Rotavirus vaccine found not guilty

October 11, 2001

N.B. Please note that if you are outside North America the embargo for Lancet press material is 0001 hours UK time friday 12th October 2001.

Worldwide, some 600 000 to 800 000 infants die yearly from severe diarrhoea caused by a rotavirus. In the USA, each year, about 50 000 infants are admitted to hospital with rotavirus infection, and of these about 20 die. These figures make a clear case for the need for a safe and effective vaccine against rotavirus infection. Such a vaccine (Rotashield) was developed and licensed for use in the USA in 1998. About one and a half million doses were given until nine and a half months later the US Advisory Committee on Immunisation Practices advised that the use of the vaccine be suspended because of reports that the vaccine was associated with an increased incidence of intussusception in infants. Intussusception is a condition where the lining of the bowel folds in on itself and causes a blockage often needing an operation to clear the blockage.

By no means all researchers agreed on the overall magnitude of intussusception risk among infants exposed to Rotashield. Lone Simonsen and colleagues from Bethesda, MD, USA studied hospital admissions of infants for intussusception in ten US states during the period when Rotashield was in use, and an estimated 28% of the infants (304,347) received the vaccine. They report in this week's issue of THE LANCET, "We observed an overall decrease of 4% to 10% in infant intussusception admissions during the Rotashield use period. This result was unexpected, since other studies have documented a strong association in the first post-vaccination week and had predicted significant overall increases in intussusception rates. Thus, we are facing an apparent paradox". The authors favour the explanation that Rotashield may trigger intussusception events in susceptible infants and that this precipitation may be compensated for by a lower risk of intussusception later in infancy.

After the initial reports of apparent adverse reactions to Rotashield, the manufacturers stopped producing the vaccine. "As of March 1st, 2001, Rotashield remains licensed but unavailable, despite benefit/risk ratios presumed to weigh heavily in favour of a rotavirus vaccine in developing countries with a heavy burden of rotavirus disease mortality."

The authors comment that the obvious strength of this study is that it documents what actually took place in terms of intussusception rates in a large subset of the US infant population when Rotashield was used. However, the main weakness is our inability to directly link intussusception and vaccination records for individual infants. In a commentary on page 1197, Andrew J Hall from the London School of Hygiene and Tropical Medicine, London, UK, agrees, "one of the weaknesses of Simonson and co-workers' study is the lack of confirmation of the diagnosis of intussusception, which could have been done by examining medical records. Nor were vaccine records obtained, which could have yielded information about potential confounders"
Contacts : Dr Lone Simonsen, 67-B Rockledge Drive, Room 3153, Bethesda, MD 208-7630, USA. T) +1 301 402 8487; F) +1 301 402 3255; E)

Dr Andrew J Hall, Infectious Disease and Epidemiology Unit, London School of Hygeine and Tropical Medicine, London WC1E 7HT, UK; E)


Related Vaccine Articles from Brightsurf:

Who should get the COVID-19 vaccine first?
Nineteen global health experts from around the world have proposed a new, three-phase plan for vaccine distribution -- called the Fair Priority Model -- which aims to reduce premature deaths and other irreversible health consequences from COVID-19.

Breakthrough with cancer vaccine
Scientists have developed a new cancer vaccine with the potential to activate the body's immune system to fight a range of cancers, including leukaemia, breast cancer, lung cancer and pancreatic cancers.

How to improve the pneumococcus vaccine
Pneumococcus kills 1 million children annually according to the World Health Organization.

US inroads to better Ebola vaccine
As the world focuses on finding a COVID-19 vaccine, research continues on other potentially catastrophic pandemic diseases, including Ebola and Marburg viruses.

Successful MERS vaccine in mice may hold promise for COVID-19 vaccine
In a new study, published April 7 in mBio, researchers from the University of Iowa and the University of Georgia demonstrate that a new vaccine fully protects mice against a lethal dose of MERS, a close cousin of COVID-19.

Coronavirus Vaccine: Where are we and what's next? (video)
You might have heard that COVID-19 vaccine trials are underway in Seattle.

Why isn't there a vaccine for staph?
A study from Washington University School of Medicine in St.

Exposing vaccine hesitant to real-life pain of diseases makes them more pro-vaccine
New research from Brigham Young University professors finds there is a better way to help increase support for vaccinations: Expose people to the pain and suffering caused by vaccine-preventable diseases instead of trying to combat people with vaccine facts.

Lifetime flu vaccine?
Another year, another flu vaccine because so far scientists haven't managed to make a vaccine that protects against all strains of flu.

On the horizon: An acne vaccine
A new study published in the Journal of Investigative Dermatology reports important steps that have been taken towards the development of an acne vaccine.

Read More: Vaccine News and Vaccine Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to