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PARENTS' GROUP APPLAUDS DECISION TO SWITCH TO SAFER INJECTIBLE POLIO VACCINE FOR CHILDREN

Will Prevent Future Cases of
Vaccine-Associated Polio in U.S.

Atlanta, Georgia, June 17, 1999 -- A number of families affected by vaccine-associated paralytic polio (VAPP) attended today as a federal advisory panel on vaccines made an historic decision to rely on the safer, injectable polio vaccine (IPV). The new policy, scheduled for implementation on January 1, 2000, recommends the exclusive use of the safer, injectable "killed-virus" polio vaccine (IPV) and is expected to eliminate the risk of future VAPP cases -- a direct consequence of the oral, "live-virus" polio vaccine (OPV).

"After 36 years, we've come full circle in our efforts to finally eliminate the last remnants of polio in the U.S.," says John Salamone, president, Informed Parents Against VAPP (IPAV) and father of a 9-year old who contracted the disease in 1991. "The recommendations provide a clear message (to all immunization providers) about the risk of vaccine-associated polio from OPV and the necessity of an all-IPV schedule. Physicians and parents need not wait until January 2000 to use an all-IPV schedule."

The CDC's Advisory Committee on Immunization Practices' (ACIP) new recommendations state that children should receive the injectable, inactivated polio vaccine (IPV) for all four doses of the polio vaccine regimen. As a transition to phase-out OPV, ACIP allows for OPV use in a sequential vaccination series only under special circumstances and only until January 2001, when only an all-IPV schedule will be recommended.

"Now, it's up to key medical groups to encourage physicians and other immunization providers to implement the new all-IPV schedule," says Salamone. "Ultimately, the immunization provider can avoid the risk that the last case of polio in the U.S. will be one of their patients by switching to an all-IPV schedule now."

Currently, four cases of VAPP that may have occurred in 1998 are under review by the CDC. For the past 20 years, a reported 8 to 10 cases of VAPP annually have been reported from OPV administration. IPAV contends that more VAPP cases may have actually occurred, but were likely misdiagnosed. The safer injectable polio vaccine (IPV) contains killed virus that cannot transmit polio.

In 1997, the CDC issued its set of recommendations for the mixed IPV/OPV schedule with all-OPV and all-IPV schedules as acceptable options. According to the CDC, the mixed schedule was intended to reduce, not eliminate, future VAPP cases. However, more VAPP cases ensued despite the new CDC recommendations. Now, the CDC has taken the final step by recommending an all-IPV schedule.

Polio is a devastating virus that attacks the nervous system. It reached epidemic proportions in the United States during the 1950s, but "wild" cases have been virtually eradicated by effective vaccination. Infants in the United States should receive four doses of injectible polio vaccine, beginning at two months of age and ending at four-to-six years of age. As long as polio exists in the world, vaccination is essential in ensuring that "wild-polio" does not re-emerge in the United States. IPAV enthusiastically supports the all-IPV recommendation, and strongly urges parents to ask their physicians for the all-injectable polio vaccine schedule to completely avoid the rare but real risk of vaccine-caused polio.

PARENTS' GROUP SUPPORTS DECISION FOR USE OF SAFER POLIO VACCINES FOR CHILDREN

Urges use of safest vaccine for
all 4 doses to avoid risk of VAPP

Washington, D.C., December 9, 1998 -- A new polio vaccination schedule recommended today by the American Academy of Pediatrics (AAP) is being welcomed by a group of parents who live with vaccine-associated paralytic polio (VAPP) as another step to completely eliminating polio in the United States. Since 1979, when the last case of "wild" polio was reported in the U.S., VAPP cases caused exclusively by the "live-virus" in the oral polio vaccine have become the remaining form of polio in this country.

The new AAP position recommends that all children receive the injectable, inactivated polio vaccine (IPV) for their first two doses of the four-dose polio vaccine regimen. According to the AAP, the 3rd and 4th doses can be either IPV or the "live-virus" oral polio vaccine (OPV). The use of an all-OPV schedule, once an acceptable option, is to be reserved only for use in special circumstances. For the past 19 years, about 8 to 10 cases of VAPP have been documented each year in the U.S. as a direct result of the oral polio vaccine. Many believe that more may have actually occurred, but were likely misdiagnosed. The equally effective injectible polio vaccine (IPV) contains killed virus, cannot transmit polio.

In 1996, the U.S. Centers for Disease Control and Prevention (CDC) issued the first set of recommendations for the mixed IPV/OPV schedule, while previous AAP guidelines did not indicate a schedule recommendation. According to the CDC, the mixed schedule is intended to reduce, not eliminate, future VAPP cases. In its new recommendations, the AAP noted that an all-IPV schedule will be recommended by the year 2001.

"We hope the Academy's decision will mean that physicians will begin to increase their use of the inactivated polio vaccine and even choose the all-IPV option to completely avoid the risk of VAPP," says John B. Salamone, president, Informed Parents Against VAPP. "Studies have shown that when given a choice of polio vaccines, parents usually opt for the safer, injectible vaccine once they are made aware of the rare but real risk of vaccine-associated polio caused by the oral vaccine."

"While AAP's new recommendation is reassuring, we believe that only an all injectible polio vaccine schedule will eliminate polio once and for all in the United States," says Salamone, whose son contracted VAPP from the oral vaccine in 1990. "Even after the CDC implemented its recommendations in 1997, four new VAPP cases have been confirmed, with others pending. We urge the Academy and other policy makers to move quickly to end the use of oral polio vaccine in the U.S. entirely within the next year."

Polio is a devastating virus that attacks the nervous system. It reached epidemic proportions in the United States during the 1950s, but "wild" cases have been virtually eradicated by effective vaccination. Infants in the United States should receive four doses of polio vaccine, beginning at two months of age and ending at four-to-six years of age. As long as polio exists in the world, vaccination is essential in ensuring that "wild-polio" does not re-emerge in the United States. IPAV supports the AAP and CDC recommendations, but strongly urges parents to ask for the all-injectible polio vaccine option to completely avoid the rare but real risk of vaccine-caused polio.

Oral Polio Vaccine Out; Shots to be Standard

By Anita Manning
Thursday, June 17, 1999
Reprinted with permission from USA Today

Starting Jan. 1, 2000, oral polio vaccine will be replaced entirely by polio shots, a federal health panel voted Wednesday.

The Advisory Committee for Immunization Practices (ACIP), which advises the Centers for Disease Control and Prevention on vaccine policy, voted 6 to 4 in favor of a vaccine schedule that eliminates the oral vaccine except in special circumstances. The vote is expected to be finalized today.

Oral vaccine, which has been used since the mid-1960s, contains live, weakened virus. It confers immunity, but it has been the sole cause of paralytic polio -- eight to 10 cases a year -- in the USA since 1979.

That happens because ''the virus has the capacity to revert back to wild type,'' making it virulent, says Paul Offit, chief of infectious diseases at Children's Hospital in Philadelphia and chairman of the ACIP polio vaccine working group.

The injected vaccine is as effective as the oral vaccine, but it contains no live virus and cannot cause polio, Offit says.

Pediatrician Michael Marcy, a member of the American Academy of Pediatrics' committee on infectious diseases, says the decision to eliminate oral vaccine has been expected and it's likely ''the academy will agree to follow the ACIP recommendation.''

Doctors have been concerned about adding another injection to the routine shots infants already get.

But even though the chance of a child getting vaccine-associated polio is very small, Marcy says, ''each of us always has in the back of our mind a little concern.''

Based on an ACIP vote two years ago, the CDC changed the polio vaccination schedule in January 1997 to recommend injected vaccine for the first two doses, given at 2 and 4 months of age, followed by oral vaccine at 12-18 months and again between 4 and 6 years of age.

But the committee at the time said an all-oral or all-injectable vaccine schedule was an acceptable alternative.

Many doctors, slow to change a 30-year practice of using oral polio vaccine, did not convert to the new schedule.


Copyright 1999, USA Today. Reprinted with permission.

End Oral Polio Vaccine, Panel Says

Switch to injections would apply in U.S. only, giving Salk a posthumous victory in long-running dispute

By Marlene Cimons
Friday, June 18, 1999
Reprinted with permission from The Los Angeles Times

A federal advisory panel recommended Thursday that the United States abandon the oral polio vaccine that has been the world's medicine of choice in battling the disease for nearly four decades and return to the injectable vaccine that ended the scourge of polio in this country and made Dr. Jonas Salk a national hero.

Salk developed his vaccine in 1954, but, despite his pioneering work, his product was largely supplanted within a decade by a vaccine developed by Dr. Albert Sabin that was less expensive, more effective and could be taken orally.

The subsequent global dominance by the oral vaccine provoked an extremely bitter and often nasty public feud between the two scientists that lasted for years until Sabin's death in 1993.

The panel's decision Thursday effectively makes Salk the posthumous winner in the longtime rivalry, although only in the United States, where polio epidemics are no longer regarded as a probability.

The move to return to the Salk vaccine was prompted by growing concerns in recent years over a small number of polio cases apparently caused by the oral vaccine. CDC Expected to Follow Panel's Advice

The panel's recommendation is not binding but is expected to be accepted by the Centers for Disease Control and Prevention, which drafts immunization policy guidelines for the public health community.

The Department of Health and Human Services will make the final decision but typically follows the CDC's advice.

Most of today's young adults received the oral version of the vaccine--often on a cube of sugar--while their parents got the shots, from the mid-1950s to the early '60s, after Salk's discovery.

There are numerous advantages to the Sabin vaccine, particularly overseas, but its use in the United States has resulted in eight to 10 cases annually of children who contract the disease.

The risk is extremely rare, about one case for every 2.4 million doses, according to the CDC.

The World Health Organization declared in 1994 that naturally occurring "wild" polio had been eradicated from the Western Hemisphere. The last documented case was in 1991 in Peru.

"The oral polio vaccine was vital to the elimination of the wild polio virus in the United States and other parts of the world and continues to be important. . . . However, oral polio vaccine, in rare instances, does cause paralytic polio. We couldn't ignore that," said CDC spokeswoman Barbara Reynolds.

The virus that causes poliomyelitis, or infantile paralysis, attacks the central nervous system and can produce paralysis and death by asphyxiation. There are no effective drugs to treat it. Patients whose respiratory cells have been destroyed usually require a respirator to control breathing and keep them alive.

To become immune to polio, children must have four doses of the vaccine before the age of 6.

Most parents have little choice over the issue of whether to vaccinate their children against polio, since all 50 states require it for entry into public schools.

If accepted, the panel's recommendation would be effective Jan. 1, although pediatricians are free to administer the shots earlier. The panel suggested that the oral vaccine still be used if children are planning to travel to areas of the world where polio outbreaks still occur.

The oral vaccine, which has been widely used since 1965, is made from a live but weakened form of the virus and is believed to provide better immunity against the disease because it results in intestinal immunity, which is necessary in polio epidemic settings.

The Salk vaccine is produced from a killed virus and provides bloodstream immunity, less effective during epidemics. But it is incapable of causing the disease.

"We've come full circle in our efforts to finally eliminate the last remnants of polio in the U.S.," said John Salamone of Oakton, Va., father of a 9-year-old boy who contracted polio in 1991 after receiving the oral vaccine. "Now it's up to key medical groups to encourage physicians and other immunization providers to implement the new . . . schedule." Salamone founded a parents' group to fight for a return to the injectable vaccine.

Until his death at age 86, Sabin steadfastly maintained that his vaccine could not cause polio. "What is the proof?" he asked in a 1983 interview with The Times. "One out of 5 million vaccinations with live vaccine doesn't mean the vaccine causes it. There are other kinds of paralysis that simulate polio that are not polio."

Salk responded in a separate interview. "Cases exist [of polio caused by live virus vaccine] which have been documented, and everyone -- all but one man -- believes the evidence. It is . . . simply remarkable that he casts doubt about it."

Salk died in 1995 at age 80.

In 1996, the CDC altered its recommended polio vaccine schedule to two injections of the killed virus, followed by two doses of the oral product, with the idea that the first two doses would decrease the risk of contracting the disease from the oral doses.

The change effectively reduced the number of cases in the United States to four in 1997 and only one last year, the agency said. And it hopes that eliminating the oral vaccine entirely will end all cases of vaccine-caused polio.

The new recommendations "will guarantee a polio-free America in the next millennium, and we are proud to be a part of this historic movement toward disease eradication," said David J. Williams, president and chief operating officer of Pasteur Merieux Connaught of Swiftwater, Pa., which manufactures the injectable vaccine. 'Virtual Eradication' of Wild Virus

The company said that it would work with government and medical organizations to implement the new policy.

Doug Petkus, a spokesman for Wyeth Lederle of Radnor, Pa., which makes the oral product, said that the company is proud its product contributed to the "virtual eradication of wild polio virus" and pledged to continue to work on vaccines that would benefit children.

The Sabin product was appealing because it was easier to administer to children. It also was very effective in provoking immunity in people who do not directly receive it but who have contact with people who do--a phenomenon known as "herd" immunity.

This is especially valuable overseas in developing countries, where immunization of children is not as widespread as it is here, and also during epidemics. And the oral vaccine does not require sterile equipment, such as needles, or trained health personnel to administer it.


Copyright, 1999, Los Angeles Times. Reprinted by permission.

December 9, 1998 - CNN Interactive
The American Academy of Pediatrics recommends that children be vaccinated with the injectable "killed" form of the polio virus to prevent VAPP caused by "live" oral vaccine

October 11, 1998 - San Francisco Chronicle
Victor Fadayel, father of Marian Fadeyel who contracted polio from oral vaccine, comments on PBS documentary and urges use of injectable polio vaccine

July 19, 1998 - Daytona News-Journal
Ciara Ceballas contracted polio through oral vaccine

January 7, 1998 - San Francisco Chronicle
Settlement for Marian Fadeyel with polio from oral vaccine

October 24, 1997 - New York Daily News
Dominick Tenuto wins right to sue the doctor who administered the oral vaccine to his daughter

October 30, 1995 - Time Magazine
CDC votes to change recommendation on polio vaccination schedule; Ryan Philips contracted polio after receiving oral vaccine