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.

Posted by Charlotte Schubert at 07:02 PM | Permalink | Comments (0)

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.

Posted by Charlotte Schubert at 04:20 AM | Permalink | Comments (0)

Yesterday, we told you about the new recommendations from the US Institute of Medicine aiming to keep junk food out of the hands of kids.

Today, a report published in Morbidity and Mortality Weekly Report gives another reason to keep sweets away from youngsters: inadvertent marijuana ingestion.

I think the journal's lay summary speaks for itself:

"It is beneficial for local health departments to establish good working relationships with law enforcement. In April, 2009, the Los Angeles Police Department and the Los Angeles County Department of Public Health launched a collaborative investigation concerning a group of preschool teachers with neurological and gastrointestinal symptoms after eating brownies purchased from a sidewalk vendor. This report summarizes the results of that investigation, which detected cannabinoids in a recovered sample of the brownies. Two patients sought medical treatment, and one patient’s urine and serum tested positive for marijuana metabolites. The findings demonstrate the utility of a collaborative investigation by public health and law enforcement and the importance of timely testing of clinical specimens after symptom onset. It also underscores the need to consider marijuana as a potential contaminant during foodborne illness investigations."

Image via Norwichnuts.

Posted by Roxanne Khamsi at 11:35 AM | Permalink | Comments (0)

There may be no rhyme or reason to why the H1N1 swine flu emerged as a global threat last spring... but some doctors and health officials are using rhythm to explain how to best avoid this nasty virus.

The US government is asking the public to vote on their favorite H1N1 public service announcement. And while some rappers might want you to throw your hands in the air and 'wave'em like you just don't care', at least one hopeful contestant, Dr. Clarke, is hoping to you'll throw your hands into the sink and start washing them. He already is gaining a bit of a following.

To see all the videos up for vote, click here.

Meanwhile, a cartoon aired at the Shanghai airport has also put the dangers of H1N1 into a rap. To see a capture of the video, click here.

Have you seen any other H1N1 flu raps out there that strike your fancy?

Posted by Roxanne Khamsi at 11:30 AM | Permalink | Comments (0)

A few weekends ago I made the mistake of volunteering for a fund-raising festival at the local toddler stomping ground. The afternoon hit 90 degrees, with full humidity. Determined to be a good mom, and a good citizen, I went to the park anyway.

The place was packed with kids, whining to ride a pony and eat pink cupcakes. The adults were sweaty, distracted and grumpy. But at least they did not have my job!

I got to feed little children this:

I knew, in a vague way, that mass-produced popcorn wasn’t a great thing. But this was in another realm entirely: a 2:1 ratio of popcorn to coconut oil, tinged with some yellow substance. My job was to extrude the pure supersaturated ooze into the sizzling machine and joyfully dispense the popcorn product.

Apparently it’s not too different from what kids must be eating every day. According to a September 1 report from the Institute of Medicine (IOM), “Local actions to prevent childhood obesity,” 16.3 percent of children and adolescents in the US between the ages of two and 19 are obese.

People started flocking to my hot corner of the playground. Parents tactfully steered their children clear of the plastic-colored cake items and to what they might have thought, in their harried state, looked a little more like normal food. Admittedly, the popcorn people did a good job with the artificial butter, it had a certain chemotactic pull.

Holding back an urge to run home fast, I instead carefully placed an unopened plastic pod of kernels on the table. Surely, with the goop right in front of them, people would hesitate before grabbing a bag of popcorn.

No such luck. Cranky parents yanked at the cheerful striped bags, shoving quarters in my hand. Grubby 8 year olds came back for seconds. It was like some sort of food hell. When a pregnant woman came up my frozen smile cracked:

“You might not want to eat that,” I said, imagining what Yellow #6 Lake (E110) did to embryonic digits. She was unfazed by my meddling, “Oh! It’s not for me! It’s for my son!”

My only conclusion from the experience is that kids will eat whatever is in front of them and that harried parents will do little to stop it. Parents are a poor filter against the proliferation of junk food targeted to children (my favorite is this baby-bottle-shaped candy, marketed by teeny bopper band the Jonas Brothers, in a wildly popular YouTube video).

If the IOM had its way I’d be prosecuted. One of their recommendations: “Implement local ordinances to restrict mobile vending of calorie-dense, nutrient-poor foods near schools and public playgrounds.”

During my hours pouring grease and yellow stuff into a machine, and inserting it into the veins of my neighbors’ children, only one child paused. He looked at the package, turned it over gingerly, and walked away.

I had poisoned many, and saved one. I went home with my two-year old, face flecked with neon frosting, to contemplate my crime.

Posted by Charlotte Schubert at 12:09 PM | Permalink | Comments (0)