Proposed U.S. Swine Flu Vaccination Program: Blueprint for Chaos

(Emphasis throughout news reports mine)

May 6, 2009, The Washington Post

U.S. May Add Shots for Swine Flu to Fall Regimen

Vaccine and pandemic experts are working with the administration to determine how to produce, test, track and educate the public about two different influenza vaccines in the same flu season.

"They have never tried this before, and there is going to be a great deal of confusion," said William Schaffner, chairman of the Department of Preventive Medicine at Vanderbilt University School of Medicine.

Memories of the nation's earlier experience with a swine flu vaccine present another challenge. In 1976, hundreds of Americans developed neurological disorders after they were vaccinated for a swine flu strain. The public was asked to receive one of two vaccines developed to combat the strain.

Health officials have asked manufacturers to ramp up production of the seasonal vaccine scheduled for rollout this fall to make way for the possible mass production of a swine flu vaccine.

A decision on whether to produce such a vaccine will have to be made soon, because it typically takes five months to produce a new vaccine and authorities would want it available for the next flu season.

Some medical experts said rolling out two vaccines would present additional challenges in terms of testing and tracking adverse reactions. Health officials and manufacturers will need to know what the negative reactions might be for each vaccine on its own and in combination with the other. Initial tests would be done on animals, and then clinical trials would be conducted with people to determine side effects before either vaccine is rolled out.

Harvey Fineberg, president of the Institute of Medicine, part of the National Academy of Sciences, said officials will have to weigh the risks of the time spent on testing.

"All this takes time, money and organization," said Fineberg, who led an investigation into the government's handling of the 1976 swine flu vaccinations.

The greater challenge will be tracking any adverse reactions as millions of Americans get multiple vaccinations in a matter of months this fall and winter.

"There will be adverse effects to any vaccine. That's just science," said Michael Hattwick, who ran the CDC's vaccine-tracking system during the last swine flu scare.

No sir, that's not science. That's poor quality-control, awful planning, and crummy logistics. But to continue:

Hattwick said a "real-time" tracking system would need to be established to provide constant updates to the CDC about adverse reactions. That information, he said, should include lot numbers for the vaccines so health officials can trace each side effect to the manufacturer and the date of production. Routine flu vaccinations are not traced with such precision because reporting is voluntary and often delayed, Hattwick said.

Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said he does not expect additional adverse reactions with two vaccinations. The traditional flu vaccine is designed to attack the three flu strains health officials believe to be the greatest threats in a regular season, he said.

"In a regular seasonal flu, you get three vaccines. Adding an additional one should not present a problem," Fauci said.

A record-keeping system would also need to be devised to track which doses patients have received, health experts said.

Without such a system, patients could lose track of which of the three shots they have received or could fail to get the second swine flu inoculation at the proper time.

"We will have to keep them straight and separate," Vanderbilt's Schaffner said. "This will be an enormous challenge, and we haven't figured out how to do it yet. That's one of the things we are trying to sort out."

May 23, 2009, The Washington Post

The federal government has asked three drug companies to make enough swine flu vaccine to immunize at least 20 million people in key positions in health care, national security and emergency services, officials said yesterday. [...]

The government's pandemic preparedness plan divides the U.S. population into five tiers of priority for getting the vaccine. The first tier, of about 24 million people, includes deployed armed forces members; critical health-care workers; fire, police and ambulance workers; pregnant women and small children. [...]

June 30, 2009, AP

Obama consults experts on 1976 swine flu outbreak

WASHINGTON — President Barack Obama is hoping that lessons learned from a 1976 flu outbreak can help the country act wisely to combat the current spread of swine flu.

The president and other top administration officials met Tuesday with six experts on the 1976 flu so that — in his words — "we can further prepare the nation for the possibility of a more severe outbreak of H1N1 flu."

In 1976, a mass vaccination against a different swine flu was marred by reports of a paralyzing side effect — and that time the flu didn't spread beyond an outbreak at Fort Dix, N.J.

Among those meeting Tuesday with Obama was the president of the Institute of Medicine, Dr. Harvey Fineberg.

June 30, 2009, CQ

Health Experts Say U.S. Is Prepared for Swine Flu Pandemic

Two public health experts painted a relatively rosy picture Tuesday of the United States’ ability to respond to the swine flu pandemic, saying the country had learned from earlier mistakes and from plans developed during the avian flu scare several years ago.

“The public health measures that were put in place were quite sensible,” said Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, at a briefing on the H1N1 virus held by the Center for Strategic and International Studies, the Congressional Global Health Caucus and the Kaiser Family Foundation.

Fauci and Harvey Fineberg, president of the Institute of Medicine, said the United States had learned from the 1976 swine flu scare. Fineberg, who wrote a book about the scare called The Epidemic that Never Was [1], said a decision to go ahead with nationwide immunizations was made in January 1976, when only a few soldiers at Fort Dix, N.J., had contracted the virus. Even though the disease didn’t spread, 40 million people were still immunized.

Then, Fineberg said, decision makers were “entirely driven by the worst-case” scenario and overreacted to the problem.

“Today, we need to not make the complementary error of only preparing for the most likely case,” he said.

Plans developed for the avian flu, or H5N1, in the middle of this decade should help combat any mass swine flu outbreak, Fauci said. Fortunately, swine flu has proven to be less deadly than its avian cousin, which has killed about half of all those it infects.

Fauci and Fineberg said health officials will need to watch how swine flu spreads and behaves in the southern hemisphere’s winter in order to prepare an appropriate response.

One worry is that the United States won’t be prepared for a mass immunization campaign, if one is necessary. “The real concern is getting organized throughout the country to administer what we need to administer,” Fineberg said.

But there likely won’t be a need for widespread immunizations.

“H1N1 now is acting like a seasonal flu that is out of season,” Fauci said.

But both experts warned predictions about the flu are notoriously difficult to make.

“The thing you can say about influenza that’s predictable is that it’s unpredictable,” Fauci said.

By gum, sir, you're right: the behavior of flu viruses is notoriously hard to predict -- especially new flu viruses of the very rare kind that show a quadruple reassortment, such as the 2009 swine flu, and which is to the 1976 swine flu virus what mashed potatoes are to kiwi fruit.

Moving along:

July 10, 2009, The Washington Post:

Students 1st in Line For Flu Vaccine: Mass Campaign Against Pandemic May Begin in Fall

School-age children will be a key target population for a pandemic flu vaccine in the fall, and they may be vaccinated at school in a mass campaign not seen since the polio epidemics of the 1950s.

The federal government should get about 100 million doses of vaccine by mid-October, if the current production by five companies goes as planned. But enough vaccine for wide use by the 120 million people especially vulnerable to the newly emerged strain of H1N1 influenza virus will not be available until later in the fall.

Those were among the messages administration officials delivered to about 500 state, territorial, city and tribal health officials yesterday at a "flu summit" at the National Institutes of Health's Bethesda campus.

President Obama, speaking by audio link from the Group of Eight summit in L'Aquila, Italy, urged "complete ownership" of preparations for what he termed a "significant outbreak" of H1N1 flu in the next few months.

"We want to make sure that we are not promoting panic, but we are promoting vigilance and preparation," he said. He added that "the most important thing for us to do is to make sure that state and local officials prepare now to implement a vaccination program in the fall."

Children, pregnant women, adults with chronic illnesses, and health-care workers would probably be first in line for the vaccine, Health and Human Services Secretary Kathleen Sebelius told the gathering. [...]

What happened to "deployed armed forces members ... fire, police and ambulance workers?" Are they still on the list of priority candidates for the vaccine?

And who are the other "vulnerable" members of the population besides "children, pregnant women, adults with chronic illnesses, and health-care workers?" The ones who won't receive swine flu vaccine until "later" in the fall?

In other words -- what happened to change the U.S. government's view between May 6 and July 9?

Here's what happened: Three days after Anthony Fauci suggested it was unlikely that a mass immunization program was needed, the bottom fell out:

Public health authorities in Hong Kong announced Friday [July 3] they have found a case of Tamiflu resistance in a woman who hadn't taken the drug. That means she was infected with swine flu viruses that were already resistant to Tamiflu, the main weapon in most countries' and companies' pandemic drug arsenals.

The two earlier cases, reported from Denmark and Japan, involved people who had been taking the medication. While always unwelcome, that type of resistance is known to occur with seasonal strains and may be less of a threat to the long-term viability of this key flu drug.

"It was not at all surprising to see resistance in patients on treatment but seeing it in someone who was not treated, it certainly is more concerning," says Dr. Malik Peiris, a flu expert at the University of Hong Kong.

There is a risk inherent in using the drug to prevent illness. If people who are already infected but aren't yet experiencing symptoms are put on prophylaxis, there won't be enough drug in their systems to kill all the viruses they house. Those that survive develop resistance to the drug.

And that, it appears, may be what happened in the resistance cases in Denmark and Japan. In both instances the women involved had been given Tamiflu prophylaxis after a contact developed swine flu.

But the Hong Kong case was different. A 16-year old girl travelling from San Francisco was stopped in Hong Kong's airport in mid-June after setting off a fever detection device.

She was taken to hospital where she tested positive for swine flu. She had not been taking antivirals and declined to be treated with the drug. She was kept in isolation until she recovered.

Dr. Jennifer McKimm-Breschkin, an influenza expert from Australia and a member of the team that developed Relenza, says this case shows resistant swine flu viruses can spread.

It was previously thought flu viruses that developed resistance to the drug would be crippled in the process and would not transmit to others. But that belief was shattered in 2008 when it was discovered Tamiflu-resistant versions of the seasonal H1N1 viruses were spreading rapidly around the globe. They have since all but wiped out Tamiflu-susceptible seasonal H1N1 viruses.

"This is a patient that hasn't been treated, who has gone from San Francisco to Hong Kong. What that means is that she has caught a resistant virus in San Francisco," says McKimm-Breschkin, virology project leader at the Commonwealth Science and Research Organization - known as CSIRO - in Melbourne. (McKimm-Breschkin does not receive royalties for sales of Relenza.)

"So that means this virus has been transmitted from somebody who's presumably been treated. Which means it's been fit enough to transmit. And that is of a lot more concern than just resistance in a treated patient."

Experts have worried the seasonal H1N1 viruses might reassort or swap genes with the swine H1N1. If swine flu picked up with neuraminidase gene - the N in a flu virus' name - from the seasonal H1N1, it would acquire the resistance its seasonal cousin has developed.

Authorities in Hong Kong have not yet told the WHO whether that is what has happened in this case.

But whether the Hong Kong resistance case is due to reassortment, or from the fact that some swine flu viruses have developed resistance on their own, the situation demands careful monitoring, Fukuda and others say.(2)

Just to make sure you're clear on the danger of the mutation found by the Hong Kong lab:

The case in Hong Kong indicates that the mutant virus is capable of being transmitted among people, said Jennifer McKimm - Breschkin [...]

“It’s very disturbing that, fresh into the human population, this one appears now to be able to retain fitness despite having the mutation and to be able to spread” [...] (3)

The hope was that as the virus continued to mutate it would lose punch. So far that hasn't happened.

As I first warned on May 20, "[I]t is very likely that Tamiflu, and not a wimpy version of a swine flu virus, explains the low death rate so far from H1N1 infections."

And I castigated public health officials for not acknowledging that widespread Tamiflu use to treat swine flu was masking the true lethality of the disease.

However, WHO officials continued to say that the swine flu virus was "very stable" -- not mutating in any significant fashion -- and so the public health establishment continued to play ostrich.

From sticking their heads in the sand to running around like chickens with their head cut off in a few weeks: now that a Tamiflu-resistant strain of the virus is out there, of course everybody on the planet has to get vaccinated yesterday.

But there's simply not enough vaccine yet, and not enough time to adequately test the first batches -- and a hastily devised triple-vaccination program for tens of millions of people is a blueprint for pandemonium.

This says nothing about the chaos that could be unleashed with any possible thrown-together plan for widespread school closures as a means to attempt to slow the virus' spread. Read the rest of the July 10 Washington Post report for information on that angle.

Not to keep pounding the lectern but note how the Hong Kong case was caught: First it walked in front of a thermal scanner at the international airport. Yet WHO deems thermal scanners useless. (4)

Then the mutation was nailed during a routine surveillance of flu specimens by Hong Kong's Public Health Laboratory Services Branch.(3)

Yet many state-run labs, the world over, are overwhelmed by swine flu cases. And WHO is preparing to recommend that the labs abandon testing for 'routine' swine flu cases.

How is that Hong Kong's lab wasn't overwhelmed? And how do those other state labs expect to catch the Tamiflu-resistant mutation if they abandon routine testing?

For a detailed answer to the first question new readers can work backward through all my posts on swine flu. The short answer, which readers who've followed my posts well know, is that Hong Kong followed China's model of fighting swine flu, which greatly slowed the spread of swine flu cases in the country. Among other things this meant their laboratories weren't overwhelmed by swine flu specimens.

Regarding the second question: I don't know the answer and I doubt any public health official does, either.

As to the emphasis I gave to the National Institutes of Health and the names Anthony Fauci and Harvey Fineberg, that's in the nature of a question mark in my mind.

In one my earlier posts on swine flu I suggested that if there was proof of intelligent life at NIH that they shove the CDC out of the way, given the CDC's flat-footed response to the H1N1 outbreak.

Of course it's easier for administration officials to get to Bethesda than Atlanta, and I don't know whether Fauci and Fineberg have a particular connection to NIH. But if a reader notes mention of NIH or those two names in a news report on swine flu, I'd appreciate it if you could send me the report. Thank you.

1) Dr Fineberg was the co-author; Richard E Neustadt was the lead author on the book, the full title of which is The epidemic that never was: Policy-making and the swine flu scare.

The three used paperback copies available at Amazon are selling for $175 each, which gives an idea how much public interest there was in the topic at the time of publication. I haven't looked up the publication date but clearly the book was written and published before the 2009 swine flu outbreak, else the authors would have added "1976" to the title's mention of swine flu.

2) Canadian Press: Tamiflu resistant H1N1 from Hong Kong more worrying than earlier findings; Helen Branswell, Canadian Press Medical Writer; July 6, 2009.

This is the best analysis of the three Tamiflu-resistant cases and their import that I've found in the general media. I note that the writer provides flu updates on Twitter at CP-Branswell.

3) Bloomberg: Tamiflu-Resistant Swine Flu Virus Found in Hong Kong (Update2); Nipa Piboontanasawat (in Hong Kong) and Jason Gale (in Singapore); July 3, 2009.

I read every Bloomberg report filed or co-filed by Jason Gale I can find; he is among the handful of 'lay' journalists who began specializing in swine flu reporting from the start and who've educated themselves about the disease. I recommend that you read the entire report; taken together with Helen Branswell's analysis it's a good briefing for the layperson on the three swine flu mutations under discussion.

4) Slate: Heat Check: Swine flu, body heat, and airport scanners; William Saletan; April 28, 2009.

Since the start of the swine flu outbreak I've plowed through many articles that point to gross incompetence and institutional bias in the biomedical and public health establishments' approach to pandemic planning. But this one takes the prize. Don't miss the reports the article links to; if you're a high-strung type I suggest you steel yourself before reading the government-funded study of the scanners.