An FDA reviewer, however, says the agency needs more information on one trial from manufacturer Merck and Co. before it fully gauges the effectiveness of Rotateq.
A company spokeswoman says the company has supplied all requested information to the FDA.
Regardless, reviewers write Rotateq is "highly likely" to be effective in protecting kids against rotavirus, which infects many kids before they reach the age of three, sometimes requiring hospitalization.
Although children in the U.S. typically develop an immunity, in developing countries with less medical care, rotavirus is much more deadly, killing one in 250 children.
The vaccine would be administered to children as a liquid during regular vaccinations at the ages of two, four and six months.
