An Open Letter to President George W. Bush about the question of making smallpox vaccinations available Updated

From: ACSH President Dr. Elizabeth Whelan

Re: Decisions Related to Distribution of the Smallpox Vaccine

Dear President Bush,

Recent press reports indicate that your administration is on the verge of making a determination about which Americans, if any, should be vaccinated against smallpox.

As a public health professional, I understand the complexity and gravity of the decision you are facing, and I wanted to offer some perspective and advice.

As you are well aware, unlike routine childhood and flu shots, the smallpox vaccine, which contains a live virus called vaccinia, carries known risks even for healthy people, with an estimated death rate of one to two per million, and a significantly higher rate of other side-effects from adverse reactions. Some people should definitely not be vaccinated at least not as a precautionary measure at a time when there is no evidence of a current or imminent attack using the smallpox virus as a weapon. People who are not candidates for smallpox vaccination in a pre-attack scenario include pregnant women, children under the age of one, immune-compromised individuals, and individuals who have eczema or atopic dermatitis or a history of these skin diseases or even individuals who live in the same household as people with these skin conditions^*.

But what about the rest of Americans, for whom the vaccine is not clearly contraindicated? Should Americans have the choice at this time even though smallpox remains a hypothetical risk to seek and receive the vaccine?

My advice is this:

Withhold the smallpox vaccine from general population access for now. Reconsider this decision within the next couple of months when there are more data on side-effects available to guide us (see below).

(I offer this advice despite the fact that a recent Wall Street Journal OnLine/HarrisInteractive Health-Care Poll concluded that nearly half of Americans would get themselves vaccinated against smallpox right now if the vaccine were made available to them and almost two thirds support some type of mass immunization campaign to reduce the threat of a possible bioterror attack. Perhaps Americans would be less likely to support universal vaccination if the risks of the vaccine were more completely spelled out for them)

After giving them complete information sufficient for making an informed consent decision, begin a voluntary program of immunizing "first responders" including, but not limited to, emergency room workers who may be the first to encounter a smallpox patient.

Authorize careful, detailed observation and follow-up of all the vaccinated first responders to determine the actual frequency and severity of the anticipated side-effects.

Obtain and analyze the data now available in Israel, where more than 15,000 military personnel and public health workers have now been vaccinated. What was the extent of negative sequelae among the vaccinated Israeli population? How might that data be extrapolated to predict risks in the United States if you make the vaccine widely available? (Recent reports from Israel indicate that the adverse consequences to the vaccine have been minimal but apparently, Israeli doctors chose at this time to vaccinate only those who had been previously vaccinated. It is believed that those who have previously been vaccinated are at lower risk of complications thus this cohort of vaccinees may not be representative of what might occur in the U.S. where persons born after l972 have never been vaccinated. Further, and more important, Israel used the Lister vaccine strain different and less virulent than the U.S. vaccines, with fewer side effects so it's possible that the Israeli data will be of limited use in predicting U.S. vaccine-related risks.)

If Americans could be assured that they would have ready, nearby access to the smallpox vaccine shortly after a case of smallpox was confirmed anywhere in the country, they would conclude that it was less urgent to seek the vaccine in advance of an attack.

For this reason, give serious consideration to the logistics of distribution of the smallpox vaccine to medical clinics around the nation to be available on an "as necessary" basis. Proper administration technique is crucial. Training sessions on these inoculation techniques, perhaps via taped lessons from the CDC, would have to accompany such distribution.

We know that smallpox vaccination can be effective in thwarting the progress of the disease even after a person has been exposed and infected (To thwart the disease, the vaccine should be given within 3 or 4 days of exposure.) Thus, if the vaccine were widely distributed and available in advance of an attack, even an individual's worst case scenario direct exposure and infection could be addressed immediately at a local medical facility.

Prior to re-evaluating the possibility of making the vaccine available to all Americans, the administration should review and analyze hard data on what the side-effects in a modern-day population might be, noting that the effects may be quite different from the side-effects reported during the l960's.

The negative effects may be greater or lesser today. The greater prevalence of immune-comprised individuals and the increase in atopic dermatitis prevalence may lead to greater adverse effects. Perhaps, however, the diluted dose that we would use now might lead to fewer negative consequences.

Results from a recent study of healthy, fit young college students raises some serious concerns here. Of 200 young adults who received the vaccine as part of a recent government study, one-third missed at least one day of work or school due to illness, 75 had high fevers and several were put on antibiotics because physicians worried that their blisters signaled bacterial infections. Among this newly vaccinated group, arms swelled, temperature spiked and the physicians attending these volunteers expressed great concern probably because in their practice of medicine, they had never seen this type of reaction from a vaccination before.

Prior to offering the smallpox vaccination to all Americans, considerable attention needs to be given to the small but real possibility that recently vaccinated persons pose a health risk to unvaccinated persons.

True, most complications occur in the person receiving the vaccine, but vaccinia virus can be transmitted inadvertently from vaccinees to others, sometimes causing serious and even fatal adverse reactions.

According to scientists writing in the Journal of the American Medical Association "the frequency of possible contact spread of vaccinia and the likelihood of adverse effects cannot be predicted." When health care workers and first responders are inoculated, we may have some solid data on what the adverse effects may be and how to reduce the risks.

Before smallpox vaccination is offered to a hundred million (or more) Americans, logistics must be worked out. Who will perform the work functions of those who are temporarily disabled by the effects of the vaccine? Who will cover the work responsibilities of the physicians doing the vaccinating? Who will be bear liability for the untoward effects of the vaccine or any illness that may occur in unvaccinated persons exposed to recently vaccinated ones? Who will compensate persons for time lost from work from vaccine-induced illness?

If the decision is made to make the vaccine widely available, the government should make a concerted effort to educate Americans as to a) what the risk/benefit ratio for use of the vaccine would be and b) what their alternatives here are. Among the alternatives would be waiting to seek the vaccine locally only after the presence of the virus had been confirmed. Even if one or more cases of smallpox were diagnosed in the United States (and make no mistake, a diagnosis of even one case would be a global health emergency), mass vaccination may not be necessary. Instead, alert public health teams may successfully arrest the spread of the disease by isolating those infected and vaccinating those with whom they have been in contact ("ring" vaccination, a technique that proved effective in past decades).

Prior to giving approval for widespread availability of the smallpox vaccine, you should ensure that the country has a substantially increased supply of VIG, vaccinia immune globulin, which can effectively treat severe reactions. VIG is derived from the blood of vaccinated persons. With a substantial population of first responders being vaccinated, there would be a readily available source of VIG.

Additionally, the federal government, as a part of its national defense, should provide incentives to drug companies to step up research and production on anti-viral drugs which might prove efficacious against smallpox.

While smallpox is a horrific disease and is worthy of the fear now manifested by many Americans, it is not the only biological weapon in the arsenals of our enemies. Smallpox is a purely hypothetical risk, but we know our enemies have access to anthrax. To protect Americans from this insidiously deadly agent, the administration should be moving toward dramatically increasing our supplies of the anthrax vaccine, a vaccine that is known to be safe and effective.

Thank you for your consideration of my suggestions.

Sincerely,

Dr. Elizabeth M. Whelan
President
American Council on Science and Health

^* It was previously thought that individuals with atopic dermatitis and eczema were only at risk of serious complications from the smallpox vaccine if they had active cases of skin disease. It is now the medical consensus that atopic dermatitis/eczema, irrespective of severity or activity, is a risk factor for developing eczema vaccinatum following a smallpox vaccination in either vaccinees or in their close contacts. According to the American College of Emergency Physicians, "Due to the increased risk for eczema vaccinatum, smallpox (vaccinia) vaccine should not be administered to persons with a history of eczema or atopic dermatitis irrespective of disease severity or activity. Additionally, persons with household contacts that have a history of eczema or atopic dermatitis, irrespective of disease severity or activity, are not eligible for smallpox vaccination because of the increased risk that their household contacts may develop eczema vaccinatum."

These guidelines may make pre-attack smallpox vaccination contraindicated for 25%-30% of all Americans.

December 13, 2002

I am wondering how those people with eczema and other conditions (who need to avoid people who are getting the vaccine) will be able to protect themselves?

Has anyone addressed this probelem?

vgibson

HFAF replies:

They would be advised to get vaccinated as soon as possible after exposure to an actual case of smallpox, if that should ever occur.

In that instance, the risk from the vaccine would be outweighed by the much higher risk of the severe consequences of getting smallpox.

Gil Ross M.D.
Medical/Executive Director
American Council on Science and Health