“The FDA, along with CDC and state and local partners, is investigating a multistate outbreak of Salmonella Oranienburg infections linked to whole, fresh onions. FDA’s traceback investigation is ongoing but has identified ProSource Produce, LLC (also known as ProSource Inc.) of Hailey, Idaho, and Keeler Family Farms of Deming, New Mexico, as suppliers of potentially contaminated whole, fresh onions imported from the State of Chihuahua, Mexico.”
Read more here.
“Eight months after authorizing the Pfizer-BioNTech COVID-19 vaccine for emergency use in the USA, the Food and Drug Administration issued its full stamp of approval.
Now that the companies’ detailed, so-called biologics license application has been granted, it’s likely that vaccination will be required by many companies, schools and other entities.
Monday, President Joe Biden called on companies, nonprofit groups, government agencies and schools to “step up vaccine requirements that will reach millions more people.”
Vaccinations allowed people in this country to stop worrying about diseases such as smallpox, polio, measles, mumps and rubella, he said, and vaccines can help do the same for COVID-19.”
Read more, here.
“The unvaccinated or people with weak immune systems at high risk of severe disease can receive an injection if exposed to an infected person.
People at considerable risk of developing severe Covid-19, including millions of Americans with compromised immune systems, now have the option of receiving a preventive monoclonal antibody treatment if they have been or are at risk of being exposed to the coronavirus.
The Food and Drug Administration’s action on Friday brings hope to the estimated 3 percent of Americans who are immunocompromised, including those with autoimmune diseases, HIV patients, cancer patients and organ transplant recipients, who may still be vulnerable to Covid even after being fully vaccinated.
This is the first time an injectable coronavirus antibody treatment has been approved for use as a prevention of Covid after someone has been exposed to the virus.”
Read more, here.
“FDA has approved Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.
Diabetes is the leading cause of chronic kidney disease and kidney failure in the United States. Chronic kidney disease occurs when the kidneys are damaged and cannot filter blood normally. Because of defective filtering, patients can have complications related to fluid, electrolytes (minerals required for many bodily processes), and waste build-up in the body. Chronic kidney disease sometimes can progress to kidney failure. Patients also are at high risk of heart disease.”
Read the full report by the FDA, here.
“Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.”
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”
Read the full press release, here.
“A panel of outside experts on Thursday recommended the Food and Drug Administration issue an emergency use authorization to the Covid-19 vaccine being developed by Pfizer and BioNTech, a vaccine that appeared to be highly efficacious in a Phase 3 clinical trial.
The 17-4 vote came after a long day in which members of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, discussed a wide range of issues related to the vaccine, including concerns about vaccinating people with severe allergies and 16- and 17-year-olds, as well as issues regarding vaccination during pregnancy or lactation.
Although the FDA does not have to follow the panel’s recommendation, it is widely expected to do so.”
Read the full article, here.