FDA launches investigation into vaccination concerns

As Americans go about their daily lives, they don’t realize how much danger their vaccine choices could create. Providing them with important information about the FDA’s decision is crucial to providing the information to…

FDA launches investigation into vaccination concerns

As Americans go about their daily lives, they don’t realize how much danger their vaccine choices could create.

Providing them with important information about the FDA’s decision is crucial to providing the information to parents and patients, said Scott Gottlieb, M.D., Commissioner of the Food and Drug Administration. The agency also is asking other drug makers to offer other vaccinations that may help public health officials fight the looming threat of diseases.

FDA: Vaxafone should only be used when other vaccinations are not

The letter was sent to GlaxoSmithKline and its unit, Primary Children’s Medical Services, which produces Pfizer’s new tablet, Vaxafone, for kids under the age of 18 who do not have the two doses of vaccination that are required to protect against pertussis, also known as whooping cough. The FDA said the tablet is “commercially available” in Europe, where it is marketed as Pertuzumab. The European regulatory approval for the Vaxafone is the second by the FDA since the agency began taking action to protect the public health in 2016.

Pertuzumab is designed to prevent pertussis and can be used off-label. In 2016, the FDA asked the drug maker to submit data and clinical information supporting the use of the drug for healthy individuals 16 and older who are not required to get two doses of vaccination against pertussis.

More than 8,000 cases of pertussis were reported to the Centers for Disease Control and Prevention between October 2016 and September 2017.

“The epidemic has demonstrated the need for new technology in the diagnosis and treatment of infants and young children, who are especially vulnerable to pertussis, and with all children,” Gottlieb said in a statement.

The FDA also has asked pharmaceutical companies to consider making an FDA-approved vaccine used to protect babies and children against measles, mumps and rubella available for adults. Researchers believe adults are vulnerable to the risk of contracting these diseases and they can spread them among family members and friends. Vaccines require two doses, two months apart. The recommended immunization schedule for U.S. adults is not ready for this proposal, but the companies want to provide their analysis.

“The FDA has received a request from a small company to seek approval to market a more highly effective vaccine in adults to prevent these diseases. We are grateful that these companies are working together to develop powerful products to benefit the public health,” Gottlieb said.

This editorial reflects the views of CNN’s editorial department. CNN is not responsible for the content.

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