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Shortage of Masks, Vaccine Underscore Pandemic Preparedness Problems-HS Today

by Mickey McCarter   
Wednesday, 28 October 2009

Congressional panel unhappy with preparedness measures for dealing with H1N1 outbreak

A nurses’ association in California is threatening to start a statewide strike Friday due to dissatisfaction with the protections available to them from H1N1 swine flu.

In July, a 51-year-old nurse died from complications related to H1N1 influenza, which authorities suspect she contracted in her workplace, noted Rep. Laura Richardson (D-Calif.) at a hearing of the House Homeland Security subcommittee Tuesday. The California nurses have since become concerned about a shortage of M95 protective masks, which could help prevent exposure to swine flu.

Lawmakers demanded answers from federal health officials at the hearing as to why the United States was experiencing a shortage of the masks and of H1N1 flu vaccine.

The Department of Health and Human Services (HHS) plans to release more masks from the Strategic National Stockpile, replied Nicole Lurie, HHS assistant secretary for Preparedness and Response, but health personnel were facing a worldwide shortage of M95 and surgical masks. Still, HHS is shipping some masks to California this week.

Members of Congress asked Dr. Alexander Garza, chief medical officer at the Department of Homeland Security (DHS), if the shortage of masks was affecting workers at the Transportation Security Administration (TSA), who were initially barred from wearing protective masks due to concerns they could frighten air travelers.

Garza could not confirm if specific individual airports had enough masks for TSA screeners but he explained that TSA changed its guidance in responder to screeners’ concerns about being unable to wear the masks.

“We feel at this moment that we have adequate supplies to meet our needs,” Garza declared, noting that TSA guidance recommends that screeners wear masks when in close in close proximity to someone with the H1N1 flu.

But screeners are permitted to wear masks when generally when interacting with the public if they first consult their supervisors, Garza said.

Lurie pointed out that TSA workers were not among high-priority groups that would receive the limited masks being distributed by HHS.

Yvette Clarke (D-NY), chair of the Subcommittee on Emerging Threats, Cybersecurity, and Science and Technology, said the shortage in masks and vaccine was evidence that federal authorities could have been better prepared to meet the challenges of pandemic influenza.

Although the United States was better prepared to deal with the outbreak of swine flu than it would have been in the past, authorities were not fully prepared to deal with the pandemic due to inadequate early warning systems, incomplete planning activities, a lack of good approaches for delivering health care under pandemic conditions, and unclear levels of preparedness.

“Unfortunately, our failure to develop these systems, activities, and policies cost us during the response. For instance, the pandemic started in North America–the one place we were not looking for it. We did not have an early warning. The alarm sounded only when people started to die. We did not have the luxury of time to observe the virus before the pandemic started–and to the surprise of the community, the virus turned out to be H1N1 not the H5N1 virus that causes avian influenza,” Clarke said in opening the hearing.

Vaccine production

Subcommittee Ranking Member Daniel Lungren (R-Calif.) voiced concerns that the egg-based techniques for developing vaccines had hindered the quest to make enough vaccine available quickly.

HHS originally projected that it would have 40 million doses of H1N1 vaccine available by the end of October, Lungren stated, but instead it would have only 28 million due to snafus in the production of the vaccine.

Lurie defended federal efforts to produce H1N1 vaccine, detailing problems manufacturers of the vaccine faced when producing it. Several manufacturers experience low yields in cultivating the virus, which slowed initial vaccine production, Lurie said.

In addition, manufacturers had to stand up new finishing lines to get the vaccine into syringes and vials and ship them. Some of those lines did not get up and running as quickly as estimated, Lurie said.

But now manufacturers have cleared those problems, which are the sort that happen every year in the production of seasonal flu vaccine. Indeed, one of three strains of seasonal vaccine is late this year due to similar problems.

“New technologies would hopefully get us there faster with more vaccine,” Lurie acknowledged.

The Centers for Disease Control and Prevention is in the third year of a five-year plan to explore the development of vaccines using new technologies such as cell-based and recombinant technologies, Lurie remarked.

In November, the first US-based cell based vaccine production facility will open its doors in North Carolina, but it wasn’t ready in time to make vaccine for the H1N1 flu, Lurie said.

Still, planning for H5N1 avian flu in years past greatly aided the rapid production of swine flu vaccine as the US government had preexisting contracts in place with vaccine manufacturers that it could engage promptly, Lurie added. she insisted enough vaccine was available to those who need from a steady stream of vaccine being produced. Each state receives vaccine in proportion to its population, she said.

Federal officials detailed other ways in which they have improved preparedness for dealing with pandemic influenza.

Garza cited vastly improved interagency cooperation, tabletop exercises that provided valuable lessons, and the delivery of information to state and local fusion centers by the National Biosurveillance Integration Center.

Richard Serino, deputy administrator at the Federal Emergency Management Agency, reported that his agency has stood up 56 incident management teams to deploy when governors request assistance in dealing with H1N1 flu. FEMA has refined its scripted responses to specific pandemic scenarios and it has strengthened its continuity of operations plans so that the federal government could support disaster response and recovery during the outbreak.

Marcy Forman, director of the Intellectual Property Rights Coordination Center at US Immigration and Customs Enforcement (ICE), told lawmakers that ICE was monitoring counterfeit vaccines that criminals might attempt to sell to American from abroad.

She identified China, India, and other countries in southeast Asia as the primary source of counterfeit pharmaceuticals and confirmed that ICE was working with those countries to identify and shut down those operations.