The FDA is expected to authorize a third dose of the Pfizer-BioNTech and Moderna COVID-19 vaccines for immunocompromised patients; the CDC revised its COVID-19 vaccine guidance to include pregnant individuals; the FDA issued a complete response letter for the once-anticipated anemia drug roxadustat.
The FDA is expected to authorize people with weakened immune systems to receive a third dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccines to better protect these vulnerable populations from the highly contagious delta variant. The New York Times said that the decision will expand the emergency use of the vaccines for patients with compromised immune systems who are most likely to benefit from a booster dose, including patients who have received solid organ transplants or take immunosuppressive medications. Some scientists argued that immunocompromised individuals are too diverse to recommend an additional dose to all of them, as some may already be more protected than others. Once the FDA’s decision is officially announced, the CDC is expected to update its vaccine recommendations to follow suit the same day.
In light of the rising hospitalizations for unvaccinated mothers-to-be, the CDC is now urging all pregnant people to get vaccinated against COVID-19, according to a report from the Associated Press. There is a higher risk of severe illness and pregnancy complications, including miscarriages and stillbirths, from COVID-19 for expectant individuals. CDC data reveal that only 23% of the pregnant population in the United States has received at least 1 dose of a COVID-19 vaccine. CDC Director Rochelle Walensky, MD, said that the vaccines are safe and effective and that it is more urgent than ever for pregnant people to get vaccinated, especially as the delta variant continues to spread rapidly across the country. The agency previously encouraged pregnant people to consider vaccination but did not make an official recommendation until now.
The FDA has sent AstraZeneca and FibroGen a complete response letter regarding their application for roxadustat, a drug intended to treat anemia associated with chronic kidney disease, according to Fierce Pharma. The letter represents a rejection for the drug, which was supposed to treat patients regardless of whether their condition is serious enough to require dialysis. The FDA has requested for FibroGen to submit additional clinical data if the company would like to try for approval again. However, some analysts doubt that AstraZeneca and FibroGen will be willing to fund an additional phase 3 trial. The letter comes after the FDA released an internal review document outlining a number of safety concerns previously unknown to investors, saying that the drug, once anticipated to become a blockbuster product, may actually increase risks of death, blood clots, and serious infections compared with erythropoietin therapy.