FDA Revises Recommendations for Rotavirus Vaccines

The U.S. Food and Drug Administration (FDA) revised its recommendations for rotavirus vaccines on May 14 after determining that it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.

After the FDA learned that components of an extraneous virus (PCV1) were present in Rotarix, the agency recommended that clinicians and public health professionals in the United States temporarily suspend the use of the vaccines to prevent rotavirus disease.

The agency reached its decision based on laboratory results from the manufacturers and the FDA’s own laboratories, scientific literature review, and input from scientific and public health experts, including members of the FDA’s Vaccines and Related Biological Products Advisory Committee that convened on May 7 to discuss these vaccines.

The FDA also considered the following in its decision:

  • Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of vaccine recipients.
  • The FDA has no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known to cause infection or illness in humans.
  • The benefits of the vaccines are substantial, and include prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the United States. These benefits outweigh the risk, which is theoretical.

The FDA has said all along that it does not believe medical follow-up is warranted for children who have been vaccinated with Rotarix and RotaTeq vaccines. The temporary hold on Rotarix use was merely a precaution, the FDA said.

Source: FDA May 14 press release


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