Today vaccine maker Moderna announced it voluntarily pulled its licensing submission for the combination seasonal influenza–COVID-19 mRNA vaccine candidate, mRNA-1083, so that it can submit efficacy data.

The news comes a day after the US Food and Drug Administration announced that seasonal COVID-19 boosters would now be recommended only for adults ages 65 and older or for those who are at risk for severe COVID-19 because of underlying health conditions.

Moderna's combination vaccine was intended for adults 50 and older. 

Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer.

"Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer," the company said in a press release. The resubmission will take place after gathering vaccine efficacy data from the ongoing phase 3 trial of its investigational seasonal flu vaccine, mRNA-1010.

England's National Health Service (NHS) announced today that it is set to launch a vaccination campaign against gonorrhea this summer.

Starting in early August, eligible patients, including gay and bisexual men who have a recent history of multiple sexual partners or a sexually transmitted infection (STI), will be able to receive an existing vaccine for meningococcal B disease (4CMenB) at local authority-commissioned sexual health clinics to prevent gonorrhea. The decision is based on a recommendation from the United Kingdom's Joint Committee on Vaccination and Immunisation.

Multiple studies have shown that the 4CMenB vaccine, which protects against four serogroups of Neisseria meningitidis, also provides moderate cross-protection against Neisseria gonorrhoeae, with vaccine effectiveness ranging from 30% to 40%. A 2002 analysis led by researchers at Imperial College London estimated that vaccinating those at greatest risk of gonorrhea infection would avert 110,000 cases and save the NHS £7.9 million (US $10.6 million) over 10 years.

Surge in gonorrhea cases

The move comes amid a surge in gonorrhea infections in England. The 85,000 cases in 2023 were three times the number reported in 2012 and the most since UK officials began tracking gonorrhea cases in 1918. It's the second most commonly diagnosed STI in the country.

"This vaccination programme is a hugely welcome intervention at a time when we're seeing very concerning levels of gonorrhoea, including antibiotic resistant gonorrhoea," Sema Mandel, MBBS, consultant epidemiologist and deputy director at the UK Health Security Agency (UKHSA), said in an NHS press release. UKHSA is supporting the rollout of the program. 

"Not only will this rollout provide much needed protection to those that need it most, but it will make the UK the first country in the world to offer this protection and a world leader in protecting people against gonorrhoea."

NHS says local providers will identify and contact those eligible for vaccination through sexual health services.

US drugmaker Innoviva Specialty Therapeutics announced today that the novel cephalosporin antibiotic Zevtera (ceftobiprole medocaril sodium for injection) is now commercially available in the United States. 

Zevtera is an advanced-generation cephalosporin with effectiveness against gram-positive and gram-negative bacteria. It was approved by the US Food and Drug Administration (FDA) in April 2024 for three indications: (1) methicillin-resistant and methicillin-susceptible Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, in adults; (2) acute bacterial skin and skin-structure infection in adults; (3) and community-acquired bacterial pneumonia in adults and children as young as 3 months. 

The approval was granted to Swiss biopharmaceutical company Basilea Pharmaceutica, which sold the rights to market the drug in the United States to Innoviva in December 2024.

New option for potentially deadly infections

Company officials say Zevtera offers physicians a new option for treating challenging and potentially deadly infections. Approximately 100,000 cases of SAB occur every year in the United States, with nearly 20,000 deaths. The 90-day mortality rate is roughly 30%. 

"Zevtera is an excellent addition to our antibiotics portfolio and its market availability further underscores our strategic commitment to deliver meaningful innovations in infectious diseases," Innoviva Chief Medical Officer David Altarac, MD, said in a company press release. 

A multicenter study published yesterday in Emerging Infectious Diseases shows significant long-term symptoms among adults hospitalized for pneumonia during acute COVID-19 infection a full year after hospitalization. 

The study observed patient from the United States, Kenya, and Peru who were enrolled in one of five clinical trials tracking outcomes from severe COVID-19 infections. At the time of enrollment in the parent studies, the authors said, 158 participants (91.3%) were not on mechanical ventilation, whereas 15 (8.7%) required mechanical ventilation or extracorporeal membrane oxygenation. The average patient age was 56, and 52.6% of participants had lung abnormality imaging at baseline.

Almost half had lasting fatigue

Of 134 patients who completed follow-up through 12 months, 29.5% reported cough, 34.7% reported shortness of breath, 32.4% had residual lung texture abnormalities on computed tomography (CT) scans, 15.0% had impaired lung capacity, 30.1% had cognitive impairment, and 44.5% noted lasting fatigue. Cardiac function remained unchanged from baseline for most participants.

Cognitive impairment and fatigue were closely related to underlying health condition seen at baseline, most notably high blood pressure, the authors said. 

 Our findings underscore the extended health effects of COVID-19 beyond its acute phase and reinforce the importance of regular monitoring of patients with severe COVID-19.

"The high prevalence of lung abnormalities at baseline, measured at a median of 155 days after participants completed the parent study, aligns with postacute COVID-19 syndrome and meets the definition for long COVID," the authors wrote. "The severity of acute infection, age, and certain underlying conditions might influence the long-term sequelae of COVID-19. Our findings underscore the extended health effects of COVID-19 beyond its acute phase and reinforce the importance of regular monitoring of patients with severe COVID-19, particularly in older patients and those with underlying health conditions."