Valneva's chikungunya vaccine granted FDA priority review

News brief

Paris-based vaccine company Valneva announced today that its single-shot chikungunya candidate vaccine, VLA1553, has been granted priority review by the US Food and Drug Administration (FDA).

Valneva submitted to the FDA promising data from a phase 3 trial of VLA1553 in March 2022, final lot-to-lot consistency results in May 2022, and positive 1-year persistence data in December 2022. The FDA assigned VLA1553 a Prescription Drug User Fee Act (PDUFA) review goal date of end of August 2023, which is the date by which the agency plans to make a decision about the experimental vaccine.

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus and has been identified in more than 100 countries. It often causes large outbreaks and has a high attack rate and has affected more than 3 million people in the Americas.

VLA1553 is a live-attenuated, single-dose vaccine created by deleting a part of the chikungunya virus genome. To make it more accessible to low- and middle-income countries, Valneva partnered with Instituto Butantan in Brazil in January 2021 for the development, manufacturing, and marketing of the vaccine. In 2019, the Coalition of Epidemic Preparedness Innovations (CEPI) provided funding of up to $24.6 million for VLA1553 with support from the European Union.

COVID vaccine tied to fewer heart attacks, strokes among previously infected

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Man having heart attackCOVID-19 vaccination is linked to fewer heart attacks, strokes, and other cardiovascular issues among previously infected adults, suggests a US study today in the Journal of the American College of Cardiology.

Researchers from Mount Sinai's Icahn School of Medicine parsed data from the country's largest SARS-CoV-2 dataset, the National COVID Cohort Collaborative, on adults infected with SARS-CoV-2 from March 2020 to February 2022. The team tracked patients for 6 months to determine any association between COVID-19 vaccination and major cardiac events (MACE) among previously infected patients.

Participants were considered fully vaccinated if they had received at least two doses of the Pfizer/BioNTech or Moderna mRNA COVID-19 vaccines or one dose of the Johnson and Johnson (J&J) version at least 14 days before infection. They were considered partially vaccinated if they received their first or second mRNA dose or one J&J dose within 14 days of infection.

Average age among the 1,934,294 participants was 45.2 years, and 81.3% were White. Among 195,136 participants, (10.1%) were fully vaccinated, 88.7% were unvaccinated, and 1.2% were partially vaccinated.

Risk factors for MACE

Overall, 13,948 patients (0.7%) had MACE. Less than 1.0% (0.7%) each among the unvaccinated and partially vaccinated patients developed MACE, as did 0.5% of the fully vaccinated. Among all MACE patients, 23% died.

Full and partial COVID-19 vaccination was tied to a reduced risk of MACE (adjusted hazard ratios, 0.59 and 0.76, respectively). Risk factors for MACE were male sex, age 66 years and older, and chronic conditions.

Patients with and without MACE diagnoses were significantly different in terms of previous MACE (29.1% vs 0.9%), type 2 diabetes (33.9% vs 7.5%), abnormal cholesterol levels (50.7% vs 14.4%), ischemic heart disease (40.6% vs 3.9%), liver disease (4.0% vs 0.8%), and obesity (29.4% vs 16.4%).

We hope our findings could help improve vaccination rates.

In a Mount Sinai news release, first author and MD/PhD candidate Joy Jiang said, "Given the magnitude of SARS-CoV-2 infection worldwide, we hope our findings could help improve vaccination rates, especially in individuals with coexisting conditions," she said.

Nipah virus outbreak in Bangladesh grows to 11 cases, 8 deaths

News brief

Bangladesh now has 11 cases, 8 of them fatal, in its latest Nipah virus outbreak, an increase of 1 case and 1 death in the past 2 weeks, the World Health Organization (WHO) said in an update late last week. This is the most cases in the country since 2015.

Map of Nipah cases
Image: World Health Organization

Nipah virus infections are seasonal in Bangladesh, with outbreaks occurring from December to May, coinciding with the harvesting of date palm sap. Since the country's first case was identified in 2001, annual cases have fluctuated, with a high of 67 in 2004. But cases fell after 2015 following an extensive advocacy campaign against the consumption of raw date palm sap, which can be contaminated with bat droppings that contain the virus.

Cases this year include 10 lab-confirmed infections and 1 probable case involving a man who died before samples could be collected. But his infection has been epidemiologically linked to the outbreak.

Six cases are in Dhaka division in central Bangladesh, and five in Rajshahi division in the west. Four patients are female and seven male. The median patient age is 16 years, ranging from 15 days to 50 years. Ten patients had consumed date palm sap, while the illness in the 15-day-old infant is considered a secondary case.

The WHO said, "A multisectoral response has been implemented by the Ministry of Health and Family Welfare, Bangladesh, including strengthened surveillance activities, case management, infection prevention and control, and implementation of risk communication campaigns."

The WHO assesses the risk of additional cases as high at the national level, moderate at the regional level, and low at the global level.

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