The US Government Accountability Office (GAO) released a report on key COVID-19 findings and recommendations, with the aim of helping federal agencies better prepare for future emergencies, according to a GAO press release.

The report is a continuation of the GAO's series on the accountability and effectiveness of the federal government's $4.7 trillion pandemic response since 2020.

The current report focuses on lessons learned from April 2022 through April 2023. Experts looked at five key areas, including public health preparedness, fraud, vulnerable populations, distribution of COVID funding, and the pandemic's impact on the US economy.

About 45% of [GAO recommendations] have been fully or partially addressed.

"As of April 2023, we've made 386 recommendations to 26 federal agencies and 19 suggestions to Congress to strengthen response and preparedness. About 45% of those have been fully or partially addressed," the GAO writes.

Heightened risk of fraud

Of note, the GAO said more federal stopgaps and surveillance measures for fraud must be taken into account as the US plans for the next pandemic.

"As federal agencies sought to expedite payments to individuals and businesses affected by the COVID-19 pandemic, agencies used some processes that GAO has previously reported can increase fraud risk,” the authors of the report wrote.

The Department of Labor, in particular, has yet to create an antifraud taskforce to address unemployment insurance, something the GAO recommended in December 2022.

The GAO also said the Department of Health and Human Services failed to update its procedures for Strategic National Stockpile inventory planning reviews and manage risks associated with inventory gaps, something that has also been recommended since 2022.

Drugmaker Melinta Therapeutics announced yesterday that it will receive funding from the Biomedical Advanced Research and Development Authority (BARDA) to advance two antibiotics targeting multidrug-resistant infections for use in children.

The two antibiotics, Baxdela (delafloxacin) and Vabomere (meropenem and vaborbactam) are already approved by the US Food and Drug Administration (FDA) for use in adults. Baxdela is used to treat acute bacterial skin and skin-structure infections and community-acquired bacterial pneumonia (CABP), and Vabomere is designed for gram-negative pathogens that produce beta-lactamase enzymes.

The $20.5 million base funding from BARDA will support plans to extend Baxdela's CABP indication to children aged 2 months to less than 18 years and Vabomere's use for complicated urinary tract infections to children aged 3 months to less than 18 years. Melinta will also use the funding to seek approval for using Vabomere to treat late-onset neonatal sepsis in infants aged less than 90 days and for Baxdela as a potential treatment option against biothreat pathogens in children and adults.

We are poised to make a lasting impact in healthcare.

The company will submit four supplemental New Drug Applications to the FDA for these new indications. Under the contract, Melinta could receive an additional $121.4 million from BARDA if all options are exercised.

"This contract fuels our excitement to explore expanded applications of Baxdela and Vabomere through innovative research," Melinta President and CEO Christine Ann Miller said in a company press release. "We are poised to make a lasting impact in healthcare, unlocking new avenues for patient care and addressing unmet needs." 

England's National Health Service (NHS) announced yesterday that it is expanding its subscription-style payment model for antibiotics.

Under a pilot program launched in June 2022, NHS England awarded subscription contracts of up to £10 million a year (US $12.9 million) for 10 years for access to cefiderocol and ceftazidime-avibactam, manufactured by Shionogi and Pfizer, respectively. The idea behind the program was to provide the companies with a fixed annual fee based on the value of the antibiotics to the NHS and patients, rather than the volumes sold, and remove any incentive to overuse the drugs while incentivizing companies to develop new antibiotics.

With the proposed expansion of the program, the annual contracts could double to £20 million (US $25.9 million), based on criteria developed by the National Institute for Health and Care Excellence, and all UK nations will have access to the antibiotics.

The development of new antibiotics is absolutely essential to help build resilience to respond rapidly to new superbugs and save lives.

"As we continue to take lessons from the COVID-19 pandemic, the development of new antibiotics is absolutely essential to help build resilience to respond rapidly to new superbugs and save lives," David Glover, NHS assistant director of medicines analysis, said in an NHS press release. "With the proposed expansion of our world-first subscription model following a successful pilot, we want to meet this challenge head on and lead the response to the global battle against antimicrobial resistance, which could undermine the ability to deliver routine hospital care and treatment for patients."

A 12-week consultation will seek input from the pharmaceutical industry, patients, healthcare providers, and academics. Proposals will prioritize products that are active against pathogens deemed by the World Health Organization to be the most urgent threats.

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