materials

Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to the contact person on or before May 4, 2010
Oral presentations from the public will be scheduled between approximately 10:50 a.m. to 11:20 a.m. and 2:45 p.m. to 3:15 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 29, 2010. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 30, 2010.

Contact Information
Christine Walsh, R.N.
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-0314 FAX: 301-827-0294
e-mail: Christine.Walsh@fda.hhs.gov

FDA Advisory Committee Information Line
1-800-741-8138  (301-443-0572) code 3014512391. Please call the Information Line for up-to-date information on this meeting.
 
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Christine Walsh or Denise Royster at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site for procedures on public conduct during advisory committee meetings2.


Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).


Official FR Notice

Comments

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Benedetta

Theresa O
You are trying to make sense of double talk!

I too am amazed that - well - honest people just do not think the way liars think. I have taught a few, rare kids in school and you can see them do something and they lie so very convincingly to the point you are not sure that you saw what you saw! They are totally alien - not like the rest of us who stutter, drop their eyes, blink or something!

I mean it takes social ----paths to say there is a difference in giving a shot containing MMR+V or give an MMR shot and then an additional V shot the same day in the same little body.

It also takes a special person to state or write with such (I cannot find the words) that a child most likly will not react to the second MMR shot, after it has reacted to the first?????
Fortunally liars do take a while to get their story line down.

It has taken them since the early 80's to finally come up with kids seizing after the pertussin vaccine have - A genetic disorder call Darvats (?), or Dravats (?) and would have seized anyway.

They should have just included the MMR in with the DPT - Darvat theory.

But like all really good liars they think if they break it up and make it more complicated, try to make it look like they are really studying it - and are just so honestly, really confused (for now) that we will be more apt to believe them later on when they conclude it was Dravats all along.

After all how many parents are going to go to the doctor and say test this gene. We are lucky if the doctors catch an on going eplipesy problem from 9 months old (even if they are having grand mals) by the age of 17.

Theresa O

Thanks for the MMRV link, MinorityView. What I can't figure out is whether there isn't something a little ridiculous about the data used to make those recommendations. Apparently, the second dose of MMRV is less likely to cause febrile seizures than the first dose of MMRV, so the CDC appears to be recommending MMR and V separately (although on the same day?) for the first dose, then MMRV for the second. What I don't see anywhere is whether a specific set of children was studied, and compelled to get the second dose of MMRV after seizing after the first dose of MMRV. I mean, it's likely that there would be fewer seizures reported with the second dose, because what doctor is going to give a kid MMRV again after the kid seized the first time? So the susceptible population eliminates itself from the second set of data. I've read this paragraph (below) over and over, and I can't tell whether kids who seized after MMRV dose #1 were given MMRV dose #2. It seems to me that seizure rates were compared, but that was as far as the math went.

"Risk for Febrile Seizure After Second Dose of MMRV Vaccine

Rates for febrile seizures are lower among children aged 4--6 years (the recommended age for the second dose of MMRV vaccine, MMR vaccine, and varicella vaccine) than among children aged 12--15 months (14). In prelicensure studies conducted among children who received their second dose in their second year of life and 3 months after their first dose, the second dose of MMRV vaccine was less likely to cause fever than the first dose (12,13). Among children aged 4--6 years who received MMRV vaccine for their second dose, the rate of fever was similar to the rate following a second dose of MMR vaccine and varicella vaccine at the same visit (19).

Assessing the risk for febrile seizures after the second dose vaccination was not an initial objective of either postlicensure study. In light of findings from first-dose studies, the workgroup requested available data on febrile seizures risk after the second dose from both VSD and Merck. In the data that VSD provided in response to this request, the febrile seizure risk after the second dose was inferred from data among children aged 4--6 years, which is the age when the second dose is routinely recommended. In the data provided by Merck, second-dose subjects were children aged 1--12 years (>95% were aged 4--6 years) who had received MMR vaccine previously, with or without varicella vaccine (for most children in the MMR vaccine and varicella vaccine group, only a second dose of MMR vaccine was administered) (20). During 7--10 days following vaccination, the VSD study identified one febrile seizure among 84,653 children aged 4--6 years who received MMRV vaccine and no febrile seizures among 64,663 children the same age who received MMR vaccine and varicella vaccine administered at the same visit (17). No febrile seizures occurred during the 5--12 days postvaccination in either group in the Merck-sponsored study (25,212 children received a second dose of MMRV vaccine, and 24,788 received a second dose of MMR vaccine and varicella vaccine at the same visit) (20). Therefore, among children aged 4--6 years, postlicensure data do not suggest that children who received MMRV vaccine as a second dose had an increased risk for febrile seizures after vaccination compared with children who received a second dose of MMR vaccine and varicella vaccine at the same visit."

Natasa

Kristina "Do you think they'll at least update the package inserts to list the newly discovered viruses in the ingredients?"


Hilariously unbloodybelievable. Thanks for the laughs !!!!!

I agree, Garbo, their next step will be proactive damage control. "Talking" to journalists and such....

Theresa O

Following Natasa's link, check out the sneaky phraseology of the pharma shill (oops, I mean reporter). "responsible for the deaths of 500,000 infants each year, primarily in low- and middle-income countries." Have you ever heard a country described as "middle-income" before? Clearly, this phrasing was designed to make readers think "low- and middle-income families," and then think, "that could be me," and then line up for the contaminated shot. A better way to put it would have been "primarily in sub-Saharan Africa."

Sandra Lopriore

Angela Warner-

I a just said the same exact thing to my mom on the phone today!! They'll warn us about the E.Coli in the lettuce but forget about the Autism epidemic we are having!! This whole thing is sickening.

MinorityView

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5903a1.htm

for the CDC article on MMRV recommendations

Garbo

Lieutenant Col. Holly Franz, Lawrence Livermore National Labs: Our capabilities go beyond what's being discussed. We can measure the micro RNAs produced. We have the tools right now to analyze how the body of an individual reacts to a vaccine once given.

FDA: [crickets]

Kristina

Do you think they'll at least update the package inserts to list the newly discovered viruses in the ingredients?

Another problem shows up today

Maybe this has been posted already, but looks like more bad news today for the vaccine industry--check out the CDC's Morbidity and Mortality
Weekly Report re the MMRV vaccine(combined MMR and varicella)--sorry can't seem to post the link but it's up on the CDC site now.

Bob Moffitt

Update .. late Friday .. as usual ..

http://online.wsj.com/article/BT-CO-20100507-716126.html?mod=WSJ_latestheadlines

The Wall Street Journal breathlessly reports:

"FDA Panel Members Back Use of Merck, Glaxo Rotavirus Vaccines"

"Karen Midthun .. acting director of FDA's Center for Biologics and Research said the agency would be "very expeditious" in making recommendions about whether either vaccine should be used."

And just who benefits most from expediency? The children .. or .. the stockholders of Merck and Glaxo?

I don't know about you .. but .. who the hell is running the FDA? Why in God's name has the FDA allowed our children to become pawns .. sacrificial lambs .. for the benefit of those heavily invested in the stock market?

Natasa

"There are some very difficult times ahead," warned panel chairman ... "Using these technologies, we are going to find unknowns, and it's going to be very difficult for the agency to convene an advisory committee every time we find one of these agents," he said.

http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/19996

Meaning the agency should be given a blank to say "no known risk to humans" and "benefits outweigh the risks" every time an unknown is found? Without even having to consult the panel. Easy peasy. Why waste everyone's time, when there is only one possible outcome every time a contaminant is uncovered? Difficult times ahead indeed.

Garbo

I second Vicky Debold ROCKS! I LOVE that she got in the bit about HERV-K contamination of MMR and Varicella. And Barbara Loe Fisher, too! And whoever that lady Holly Franz (?) is from Lawrence Livermore National Labs!

There seemed to be a general acknowledgment/resignation that the cat is out of the bag, the new techniques are going to be used, and they'd better get on board so they can be ahead of the curve rather than behind. Most interesting is good old Bruce Gellin. His takeaway (paraphrased) is "don't try this at home" even though the costs of these tests are coming down radically, and "we probably need to talk to the the journals", to develop strategies for evaluating the studies and data that are going to inevitably be coming from disparate sources -- like people who don't work for pharma companies. That smells to me like an effort at suborning prior restraint of publication of studies they don't want validated. Wonder if he's ever lobbed a call in to Neurotoxicology. Note to Bruce: You might as well give it up. The monkeys are winning this one, in the end. This ain't Simpsonwood 1999.

Kim Spencer

I met a 21 month old today who had rotavirus vaccine at 2 and 5 months (amongst the fistfuls of the others). He IS wasting. His bowels are beyond a mess and they can't find a food he can tolerate. No immunologist, GI doc, neurologist as even gotten close to a guess at what's wrong. Well, now the parents know. I just hope they find the lot #s and get the money they are going to need to bring this baby back from very serious illness.

Alison MacNeil

And this little piggy went to...jail.

Angela Warner

Corruption at it's finest. Which vaccine are they going to use? Most on the panel are saying they are pretty comfortable with the PCV 1, but not so with the PCV 2 until they have more information.

Yet as it looks right now, they're going to continue to use good 'ole Piggy boys (oops, I mean Paulie's) vaccine. WTF??? Did I miss something?

Angela Warner

Vicky DeBold!!!!!! I Love You!!! You ROCK! Thank you for your tireless efforts to make sure our kids are safe and parents are informed!

Jack

Maybe they'll just add PCV to the schedule and charge twice the price. Problem solved.

JenB

I think Paul Offit was quoted as saying that vaccines are so much safer today because they actually contain less antigen.

Well, do they?

Sue Cranmer

I can imagine the additional steps to address this problem- the same ones taken at Simpsonwood. COVER IT UP, COVER IT UP, DENY IT, DENY IT & CALL ANYONE WHO SPEAKS THE TRUTH A LIAR AND A KOOK!!!

Angela Warner

23 states. 19 sick. E.Coli contaminated lettuce again... An immediate recall is issued. People have been hospitalized. This is dangerous, folks.

http://news.yahoo.com/s/ap/20100507/ap_on_bi_ge/us_lettuce_recall

But we have unexpected findings of porcine virus DNA (two types) known to cause wasting disease in pigs. No problem. It doesn't matter one bit. We assure you, it's safe. Any thing you may hear about people getting sick, developing autism or another disability, or dying after receiving a vaccine or a series of them; well it's just plain hogwash.

The country can go without lettuce for awhile, but we can not let them go without these life saving vaccines because unlike lettuce, vaccines are the greatest medical miracle EVER!

Now back to E.Coli and the lettuce producer we've narrowed this down to in Yuma, AZ.

Craig Willoughby

I'm actually taking bets on how this will be spun.

My bet is that the "Science-based" clowns(who are realistically more like Scientology-based clowns) will all say, "Look, the FDA is doing their job! Nothing to worry about here..."

I can only wonder how bad this is going to back-fire. Will they continue to blame parents of vaccine injured children for the decline in vaccine rates, or will they start pointing the fingers at the watchdogs who are falling asleep at the job.

I know where my bet lies...

Jack

Well, GSK commits to new cell bank. Big expense and cost, but will be another case of, "Well, we're removing it, but even though we are, it was safe and fine." Offit already has his spin for that. He just has to do a find and replace with PCV and thimerasol and he can spit out the same statement.

Jack

This will be interesting. I'd actually have criticized FDA for spending the last decade ONLY caring about this one issue: viral contaimination of cell culture. I'd say they turned a blind eye to everything else to focus on this. All industry costs and effort have been in this one aim.

And now, if they gloss over it and say it is fine, well, that'd be a sad.

I'm sure that's what they'll say, but quietly industry will have to stop using trypsin and serum, which is what they've been pushing hard for anyway. That will have a huge impact on industry costs.

Natasa

I feel for the FDA guys.

Consider this: an ouside research team brings about this discovery (albeit one they themselves didn’t anticipate or welcome) and puts FDA in the hotspot – use of deep sequencing technique to check for vaccine contaminants is REALLY something that FDA should have pushed for as soon as the technique became available. We can only speculate why they didn’t …

The outcomes of the afternoon session will be very very interesting and indicative of where FDA stands right now, and how good they are of wriggling their way out of this “unconfortable” situation.

In the morning session “The committee will discuss what additional steps should be considered to address this finding (of contamination)”.

But in the afternoon session “the committee will discuss and make recommendations on the use of advanced analytical detection methods not currently applied for the characterization of cell substrates, viral seeds, and other biological materials used in the production of viral vaccines for human use.”

Now this is something HOT HOT HOT. If they do recommend these new “advanced analytical detection methods” all hell just might break lose for themselves and their pharma friends. God only knows what else is hiding in those biologicals that deep sequencing can reveal!!! If they push for manufacturers to check their products, they could well open the Pandora’s box. Very very risky.

If on the other hand they say something like “oh there is this new techique, it is your decision whether to use it or not…”, then FDA will leave themselves open to future criticism in case any naughty naughty external parties again have the cheek to carry out random deep sequencing on those products and again reveal some inconvenient contaminants…

Damned if they do, damned if they don’t.

I really feel for them, poor old FDA.

Shari Blacnhard

My son and I are recovering from a Lyme infected tick - aka Lyme Disease and Rocky Mountain Spotted fever along with EBV virus and probably more since we haven't had the funds to further our testing. My son was damaged by vaccines in the late 80's when he was a toddler. The research I do about Lyme often leads to the autism community.
There is much for the public to learn about taking charge of their own health. I am off to work now- so only had a moment now... but will be home during the day for bit and will tune in as I can......

Speak out people:)

Jack

This will be a big deal in industry. They are asking some of the right questions. They are taking this seriously.

Bob Moffitt

Why should we expect the FDA to do anything different than the financial regulatory bodies did when they first learned of the problems regarding "over-extended" mortages courtesey of Fannie Mae and Fredie Mac?

They did absolutely nothing .. instead .. they accused those demanding immediate steps to prevent the pending collapse of the financial markets of unwarranted fear mongering.

I suspect our public health agencies are following the same "no problem here, let's move one" road our financial regulatory agencies traveled just before they collapsed.

AnneS

Should be a recall, not only for the pig virus, but because it STILL causes intesusseption (see VAERS)

Beth

Will there be a recall after today's meeting? History tells us it's unlikely...The SV40 story of monkey-virus contaminated polio vaccines in the 50's and 60's will likely be replayed in this instance.

If you haven't read the SV40 book yet, you should - especially given today's news of this wasting pig virus contamination. "The Virus & the Vaccine" - the true story of polio vaccines contaminated with cancer causing simian virus. It's a great read.

If history repeats itself, here's what we can expect today:

"So it's an animal virus, and yes, there's quite a bit of evidence it causes problems in small animals in the lab. But it will be very difficult to detect problems in people and to then associate those problems back to the vaccine. Therefore, we will keep shipping the contaminated vaccines, keep administering them to children and we'll implement measures to remove the pig DNA in future batches. The small theoretical risk of vaccine injury is very much outweighed by the overall risk of decline in public faith in our almighty vaccine program."

Hope I'm wrong...but I think the unpleasant and injurious sacrificial nature of the vaccine program will be exposed for what it is today.

DebinIL

"Calm down, everyone. The government is not here to create disorder. We're here to preserve disorder" - Altering quote from a Former Chicago Mayor. :)

Teresa Conrick

"Note, the announcement does not appear to have been updated to include the findings announced yesterday of both PCV1 and PCV2 in Merck's RotaTeq."

Does not surprise or shock. Let's see when and if it is updated. It is negligent and just further illustrates the lack of transparency. Watch dogs vs guard dogs there?

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