The FDA has granted “fast-track” development status to a potential vaccine for gonorrhea. The sexually-transmitted infection is the second most common STI in the US, behind chlamydia.
Usually, drugs and vaccines can take years of development. However, when a medication shows particular promise, or there is an urgent need, the FDA grants fast-track development to speed up the process. It enables vaccines like that used against COVID to be rolled out quickly.
At the moment, there is no vaccine against gonorrhea. Worryingly, several antibiotic-resistant strains of the infection have sprung up. This has sped up the search for a potential vaccine.
The vaccine granted fast-track approval is made by UK-based GSK. It’s currently in the middle of a phase II trial. It’s checking the safety and efficiency of the vaccine in 750 individuals at high risk of acquiring the infection. The trial started last November.
In the US, rates of gonorrhea have increased 118% from 2009 to 2021. The CDC reported 710,151 new cases in the US in 2021.
When the CDC released its most recent STI statistics in April, the organization noted, “2021 data show STIs continue to disproportionately affect gay and bisexual men and younger people. Additionally, a disproportionate number of cases were diagnosed among Black/African American and American Indian/Alaska Native people, groups more likely to face social conditions that make it more difficult to stay healthy.”
Although gonorrhea typically results in an unpleasant discharge from your penis, it can present with no symptoms. This is especially true if it’s in your throat or anus only. Symotoms or not, it’s very important to receive treatment. This prevents longer-term problems and prevents you from passing it on to others.
Phil Dormitzer, Global Head of Vaccines R&D, GSK, said: “We welcome the FDA’s decision to grant Fast Track designation for our new vaccine candidate against Neisseria gonorrhoeae infection. With a high and growing incidence, gonorrhea is a major concern for sexual and reproductive health around the globe.”
DoxyPEP
At the moment, gonorrhea is treated with antibiotics. There is some optimism about the use of DoxyPEP to help beat the bug.
DoxyPEP is short for Doxycycline Post-Exposure Prophylaxis. It involves taking the antibiotic doxycycline after a sexual encounter to minimize the chances of acquiring an STI such as gonorrhea or syphilis.
A study last year found that when used within three days after unprotected sex, doxycycline reduces STIs by more than 60% in gay men. It’s already available in some clinics in San Francisco. The CDC has yet to officially support DoxyPEP but could do so within months.