Lucira announces US launch of combo COVID-flu home test

News brief

Lucira today announced the US launch of its at-home combination COVID-19 and flu test, the first of its kind, following the February emergency use authorization (EUA) from the Food and Drug Administration (FDA).

The biotechnology company, based in Emeryville, California, also announced that the test is now cleared for use as a point-of-care test in Australia.

In earlier clinical trials, the molecular test has performed similarly for both COVID and flu when assessed against polymerase chain reaction (PCR) tests. Lucira's combo test also marks the availability of the first over-the-counter test for flu. The test involves nasal swabbing and runs on two AA batteries, delivering a result in about 30 minutes. The introductory price is $34.99, and the product is available on the company's website.

US consumers will, for the first time ever, be able to diagnose if they have COVID-19 or Flu A or B while at home.

Erik Engelson, MBS, MS, the company's president and chief executive officer, said, "US consumers will, for the first time ever, be able to diagnose if they have COVID-19 or Flu A or B while at home. With one-touch access to telehealth via our Lucira Connect web platform, they can now get onto the path to treatment and recovery within hours of receiving a test result from the comfort of home.”

Last month as the company received the EUA from the FDA it announced that it filed for bankruptcy due to the prolonged review process. The company said it had produced inventory for an autumn 2023 launch.

WHO vaccine advisers update COVID vaccine recommendations

News brief

The World Health Organization (WHO) vaccine advisory group today announced its latest recommendations for COVID-19 vaccines, which take into account high levels of immunity due to vaccine and prior infection, prioritizes highest-risk groups, and balances COVID vaccination for lower-risk groups with other preventive health actions.

In a statement, the WHO Strategic Advisory Group of Experts (SAGE), along with a prioritization roadmap, weighed in on booster doses, timing of booster doses, and vaccine composition. It laid out three prioritization tiers—high, medium, and low—based on risk for severe disease and death.

The highest tier includes older adults, younger adults who have underlying health conditions, immunocompromised people ages 6 months and older, pregnant women, and frontline health workers. For the highest tier, the group recommends a booster shot 6 or 12 months after the last dose, depending on age and underlying conditions. It emphasized that the interval applies only to the current epidemiological situation and isn't a recommendation for annual boosters. "The aim is to serve countries planning for the near- to mid-term," it said. 

The medium priority group includes healthy adults younger than 60 and children and adolescents with underlying conditions, who should get their primary series and one booster. Though additional boosters are safe, SAGE said it didn't recommend them, because public health returns are relatively low.

The aim is to serve countries planning for the near- to mid-term.

Meanwhile, the low-priority group is made up of healthy children and adolescents as old as 17. The experts said the primary series and booster doses are safe, but owing to the low burden of disease, countries should base their decisions on a range of factors, including cost-effectiveness and other health priorities. It added that the public health impact of vaccinating healthy kids against COVID is lower than the benefits of other routine vaccinations such as rotavirus, measles, and pneumococcal conjugate.

The group examined the data about the impact of COVID-19 vaccine on long COVID, but said the evidence on the extent of the impact is inconsistent.

Separately, WHO's SAGE also recommended that countries consider using bivalent mRNA vaccines for the primary series.

High-path avian flu outbreaks strike more poultry in 7 states

News brief

The US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) over the past few days has reported more highly pathogenic avian flu outbreaks in poultry from seven states.

In New York, the virus struck an upland game bird producer in Tompkins County, plus a live-bird market in Queens County that had 140 birds. South Dakota also reported an outbreak at an upland game bird farm, a location in Spinks County that houses 570 birds. Michigan also reported an event involving a poultry farm, a producer in Lapeer County.

Also, four states reported more outbreaks in backyard poultry flocks. They are Colorado (Arapahoe County), Kansas (Ellsworth County), Oregon (Klamath County), and Texas (Hale County).

H5N1 outbreak activity in the United States that began in February 2022 has now led to the loss of a record 58.6 million birds across 47 states, according to the USDA.

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