FDA Grants “Fast-Track” Status to Potential Gonorrhea Vaccine
The US Food and Drug Administration (FDA) has recently granted “fast-track” development status to a potential vaccine for gonorrhea, the second most common sexually-transmitted infection (STI) in the country. The move aims to expedite the development process and address the urgent need for a vaccine against the antibiotic-resistant strains of the infection that have emerged.
The vaccine, developed by UK-based pharmaceutical company GSK, is currently undergoing a phase II trial to evaluate its safety and efficiency. The trial, which started in November 2021, involves 750 individuals at high risk of acquiring the infection. The fast-track approval by the FDA signifies the potential promise of the vaccine and highlights the crucial role it could play in combating the rising rates of gonorrhea.
According to the Centers for Disease Control and Prevention (CDC), rates of gonorrhea in the US have soared by 118% from 2009 to 2021. In 2021 alone, there were 710,151 new cases reported. The CDC has also noted that gonorrhea, like other STIs, disproportionately affects gay and bisexual men, younger individuals, and specific racial and ethnic groups such as Black/African American and American Indian/Alaska Native people.
Gonorrhea is a particularly concerning STI because it can often present with no symptoms, especially if it is solely localized in the throat or anus. Therefore, prompt and effective treatment is crucial to prevent long-term complications and the transmission of the infection to others.
Expressing their enthusiasm for the FDA’s fast-track designation, Phil Dormitzer, Global Head of Vaccines R&D at GSK, emphasized the significance of addressing the growing incidence of gonorrhea and its impact on sexual and reproductive health globally.
In addition to the potential gonorrhea vaccine, there is also hope surrounding the use of a prophylactic treatment called DoxyPEP. Short for Doxycycline Post-Exposure Prophylaxis, DoxyPEP involves taking the antibiotic doxycycline after a sexual encounter to minimize the risk of acquiring STIs such as gonorrhea or syphilis. A recent study found that using doxycycline within three days after unprotected sex reduced STI rates by over 60% in gay men. Although it is available in some clinics in San Francisco, the CDC has not officially endorsed DoxyPEP, but this could change in the coming months.
The fast-track development status granted to the potential gonorrhea vaccine and the potential benefits of DoxyPEP offer hope for improved prevention and control measures against this prevalent and antibiotic-resistant STI.