June 28, 2023 – The FDA announced Tuesday that it could “accelerate” review of a vaccine under development to forestall gonorrhea infections.
The FDA sometimes decides to hurry up its usual process to “get important new medicines to patients sooner,” the agency says. This measure applies to drugs and vaccines when the agency sees an unmet need. Gonorrhea is a chief example. There are not any vaccines anywhere on the planet to forestall this sexually transmitted infection, and in 2021, greater than 710,000 cases were reported to the CDC within the United States.
At the moment, Neisseria gonorrhoeae Infections are subsequently treated with antibiotics. Symptoms of gonorrhea are more common in men than in women. In fact, most ladies have only mild symptoms or no symptoms in any respect. If left untreated, gonorrhea also results in infertility and the next risk of HIV infection.
There is one other big problem. The CDC warns that drug-resistant gonorrhea is a Urgent public health problem since the antibiotics used for treatment change into less and fewer effective over time.
The effectiveness of the vaccine developed by GlaxoSmithKline is being tested on humans for the primary time. The ongoing Phase II trial will involve 750 healthy adults susceptible to gonorrhea. The study will involve people aged 18 to 50 from the USA, Great Britain, Germany, Spain, Brazil, the Philippines and South Africa.
Although the FDA review only applies to the United States, a vaccine against gonorrhea would even have global implications. The World Health Organization estimates that 82 million new infections of gonorrhea Every yr, 129 million cases are reported, making it the second most typical sexually transmitted disease worldwide. Only chlamydia infections surpass this number with 129 million reported cases.