Danish drugmaker Bavarian Nordic announced today that the US government has placed a $144 million order for a freeze-dried version of its mpox vaccine, which can also be used to prevent smallpox.

The freeze-dried formulation of the Jynneos vaccine was approved by the US Food and Drug Administration (FDA) in March. It will be easier to store and transport, and has a longer shelf life, than the liquid-frozen formulation that Bavarian Nordic has been supplying to the US government since 2010. The company ramped up production of Jynneos in response to the mpox outbreak that began in 2022. 

Jynneos was first approved by the FDA in 2019 and is one of two FDA-approved vaccines for the prevention of smallpox and mpox.

The options exercised under Bavarian Nordic's existing contract with the Biomedical Advanced Research and Development Authority (BARDA), which was awarded in 2017, are valued at $143.6 million and will support manufacturing and supply of freeze-dried Jynneos starting in 2026.

"We applaud the U.S. government’s steadfast commitment to improving national health security through the exercise of these options," Bavarian Nordic President and CEO Paul Chaplin, PhD, said in a company press release. "The freeze-dried vaccine, with its improved shelf life, provides a significant contribution to securing the long-term availability of countermeasures to protect U.S citizens against life-threatening diseases."

A study in European Heart Journal yesterday shows a 23% lower risk of cardiovascular events in recipients of the shingles vaccine in the 8 years following vaccination. 

The study was based on outcomes seen among 1,271,922 people aged 50 or older in South Korea who received the shingles vaccine from 2012 to 2021. Information on whether people received a shingles vaccine (live zoster) was combined with data on cardiovascular health, as well as other factors that can influence health, such as age, sex, wealth, and lifestyle.

On average, patients were 61 years old and followed for 6 years. Overall, recipients had a 26% lower risk of major cardiovascular events (stroke, heart attack, or death from heart disease), a 26% lower risk of heart failure, and a 22% lower risk of coronary heart disease. 

Protection, especially for men, was strongest 2 to 3 years following vaccination but extended into year 8 of follow up.

Younger recipients more protected 

“A shingles infection can cause blood vessel damage, inflammation and clot formation that can lead to heart disease,” said study author Dong Keon Yon, PhD, from the Kyung Hee University College of Medicine, Seoul, in a press release from the European Society of Cardiology. “By preventing shingles, vaccination may lower these risks. Our study found stronger benefits in younger people, probably due to a better immune response, and in men, possibly due to differences in vaccine effectiveness.”

A shingles infection can cause blood vessel damage, inflammation and clot formation that can lead to heart disease

The live zoster vaccine is being phased out in many countries, the authors note, replaced with a non-live, recombinant vaccine. More research on the recombinant vaccine is needed to see if that vaccine offers any cardiac health protection. 

“These findings suggest that live zoster vaccination may be beneficial as a public health strategy with potential implications for cardiovascular disease burden in the general population,” the authors concluded. 

A new analysis of existing literature in Annals of Internal Medicine suggests patients prescribed antivirals for nonsevere influenza infections have no reduction in risk of hospital admission or mortality. There is some evidence, however, that antivirals can reduce symptom duration. 

Included in the analysis were 73 randomized control trials, of which 40 reviewed oseltamivir (Tamiflu).

Across all studies, influenza-related mortality or hospital admission was rare, seen in less than 2 and 21 patients per 1,000, respectively. No antiviral reduced the risk of these events.

Time to symptom resolution, however, dropped in patients taking antivirals, but the effect was small: 0.75 days in oseltamivir groups, and 1.02 days in patients treated with baloxavir (Xofluza). 

More resistance seen with Xofluza

Also of note, trials with oseltamivir had more treatment-related adverse events (AEs) than standard care or placebo. The antiviral baloxavir did not increase treatment-related AEs, but resistance developed in 9.97% of those treated. 

 Influenza vaccinations must remain the first line of defense.

In an attached commentary on the analysis by researchers at the Mayo Clinic, the authors write, “Baloxavir is probably more effective and better tolerated than other available anti-viral drugs but should not be expected to reduce influenza-related hospitalization or death. Influenza vaccinations must remain the first line of defense.”

Today in Emerging Microbes & Infections, researchers at Weill Cornell Medicine–Qatar present a systematic review of 35 studies on new-onset diabetes after COVID-19 infection, estimating an incidence of 1.37%.

The researchers mined databases to identify and analyze studies from around the world on COVID-related type 1 or type 2 diabetes published up to October 2023. The studies included a total of 4.4 million COVID-19 patients of all ages, and 47.7% were male.

Vast majority of cases were type 2

Of the 4.4 million COVID-19 patients, 60,189 (1.37%) had new-onset diabetes (0.84% type 2, 0.017% type 1). The type of diabetes wasn't available for 28 studies (0.51% of cases). 

A multidisciplinary approach involving endocrinologists, primary care physicians, and infectious disease specialists should be implemented in the management of post-COVID patients.

Factors associated with incident diabetes were SARS-CoV-2 variant type, severity of infection, underlying medical conditions, demographic factors, and vaccination status. The risk of diabetes rose over time, with the highest rates seen at 3 to 12 months post-infection.

The study authors noted that the real-world incidence could be higher because many studies reported cases of new-onset diabetes only for patients who returned to the hospital for readmission or follow up. 

"However, this rate is still higher than the estimated rate of new onset diabetes in a general population," they wrote. "For example, among adults aged 18 years or older in the USA, the crude estimates for 2021 were 1.2 million new cases of diabetes (0.59%)."

The exact causes of post-COVID diabetes are unclear, the researchers said: "The mechanisms behind COVID-19-induced diabetes may include direct damage of the pancreatic beta cells, inflammation, insulin resistance, and autoimmune responses."

They recommended that healthcare providers monitor COVID-19 survivors for signs of new-onset diabetes, particularly those with risk factors such as hospitalization, intensive care unit admission, severe infection, pre-existing metabolic disorders, and COVID-19 variants associated with higher risks.

"A multidisciplinary approach involving endocrinologists, primary care physicians, and infectious disease specialists should be implemented in the management of post-COVID patients to address both the acute and long-term complications, including metabolic changes and risk of diabetes," they added.