The profligate use of public health resources has not been confined to the billions spent on Tamiflu and swine flu vaccines. The Wall Street Journal points out that public health staff around the US have been “forced to cut back on childhood immunization clinics, restaurant inspections and planning anti-obesity programs to get the H1N1 job…
David Kelly was the British scientist and WMD expert (I met him once at an anthrax meeting in 1998) who leaked information to the BBC that Tony Blair’s government had “sexed up” (read “made up”) its report on Iraqi WMD. Soon he was found dead in the woods near his home. The Telegraph explains that…
Sir Liam Donaldson, the UK’s chief medical officer, reports the swine flu pandemic is “considerably less lethal” than feared, according to the BBC. A study led by Sir Liam found a death rate of just 0.026% in those infected, the British Medical Journal reported. In the US, approximately 2,000 lab-confirmed deaths have occurred from swine…
From FOX: a story about a young marine who nearly died after receiving smallpox vaccine. But when deploying soldiers get so many vaccines at once, including anthrax vaccine, how did the military manage to identify smallpox vaccine as the single cause? Lance Cpl. Josef Lopez still suffers from injuries he began experiencing in Iraq three…
From Dr. Sherri Tenpenny in the Dec. 8, 2009 Huffington Post: On November 24, 2009, Novartis officially opened its first, large-scale vaccine manufacturing facility in the U.S. Located in Holly Springs, North Carolina. The project is a collaborative effort between Novartis and the U.S. Department of Health and Human Services, which contributed $457M for the…
The vaccine/bioterrorism industry is expert at making silk purses out of sows’ ears. Novartis, the company that failed to get its 50% share of swine flu vaccine out in a timely manner, and has a long history of vaccine failures, received a $400 million grant to open a vaccine plant in the US.However, the University…
The NY Times reports that after 2 months of wide use, there are no worrying patterns of adverse reactions found for swine flu vaccine, according to CDC. No increase in Guillain Barre cases has been identified. However, 5 children did die soon after vaccinations; the deaths are being investigated.
“We had to do something about swine flu!” And so the makers of Tamiflu (oseltamvir) are several billion dollars richer. As the BMJ (a.k.a. British Medical Journal) put it in 2005: “From a bit of a dud to the world’s most sought after drug in the space of six months, surely Roche cannot believe its…
According to HHS, BARDA “determined that none of the vaccine developers submitting proposals could meet the Project BioShield statutory requirements of having a product ready for licensure within 8 years. In response to this development, BARDA will modify its approach to the advanced development of a next-generation anthrax vaccine.” It is unclear why this happened,…
Meantime, today we have had the Irish and US CDC reporting the epidemic has passed its peak, while federal health officials “fear that if they concede the flu has peaked, Americans will become complacent and lose interest in being vaccinated“; there is more tamiflu resistance appearing in both the US and Wales; Canada has had…
The swine flu pandemic triggered a variety of government responses throughout the world. In the United States, plans to deal with the disease required that a variety of emergency procedures be used. Both the HHS Secretary and President had to declare emergencies. CDC advised FDA, which issued Emergency Use Authorizations. To invoke the Public Readiness…
Excerpts from another excellent Gardiner Harris piece: In a report expected to be made public on Thursday, Daniel R. Levinson, the inspector general of the Department of Health and Human Services, said 90 percent of universities relied solely on the researchers themselves to decide whether the money they made in consulting and other relationships with…
Sen. Charles Grassley has been pursuing various forms of medical malfeasance for years. On November 17 he honed in on the practice of ‘ghostwriting,’ in which medical ‘opinion leaders’ are sought after as authors of medical journal articles supporting a new drug, vaccine or medical device. Only problem is, the articles they ‘author’ were actually…
Excerpts from this Reuters article indicate, imho, that the pregnant patients have more sense than the doctors offering them vaccine. … “In all the pregnant women we’ve offered it to, I think only about one in20 has agreed,” Dr Chris Udenze, a family doctor based in Nottingham, centralEngland, said in the survey… Original estimates that…
From Dr. Heath A. Kelly, head of the epidemiology unit at Victoria’s Infectious Disease Reference Laboratory, comes this well-documented and clearly reasoned piece reviewing Australia’s experience with swine flu. Here are the main points: From the recognition of the swine flu pandemic in late April 2009, health professionals, politicians and the public needed to know…
Canada’s Minister of Health, Leona Aglukkaq (a politician with no medical training) issued an “interim order” for the sale of swine flu vaccine in Canada on October 13, 2009. Under the section titled “Authorization for Sale” are the following requirements that must be met to issue an interim order. These are: “… it is reasonable…
Excerpts from an article in the National Post, detailing remarks by Dr. Richard Schabas, Ontario’s former chief medical officer and a top health officer in the province: “In eastern Ontario where I live and work the outbreak is effectively over. If we’re immunizing people now essentially you’re barring the barn door after the horse is…
U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg spoke at the Reuters Health Summit in New York, November 12, 2009. An excerpt from the Reuters article on her talk follows: Some experts have suggested the government could have increased supplies by embracing adjuvant vaccine technology that is widely used in Europe. Adjuvanted vaccines contain…
CDC updated its tables today with last week’s data. Swine flu hospitalizations for the last week of October increased more than 1,000 from CDC’s figure last week, presumably due to late reporting. Deaths similarly increased. However, the percentage of positive tests for flu has fallen over 20% from its peak, during the last 2 weeks…
Using modelling to estimate the number of flu-related deaths makes a lot of sense when many of those who die are in nursing homes, not hospitalized, and not tested for flu. “Many are close to death, with flu being only one factor leading to their demise,” notes today’s Washington Post. I would expect that several…
Nature (Brendan Maher & Declan Butler) report from three laboratories scrutinizing the pandemic flu virus.This is an interesting article about basic research on the swine flu virus at CDC Atlanta, Mount Sinai School of Medicine, NY, and INSERM at Lyon. Plenty of background as in a Laurie Garrett story, but no amazing new insights.
“Once you start requiring doctors to get it, doctors are going to think it’s reasonable to make patients get it. It starts you down that mandatory route, and I don’t think we want to go there.” So said George Annas, renowned bioethicist, NEJM columnist and department chair of Health Law at Boston University School of…
I happened to stumble across this Congressional website tonight. It includes my answers to additional questions posed by the Committee after I testified on GWS in July 2007. It also includes my Senate testimony on GWS of September 2007. However, of special interest is a list of statistical analyses and informal studies conducted by the…
Sorry for repeating myself regarding this new method of dealing with injuries, but this is what the US government (DHHS) says: The PREP Act also authorizes a fund to provide compensation to eligible individuals who suffer specified injuries from administration or use of a countermeasure pursuant to the declaration. Any requests for compensation must be…
Excerpts from this NY Times article: … While the city’s health commissioner, Dr. Thomas A. Farley, said the clinics had the staff and enough vaccine to accommodate about 500 middle- and high-school students per clinic per hour — or as many as 31,500 vaccinations a day — a department spokeswoman put the total vaccinations administered…
Funny that I was only able to find one US news source (a Texas TV station) that carried this AP story. From the Canadian Press: Polish Prime Minister Donald Tusk said Friday that his government won’t buy vaccines for swine flu that have not been properly tested or from producers who won’t take responsibility for…
A well-researched piece on adjuvants from CIDRAP (Oct. 30, 2007), by Maryn McKenna. US citizens will need to be concerned about novel adjuvants when the next pandemic strikes, but people in the rest of the world will be offered swine flu vaccine with these adjuvants now. Excerpts: There is currently no regulatory pathway by which…
Very nice summary article by Helen Branswell regarding assumptions scientists have made about influenza, and how many of these assumptions have had to be discarded, as swine influenza furnished plenty of surprising facts.
According to CDC, weekly swine flu hospitalizations began dropping the last week of October; the death rate also dropped. UPDATE: I called CDC on Monday, November 9, to ask why this wasn’t updated, as usually occurs on Fridays. I was told that 15 deaths (swine flu) and 3 deaths (non-subtyped influenza A) were reported last…
Another hospital’s mandatory flu vaccination program will end after rulings were made Monday in favor of two unions. Who’s fooling who? If, as the NEJM reported, the live nasal flu vaccine used last winter was only 29% effective in adults, mandatory vaccination of employees who use this vaccine will still leave 71% susceptible to the…
By the NYT’s Andrew Pollack; excerpts follow: On Thursday, the federal government ordered, on an emergency basis, 10,000 treatment courses of peramivir for its national stockpile. It is paying $22.5 million, or about $2,250 a patient. Shares of BioCryst rose nearly 13 percent, to $11.39. Peramivir is given intravenously, making it usable by hospitalized patients…
By Huffington Post’s Allen McDuffee: …Mandatory vaccine programs are a sensitive subject in the military, so it’s not a huge surprise that swift and visceral reactions to the [swine flu vaccine] program gained speed. With a vaccine that was so new and little known about it, like many Americans, troops were heading to the web…
Interviews with GPs in the UK/ Pulse Magazine: …Dr Niall Finegan, a GP in Salford, Manchester – close to a hot spot in Trafford – said he, the four other GPs and six staff members at his practice planned to refuse the vaccine, and that he did not believe there was enough evidence it was…
Re: Evaluation of Preterm Births and Birth Defects in Liveborn Infants of US Military Women Who Received Smallpox Vaccine. Margaret A. K. Ryan, Gia R. Gumbs, Ava Marie S. Conlin, Carter J. Sevick, Isabel G. Jacobson, Katherine J. Snell, Christina N. Spooner, Tyler C. Smith, for the Department of Defense Birth and Infant Health Registry…
You may wonder why I keep harping on inadequate testing and safety concerns. In addition to my experience treating patients who became ill following vaccinations, I have reviewed medical literature on vaccine safety. There are many stories of vaccines that appeared safe, but were later found to be dangerous. The Edmonston-Zaghreb “high titre” measles vaccine,…
Thanks to Eileen Dannemann for obtaining this memo from Iowa’s Assistant Attorney General. It includes a very clear explanation from DHHS explaining the Public Readiness and Emergency Preparedness Act, Emergency Use Authorizations and Emergency Declarations in the context of H1N1 flu. Appended to it are a few additional comments from the Iowa AG’s office. This…
How much mercury? Contraindications? Dosing? It’s here in a simple format. And systemic reactions rates are reported to be 45%, said to be the same as for seasonal flu vaccines. (Why, if this vaccine only includes one third as much antigen, would adverse reaction rates be the same? Not sure if this is based on…
This week it was Neisseria meningitidis–which can rapidly kill (and spread). The affected grad student diagnosed himself. Last time (2004) several researchers at BU developed tularemia, a less acute illness. The diagnosis took longer, the disease was less likely to spread, but notifying the authorities took 6 months. The problem is that you can’t run…
The feds have done a lot right in terms of swine flu vaccine production. While they are receiving criticism right now, it’s only fair to note the things that have been done well. At the beginning of the epidemic, with lots of deaths in Mexico, the government decided to procure enough vaccine for all who…
This is an important short piece from Nature (online February 25, 2009) that I missed last February. It explains why the anthrax letter spores did not come directly from Ivins’ flask: they incorporate metals not found in Ivins’ spores, and were therefore grown under different conditions. Their progenitors probably did come from the flask, but…
Thanks to Shannon Brownlee and Jeanne Lenzer, well known health journalists, for this erudite piece on the limitations of epidemiological data for flu vaccines and antiviral drugs. They are brave women to tackle and publish this piece: kudos! A new GAO report on FDA’s reliance on surrogate endpoints (such as using antibody levels generated by…
This NEJM Article points out that, although, “Drug labels are written by drug companies, then negotiated and approved by the FDA,” still, “information gets lost between FDA review and the approved label.” What often gets lost is data on harms due to the drug. Several examples are included, and it turns out that two popular…
Parents are concerned about the best way to protect their children, and are asking whether to vaccinate them. Parents have to make their own risk/benefit decisions. I hope the following is helpful: 1. Do you feel comfortable enrolling your child in clinical trials? At this point in time, the swine flu vaccine program in children…
Med Microbiol Immunol. 2009 Oct 23. [Epub ahead of print] Bhakdi S, Lackner K, Doerr HW. Institute of Medical Microbiology and Hygiene, University Medical Center, Augustusplatz, 55101, Mainz, Germany, sbhakdi@uni-mainz.de. Programs for vaccination against the new influenza A/H1N1 targeting many hundred million citizens in Europe and the USA are to be launched in the fall…
I apologize for ignoring this subject until now. Celvapan is the Baxter non-adjuvanted swine flu vaccine that is being used in many countries outside the US. It has no thimerosal. It is not grown in eggs, but instead is grown in tissue culture using Vero cells. This is a major advantage to people who have…
Here is an FDA briefing document for the Vaccines and Related Biological Products Advisory Committee meeting of July 23, 2009. It lays out the plan that has been followed since then. The plan involved very limited safety data collection before starting vaccinations, and a detailed plan for obtaining data on adverse reactions after vaccinations have…
I was asked if any other vaccines have been approved that contain ASO3. The answer is yes, and no. No licensed US vaccines have ever contained this adjuvant. I am not aware of its presence in licensed vaccines used in any other countries, prior to the H1N1 adjuvanted vaccines. However, ASO3 was approved by the…
From Jon Cohen and Martin Enserink, excerpts: For proprietary reasons, Lurie would not name the delay issues at each manufacturer, but said “one company was just really overoptimistic” in its delivery predictions to HHS. Initially, all of the makers of inactivated vaccine had trouble with the “potency assay” used to ensure that 15 micrograms of…
From Spiegel Online comes this story about how the German government and army ordered adjuvant-free vaccine for themselves, but adjuvanted Pandemrix (containing ASO3) for the rest of Germany. Excerpts follow: Damage control is the name of the game in Berlin on Monday as politicians rush to deny that they are receiving a better, safer swine…
From the Globe and Mail: Canada’s vaccine uses an adjuvant, which consists of squalene (shark liver oil), DL-alpha-tocopherol (vitamin E) and polysorbate 80 (an emulsifier also used in ice cream). An adjuvant is a chemical product that boosts the immune response. There were claims that squalene, used in the anthrax vaccine, was to blame for…
From the Globe and Mail, Canada: Peramivir first new antiviral in years. This might be excellent: it might be just what severely ill patients with swine flu need. However, before using this unlicensed drug, wouldn’t you like to know what data exist on its safety and efficacy? What do we know about iv zanamivir and…
Following issuance of a TRO last week, but possibly unrelated to it, NY State governor Patterson suspended the directive that all health care workers must receive influenza vaccinations. The lawsuit will now be moot.
I have been waiting for cases to peak and then go away. Maybe that is what is happening in Virginia. It is too bad no one is collecting seroprevalence data to learn how many people have already been affected and are now immune. State health officials say that the H1N1 flu may be peaking in…
A 2200 subject trial of Chinese H1N1 vaccines (developed from the same CDC virus as vaccines developed by western manufacturers) was published in the NEJM. Four strengths of antigen were used in 4 age groups, with and without an aluminum phosphate (not a novel) adjuvant. Of interest: 15 mcg of antigen was sufficient. (This is…
ASO3 is the GlaxoSmithKline adjuvant being used in some swine flu vaccines. It is not being used in the United States. It does contain squalene. It is being used in Canada and Europe. The presence of novel adjuvants in swine flu vaccines has become very controversial in some countries. WHO recommended that countries use the…
Ha’aretz tells us that Israel only has adjuvanted vaccine available currently, and The Health Ministry has decided to hold off on giving the swine flu vaccine to pregnant women and chronically ill children because vaccine stocks now in Israel contain a substance whose safety and effectiveness in pregnant women has not been fully substantiated. They…
As I’ve said previously, before the 2009 swine flu came along, public health officials knew that vaccinations sometimes led to small increases in cases of GBS. GBS cases (above baseline incidence levels) were not limited to the 1976 swine flu vaccine, but have occurred after other vaccines, although less commonly. During the 1992-3 flu season,…
Adjuvants stimulate increased, nonspecific immunity and are included in many “killed” vaccines. Until October 16, all adjuvants in licensed vaccines in the US were aluminum salts. They are included in tetanus, Hepatitis A and B, anthrax and other killed vaccines. Thimerosal is a compound composed of 50% mercury which has been included in many killed…
Despite data showing twice the rate of miscarriages in women who received Cervarix, FDA approved this new HPV vaccine from GlaxoSmithKline for the US market: the first-ever vaccine licensed in the US with a novel adjuvant, named ASO4. According to a GSK press release, “In clinical trials, the most common side effects after vaccination with…
Children under 5 years of age are at relatively low risk from Swine Flu, while teens are at relatively greater risk. CDC finally acknowledged this on October 17, although CDC’s data, published August 21, showed it then. What’s also surprising, Schuchat said, is that about half of the children who have died since the end…
from the NY Times: A temporary restraining order has been issued for mandatory vaccinations in New York state. In response, “the State Department of Health vowed to fight the restraining order, saying that the authorities “have clear legal authority” to require vaccinations, and noted that state courts had upheld mandatory vaccinations of health care workers…
Dr. Paul Offit, head of pediatric infectious diseases at Children’s Hospital, Philadelphia PA, and originator of a licensed Rotavirus vaccine recommended for all children, is an inveterate vaccine booster. In his Oct 11 NYTimes Op-ed, he makes four claims about the new swine flu vaccine. I’ll briefly comment on each. 1. The vaccine is safe because…
From The Local, an English-language German newspaper, comes this report. Interesting.
The presentation discussed the legal framework for scientific misconduct, other questionable practices in science that are not legally prohibited, and how such practices were employed to create a body of literature that falsely proclaims anthrax vaccine’s safety. Also discussed was the role of anthrax vaccine in bioterrorism, its history since 1970, and the new laws…
From Reuters: A U.S. government media event to promote H1N1 school vaccinations on Friday included VIPs, cute kids and a phalanx of television cameras — but only one in five children at the school had proper parental consent to get immunized. . . But the small numbers also underscored the challenge facing the U.S. government’s…
Senator Joe McCarthy has been dead over 50 years, but the loyalty oaths that became notorious after his fall are alive and well in America today. Loyalty oaths? Perhaps you haven’t seen any. But perhaps you’ve simply missed what was right before your eyes. There are different kinds of loyalty oaths. Some require you to…
French physician and pharmacoepidemiologist Marc Girard has written a valuable piece on swine flu vaccines, their risk assessment and their rushed approval, contrasting this with what should ordinarily take place before a drug or vaccine enters the market.
From the Washington Post: According to the Post, 19 of the 76 deaths occurred during the past week. But according to CDC, the 19 deaths actually occurred between July 19 and October 3. They were reported last week. So far, approximately one in a million US children have died from swine flu-associated causes. But only…
According to the CDC, US deaths from influenza and pneumonia were significantly greater in 2008 than they have been in 2009, despite all the hoopla about pandemic swine influenza. Here is CDC’s own data. CDC also tells us, on the same website, that 60 children have died from swine flu in the US in the…
My friend Mark Crispin Miller has urged me to be more specific about why I am concerned about the safety of swine flu vaccines in the US. In a nutshell: 1. Newness I am always concerned about new drugs and vaccines. A former FDA Commissioner, Dr. Jane Henney, once said she did not use drugs…
This Wall Street Journal article provides a fascinating glimpse into what I will call, for lack of a better term, scientific xenophobia. It suggests an unwillingness to grapple with important data originating from another nation, perhaps because the data suggest US public health professionals should consider veering from the federal flu vaccine strategy being followed….
The CDC Advisory Committee on Immunization Practices posted its new but provisional recommendations for anthrax vaccine on October 5. Post-exposure use is recommended, although this is not an approved indication per FDA. Therefore, the ACIP recommends that anthrax vaccine be administered under an Investigational New Drug (IND) application or an Emergency Use Authorization (EUA). The…
There are only two questions you need to ask about any drug or vaccine. Does it work? Is it safe? Efficacy is commonly measured by a rise in antibody titer. However, the antibody being measured has not always been a good surrogate for level of protection. What one really needs to do is measure the…
Interesting take by the Associated Press on how Cuba plans to deal with a swine flu epidemic–sans vaccine. Excerpts: As the U.S. prepares an extensive health survey for side affects from its massive inoculation plans, Cuba’s No. 2 health official says relying on a shot to contain a world pandemic is risky as best —…
Excerpts from the Washington Post: As the federal government launches the most ambitious inoculation campaign in U.S. history, several surveys indicate the public is decidedly ambivalent. “Safety is our top priority,” said Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases. “What I want people to know is that no corners…
Who’s calling the shots? This WaPo article includes a surprisingly frank assessment of military vaccinations: …”Because I can compel people to get the shots, larger numbers will have the vaccine,” General Renuart said. “They will, as a percentage of the population, be vaccinated more rapidly than many of us. So we may see some objective…
Coverage from USA Today and CBS News.
Article by Patrick White: A “perplexing” Canadian study linking H1N1 to seasonal flu shots is throwing national influenza plans into disarray and testing public faith in the government agencies responsible for protecting the nation’s health. Distributed for peer review last week, the study confounded infectious-disease experts in suggesting that people vaccinated against seasonal flu are…
From the LATimes: In a poll of 1,678 U.S. parents conducted by the University of Michigan’s C.S. Mott Children’s Hospital, 40% said they would get their children immunized against the H1N1 virus — even as 54% indicated they would get their kids vaccinated against regular seasonal flu.
A domino effect is cascading through the country, as officials rush to impose vaccination mandates on citizens (Massachusetts) and health care employees (New York), as well as mandate influenza (seasonal +/-swine) vaccinations in many other healthcare systems and hospitals. Many state laws are written such that in a declared emergency, vaccination or, alternatively, quarantine are…
Important article by Gardiner Harris about the new, improving FDA: The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting… The agency has never…
From Jefferson T et al. in this week’s BMJ: The disparity in effectiveness between the high profile of influenza vaccines and antivirals and the low profile of physical interventions is striking. Public health recommendations are almost completely based on the use of vaccines and antivirals despite the lack of strong evidence.1 Vaccines work best…
by Australian Infectious Diseases professor Peter Collignon at the ANU: In 1976, a small group of soldiers at Fort Dix in the US were infected with a swine flu virus. It had an apparent high mortality rate and was deemed similar to the virus responsible for the great 1918-19 worldwide flu pandemic. The US government…
From the Sept. 21 Newsday: Dozens of Long Island nurses – many from Stony Brook University Medical Center – plan to rally with health care workers from across the state next week in Albany to protest a state regulation that mandates they be vaccinated for swine flu or lose their jobs. The New York State…
With respect to squalene-containing (a.k.a. oil-in-water emulsion) adjuvants, the September 21 New York Times’ Andrew Pollack has done some excellent reporting: …“These are products that potentially can be given to millions of healthy people,” said Dr. Jesse Goodman, chief scientist at the Food and Drug Administration. “There is not a known, specific safety danger or…
From the NY Times: “This is just not the right flu season to take this on,” said Dr. Frieden, who previously was the New York City health commissioner.[He was responding to questions about mandatory flu vaccinations–Nass] …Over all, virologists say, of every 100 people who faithfully get flu shots, only about 70 are fully protected…
from the Canadian Press: Researchers from Melbourne, Australia tested pregnant patients with life-threatening swine flu infections for levels of antibody in different antibody subclasses. This test is rarely done, but is used to investigate possible immune deficiencies. Serendipitously, the researchers and treating physicians found that one class of antibody (IgG2) was low in most of…
APIC is the Association for Professionals in Infection Control and Epidemiology. Its President and most officers are RNs, but no particular qualifications are required for membership, apart from a $175 annual fee. An August 31, 2009 APIC announcement says, “The association’s more than 12,000 members direct infection control programs that save lives and improve the…
A notice was issued in December 2007 regarding the process for seeking compensation under the 2006 Public Readiness and Emergency Preparedness Act (PREPA). The DHHS Secretary Sibelius has designated the Health Resources and Services Administration (HRSA) to address adverse vaccine reactions. HRSA created a Countermeasures Injury Compensation Program, modeled on the VICP, with the potential…
Everybody knows some things are good for health and some things are bad. Yet one rarely learns the magnitude of the positive or negative effect, making it impossible to take the logical approach, which is to balance risks and benefits as we make all sorts of choices. For example, how much benefit will I receive…
Over and over, I have seen media reports that claim, regarding the 1976 flu vaccine and Guillain Barre Syndrome (GBS): “scientists never proved whether that link was real or coincidence”–as reported in Lauran Neergard’s Associated Press article Sept. 15 and again by her on September 27. Or by Maggie Fox (Reuters) on Sept. 17: “Guillain-Barre…
An FDA Press Release today notes that vaccines made by MedImmune (the nasal spray attenuated live virus vaccine) and killed vaccines from CSL (Commonwealth Scientific Laboratories, Australia), Novartis and Sanofi Pasteur have been approved for use (licensed). These are the vaccines made without novel adjuvants. Based on FDA’s statement that, “All four firms manufacture the…
The UK head of immunization, Dr. David Salisbury, wrote today to the Guardian that the decision had been taken to add adjuvants to the H1N1 vaccine, if the virus mutates. Salisbury claims this would offer cross-protection. It might, but it might not. Until the virus mutates you won’t know. Salisbury contends that, “the UK has…
On December 2-3, 2008, FDA with joint NIAID sponsorship held a public workshop “for academics, government researchers, government regulators, vaccine clinical trial experts and industry representatives. The purpose of this workshop is to assess the scientific knowledge base regarding vaccine adjuvants and to facilitate the development of a research agenda to improve the safety and…
With 45 million doses expected October 15, and 20 million vaccine doses available weekly thereafter, 85 million high-risk Americans will be able to receive their single needed swine flu vaccination during October. By the end of November, another 80 million (lower risk) Americans could be vaccinated. That will probably cover everyone who wants to be…
Associated Press In accord with what we’ve learned from the mortality data, the G-7 plus Mexico group chose to omit children, but include pregnant women, in the group most at risk of death or severe illness from swine flu infection: those who should be offered vaccination first. Wedded to its earlier pronouncements, however, CDC continues…
If you convene an expert group to issue a set of recommendations, they will be issued. What the groups’ report may omit is an explanation of the sufficiency of the data. Nor will their report provide an idea of how statistically likely the conclusions are to be right or wrong. Historically, the experts usually issue…
From the Associated Press: Roughly half of health workers skip the immunizations, raising two concerns: If doctors and nurses get sick, who will treat what could be millions of Americans reeling from seasonal or swine flu? And could infected health workers make things worse by spreading flu to patients? New York, the first state to…
Thanks to Merrill Goozner: FDA’s Vaccines and Related Biological Products Advisory Committee meets on Tuesday, September 9. It will consider the safety and efficacy of an HPV vaccine for girls from GlaxoSmithKline called Cervarix. In an earlier post, I noted that the safety of Cervarix (which includes the squalene-containing adjuvant ASO4) was controversial. No US…
Finally, a series of logical experiments were done by Drs. Nareen Abboud and Arturo Casadevall to see what small peptides might stimulate immunity to anthrax. Two were found: one is five and the other six amino acids long. Each is immunogenic and protected macrophages from anthrax toxin. Their efficacy and safety in other models is…
End of content
End of content