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…