In Idaho, Ivermectin Can Be Sold Over the Counter — After Gov. Little Signs Bill
Idaho Gov. Brad Little signed into law a bill to let ivermectin be sold as an over-the-counter medicine — without a prescription or consultation with a health care professional. Typically used to treat parasites in humans, ivermectin has drawn interest since the COVID-19 pandemic — after largely conservative activists, doctors and politicians inaccurately touted it as an alternative medicine.
Usually, the U.S. Food and Drug and Administration, or FDA, handles whether drugs should be made available over-the-counter, a process that uses data on safety and effectiveness. The FDA hasn’t approved ivermectin to treat or prevent COVID-19, saying the federal agency finds existing clinical trial data don’t show “ivermectin is effective against COVID-19 in humans.” The federal regulator’s website also warns large doses of ivermectin “can be dangerous,” overdose can risk death, and human-appropriate doses can interact with other medications, such as blood thinners.
Little on Monday signed Senate Bill 1211, the ivermectin deregulation bill, according to the governor office’s legislation tracker. The new law takes effect immediately — through an emergency clause. Passed during the last week of this year’s legislative session, Idaho lawmakers didn’t hear public feedback on the bill from doctors, pharmacists or health care professionals.
Vaccine Panel Urges More Protection Against RSV, Meningitis and Chikungunya
U.S. News & World Report reported:
A panel of federal health experts on Wednesday recommended expanded vaccine options for several diseases, including respiratory syncytial virus (RSV), meningitis and a mosquito-borne illness called chikungunya.
The panel, known as the Advisory Committee on Immunization Practices, makes vaccine use recommendations to the director of the U.S. Centers for Disease Control and Prevention (CDC), The Associated Press reported. These recommendations are almost always approved. But recent leadership changes at the CDC may complicate next steps.
The new recommendations include:
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- Adults aged 50 to 59 with certain health problems, like heart disease, diabetes or chronic obstructive pulmonary disorder should be able to get the RSV shot.
- A new combination vaccine from GSK was endorsed. It protects against five types of meningococcal bacteria, including one linked to college campus outbreaks about 10 years ago.
Moderna Advances Pandemic Preparedness Agenda With UK Clearance for Commercial mRNA Vaccine Plant
Furthering its goal to grow the reach of its mRNA vaccines and guard against future pandemics, Moderna cleared a key regulatory hurdle at its flagship production plant in the U.K. The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted Moderna a manufacturer and importer’s license at its vaccine facility in Harwell, Oxfordshire.
With license in hand and the plant now fully operational, Moderna is free to use the site for commercial production of mRNA shots, which will then be beholden to MHRA’s standard review process, the company said in an April 15 press release.
The facility, dubbed the Moderna Innovation and Technology Centre, forms a major component of the company’s 10-year partnership with the U.K. government and its Health Security Agency to prepare for future pandemics. The pact is designed to shore up domestic vaccine production in the U.K., bolster the country’s R&D prowess and ensure “priority access” to mRNA vaccines in the event of an emergency, Moderna noted in its release.
CDC’s Broader RSV Recommendation Could Be Boon for GSK, Pfizer
After revenues for GSK and Pfizer’s respective respiratory syncytial virus (RSV) vaccines took a hit last year, a new recommendation from the U.S. Centers for Disease Control and Prevention (CDC) could help them gain back some ground.
The meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP) took place this week after a nearly two-month delay. Originally scheduled for late February, the panel was postponed shortly after Robert F. Kennedy Jr. was sworn in as Health and Human Services (HHS) Secretary.
On Wednesday, ACIP voted to widen its recommendation on who should receive an RSV jab to include adults ages 50 to 59 who are at an increased risk of severe RSV disease. Pfizer’s Abrysvo and GSK’s Arexvy, both of which already have FDA approval in that patient population, stand to benefit from the expanded recommendation.
Last year, ACIP released a narrow vaccination recommendation that only applied to individuals 75 and older, as well as high-risk adults between the ages of 60 and 74 — a limited scope compared with the committee’s broader 2023 policy, under which all adults over the age of 60 “may receive” an RSV jab following discussions with their healthcare provider.
GSK Scolded After Complainant Flags ‘Shocking Error’ in Prescribing Information
GSK has been found guilty of bringing discredit on the pharma industry after a complainant flagged “a shocking error” in the prescribing information for the JAK inhibitor Omjjara.
A person who self-identified as a health professional wrote to the PMCPA, the body that oversees the U.K. marketing code, after finding fault with prescribing information for Omjjara. The drug is contraindicated in pregnancy, and the line that startled the complainant says, “Women using oral hormonal contraceptives should add a barrier method during treatment and for at least 1 week after the last dose of Omjjara.”
According to the complainant, “common sense and reasoning suggests any non-oral hormone contraception will raise the same concern,” leading them to “query the ability of GSK to accurately produce prescribing information and query whether sufficient checks have been made to these items prior to release.”
