FW: ROTAVIRUS VACCINE WILL BE A HARD SELL

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Acceptance Of Rotavirus Vaccine Called Hard Sell

Barbara Baker, San Francisco Bureau

Pediatric News 32(8):22, 1998. © 1998 International Medical News Group

RAPID CITY, S.D. -- It'S Going To Be Tough To Convince Parents And

Physicians Of The Need To Routinely Immunize Infants With The New

Rotavirus Vaccine, Dr. Larry K. Pickering Predicted At A Meeting On

Clinical Pediatrics Sponsored By The University Of South Dakota. An Oral

Live Tetravalent Rotavirus Vaccine, To Be Given At 2, 4, And 6 Months Of

Age, Is Pending Licensure By The Food And Drug Administration. If And

When The Vaccine Is Approved, One Of The Difficult Tasks Will Be To

Educate Parents, As Well As Physicians Who Don'T Have Hospital-Based

Pediatric Practices, That Rotavirus Infection Can Be A Serious Disease,

Said Dr. Pickering, A Member Of The American Academy Of Pediatrics' Red

Book Committee. The AAP Has Not Yet Issued A Statement On The Vaccine,

And He Stressed That He Was Giving His Personal Views.

Rotavirus Infection Accounts For About 50% Of Hospitalizations Caused By

Gastroenteritis In The United States. It Results In 50,000

Hospitalizations And 20-40 Deaths Annually. The Highest Incidence Of

Severe Infection Occurs At 3-24 Months Of Age, But Rotavirus Also Causes

Significant Illness In Infants 24-36 Months Of Age. Another Sticking

Point In Getting The Vaccine To Be Widely Accepted Is That It'S Only

About 50% Effective In Preventing Diarrhea Caused By Rotavirus

Infection, According To The Five Published Placebo-Controlled Trials.

However, It Needs To Be Emphasized That The Vaccine Was About 80%

Effective In Preventing Severe Rotavirus-Induced Diarrhea In The Three

U.S. Trials,

Said Dr. Pickering, Professor Of Pediatrics At Eastern Virginia Medical

School, Norfolk.

Although Most Of The Studies Looked Only At 1-Year Efficacy Rates, It'S

A Live Vaccine " And There'S No Reason To Think It Won'T Give

Long-Lasting Protection, Similar To A Natural Rotavirus Infection, " He

Added. Parents Will Need To Be Counseled That Perhaps Only Half Of The

Average Eight Episodes Of Diarrhea That A Child Has During The First Few

Years Of Life Are Caused By Rotavirus Infection.

" We Will Need To Educate Parents That This Isn'T A Diarrheal Vaccine;

It'S A Rotavirus Vaccine. Their Children Will Still Get Diarrhea. But

The Other Causes Don'T Result In As Severe Diarrhea As Rotavirus. The

Vaccine Will Keep Kids Out Of The Hospital, " Dr. Pickering Said. Parents

And Physicians Can Be Reassured That The Vaccine Is " Pretty Safe, " He

Added. The Only Real Side Effect, Which Occurs Within 5-6 Days Of

Vaccine Administration, Is Fever. It Develops Only After The First Of

The Three Doses And Is Generally Between 38? And 39?C. In The U.S.

Trials, 7%-14% Of Infants Developed Fever After The First Dose Of The

Vaccine, Compared With 4%-7% Of Those Given Placebo.

The Older The Infants Were When They Received Their First Dose, The More

Likely They Were To Develop Fever. Dr. Pickering Predicted That If And

When The Vaccine Is Approved, The Package Insert Will Strongly Recommend

That The First Dose Be Administered Before 6 Months Of Age, In Part For

This Reason. Vaccine Administration Has Not Been Associated With An

Increased Risk Of Diarrhea Or Vomiting. Dr. Pickering Noted That A Key

Factor In The Acceptance Of The Vaccine Will Be Cost, Which Has Not Yet

Been Disclosed By The Manufacturer, Wyeth-Ayerst Laboratories. If

Approved, The Vaccine Will Be Marketed As RotaShield.