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…

The Lancet’s H1N1 Flu Resource Center includes this interesting article on the provenance of the swine flu virus.  CDC submitted a first set of completed coding sequences (8 gene segments) for the 2009 swine flu virus to GenBank on April 27, 2009. Drs. Hong Zhang and Ling Chen of Zunyi Medical College, China, compared the…

I think I have had influenza twice, based on my symptom pattern and the fact I was exposed to flu cases.  But every winter I care for flu patients, so I have probably been exposed to flu viruses repeatedly each season.  But I generally stay well.  Why? For each infectious disease, an “infectious dose” has…

Xinhua, September 5, 2009: Total US swine flu deaths are at 593; this is confirmed by CDC.  Total US hospitalizations are 9,079.  California has had 144 deaths. New cases at 165 US universities totalled 1,640 last week.  No college students have died. WHO reported total global deaths of 2,837. The MMWR mortality in children report…

The Atlanta Journal Constitution tells us that Atlanta’s large public hospital, Grady Memorial, is requiring that seasonal flu shots be given to all employees. “Several factors led Emory officials to make taking the seasonal flu vaccine mandatory — protecting patients and providing a safe environment for workers; the fact that the seasonal flu and swine…

The BBC reports:  The UK has lowered its worst-case scenario estimate of possible swine flu-related deaths from 65,000 to 19,000.  Seventy people have died so far in the UK, while 6,000 to 8,000 die yearly from seasonal flu.    Advisors have now agreed that the swine flu death rate is lower than previously thought, likely to…

From the LA Times blog: Since the outbreak this spring of the novel H1N1, public health officials have treated the new so-called swine flu as if it were a replay of the devastating 1918 Spanish flu, which claimed tens of millions of victims and was particularly devastating to people who were otherwise young and healthy……

From today’s Bloomberg News Kudos to Dr. Frieden, who said, perhaps in response to front page news that Novartis’ (squalene-adjuvanted) swine flu vaccine would require only one dose (after initial testing in 100 subjects): “We don’t anticipate that we’ll be using adjuvanted vaccine in most of the scenarios that we anticipate now, though that could…

It’s September.  Kids are back in school.  A federal panel predicted a worst-case scenario of 90,000 Americans dead from complications of swine flu ten days ago. CDC’s Clinician Guidance:  Identifying and Caring for Patients is still dated May 4 and fails to provide any guidance based on study of the pandemic’s characteristics. It still says,…