Merck updates Rotateq prescription information

Merck has announced that it is updating the prescribing information for the Rotateq vaccine, designed to prevent the onset of rotavirus gastroenteritis in young children.

Under the new prescription data, labels will include post-marketing reports to the Vaccine Adverse Events Reporting System, the vaccine safety surveillance programme, in a move intended to improve transparency. The new labelling will also help fuel customer assurance in the safety of Rotateq.

Since it was originally approved for distribution over 3.5 million doses of Rotateq have been sold, underlining the vaccine’s popularity and success. Bosses at Merck are confident that updated prescription information will encourage users to continue using the vaccine.

Mark Feinberg, vice-president of policy, public health and medical affairs at Merck Vaccines asserts that the company will continue working with regulatory bodies such as the US Food and Drug Administration (FDA) to ensure high safety standards and quality control.

“Merck places public health and patient safety as our highest priorities,” he stated.

“Merck will continue to work with the FDA and the Centres for Disease Control and Prevention to monitor post-marketing experience with Rotateq by collecting data from additional systems including active controlled surveillance studies.”

The FDA recently issued a public health warning on Rotateq following reports of 28 cases of intussusception.