FDA to ‘Fast Track’ Review of Experimental Gonorrhea Vaccine

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June 28, 2023 – The FDA announced on Tuesday that it will "fast track" review of a vaccine in development to prevent gonorrhea infections. 

The FDA sometimes decides to speed up its usual process to “get important new drugs to the patient earlier," the agency said. The action applies to medications and vaccines when the agency sees an unmet need. Gonorrhea is a prime example. There are no vaccines anywhere in the world to prevent this sexually transmitted infection,  and more than 710,000 cases in the United States were reported to the CDC in 2021.

Currently, Neisseria gonorrhoeae infections are treated after the fact with antibiotics. Gonorrhea symptoms are more common in men than women. In fact, most women have mild or no symptoms at all. Left untreated, gonorrhea is also linked to infertility and a greater risk for contracting HIV. 

There is another big concern. The CDC warns that drug-resistant gonorrhea is an urgent public health issue because antibiotics used to treat it are getting less and less effective over time. 

The efficacy of the vaccine in development by GlaxoSmithKline is being tested in people for the first time. The ongoing phase II study will include 750 healthy adults considered at risk of getting gonorrhea. People 18 to 50 years old in the U.S., United Kingdom, Germany, Spain, Brazil, the Philippines, and South Africa will take part. 

Although FDA review only applies to the U.S., a gonorrhea vaccine would have global implications too. The World Health Organization estimates there are 82 million new cases of gonorrhea reported each year, making it the second most common STI worldwide. Only chlamydia infections exceed this number, with 129 million reported.