MUST_READ from NPR (thanks to Marc Crispin Miller) … armed with the firm conviction that he was about to do good in the world, and coincidentally sell a ton of drugs for Merck, Jeremy Allen set out to completely rework the way that bone was measured in America. Now, to do this, he figured, the…

From 3/2008 CIDRAP: Until now, the Centers for Disease Control and Prevention (CDC), which is advised by the ACIP, recommended flu vaccination for children from 6 through 59 months old. The new ACIP recommendation expands the target groups to include children from ages 5 through 18 years. That adds about 30 million children to the…

verbatim from National Public Radio: … [Gerberding] came to the CDC in 1998, and was credited with smoothly handling the media after the mysterious anthrax attacks that followed the World Trade Center attack. Merck is one of the largest vaccine makers in the world; Gerberding will be overseeing a $5-billion-a-year business starting in late January……

photo of Julie Gerberding, Reuters From Reuters’ Maggie Fox, we learn that the swine flu “pandemic” has opened avenues for increasing vaccine uptake in the US… by grabbing children in schools, which might reduce the impact of seasonal influenza. (Let’s experiment on tens of millions of American children to find out.) The vaccine spin doctors…

According to David Brown, 111 million doses of swine flu vaccine have been released to the cities and states by now. CDC estimated that in the second week of December 46 million Americans had received the vaccine. And I saw a new case of Bell’s palsy this week in someone a week after receiving both…

Does Taiwan allow law suits against the government for possible swine flu-related deaths? US law does not. Nor can you sue the manufacturer. Instead, you must apply to DHHS and only if a medical officer employed by DHHS says the vaccine caused the death can you be compensated by DHHS. About $300,000 is the maximal…

According to Reuters via the One Click Group, alternatively these countries could resell vaccine to other countries if manufacturers will not accept vaccine back. “… The Geneva-based WHO is coordinating efforts to encourage rich countries toshare vaccines with poorer nations who had little or no access to supplies.Fukuda said six manufacturers and 12 countries had…

Thanks to website “The Flu Case” we have a story in English derived from reports in two German newspapers, Zeit and Tages Spiegel: Wolfgang Wodarg , former SPD member of parliament, and chairman of the European parliament’s health committee, initiated the inquiry. The motion was passed unanimously by his colleagues in the European parliament‘s health…

from NPR: … In the U.K., under two percent of the population has stepped up, and only 17 percent of those at special risk of flu complications, according to Bloomberg News… Ah, but look at the Scandinavians. They are Europe’s model citizens when it comes to doing what public health officials want. According to Andrea…

From Theresa Boyle at Healthzone, Canada: Public health officials are misleading Canadians by continuing tocharacterize the H1N1 virus as a threat in the hopes of unloading millions ofdoses of unused vaccine, charges Ontario’s former chief medical officer ofhealth. They are trying to save face because of an expensive overreaction, Dr.Richard Schabas said Thursday as lineups…

According to FDA, “while no safety concerns have been identified to date, a project will be initiated this fall to focus on the safety of the pandemic (H1N1) influenza vaccine and of antiviral medicines for pregnant women and their newborns…” [a.k.a. the ‘Shoot first, answer questions later’ principle–Nass] “FDA is collaborating with CDC, HHS, private…

FDA’s website provides the following somewhat contradictory information on swine flu drugs in pregnancy: Yes, they are approved, and CDC recommends their use… but No, they have not been studied in pregnant women. Treatment of Influenza During Pregnancy The Centers for Disease Control and Prevention (CDC) recommends women in any trimester of their pregnancy who…

Excerpts from the AP’s Mike Stobbe: The recall is for about 800,000 pre-filled syringes intended for young children, ages 6 months to nearly 3 years. The shots, made by Sanofi Pasteur, were distributed across the country last month and most have already been used, according to the Centers for Disease Control and Prevention. Doctors were…

From the Nov. 25 WSJ: Cell culturing vaccines is not a well-developed technology, and may not shave much time off vaccine production. Nor will the plant’s cutting-edge technology do much to solve one of the biggest problems vaccine makers have faced in churning out this year’s swine-flu vaccine: a slow-growing virus. High-speed techniques that bypass…

From Infectious Disease News. It may be that media-induced fears and intellectual arguments have ‘maxed out’ the number of Americans choosing to be vaccinated. Perhaps the only way to increase vaccine ‘demand’ in future will be through mandatory vaccinations. School mandates make vaccines a requirement for children, but so far there are no adult mandates,…

per CDC: Dropping from a peak of over 50% positive swine flu tests, we had only 2% positive the week of Dec 1,2009. Approximately 98% of those with respiratory infections who were tested then for swine flu had something else. And since CDC has only advised testing severe cases, we can safely assume that under…

From Jacob Goldstein at the WSJ blogs: Swine-flu shots are going begging in Germany, and the government is selling some of its vaccine on the foreign market, NPR’s Shots blog notes. Only 5% of the overall population and 15% of doctors have gone to the trouble of getting vaccinated.

from the UMinn’s CIDRAP: “… It will be several more years before we are able to wean ourselves away from egg-based vaccine, but we are committed to moving ahead with 21st century vaccine development,” Health and Human Services (HHS) Secretary Kathleen Sebelius said in a taped opening statement. Federal investments made since 2005 should improve…

BEIJING (Reuters) – “China’s vaccination campaign against the H1N1 flu strain is not proceeding as fast as it should be partly because people are needlessly worried about the safety of the vaccine, officials said on Friday…”

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…