We need CAREFUL LONG-TERM STUDIES of their new vaccines. Here's why. MCM
H1N1 vaccines with novel adjuvants being developed for potential mass use by Meryl Nass, MD >All non-live vaccines need adjuvants to stimulate sufficient >immunity in recipients. All adjuvants in currently- licensed US >vaccines are aluminum-based. > >Many other vaccines adjuvants have been developed, and most are >stronger than those in current use, but their safety is not >established. > >Pandemics provide vaccine manufacturers with a major opportunity to >get these new adjuvants into use. New diseases can provide the >excuse to abbreviate testing of new vaccines; and the need to use >the vaccines soon after development means there will be NO long-term >data on safety available before mass use. > >Into this setting come two squalene-based adjuvants whose owners >have been struggling to get them into the US market. The prize >--licensure--will be worth billions of dollars, and if such >adjuvants attain routine use, many new, poorly-immunogenic vaccine >antigens will become components of marketable vaccines. If no >high-quality, long-term safety studies are performed by those >without a vested interest (this is a major problem with current >vaccines: no one is looking for problems), we may never know the >injuries caused by such vaccines. The US government has contracted with at least 5 pharmaceutical manufacturers to develop and produce H1N1 vaccines, using a variety of platforms and manufacturing methods. This is an excellent approach, since at this point no one knows which will succeed and how long it will take to obtain desired quantities of vaccine. A novel feature of the two H1N1 vaccines being developed by companies Novartis and Glaxo-Smith Kline is the addition of squalene-containing adjuvants to boost immunogenicity and dramatically reduce the amount of viral antigen needed. This translates to much faster production of desired vaccine quantities. Each company has its own proprietary adjuvant, acquired in each case at high cost and intended for the high-stakes business of rapidly producing vaccines for novel pandemics or biological warfare threats. Novartis' adjuvant is named MF-59, and Glaxo's is ASO3. We know they work beautifully to strengthen vaccine efficacy. But how safe are they? That is a very difficult question to answer. Novartis claims MF-59 has been used safely by over 40 million people. However, FDA has not seen fit to approve even a single US vaccine that contains these novel adjuvants. One European vaccine contains MF-59, and two European vaccines contain ASO4, which is a Glaxo adjuvant related to ASO3. Fluad (with MF-59) is only licensed for use in the over-65 population. This age group responds weakly to standard flu vaccines, and whether standard flu vaccines actually reduce flu cases in this age group is controversial. So a stronger vaccine may be indicated for this group. And as we age, we are much less likely to develop autoimmune disorders, so potential autoimmune side effects should also be less in this age group. However, in the 12 years since Fluad was approved in Italy for older adults (and later in the EU) I am not aware of any other vaccine containing MF-59 that has been licensed... even though MF-59 has been used in a large number of vaccine trials. Virtually all the scientific literature on this adjuvant has been produced by scientists working for the manufacturer, precluding an unbiased assessment of safety at this time. Glaxo's ASO4 is used in Fendrix (a Hepatitis B vaccine). Fendrix may only be used for people with kidney disease. Patients on kidney dialysis have a high rate of Hepatitis B infection, and a weak immune system. So they are good candidates for an especially potent vaccine against a disease to which they are highly susceptible, and these recipients are unlikely to develop autoimmune complications. Cervarix is a vaccine directed against several strains of human papilloma virus (HPV), licensed in both Europe and Australia, which contains ASO4. It is difficult to assess Cervarix' safety at this point in time, as data are limited. It is worth noting that FDA has delayed giving Cervarix a US license at least twice. The June 19, 2009 Science magazine discusses use of these "next-generation," antigen-sparing adjuvants for an H1N1 pandemic. It quotes Norman Baylor, director of FDA's Office of Vaccine Research and Review, who noted that antigen-sparing strategies benefit populations, not individuals. "You have to think about those trade-offs," Baylor said.log backgrounder: > > >All non-live vaccines need adjuvants to stimulate sufficient >immunity in recipients. All adjuvants in currently- licensed US >vaccines are aluminum-based. > >Many other vaccines adjuvants have been developed, and most are >stronger than those in current use, but their safety is not >established. > >Pandemics provide vaccine manufacturers with a major opportunity to >get these new adjuvants into use. New diseases can provide the >excuse to abbreviate testing of new vaccines; and the need to use >the vaccines soon after development means there will be NO long-term >data on safety available before mass use. > >Into this setting come two squalene-based adjuvants whose owners >have been struggling to get them into the US market. The prize >--licensure--will be worth billions of dollars, and if such >adjuvants attain routine use, many new, poorly-immunogenic vaccine >antigens will become components of marketable vaccines. If no >high-quality, long-term safety studies are performed by those >without a vested interest (this is a major problem with current >vaccines: no one is looking for problems), we may never know the >injuries caused by such vaccines. > >Meryl >Meryl Nass, MD >Mount Desert Island Hospital >Bar Harbor, Maine 04609 >W 207 288-5081 ext. 1220 >C 207 522-5229 >H 207 244-9165 >pager 207 818-0708 ><http://anthraxvaccine.blogspot.com>http://anthraxvaccine.blogspot.com ><http://www.anthraxvaccine.org>http://www.anthraxvaccine.org > > > >On Jul 5, 2009, at 9:08 PM, Mark Crispin Miller wrote: > >>Meryl, we're still here, leaving for BH on the 18th. (I meant it >>when I said I'd call you!) >> >>This didn't work?-- >> >><http://www.brasschecktv.com/page/658.html>http://www.brasschecktv.com/page/658.html >> >>You know Barbara? Some have asked me what her credentials are. >> >>And, finally, can you tell me in a paragraph for laypersons what the gist of >>your blog item is? >> >>Many thanks! >> >>MCM >> >>>Original-recipient: rfc822;<mailto:m...@mail.nyu.edu>m...@mail.nyu.edu >>>DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; d=gmail.com; >>> s=gamma; >>>h=domainkey-signature:received:received:message-id:date:from >>> :user-agent:mime-version:to:subject:content-type; >>> bh=E2FN7+2xZ7icd/PlwbA34rJ1Za3rOX8xb1KsYNcFjrw=; >>> b=JAbz4dwHC7v2PBI+03lPEEJ/VYHiOgmOEOGhpDtaoECbJ7anVl6wPFOoXflkWsF3+y >>> 9TyGrn2e+GQxJYuYr/V/PhrAMvpp8GFeo2ADtfF2hosf88q34QcqWw57XDHiOaJwG46E >>> MGYTH/SMXs/f1zU7MQuMetG+gMWrqc3zGFFQQ= >>>Date: Sat, 04 Jul 2009 19:45:33 -0400 >>>From: Mark Crispin Miller >>><<mailto:markcrispinmil...@gmail.com>markcrispinmil...@gmail.com> >>>To: <mailto:mark.mil...@nyu.edu>mark.mil...@nyu.edu >>>Subject: [Fwd: Re: [MCM] Religious exemptions from vaccination] >>> >>> >>> >>>-------- Original Message -------- >>> >>>Subject: Re: [MCM] Religious exemptions from vaccination Date: >>>Sat, 4 Jul 2009 18:02:45 -0400 From: Meryl >>>Nass <mailto:mn...@gwi.net><mn...@gwi.net> >>>To:<mailto:newsfromunderground+ow...@googlegroups.com>newsfromunderground+ow...@googlegroups.com >>> References: <mailto:4a4fcca7.7080...@gmail.com><4a4fcca7.7080...@gmail.com> >>> >>> >>> >>>Hi. No video for link for my friend Barbara Loe Fisher. >>> >>> >>>You in Bar Harbor or slaving at the computer in NYC? >>> >>> >>>fyi my own blog from yesterday. PS--the PREP Act waiver was >>>officially invoked for H1N1 and relenza/tamiflu two weeks ago (in >>>June 19 Fed. Register). I don't think they have used it for H1N1 >>>vaccine yet, since it is not clear which of the vaccines will be >>>used...and the adjuvants I discuss are likely to be added at the >>>last minute, so any company's antigen may be used with any other >>>company's adjuvant. >>> >>> >>>Meryl >>> >>> >>> >>>H1N1 vaccines with novel adjuvants being developed for potential mass use >>> >>> >>> >>>The US government has contracted with at least 5 pharmaceutical >>>manufacturers to develop and produce H1N1 vaccines, using a >>>variety of platforms and manufacturing methods. This is an >>>excellent approach, since at this point no one knows which will >>>succeed and how long it will take to obtain desired quantities of >>>vaccine. >>> >>> >>>A novel feature of the two H1N1 vaccines being developed by >>>companies Novartis and Glaxo-Smith Kline is the addition of >>>squalene-containing adjuvants to boost immunogenicity and >>>dramatically reduce the amount of viral antigen needed. This >>>translates to much faster production of desired vaccine quantities. >>> >>> >>>Each company has its own proprietary adjuvant, acquired in each >>>case at high cost and intended for the high-stakes business of >>>rapidly producing vaccines for novel pandemics or biological >>>warfare threats. >>> >>> >>>Novartis' adjuvant is named MF-59, and Glaxo's is ASO3. We know >>>they work beautifully to strengthen vaccine efficacy. But how safe >>>are they? >>> >>> >>>That is a very difficult question to answer. Novartis claims MF-59 >>>has been used safely by over 40 million people. However, FDA has >>>not seen fit to approve even a single US vaccine that contains >>>these novel adjuvants. >>> >>> >>>One European vaccine contains MF-59, and two European vaccines >>>contain ASO4, which is a Glaxo adjuvant related to ASO3. Fluad >>>(with MF-59) is only licensed for use in the over-65 population. >>>This age group responds weakly to standard flu vaccines, and >>>whether standard flu vaccines actually reduce flu cases in this >>>age group is controversial. So a stronger vaccine may be indicated >>>for this group. And as we age, we are much less likely to develop >>>autoimmune disorders, so potential autoimmune side effects should >>>also be less in this age group. >>> >>> >>>However, in the 13 years since Fluad was approved in Europe for >>>older adults, I am not aware of a single other vaccine containing >>>MF-59 that has been licensed... even though MF-59 has been used in >>>a large number of vaccine trials. Virtually all the scientific >>>literature on this adjuvant has been produced by scientists >>>working for the manufacturer, precluding an unbiased assessment of >>>safety at this time. >>> >>> >>>Glaxo's ASO4 is used in Fendrix (a Hepatitis B vaccine). Fendrix >>>may only be used for people with kidney disease. Patients on >>>kidney dialysis have a high rate of Hepatitis B infection, and a >>>weak immune system. So they are good candidates for an especially >>>potent vaccine against a disease to which they are highly >>>susceptible, and these recipients are unlikely to develop >>>autoimmune complications. >>> >>> >>>Cervarix is a vaccine directed against several strains of human >>>papilloma virus (HPV), licensed in both Europe and Australia, >>>which contains ASO4. It is difficult to assess Cervarix' safety at >>>this point in time, as data are limited. It is worth noting that >>>FDA has delayed giving Cervarix a US license at least twice, so >>>far. >>> >>> >>>The June 19, 2009 Science magazine discusses use of these >>>"next-generation," antigen-sparing adjuvants for an H1N1 pandemic. >>>It quotes Norman Baylor, director of FDA's Office of Vaccine >>>Research and Review, who noted that antigen-sparing strategies >>>benefit populations, not individuals. "You have to think about >>>those trade-offs," Baylor said. >>> >>>Meryl Nass, MD >>> >>>Mount Desert Island Hospital >>> >>>Bar Harbor, Maine 04609 >>> >>>W 207 288-5081 ext. 1220 >>> >>>C 207 522-5229 >>> >>>H 207 244-9165 >>> >>>pager 207 818-0708 >>> >>><http://anthraxvaccine.blogspot.com>http://anthraxvaccine.blogspot.com >>> >>><http://www.anthraxvaccine.org>http://www.anthraxvaccine.org >>> >>> >>> >>> >>>On Jul 4, 2009, at 5:41 PM, Mark Crispin Miller wrote: >>> >>> >>>>From a friend: >>>> >>>> >>>>People should know you can get a religious exemption to get out >>>>of vaccinating your kids >>>> >>>> >>>>My 19-year-old almost died when he was 4 months old after he got >>>>the first of the whooping >>>> >>>>cough combos. >>>> >>>> >>>>That's when I started paying attention, and since then my >>>>children haven't been vaccinated. >>>> >>>> >>>>Even atheists can get a note from a rabbi. I've didn't even have >>>>to renew it went my son >>>> >>>>went off to college. >>>> >>>> >>>> >>>>On Sat, Jul 4, 2009 at 1:06 PM, Mark Crispin Miller >>>><<mailto:mark.mil...@nyu.edu>mark.mil...@nyu.edu> wrote: >>>> >>>>Mandatory vaccinations are on the horizon, with the state >>>>prepared to force you to comply >>>> >>>>--even though the new vaccine has not been adequately tested. >>>> >>>> >>>>The first ones to receive the shots? Our children--in their schools. >>>> >>>> >>>>This is no joke. We have to educate ourselves, and organize ASAP, >>>>so as to make the >>>> >>>>government back down, even though such activism will be deemed >>>>"low-level terrorism." >>>> >>>> >>>>Please take these eight minutes to watch this video presentation >>>>by Barbara Loe Fisher, >>>> >>>>President of the National Vaccine Information Center. (The >>>>commentary starts slow, so >>>> >>>>be patient until 3:30, at which point it "gets serious," as >>>>Brasscheck TV puts it.) >>>> >>>> >>>>Then, send the URL to everyone you know. >>>> >>>> >>>>MCM >>>> >>>> >>>> >>>>>>>> >> --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to Mark Crispin Miller's "News From Underground" newsgroup. To unsubscribe, send a blank email to newsfromunderground-unsubscr...@googlegroups.com OR go to http://groups.google.com/group/newsfromunderground and click on the "Unsubscribe or change membership" link in the yellow bar at the top of the page, then click the "Unsubscribe" button on the next page. For more News From Underground, visit http://markcrispinmiller.com -~----------~----~----~----~------~----~------~--~---
