FDA grants priority review for new oral gonorrhea antibiotic

News brief

British drugmaker GSK said yesterday that the US Food and Drug Administration (FDA) has accepted its application for priority review of gepotidacin as an oral option for uncomplicated gonorrhea infections.

Gepotidacin is a first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by targeting a distinct binding site. In March, the FDA approved the antibiotic for treatment of uncomplicated urinary tract infections. But GSK, which developed gepotidacin in collaboration with the US government's Biomedical Advanced Research and Development Authority, has also been evaluating its potential as a treatment for uncomplicated gonorrhea.

GSK's supplemental New Drug Application was supported by data from the EAGLE-I trial, which involved more than 600 people with Neisseria gonorrhoeae infections in 5 countries. The results showed that two doses of oral gepotidacin were noninferior to the standard regimen of intramuscular ceftriaxone plus oral azithromycin, with a treatment success rate of 93% and no new safety concerns.

A much-needed new treatment option for gonorrhea

If gepotidacin is approved for gonorrhea, it would be a much-needed new option for the sexually transmitted bacterium, which causes more than 82 million infections globally each year. Ceftriaxone is the last remaining empiric treatment option for N gonorrhoeae, a bacterium that has quickly developed resistance to every antibiotic that's been used for treatment. But resistance to ceftriaxone is already high in parts of Asia and has been spreading to other parts of the world. GSK also noted that injectable ceftriaxone may not be suitable for all patients.

The threat of untreatable gonorrhea, which can cause pelvic inflammatory disease, ectopic pregnancy, and infertility in women, has led the World Health Organization and the Centers for Disease Control and Prevention to label drug-resistant N gonorrhoeae a serious and urgent public health threat. The last new antibiotic for gonorrhea was introduced in the 1990s.

GSK said the FDA has set a target date of December 11, 2025, for its decision.

Virologist network reaffirms support for mRNA vaccine platform

News brief

Lisa Schnirring

An international virologist group representing more than 80 research labs across more than 40 countries yesterday reaffirmed their support for the continued development and deployment of mRNA vaccines, a statement that came in response to the United States’ top health agency announcement earlier this month that it was scrapping further work on projects involving the mRNA vaccine platform.

lab scientist pipetting — *gorodenkoff / iStock*

Scientists and public health experts said dismantling the research is a dangerous move that will dramatically hobble US pandemic preparedness. However, the head of the National Institutes of Health (NIH), Jay Bhattacharya, MD, PhD, on X yesterday amplified what many scientists say is misinformation about mRNA risks and benefits by posting a clip from a far-right political talk show where he said the mRNA vaccine platform is no longer viable for public health purposes.

The Global Virus Network (GVN), which is dedicated to advancing pandemic preparedness, said vaccination is one of public health’s greatest achievements and has prevented 4.4 million deaths each year. It added that mRNA vaccine platforms have emerged as one of the most significant biomedical achievements of the 21^st century, and have reshaped the world’s ability to quickly respond to new viral threats.

The group estimated that the COVID-19 vaccines averted 7.5 million deaths between 2000 and 2024 globally, and that of the more than 298 million doses administered in the United States in the first 6 months of rollout, fewer than 1% of recipients experienced adverse reactions or complications. GVN added that clinical data suggest between March 2021 and January 2022, mRNA cut the death rate by about 90% and were 94% effective against severe disease during the Omicron wave.

mRNA work continues for other disease threats and cancer therapy

Johan Neyts, PhD, who directs the GVN Center of Excellent in at KU Leuven in Belgium, said in a statement, “Various members of the GVN are working across continents to accelerate innovation in mRNA-based vaccines, not only for coronaviruses but also for dengue, Zika, Lassa fever, and other high-consequence pathogens.” The group noted that the mRNA vaccine platform has also shown promise for cancer immunotherapy.

The statement also said scientific transparency, public health engagement, and a global commitment to research must remain at the heart of mRNA vaccine deployment strategies. GVN said it advocates for a globally coordinated approach to mRNA vaccine development and deployment that hinges on expanding capacity in low- and middle-income countries, supporting next-generation mRNA innovation, and battling misinformation through collaboration.

Report details first suspected H5 avian flu detections in seabirds in Antarctica

News brief

Mary Van Beusekom, MS

In Scientific Reports today, Chilean researchers describe the first-time detection of suspected H5 highly pathogenic avian influenza virus (HPAIV) in penguins and cormorants in Antarctica, which they say could indicate a significant expansion of the virus into the continent that would put susceptible bird species at risk.

The team conducted a geographic survey of seabirds at 13 breeding sites ranging from the northeastern Antarctic Peninsula to the Ross Sea, including the coasts of the Bellinghausen and Amundsen seas, in December 2023 and January 2024.

Beginning in 2020, clade 2.3.4.4b avian flu rapidly spread across continents, mainly driven by wild bird movements. "In Chile, it was detected for the first time in October 2022," the investigators wrote. "Given its close proximity to the Antarctic continent and the migratory movements of birds between both regions, transmission is highly likely, causing a significant threat to the Antarctic wildlife."

No clinical signs of avian flu

Of the 115 birds sampled, polymerase chain reaction (PCR) test results for 9, including 8 Adelie penguins (12%) at 2 different locations and 1 Atlantic cormorant, were suspected positive for H5 avian flu. Nearly all suspected infections were from Beagle Island, close to the Danger Islands at the northern tip of the Antarctic Peninsula. Another infected penguin was identified on the West Antarctic Peninsula, south of the Antarctic Circle in Margaret Bay.

This study suggests the possibility of the first cases of HPAIV H5 in the Antarctic continent, potentially adding two new species to the list of infected species.

None of the birds sampled showed clinical signs of influenza infection, and the seven penguins with suspected infection on Beagle Island were still foraging as of March 2024, more than 2 months after testing.

"This study suggests the possibility of the first cases of HPAIV H5 in the Antarctic continent, potentially adding two new species to the list of infected species," the study authors wrote. "It also highlights the southernmost suspected cases identified to date of surveillance, and notably, no cases were detected between the Antarctic Peninsula and the Ross Sea."