FDA Set To Authorize Booster Dose For People With Weaker Immune Systems
The Food and Drug Administration is expected as soon as Thursday to expand its emergency use authorization to allow a third dose of the Moderna and Pfizer vaccines for people who are immunocompromised.
The New York Times:
F.D.A. To Authorize Third Vaccine Dose For People With Weak Immune Systems
Federal regulators are expected to authorize a third shot of coronavirus vaccine as soon as Thursday for certain people with weakened immune systems, an effort to better protect them as the highly contagious Delta variant sweeps the nation. The decision to expand the emergency use of both the Pfizer-BioNTech and Moderna vaccines is meant to help those patients with immune deficiencies who are considered most likely to benefit from an additional shot. It covers people who have had solid organ transplants and others whose immune systems are similarly compromised, according to an official familiar with the plan. (LaFraniere and Weiland, 8/11)
NBC News:
FDA Poised To OK 3rd Vaccine Dose For Immunocompromised People
The move would come after a panel of advisers to the Centers for Disease Control and Prevention met in Julyand urged action on extra doses for immunocompromised adults. Doctors say it is increasingly clear that many such patients are still vulnerable to Covid following vaccination because they may not mount an effective immune response to the shots. (Edwards and Przybyla, 8/11)
CNN:
FDA Expected To Authorize Covid-19 Vaccine Booster Shots For Some Immunocompromised People Within The Next 48 Hours
This would be a third shot of the current two-dose Pfizer and Moderna vaccines. That announcement could slide, the source cautioned, but this is the current timing. “The FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals,” an FDA spokesperson told CNN. “The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future.” (Collins and Bonifield, 8/11)
In related news about booster shots —
AP:
Study: Extra COVID Shot Helps Protect Transplant Patients
A third dose of Moderna’s COVID-19 vaccine substantially improved protection for organ transplant recipients whose weak immune systems don’t always rev up enough with the standard two shots, Canadian researchers reported Wednesday. The study, published in the New England Journal of Medicine, was small but it’s the most rigorous type of third-dose testing so far for this vulnerable group. (Neergaard, 8/11)
Fox News:
Over 1 Million People Given COVID-19 Booster Shots Ahead Of Regulatory OK: Report
More than 1 million people vaccinated with Pfizer or Moderna’s COVID-19 shots went back for a third dose ahead of any OK from regulators, according to a report citing estimates from the Centers for Disease Control and Prevention (CDC). The 1.1 million estimate cited in an internal agency briefing document, reportedly obtained by ABC News, likely represents an underestimate because it excluded recipients of the Johnson & Johnson vaccine who may have returned for a second unauthorized dose. Florida was reported among states with the largest number of people seeking third shots. Other states listed were Ohio, California, Illinois and Tennessee. (Rivas, 8/11)