Health News Roundup: FDA warns CVS, others against selling unapproved eye products; Moderna flu shot succeeds in late-stage study and more
Shots were being delivered in some locations on Wednesday, including at a Northwell Health facility in New York. US CDC recommends broad use of updated COVID-19 vaccines The U.S. Centers for Disease Control and Prevention director on Tuesday signed off on broad use of updated COVID-19 vaccines approved by the government - covering ages 6 months and up - as the country prepares to start a vaccination campaign within days.
Following is a summary of current health news briefs.
FDA warns CVS, others against selling unapproved eye products
The U.S. Food and Drug Administration on Tuesday warned eight companies, including pharmacy giants CVS Health Corp and Walgreens Boots Alliance, against manufacturing or marketing unapproved eye products. The eye products addressed in the FDA's letters to these companies are illegally marketed to treat conditions like conjunctivitis, cataract and glaucoma, the agency said, adding that such drugs pose an increased risk to users as they can bypass some of the body's natural defenses.
US FDA panel says popular decongestant used in cold medicines ineffective
An outside panel of experts to the U.S. Food and Drug Administration on Tuesday refused to back the effectiveness of oral over-the-counter (OTC) medicines made with phenylephrine, an ingredient widely used in cold and cough syrups. The panel unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no more trials were required to prove otherwise.
US declares public health emergency in Georgia after Hurricane Idalia
The U.S. Department of Health and Human Services (HHS) on Wednesday declared a public health emergency (PHE) for the state of Georgia to deal with the ramifications of Hurricane Idalia. The hurricane hit Florida's Gulf Coast in late August with fierce winds, torrential rains and pounding surf before turning to southeastern Georgia, where floodwater trapped some residents in their homes.
Over 700 people tested for Nipah virus after two deaths in India
The southern Indian state of Kerala shut some schools, offices and public transport on Wednesday in a race to stop the spread of the rare and deadly Nipah virus, which has killed two people. Two adults and a child were still infected in hospital, and more than 700 people were being tested for the virus, spread via contact with the bodily fluids of infected bats, pigs or people, a state health official said.
ICON to partner with US govt agency to test COVID vaccine candidates
Contract research firm ICON Plc said on Wednesday it is partnering with the U.S. government for a clinical trial to test the effectiveness of next generation COVID-19 vaccine candidates. As part of the collaboration with Biomedical Advanced Research and Development Authority, ICON will conduct a mid-stage trial of 10,000 participants to assess the efficacy of a next generation COVID-19 vaccine relative to currently available shots.
Moderna flu shot succeeds in late-stage study
Moderna on Wednesday said its flu vaccine had generated a stronger immune response against all four A and B strains of the influenza virus compared to traditional flu shots in a late-stage trial, sending shares up about 6% in early trading. The effectiveness of Moderna's flu vaccine was demonstrated across all age groups, including older people, and was found to be safe and tolerable, according to the company. Moderna also said it had found that its shot was equal or superior to Sanofi's high-dose flu vaccine in a separate early head-to-head study.
Explainer-Who should get a COVID vaccine this year?
The U.S. drug regulator authorized updated COVID-19 vaccines from Pfizer and its partner BioNTech as well as from Moderna this week as the country prepares to start an autumn vaccination campaign. A third vaccine from Novavax remains under review. On Monday, the U.S. Food and Drug Administration approved the shots for those aged 12 and above, and authorized them for emergency use in children aged 6 months through 11 years. Advisers to the U.S. Centers for Disease Control and Prevention voted on Tuesday to recommend the use of the vaccines widely. CDC Director Mandy Cohen said last month she expects the shots to be given annually, but not all doctors agree everyone needs them each year.
US pharmacy chains gear up to administer updated COVID shots
U.S. drugstore chains CVS Health and Walgreens Boots Alliance said on Wednesday that updated COVID-19 vaccines would be available at their stores as soon as this week. Shots were being delivered in some locations on Wednesday, including at a Northwell Health facility in New York.
US CDC recommends broad use of updated COVID-19 vaccines
The U.S. Centers for Disease Control and Prevention director on Tuesday signed off on broad use of updated COVID-19 vaccines approved by the government - covering ages 6 months and up - as the country prepares to start a vaccination campaign within days. The final recommendation from director Mandy Cohen comes after a panel of advisers to the agency voted 13-1 to recommend the shots made by Pfizer and partner BioNTech SE as well as Moderna.
Indian firms linked to cough syrup deaths had received warnings
The deaths of 12 children in northern India between December 2019 and January 2020, police allege, were caused by adulterated cough syrup made by drugmaker Digital Vision. It was not the first time the company's medicines have come under scrutiny. Indian drugs regulators found quality shortfalls in drugs made by Digital and its unit Orison Pharmaceuticals at least 22 times between 2012 and July this year, according to a Reuters review of records from five states and India's federal drugs regulator CDSCO.
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