H1N1 vaccine shortage leaves doctors managing crowds, anxieties

Many physicians are struggling, often in vain, to find H1N1 vaccine or locate alternative sources for patients.

By — Posted Nov. 2, 2009

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The unexpected delays in producing influenza (A)H1N1 vaccine, coupled with the virus' rapid spread, have left doctors nationwide scrambling to determine how to allocate meager vaccine supplies, and manage offices full of sick and worried patients and their families.

"People are scared. People are frightened. And they're feeling like, 'Oh my God, I need the vaccine and it's not available,' " said John Sage, MD, a family physician and medical staff president at Lutheran General Hospital in Park Ridge, Ill.

As of Oct. 23, around 11.3 million vaccine doses had been shipped to communities across the country, which is "nowhere near" the amount the Centers for Disease Control and Prevention expected to have in circulation by then, said CDC Director Thomas Frieden, MD, MPH.

Meanwhile, the H1N1 virus has swelled to epidemic levels nationwide -- pandemic globally -- with widespread flu activity reported in 46 states by Oct. 17.

People are waiting in line for hours at community vaccine clinics, many of which are reporting running out of vaccine before satisfying the demand.

Vaccine supply is not impacted by President Barack Obama's Oct. 24 declaration that the outbreak of H1N1 is a national emergency. But that order does allow hospitals to more easily set up temporary treatment centers to ease overwhelmed EDs.

Some hospitals are trying to stem transmission by refusing to let children, and anyone with flu-like symptoms, visit inpatients. Many physician practices, trying to limit patient unease as well as disease spread, require anyone with flu-like symptoms to wear face masks or use separate entrances to bypass waiting rooms.

The H1N1 virus has been cited in more than 1,000 deaths and more than 2,000 hospitalizations since the U.S. pandemic began in April, the CDC reported.

At this stage, the objective is to do the greatest good for the greatest number of people, said Jeffrey Levin, MD, MSPH, chair of the Texas Medical Assn.'s Council on Public Health.

A shortage of vaccine

The CDC had anticipated approximately 40 million H1N1 vaccine doses being available by mid-October, based on manufacturers' estimates. Instead, Dr. Frieden said at a news conference, 22.4 million doses were available for shipping as of Oct. 27. The government has purchased a total of 250 million doses.

CDC spokeswoman Amanda Aldridge said "a combination of things that didn't go as anticipated" have caused delays in vaccine production.

First was the lower-than-normal yields in the initial H1N1 production seed strain provided by the World Health Organization. Novartis, for example, experienced a yield of 20% to 25% of that seen with seasonal strains. Similar problems were reported by the other injectable vaccine makers, CSL Limited and Sanofi Pasteur.

Novartis said the need to balance production of the H1N1 vaccine with that of seasonal influenza vaccine also contributed to slowing production. Requests by the Food and Drug Administration, including a call for changes to patient inserts, as well as a suspension on vaccine formulation due to reagent differences, also had an impact.

All three vaccine makers say production is accelerating and the pace of shipments is expected to grow significantly. During an Oct. 23 media briefing, the CDC's Dr. Frieden said steady progress was being made in shipping vaccines, noting that 5.4 million doses were shipped in the week between Oct. 14 and Oct. 21.

Meanwhile, vaccine shortages have prompted state health departments to revise vaccination strategies. Likewise, physicians who have gotten vaccine are rethinking how to distribute it to their patients in the most equitable ways.

"It's frustrating," said Donald Murphey, MD, medical director of pediatric infectious disease at Cook Children's Medical Center in Fort Worth, Texas. Doctors "are a little anxious that they're not doing it right."

The CDC identified at-risk groups, including pregnant women, children and young adults, and recommended they be vaccinated first. But in many cases, even physicians who have vaccine don't have enough to inoculate all their high-risk patients.

"I think we have to do the best we can to maintain open communication with our patients and the public. [We have] to try to be as transparent as we possibly can [and assure them] that this is not a hoarding [of vaccines] for just the few or just the entitled," Dr. Levin said.

Physicians who are expecting to receive more vaccine should tell patients that, he said. Assure them that "today is not going to be the end of the supplies."

Managing the office

Physicians are reporting unusually large patient surges for this time of year.

"Three weeks ago we had more kids in the ER than we had at the peak of [flu season] during the last couple winters. ... We ended up with a huge overflow waiting room," Dr. Murphey said.

The medical center called in additional staff. Children arriving with flu-like symptoms were given face masks -- as were their parents -- and separated from other patients.

The CDC recommends physicians offer antivirals to patients who have suspected H1N1 and evidence of severe illness. Because the benefits are greatest when treatment begins within 48 hours of symptom onset, doctors are encouraged to start the medication without waiting for laboratory confirmation of viral strain.

Some localities have reported difficulty finding pediatric oseltamivir, but the CDC said compounds can be made from the adult version.

The FDA, responding to a CDC request, on Oct. 24 approved emergency use of intravenous peramivir.

The CDC said this agent should be reserved for hospitalized patients "who do not respond to either oral or inhaled antiviral therapy, or when drug delivery by a route other than an intravenous route ... is not expected to be dependable or feasible."

Meanwhile, patient education is essential. Dr. Murphey said staff throughout his Texas center were educated about the virus, including precautions, treatment and testing, so they could help answer phone calls from concerned parents.

"Everyone remotely related to health care was having to answer a million questions," he said.

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Pediatric morbidity and mortality from flu

The Centers for Disease Control and Prevention is reporting widespread flu activity in 46 states. Since Aug. 30, the CDC has received 53 reports of pediatric flu-related deaths this season, with 47 of those attributed to the H1N1 virus.

As of Oct. 17, Dept. of Health and Human Services surveillance regions were reporting:

Region 1: (Conn., Maine, Mass., N.H., R.I., Vt.) 268 pediatric H1N1 cases; no pediatric flu deaths

Region 2: (N.J., N.Y., Puerto Rico, U.S. Virgin Islands) 91 cases; no deaths

Region 3: (Del., D.C., Md., Pa., Va., W.Va.) 2,694 cases; 4 deaths

Region 4: (Ala., Fla., Ga. Ky., Miss., N.C., S.C., Tenn.) 2,537 cases; 16 deaths

Region 5: (Ill., Ind., Mich., Minn., Ohio, Wis.) 2,618 cases; 3 deaths

Region 6: (Ark., La., N.M., Okla., Texas) 1,495 cases; 19 deaths

Region 7: (Iowa, Kan., Mo., Neb.) 1,641 cases; 1 death

Region 8: (Colo., Mont., N.D., S.D., Utah, Wyo.) 2,547 cases; 5 deaths

Region 9: (Ariz., Calif., Guam, Hawaii, Nev.) 2,163 cases; 2 deaths

Region 10: (Alaska, Idaho, Ore., Wash.) 1,054 cases; 3 deaths.

Source: Centers for Disease Control and Prevention

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