US SMALLPOX VACCINE PROGRAMME STALLS



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Last Updated

11 May 2003

Source: The Lancet, May 10, 2003

MEDICINE AND HEALTH POLICY

US smallpox vaccine programme stalls as volunteers balk

by Alicia Ault

Even as the US government looks ahead to vaccinating fire, police, and emergency personnel against smallpox, the first phase of its programme has come to a near standstill --far short of its initial goal, state and federal health officials told an advisory panel meeting in Washington, DC, on May 1.

Last autumn, US officials projected that 500 000 health-care workers and public-health officials would be immunised as part of the bioterrorism preparedness effort. All 500 000 vaccinations were to be completed during a 30-day period from March 1 to March 31. But as of April 18, only 33 444 health-care workers had been vaccinated, US Centers for Disease Control (CDC) and Prevention officials told an Institute of Medicine (IOM) smallpox advisory committee.

The US Department of Defense programme has been much more successful, with 411 000 military personnel immunised as of April 22. Smallpox vaccination, however, is mandatory for troops and few have refused immunisation. The civilian programme is entirely voluntary.

The CDC is still gathering information on why health-care workers have opted out. But Mary Selecky, president of the Association of State and Territorial Health Officials (ASTHO), told the IOM panel that an ASTHO survey of 34 of the 62 state and territorial vaccination programmes confirmed that the lack of a clear compensation mechanism for lost work, injury, or death was a main reason for dismal participation.

Under the federal programme, volunteers who had to take time off, or became ill or died had no recourse except to petition state workers' compensation programmes for reimbursement. Most states have no provision for smallpox. Labour unions, individual hospitals, and some nursing trade associations urged volunteers to hold off on vaccination until the US government provided compensation.

Faced with pitiful vaccination rates, President George Bush signed a law, on April 30, to provide compensation for lost wages, illness, and death due to the vaccine. This could eventually help to boost volunteer participation, but not until details are fully absorbed at the local level, Selecky said.

The CDC recently said that the USA could be fully prepared for a smallpox attack with just 50 000 immunised health workers. But both Selecky and CDC officials agreed that preparedness cannot be judged by the total number of vaccinated alone. In 52 of the 62 jurisdictions with approval to vaccinate, fewer than 1000 people have been immunised. The state of Nevada is just beginning to immunise its workers, and no shots have been administered in seven territories.

The gaps leave many areas vulnerable if there is an attack, and does not give officials enough safety or efficacy information to decide whether they should move ahead with vaccination of police, fire, and other first-responders. That programme could begin as early as August, said Joe Henderson, CDC associate director for terrorism preparedness and response. The US General Accounting Office agreed in an April 30 report that the spotty participation and slow ramp-up have hampered CDC efforts to collect safety data.

ASTHO survey respondents also said that uncertainty about vaccine side-effects -- especially an unexpected number of ischaemic cardiac events -- has given volunteers pause. On March 28, the CDC warned physicians against vaccinating people with coronary disease or who have three or more risk factors for coronary conditions. Ten civilians and 17 military vaccinees have had perimyocarditis; all have recovered. There have been nine myocardial infarctions, leading to three deaths. The perimyocarditis is thought to be linked to vaccination, but the ischaemic events have been temporally associated with immunisation, but not causally linked.

In the civilian programme, there have been 483 reports of adverse events until April 18, 75% of which were in women. Most were not serious, but 45 cases resulted in hospital admission, permanent disability, or life-threatening illness.

There has been one case of generalised vaccinia, two of ocular vaccinia, and two of inadvertent, non-ocular vaccination. The CDC also reported on May 1 that 103 women were vaccinated while pregnant, or conceived just after immunisation. The agency has not determined whether two miscarriages were related to the vaccine.

Many health workers remain unconvinced that there is a credible threat of a smallpox attack, said Selecky. About 10% said they were not as enthusiastic about vaccination with the war ending in Iraq and the lack of any evidence that a threat is imminent. "This issue about threat is very real and asked about all the time", she said.