October 26

Smallpox Vaccine Reactions Jolt Experts – WashPost

Smallpox Vaccine Reactions Jolt Experts – WashPost

Thu, 5 Dec 2002

The Washington Post reports that even experts conducting clinical trials of the smallpox vaccine found the side effects “startling”: “If Bush moves forward with vaccination, Dr. Kathy Edwards the Vanderbilt University physician overseeing the study, warns doctors to expect the array of unsightly, unfamiliar complications that will come.”

“Even at the CDC, where health experts work with an array of germs, smallpox vaccinations were briefly halted when 10 people had serious enough reactions to begin antibiotics, said Walter Orenstein, director of the CDC’s National Immunization Program.”

Preparing stockpiles of vaccines against a potential, speculated threat of bioterrorism for is one thing, but given that the vaccine is effective AFTER 3-4 days of exposure, and there is no evidence of a real smallpox threat, why then is the administration pushing for mass inoculations? A small but significant number of those vaccinated will suffer “an array of unsightly” complications–some of which will be severe and life-threatening.

Today’s editorial, the Post notes, “The homeland security bill went out of its way to protect the vaccine’s manufacturers, as well as those doing the vaccinating, from any liability for these injuries and deaths. No provisions were made, however, to compensate anyone injured by the vaccine, or the families of those who die from it. This was not an accidental omission.”

Given that the threat of a bioterrorist attack is speculative, a risk/ benefit analysis of the proposed vaccine program shows that the American public will bear all the risks, the immunized vaccine manufacturers will reap all the benefits.


Smallpox Vaccine Reactions Jolt Experts
From Rashes to Fevers, Array of Side Effects Is Uncommon Today
By Ceci Connolly
Washington Post Staff Writer
Thursday, December 5, 2002; Page A01

As physical specimens, the Baylor University students were fit and healthy, the “crème de la crème,” in the words of researcher Kathy Edwards. Yet when she inoculated them with smallpox vaccine, arms swelled, temperatures spiked and panic spread.

It was the same at clinics in Iowa, Tennessee and California. 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, 75 had high fevers, and several were put on antibiotics because physicians worried that their blisters signaled a bacterial infection.

Even for experts such as Edwards, the Vanderbilt University physician overseeing the study, the side effects were startling. “I can read all day about it, but seeing it is quite impressive,” she said. “The reactions we saw were really quite remarkable.”

President Bush is poised to announce plans, perhaps as early as this week, to resume vaccinating Americans against smallpox as part of a massive push to protect the nation from a biological assault. As he weighs the decision, researchers are becoming reacquainted with the unpleasant — often severe — complications of the vaccine.

The experiences in a half-dozen clinical trials offer an early look at what military personnel, hospital workers and other emergency workers will likely encounter if Bush adopts the recommendations of his top health advisers to vaccinate as many as 11 million people in the coming months. What is disconcerting, say the people participating in the clinical trials, is that when it comes to smallpox vaccination, what had once been considered ordinary is rather extraordinary by today’s standards.

“I just wanted to go to bed for a day or two there,” said Alison Francis, a New York University graduate student who received the vaccine. Francis, 24, said she felt tired and achy after getting her shot. Her arm was heavy, warm to the touch and terribly itchy. “I thought, ‘Can you just chop off my arm?’ ”

Participating in the study was part patriotism and part selfishness, she said. “Now I’m protected.”

Once among the deadliest scourges on earth, smallpox was declared eradicated worldwide in 1981. But growing hostilities with Iraqi President Saddam Hussein, Osama bin Laden and others have renewed fears that the virus could be used as a potent, stealthy weapon. Vaccination is surefire protection against the disease, but it is risky. For every 1 million vaccinated, between 15 and 52 people will suffer life-threatening consequences such as brain inflammation, and one or two will die, according to historical data. Pregnant women, babies, people with eczema or weakened immune systems should not receive the vaccine.

Federal health officials have proposed resuming vaccination in stages, beginning with as many as 500,000 hospital workers most likely to see an initial case. Later, as many as 10 million police, fire and medical personnel would be offered the vaccine. The Pentagon hopes to vaccinate 500,000 soldiers.

Over the past year, federal researchers have been testing the 40-year-old vaccine for its safety and potency. None of the 1,500 volunteers has died or been seriously injured by the vaccine. But even the most mundane cases can be disturbing to doctors and patients unaccustomed to the live virus used in the vaccine and its side effects.

Unlike most modern vaccines, the smallpox vaccine is administered by 15 quick pricks that “establish an infection in your skin,” said Julie Gerberding, director of the Centers for Disease Control and Prevention in Atlanta. “There is the immediate discomfort of getting poked in the arm and a range of annoying reactions.”

Within three to four days, a red itchy bump develops, followed by a larger blister filled with pus. In the second week, the blister dries and turns into a scab that usually falls off in the third week. During the three weeks, many people experience flu-like symptoms — aches, fever, lethargy — and terrible itchiness.

“You can’t scratch it; it’s all bandaged up; all I could do was smack it,” said Meg Gifford, a University of Maryland junior who participated in one study. For a weekend, she was “pretty miserable,” suffering from a slight fever, an arm that was hot to the touch and swollen lymph nodes in her armpit.

At the University of Rochester Medical Center, researcher John Treanor saw a wide range of reactions, from a small rash to swelling the size of a grapefruit. About 5 percent of the 170 participants had rashes that spread to other parts of the body. It took time and experience, he said, for the team to get comfortable with the natural course of the vaccine.

“The reactions we are seeing are totally out of line with today’s vaccine experience and absolutely in line with historical experience,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “In the 30 years since we had routine vaccination, the public’s tolerance level has gone way down.”

Maryland researchers have begun a second trial revaccinating older adults to see how much immunity stays in the system. Early indications are that people who have been previously inoculated do not suffer as many severe side effects. “I had a small red mark and that was about it,” said Edward Dudley, 33.

Very few of today’s physicians have administered the vaccine or treated its side effects. Even at the CDC, where health experts work with an array of germs, smallpox vaccinations were briefly halted when 10 people had serious enough reactions to begin antibiotics, said Walter Orenstein, director of the CDC’s National Immunization Program.

“The clinic physician couldn’t decide if this was a normal, primary exuberant take or a bacterial infection,” he said. He added that, in fact, the swollen, itchy, red arms were routine.

As a first-year medical student 33 years ago, Orenstein was so alarmed by the fever, swollen glands and red streak up his arm after he was vaccinated that he went to the emergency room for antibiotics. “I respect this vaccine,” he said.

If Bush moves forward with vaccination, Edwards warns doctors to expect the array of unsightly, unfamiliar complications that will come.

“You are going to have to be prepared to see these individuals and to see really bad takes,” she told state health officers. “You’ll wonder if they are bacterial infections; in some cases the rash will move up the arm and onto the chest. The vaccinee requires a lot of TLC.”

© 2002 The Washington Post Company

http://www.washingtonpost.com/ac2/wp-dyn/A11344-2002Dec4?language=printer washingtonpost.com
Thinking About Smallpox

Thursday, December 5, 2002; Page A34

WITHOUT MUCH FANFARE, the Bush administration has been slowly preparing American health care workers to be vaccinated against smallpox, the deadly disease that was eliminated in its natural form in 1980 but that exists in laboratories in the United States, Russia and, possibly, Iraq and North Korea. State public health officials have submitted plans detailing how they would organize a mass smallpox vaccination if the disease were deliberately reintroduced by terrorists. Next week they will identify which health care workers will need to be vaccinated in advance simply in order to carry out those plans. This week the Centers for Disease Control and Prevention will begin a formal training program for the doctors and nurses who will give the vaccination to those workers who volunteer to receive it. After the president gives the word — an announcement is expected any day now — deliveries of the vaccine, out of use in the United States since 1971, will begin.

In a remarkably short period of time, the administration has completed preparations for this unprecedented and even historic vaccination against a disease no one has thought much about for a quarter of a century. Yet while the speed is commendable, it has come at a cost. A small percentage (perhaps 15 in a million) of the doctors, nurses and emergency workers who receive this vaccine will become seriously ill, and one or two will die. An unknown percentage of those who come into contact with vaccinated people may become sick as well. The homeland security bill went out of its way to protect the vaccine’s manufacturers, as well as those doing the vaccinating, from any liability for these injuries and deaths. No provisions were made, however, to compensate anyone injured by the vaccine, or the families of those who die from it.

This was not an accidental omission. Fears that a victims’ compensation fund might be abused and legal complications created by previous funds led legislators to drop the idea. Not wanting to hold up the entire procedure, the administration didn’t push it. There is talk of creating such a fund at some point in the future, if the decision is made to offer the vaccination to a wider group of people. Those set to receive it now, however, are left without any support — particularly health care workers who have no health insurance, and there are some. At fault, in part, is a legal culture that has made injury compensation such a minefield. Also at fault is a Congress willing to take everyone’s pet concerns into account when drawing up the homeland security bill — except those of the health care workers who will be most critical to homeland security itself. At the next opportunity, Congress should look at this issue again, remembering who it is that the nation will rely on when the first case of smallpox is announced.

© 2002 The Washington Post Company

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