The U.S. Food and Drug Administration (FDA) has issued warnings to eight companies, including CVS Health Corp and Walgreens Boots Alliance, for manufacturing or marketing unapproved eye products. These products are being marketed illegally to treat conditions such as conjunctivitis, cataract, and glaucoma. The FDA has stated that these unapproved drugs pose an increased risk to users as they can bypass the body’s natural defenses.
Furthermore, an outside panel of experts to the FDA has declared that oral over-the-counter medicines containing phenylephrine, a common ingredient in cold and cough syrups, are ineffective as nasal decongestants. The panel unanimously voted against the effectiveness of phenylephrine and stated that additional trials were not needed to prove otherwise. This finding raises concerns about the use of phenylephrine in cold medicines.
In other news, the U.S. Department of Health and Human Services (HHS) has declared a public health emergency for the state of Georgia in response to the aftermath of Hurricane Idalia. The hurricane caused severe damage in Florida and Georgia, leading to the need for emergency measures to deal with the health consequences. The floodwater trapped residents in their homes, and urgent actions are required to mitigate the impact of the hurricane.
Additionally, the southern Indian state of Kerala has taken preventive measures after the emergence of the rare and deadly Nipah virus. This virus has already claimed two lives, and authorities are working to stop its spread. Schools, offices, and public transport have been closed to prevent further contamination. The Nipah virus is spread through contact with the bodily fluids of infected bats, pigs, or people.
In the realm of COVID-19, contract research firm ICON Plc has announced a partnership with the U.S. government to conduct a clinical trial for the effectiveness of next-generation COVID-19 vaccine candidates. The trial, which will involve 10,000 participants, aims to assess the efficacy of these vaccines relative to currently available shots. This collaboration aims to further the development of effective vaccines against COVID-19.
Moreover, Moderna has reported positive results from a late-stage trial of its flu vaccine. The vaccine generated a stronger immune response against all four A and B strains of the influenza virus compared to traditional flu shots. The effectiveness of the vaccine was observed across all age groups, demonstrating its potential to protect against the flu. Moderna’s flu shot was found to be safe and tolerable and showed comparable or superior performance to Sanofi’s high-dose flu vaccine.
In light of the upcoming autumn vaccination campaign, the U.S. has authorized updated COVID-19 vaccines from Pfizer-BioNTech and Moderna for emergency use. The shots have been approved for those aged 12 and above, with additional authorization for children aged 6 months through 11 years. The U.S. Centers for Disease Control and Prevention has recommended broad use of these vaccines and expects them to be administered annually, although not all doctors agree on the necessity of annual vaccination.
Lastly, U.S. pharmacy chains CVS Health and Walgreens Boots Alliance have announced that they will administer the updated COVID-19 vaccines in their stores. These vaccines will be available to the public, with distribution already underway in some locations. As the country prepares to start a vaccination campaign, the U.S. Centers for Disease Control and Prevention has given its final recommendation for the use of the updated vaccines for individuals aged 6 months and older.
It is worth noting that Digital Vision, an Indian drugmaker, has come under scrutiny for producing adulterated cough syrup allegedly responsible for the deaths of 12 children. The company has previously faced quality concerns regarding its medicines. Indian drugs regulators have found quality shortfalls in drugs produced by Digital Vision and its subsidiary Orison Pharmaceuticals multiple times over the past few years.
Sources:
– FDA – https://www.fda.gov/news-events/press-announcements/fda-warns-eight-companies-against-selling-illegal-unapproved-products-treat-alzheimers-disease
– Reuters – https://www.reuters.com/article/us-india-coughsyrup-deaths-insight-idUSKBN28V00F