COVID News: Hydroxychloroquine sulfate/ chloroquine phosphate revocation, Vaccine development guidance, Partnering with EU, Warning against methanol containing hand sanitizers
Revocation of EUA for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) to treat COVID-19
FDA believe’s the suggested dosing regimens for CQ and HCQ unlikely to produce an antiviral effect
- Earlier observations of decreased viral shedding with HCQ or CQ treatment have not been consistently replicated
- Recent data from a randomized controlled trial showed no difference between HCQ vs. standard of care slone
- Current U.S. treatment guidelines do not recommend the use of CQ or HCQ outside of a clinical trial; NIH guidelines now recommend against such use outside of clinical trial
- Recent data from a large randomized controlled trial with HCQ showed no evidence of benefit for mortality or hospital length of stay or need for mechanical ventilation
- Additionally, the serious cardiac adverse events and other serious side effects cause the risks to outweigh benefits
Development and Licensure of COVID-19 vaccine
Recommendations :
- Using different technologies such as DNA, RNA, protein and viral vectored vaccines
- Help expedite vaccine development without sacrificing our standards for quality, safety, and efficacy
- Guidance provides overview of key considerations chemistry, manufacturing and control, nonclinical and clinical data
- Studies to directly evaluate the ability of the vaccine to protect humans from SARS-CoV-2 infection and/or disease
Partnering with the European Union and Global Regulators on COVID-19
FDA, European Commission (EC) and European Medicines Agency (EMA) have a multitude of critical scientific and regulatory collaborations for COVID-19 response
- 30 technical expert groups, or “clusters”
- Exchanging information on interpretation of data supporting regulatory decisions
- Virtual bilateral meetings to review high-priority areas
- Engagement with global regulators, under the International Coalition of Medicines Regulatory Authorities (ICMRA) forum, which is comprised of 28 regulatory authorities from around the globe
- International collaborations in medical device work
- READ
Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol
Hand sanitizer products containing methanol, or wood alcohol
- Often used to create fuel and antifreeze
- Can be toxic when absorbed through the skin as well as life-threatening when ingested
- Reported recent adverse events from adults and children including blindness, hospitalizations and death
Webpage for a full list of FDA-tested and recalled hand sanitizers:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitzers-methanol
Image credit: FDA