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FDA Actions

Updated: December 28, 2010

On May 7, 2010, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened to discuss the findings of PCV and PCV DNA in rotavirus vaccines. The meeting included a discussion of FDA’s evaluation of laboratory results from the manufacturers of Rotarix and RotaTeq rotavirus vaccines and FDA’s own laboratories.

Based on a careful evaluation of information, a thorough review of the scientific literature, and input from scientific and public health experts, the Agency revised its recommendation and lifted the temporary suspension of the use of the Rotarix vaccine.

FDA determined based on the benefit of the vaccine over the theoretical risk of PCV that it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq. FDA also recommended that clinicians and public health professionals inform parents of the findings of PCV DNA or PCV in rotavirus vaccines, and that there is no evidence that these findings pose a safety risk in humans. FDA approved revised prescribing information and patient labeling for both Rotarix and RotaTeq vaccines on September 1, 2010, to include this information.

FDA has confirmed that there is no evidence that infectious PCV2 was present in RotaTeq. This was determined by studies conducted by the manufacturer, Merck and Co. Inc. and by FDA’s own laboratory analysis. Merck presented their findings during the October 28, 2010 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Based on the May 7, 2010, VRBPAC discussion, FDA is also assessing its current regulatory recommendations for testing of other vaccines for the presence of adventitious agents. On August 12, 2010, FDA sent written inquiries to manufacturers of licensed viral vaccines and/or combination vaccines containing viral antigens asking them to provide additional information to assist with FDA’s assessment. Specifically, FDA requested information regarding plans that the manufacturers may have to implement additional adventitious agent testing methods as part of their manufacturing process as these methods become available including, but not limited to, screening for PCV and PCV DNA, as well as any additional in-process testing for adventitious agents that they may have recently added, but not reported to FDA.

As new information becomes available, FDA will provide updates to the public and clinical community through http://www.fda.gov and other communications.
Approved Products > FDA Actions