November 1, 2021
Life Sciences
  • The FDA issued emergency use authorization on Friday for Pfizer’s Covid-19 vaccine for children 5 to 11 years old. The agency authorized a two-dose series of the vaccine, but with just one-third of the active ingredient compared to the adult dosage. The CDC’s Advisory Committee on Immunization Practices will meet tomorrow (November 2) to discuss whether to recommend use of the vaccine among U.S. children. The White House will begin distributing the vaccines as soon as CDC Director Dr. Rochelle Walensky signs off. (Articles here, here, here, and here)
  • Moderna Inc. said the FDA is delaying a decision on authorizing its COVID-19 vaccine for adolescents while the agency reviews whether the shot increases the risk of myocarditis. The biotech company said international data doesn’t suggest an increased risk of myocarditis among adolescents. However, Moderna¬†will also delay asking regulators to authorize a lower dose of its vaccine for younger children. The FDA analysis may not be finished until January. (Articles here, here, here, here, here, and here)
  • Johnson & Johnson said it reached a settlement in most of the roughly 9,000 cases it faced regarding its anti-psychotic drug Risperdal. Patients claimed that the company marketed the drug for off-label, unapproved use in children and failed to warn them of the risk of gynecomastia, a condition marked by excessive breast tissue in men and boys. Johnson & Johnson denied the allegations, and recorded $800 million in expenses tied to the agreement in the third quarter. (Article here)