The United States Food and Drug Administration is expected to issue guidance to the industry on how to interpret a new section of its labeling law that allows manufacturers to include a disclaimer that a vaccine may cause serious adverse events.
The FDA issued its draft guidance on Wednesday that said the wording of the disclaimer is optional.
The agency said it expects to issue a final rule in 2018 that will clarify the language.
In February, the FDA said the labeling language could apply to many vaccines and drugs sold under the brand names of the same manufacturer, and it did not clarify how it would apply to vaccines that are generic and sold in other countries.
The guidance said it would not apply to those that were made by other companies and that the label could not be used to identify them.
The draft guidance was the result of an April 2017 meeting of the advisory committee on the labeling of vaccines and medical devices.
The advisory committee included representatives from many pharmaceutical companies, including Johnson & Johnson, Pfizer and Amgen, among others.
The panel was tasked with developing a final guidance on labeling.
It was also responsible for drafting the final rule.
The vaccine labeling language is one of the most controversial topics in the vaccine manufacturing industry.
It could affect the safety of all types of vaccines.
It has drawn a wide array of scientific and medical experts, including several from the U.S. Centers for Disease Control and Prevention.
