Swine flu seems to be ebbing in much of the Northern Hemisphere, according to the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC). But health officials maintain that the pandemic is far from over, and they are continuing to urge people to get vaccinated.

In the US, health experts convened a press conference before the holidays at the National Press Building in Washington, DC, warning that the virus could resurge and that there’s still plenty of swine flu going around. According to the latest CDC report, ending the week of December 19, only seven states still suffer from widespread influenza, compared to the outbreaks that hit most of the country earlier in the fall.

At the press conference FDA head Margaret Hamburg defended the decision not to use adjuvants, which could have meant more vaccine delivered sooner. She said that regulatory agencies were not prepared to go outside of the regular review process to approve them on an emergency basis given that the vaccine worked fine without the additive. She also cited potential safety concerns and a public that remains jittery about vaccines in general.

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A deadly strain of distrust has infected leaders in Poland this flu season.

The country’s prime minister and the health minister have said that the government will not import swine flu vaccine. “If I had a 100 percent certainty that the vaccine was a panacea for the swine flu, I would certainly buy it," said health minister Ewa Kopacz, in an interview, according to this report. She added that she felt drug companies were “covering up” some information about the vaccines. Prime Minister Donald Tusk, meanwhile, has said that he will not buy from producers that will not take responsibility for possible side effects.

Apparently these politicians have not been reading this blog—as we noted last week, the World Health Organization and US Centers for Disease Control and Prevention have not seen consistent serious adverse effects.

As you might imagine, some people in Poland want a swine flu shot. Janusz Kochanowski, for instance, heads Poland’s human rights office, and is threatening the health minister with prosecution.

The uproar reminds me of the AIDS-denialism of the Thabo Mbeki, who if he lived down the street would be a relatively harmless adherent of errant web sites. But he happened to be the president of South Africa, and his lax policies on HIV drugs led to hundreds of thousands of deaths.

Fortunately, this a relatively mild pandemic, as a report today details. Nonetheless, Poland is a country of about 40 million people and the swine flu kills about 1 in 2000 people who get sick, according to recent US data, many of them children, pregnant women and people in other high risk groups.

Vaccine campaigns in the rest of Europe are well underway. But, according to this report from Bloomberg, a good proportion of the population has skipped a shot because they are worried about safety. It’s clear that public health offices could do a better job of explaining the safety of the vaccine—but what do you do when it’s the health officials who are afraid?

Image by Mike Licht, NotionsCapital via Flickr Creative Commons

Hey doc, who wears the pants?

Researchers have been particularly watchful for signs of Guillian-Barre syndrome (GBS), a disease that afflicted approximately 1 out of every 100,000 people in the US who received vaccines for the 1976 Swine flu (the flu that never materialized.) A report from the Washington Post this weekend examines what researchers know (not much) about the trigger for the condition, which most often arises after infection with Campylobacter jejuni, a bacterium that causes food-borne illness.

In any vaccination campaign, some people will die or experience severe illness after vaccination; much of this will be coincidence. So the job of health agencies is to figure out if there is a consistent issue with safety. In the US, vaccine safety is monitored in part through, the ‘vaccine adverse event reporting system,’ which collects reports of potential reactions to vaccines from patients and doctors.

So far, ten cases of GBS have been reported in people who got the swine flu shot, according to the CDC; that number is in line with normal background rates for the illness, suggesting that vaccination is not causing a spike in GBS. The CDC says they saw no common underlying pattern in the other events reported, also consistent with their being due to chance. The WHO reports similar findings.

So, is that enough for Mehmet Oz, who bills himself as “America’s Doctor” to vaccinate his kids? In a recent interview the Oprah regular said his kids were not getting swine flu shots because at home he is “Mr. Oz, not Dr. Oz.” At least his website, although dated, seems fairly run-of-the-mill; no anti-vaccine screeds from Mrs. Oz.

image:: David Berkowitz, Wikimedia Commons https://bit.ly/5Z7Ro1

Jenny McCarthy: vaccine expert

When it comes to swine flu vaccine, US health officials seem to be fearing fear itself.

Unlike most countries, the US is not using adjuvants in its swine flu vaccine. To do so, US health authorities must approve them in the vaccine on an ‘emergency’ basis. Why haven’t they?

One reason is that officials are concerned that people will reject the vaccine. That seems clear from recent congressional testimony by Anne Schuchat, head of immunization and respiratory diseases at the US Centers for Disease Control and Prevention.

Here is an exchange at a hearing last week between Schuchat and representative Bark Stupak:

Stupak: What is the problem with the adjuvant other than we haven’t done the test here in this country? [Referring to data obtained in Europe on the safety of the swine flu adjuvant]

Schuchat: Well, you know — as you know, the public’s confidence in our vaccine system and in vaccines in this country — very, very fragile.

Schuchat voiced similar concerns in an interview with Reuters. The decision surely was not easy for Shuchat and other health officials: if they had decided to use adjuvants, which reduce the dosage needed in a flu shot, the US would probably not be facing vaccine shortages—something I have blogged about before.

Other considerations, of course, factored into the decision. For instance, Jesse Goodman, an FDA official, told congress that the bulk of the safety data for the adjuvanted vaccine has been obtained in people over age 50, “So in terms of the kind of broad experience with millions of people that’s only in the elderly who were not a focus population of this vaccine…we don’t have enough data about those at this point or at the beginning of the pandemic for them to meet the standard of FDA licensure.”

Clearly, officials have the concerns and safety of the public in mind. It is also difficult to fault US agencies for considering the concerns of a public inundated with faulty information on vaccine safety, proliferating on the internet and aired by Don Imus, the Huffington Post and Oprah. Oprah, for instance, recently signed a deal with celebrity anti-vaccine activist Jenny McCarthy. The former playboy bunny is a regular guest on her show.

I wonder if Oprah has got her flu shot yet.

Blame the chicken

The lines are long, and people have been turned away in droves. Only the lucky and persistent—including the Obama girls—have got their swine flu shots in the US.

The vaccine is late, and in short supply—just at the US epidemic may be hitting its peak (see this ominous interactive map from the Wall Street Journal.)

But there is no shortage of blame: slow-growing viruses, chicken shortages, and, according to one opinion piece, higher doses of vaccine going to women than they may need. So, why not add another culprit to the mix: the lack of adjuvants. These are substances added to vaccines to increase their potency and decrease dosage.

The US is not using adjuvants in swine flu vaccines, whereas European regulators have approved them. As a consequence, each US citizen lucky enough to get a shot will be injected with 3 times as much vaccine material than people in Europe (15 vs. 3.75 micrograms).

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I got a phone call tonight from the US Centers for Disease Control, asking if I was planning to vaccinate myself and my child against pandemic H1N1 ‘swine’ flu.

The woman on the line said that the agency was conducting the survey to find out more about attitudes towards vaccination, trying to find the demographic of people reluctant to vaccinate.

I could point them to one demographic: one of my local online parents’ groups. “Don’t get your kids vaccinated!” warned one poster. “The risks outweigh the risks of the illness.” She said, citing unnamed ‘sources’ at NIH.

Apparently that mom is not alone in her safety concerns. A recent poll from Consumer Reports finds that just 35 percent of parents were sure they would get their children vaccinated, while 14 percent of parents would ‘definitely’ not. Even more disturbingly, a separate survey found that only 38 percent of health care workers were planning to get vaccinated. You can read more about the polls at the Los Angeles Times blog “booster shots.”

With the first swine flu shots coming on deck next week, the CDC does not have a lot of time to figure out how to get safety messages out to the public. Its website does a decent job, but it might be appropriate to link to a web page with a more detailed message outlining results of clinical trials with flu vaccines and explaining exactly how the vaccine is made. Or perhaps the agency has consciously chosen to go with a simple message.

My feeling is the agency might be facing some powerful anti-vaccine sentiment in the this country. I hope that the agency is ready with smart, detailed and to the point explanations. My phone call last night indicates they are at least thinking about how to craft their public health message on vaccine safety.

You can see the CDC website here. What do you think? Does it do a good job of explaining why the agency expects the vaccine to be safe?

The data are piling in, and it looks like one shot of H1N1 pandemic flu vaccine is enough to protect most healthy adults. And today, the FDA announced it has approved the vaccine.

That’s better news than expected—many experts had predicted two shots would be needed, putting pressure on tight supplies. But there clearly will still not be enough vaccine to go around, particularly in poor countries.

In the US, it is conceivable that high-risk populations like pregnant women might get vaccinated before the flu season hits full force, and most people could ultimately get the shot. That’s because the US has bought billions of dollars of vaccine—a price many countries cannot pay for such a limited commodity. Today the head of the World Health Organization, Margaret Chan, said she expected this “virus of extremes” to cause far more deaths in poor countries than in affluent ones.

The dosage in a single shot is 15 micrograms. But there is a way to bring down the dosage and further stretch the supply—using oil-in-water adjuvants, which have been approved for seasonal flu vaccines in Europe. Glaxo Smith Kline (GSK) recently showed that, with its AS03 adjuvant, a 5.25 microgram dose will protect 98 percent of adults (95 percent of the adults in its trials were protected with unadjuvanted vaccine at a 15 microgram dose). Stretching supplies further, GSK says it plans to sell shots with 3.75 microgram.

That’s a substantial reduction in dosage. But as I report in the latest issue of Nature Medicine, US regulatory authorities have not seemed eager to exercise their option to approve adjuvants in pandemic flu vaccine on an emergency basis—a decision that could have implications for global supply.

What do the recent data and vaccine approval mean for the prospects of using adjuvants in the US? I asked Amesh Adalja, a fellow at the Center for Biosecurity in Pittsburgh, Pennsylvania and a physician at the University of Pittsburgh Medical Center.

“I think the approval means that the pandemic vaccine will not be adjuvanted,” said Adalja.

Nonetheless, clinical trials are on deck at NIH to test adjuvanted vaccine. Adds Adalja: “I think that there is enough clamor about adjuvants that maybe we will see some trials using adjuvanted vaccine. The GSK adjuvant, AS03, can be mixed with some of the other manufacturers’ vaccines after production and we might get enough data for an approval (but probably too late for this flu season)."

You can access a great rundown of the new vaccine data by Adalja in his blog posting. Despite the new findings, he is skeptical about whether enough vaccine will be ready, even in affluent countries, by the time the peak of the pandemic is expected to hit.

US regulators may allow the next generation of vaccines to pass their high bar for approval.

On Wednesday, an advisory committee to the US Food and Drug Administration recommended approval of the cervical cancer vaccine, Cervarix, which contains a new adjuvant-substances that give extra pep to vaccines.

If the agency follows through on the committee’s advice, Cervarix will be the first vaccine approved in the US with an adjuvant other than alum-an adjuvant based on aluminum salts used for more than 60 years. The agency is expected to issue a decision by the end of September.

But the big question is whether the US will consider using adjuvants in pandemic H1N1 flu vaccine, a decision that has serious potential to stretch a limited world-wide supply. A positive decision on Cervarix could change the way the agency perceives adjuvanted H1N1 pandemic flu vaccine, an option that does not seem to be its first-choice, as I report in a recent article on adjuvants in Nature Medicine.

Cervarix, made by Glaxo Smith Kline, has already been approved dozens of countries, as have other vaccines with next-generation adjuvants, including several vaccines for seasonal flu.

European regulators are poised to approve vaccines for pandemic H1N1 flu vaccine containing an oil-in-water adjuvant-the same adjuvant used in seasonal flu shots given safely to millions of people in Europe. But US regulators are widely perceived by public health researchers as much more cautious.

The agency, nonetheless, also gave the green light on Thursday to clinical trials of an adjuvanted hepatitis B vaccine, manufactured by the biotechnology company Dynavax. The FDA had put the trials on hold 18 months ago pending investigation into whether vaccination may have been linked to a rare autoimmune condition that had developed in a trial participant. Now the company can continue to test its vaccine in people with chronic kidney disease who do not respond well to the standard hepatitis B shot.

So, it’s been a good week for adjuvants at the US FDA. We will see what that means ultimately for pandemic flu shots.

Researchers at Novartis are still awaiting data on the degree to which adjuvants can cut down the dosage of pandemic H1N1 vaccine. Meanwhile, studies out Thursday in the New England Journal of Medicine suggest that one shot of vaccine may be sufficient. And this Friday the NIH will also discuss early results from its clinical trials. Stay tuned.