Health News Roundup: FDA identifies recall of Emergent's decontamination kits as most serious; California law aiming to curb COVID misinformation blocked by judge and more

The company suggested that the U.S. Food and Drug Administration select the prevalent variant of coronavirus in the first quarter each year, similar to the model employed to choose the composition for annual flu shots. U.S. CDC still looking at potential stroke risk from Pfizer bivalent COVID shot New data from one U.S. Centers for Disease Control and Prevention (CDC) database shows a possible stroke risk link for older adults who received an updated Pfizer/BioNTech COVID-19 booster shot, but the signal is weaker than what the agency had flagged earlier in January, health officials said on Thursday.

Following is a summary of current health news briefs.

EU drug regulator decides antibiotic shortage not a 'major event'

Europe's drug regulator has decided not to label the antibiotic shortage on the continent a "major event", given existing measures to tackle the shortfall were working in the short term, it said in a statement on Thursday, A "major event" label would allow the European Medicines Agency (EMA) to coordinate action at a pan-European level and increase the reporting obligations of manufacturers.

FDA identifies recall of Emergent's decontamination kits as most serious

The U.S. Food and Drug Administration on Thursday classified the recall of Emergent BioSolutions Inc's skin decontamination lotion kits as the most serious type. The contract manufacturer began the recall of 3,500 units of the kit in November, after receiving three customer complaints of leakage from the packets. No serious injuries or deaths related to the issue were reported.

California law aiming to curb COVID misinformation blocked by judge

A U.S. judge has blocked a California law that sought to penalize doctors who spread "misinformation or disinformation" about COVID-19 while he considers a pair lawsuits challenging it on free speech grounds. Senior U.S. District Judge William Shubb in Sacramento ruled on Wednesday that Assembly Bill 2098, which was signed last October by California Governor Gavin Newsom, a Democrat, was too vague for doctors to know what kind of statements might put them at risk of being penalized."COVID-19 is a quickly evolving area of science that in many aspects eludes consensus," he wrote.

Novavax needs 6 months to produce annual COVID shots that match new variants

Novavax Inc said on Thursday it would require six months to produce a COVID-19 vaccine designed to match whichever coronavirus variants are circulating for an annual immunization program each fall season in the United States. The company suggested that the U.S. Food and Drug Administration select the prevalent variant of coronavirus in the first quarter each year, similar to the model employed to choose the composition for annual flu shots.

U.S. CDC still looking at potential stroke risk from Pfizer bivalent COVID shot

New data from one U.S. Centers for Disease Control and Prevention (CDC) database shows a possible stroke risk link for older adults who received an updated Pfizer/BioNTech COVID-19 booster shot, but the signal is weaker than what the agency had flagged earlier in January, health officials said on Thursday. U.S. Food and Drug Administration officials said they had not detected a link between the shots and strokes in two other safety monitoring databases.

U.S. FDA calls for new regulatory framework for use of cannabis compound CBD

The U.S. Food and Drug Administration said on Thursday it does not intend to make any new guidance on the use of the popular cannabis compound CBD in food and supplements, saying the United States needs to develop a new framework to ensure its safe use. The health regulator said it would work with Congress to develop a new, cross-agency regulatory framework. The FDA denied three citizen petitions that had requested the agency to provide guidance.

U.S. Senator Warren 'particularly concerned' about Amgen, Indivior deals

Sen. Elizabeth Warren, an outspoken critic of corporate consolidation, wrote to the U.S. Federal Trade Commission to express concern about two pending pharmaceutical deals. In a letter dated Wednesday, Warren said that she was focused on Amgen's plan to buy Horizon Therapeutics, and addiction specialist Indivior's plan to buy Opiant for $145 million, which was announced in mid-November.

Spain to scrap mandatory masks on public transport on Feb. 7

Spain, one of the last countries in Europe to still require people to wear masks on public transport to prevent the spread of COVID-19, will likely lift the obligation on Feb. 7, Health Minister Carolina Darias said on Thursday. She said the epidemiological situation in the country was stable and health emergency services had proposed lifting the restriction. Masks will remain mandatory in health facilities.

U.S. FDA pulls authorization for AstraZeneca's COVID-19 treatment Evusheld

The U.S. health regulator has withdrawn emergency-use authorization for AstraZeneca's COVID-19 antibody cocktail Evusheld as the treatment is not expected to neutralize the currently dominant XBB.1.5 subvariant of Omicron. The Food and Drug Administration (FDA) had limited Evusheld's use earlier this month for the same reason and the agency's Thursday announcement sent U.S. shares of London-based AstraZeneca down 1.31% to $65.75.

Roche launches new test to detect fast spreading Omicron sub-variant

Roche has launched a new PCR test to detect a fast-spreading sub-variant of the Omicron variant of Coronavirus, the Swiss drugmaker said on Thursday. The new test specifically targets the XBB.1.5 Omicron variant and will help researchers closely track the virus’s lineage and provide insights into the epidemiology and impact it has on public health, the company added.

(With inputs from agencies.)