The American Academy of Pediatrics Tells the FDA to Speed Up and Stop Endangering Patients

Quote:We understand that the FDA has recently worked with Pfizer and Moderna to double the number of children ages 5-11 years included in clinical trials of their COVID-19 vaccines. While we appreciate this prudent step to gather more safety data, we urge FDA to carefully consider the impact of this decision on the timeline for authorizing a vaccine for this age group. In our view, the rise of the Delta variant changes the risk-benefit analysis for authorizing vaccines in children. The FDA should strongly consider authorizing these vaccines for children ages 5-11 years based on data from the initial enrolled cohort, which are already available, while continuing to follow safety data from the expanded cohort in the post-market setting. This approach would not slow down the time to authorization of these critically needed vaccines in the 5–11-year age group.

In addition, as FDA continues to evaluate clinical trial requirements for children under 5 years, we similarly urge FDA to carefully consider the impact of its regulatory decisions on further delays in the availability of vaccines for this age group. Based on scientific data currently available on COVID-19 vaccines, as well as on 70 years of vaccinology knowledge in the pediatric population, the Academy believes that clinical trials in these children can be safely conducted with a 2-month safety follow-up for participants. Assuming that the 2-month safety data does not raise any new safety concerns and that immunogenicity data are supportive of use, we believe that this is sufficient for authorization in this and any other age group. Waiting on a 6-month follow-up will significantly hinder the ability to reduce the spread of the hyper infectious COVID-19 Delta variant among this age group, since it would add 4 additional months before an authorization decision can be considered. Based on the evidence from the over 340 million doses of COVID-19 doses administered to adults and adolescents aged 12-17, as well as among adults 18 and older, there is no biological plausibility for serious adverse immunological or inflammatory events to occur more than two months after COVID-19 vaccine administration.

Quote:The envelope was addressed by hand in pen to: "The Pope, Vatican City, St. Peter's Square, Rome," and contained three bullets presumed to be for a pistol and a message referring to financial operations at the Vatican.

Quote:On July 27, a trial got under way in which 10 people, including a senior cardinal, have been indicted over allegations of mishandling of Vatican funds. The multi-million euro scandal revolves around the purchasing of a luxury property in London.

According to Reuters, an indictment revealed as part of the process showed Pope Francis gave his personal approval for the trial against senior figures to commence.

• “Discretion to utilize National Guard and State Guard members in connection with certain health care and emergency services operations.”
  
• “Telephone assessments for involuntary commitment cases are permitted.”
  
• “Temporary quarantine and isolation facilities may be constructed.”