Vaccines are the safest kind of medicine, aren’t they?

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,…

What do PREPA and EUAs mean for public health officials?/ Iowa’s Asst Attorney General

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…

Medscape and Dr. John Bartlett provide US swine flu vaccine comparisons

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…

Another BU researcher catches the bug he is studying/Boston Globe

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…

Anthrax investigation still yielding findings: Chemical composition of spores doesn’t match suspect flask/Nature

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…

Lost in Transmission — FDA Drug Information That Never Reaches Clinicians

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…

Possible hidden hazards of mass vaccination against new influenza A/H1N1: have the cardiovascular risks been adequately weighed? (Abstract)

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…

FDA plans (dated June 26, 2009) for safety evaluation of Swine Flu Vaccines

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…

Vaccine Delays: limited info on the problems/Science Insider

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…

Germans Unhappy with Alternative Swine Flu Vaccine for Politicians/Spiegel

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…

Adjuvanted vaccinations start Monday in Canada/ Globe and Mail

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…

Emergency Use Authorization Issued for new, unlicensed antiviral drug Peramivir

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…

Israel: H1N1 flu vaccine not suitable for pregnant women, sick kids/ Haaretz

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…

The Guillain-Barré syndrome and the 1992-1993 and 1993-1994 influenza vaccines/ NEJM

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 and Thimerosal (aka Thiomersal)

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…

Cervarix: Novel (but NOT Squalene-containing) Adjuvant Approved in US

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…

Kids Under 5 Not at High Risk

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…

Judge Halts Mandatory Flu Vaccines for Health Care Workers/ NYT

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 Speaks/ NY Times

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…

My powerpoint presentation to NVIC conference

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…

U.S. school swine flu event shows vaccine challenge/ Reuters

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…

What Pandemic?

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…

Study Prompts Canada to Delay Flu Shots/ WSJ

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….

New ACIP recommendations for anthrax vaccine include post-exposure regimen

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…

Vaccine Is On Its Way, But Public Still Wary. Swine Flu Campaign Faces Key Barriers: Unease, Ambivalence

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…

End of content

End of content