Third shot for immunocompromised patients, ACP and others urge vaccine in pregnancy, more COVID-19 news

The FDA on Aug. 12 amended the emergency use authorizations for both the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow for the use of an additional dose in certain immunocompromised individuals, specifically solid organ transplant recipients or patients considered to have an equivalent level of immunocompromise. The CDC's Advisory Committee on Immunization Practices agreed at its Aug. 13 meeting, recommending a third shot for moderately to severely immunocompromised patients ages 12 years and over, according to a CNN report. A letter published by the New England Journal of Medicine (NEJM) on Aug. 11 reported that a third dose increased antibody levels in transplant patients. The randomized, placebo-controlled trial included 120 patients with solid organ transplants and found no hospitalizations or organ rejections resulting from the extra vaccination. “Overall, at this juncture, the benefit of third-dose vaccination, at least with the mRNA-1273 vaccine, appears to outweigh the risks,” said an accompanying editorial. Another letter in NEJM, published Aug. 12, reported similar results from third doses given to about 100 transplant recipients. Two research letters published by JAMA Oncology on Aug. 11 focused on the limited effectiveness of two-shot vaccination in immunocompromised patients, specifically those in active cancer treatment and with hematologic malignant disease.

Details on vaccine-induced immune thrombocytopenia and thrombosis (VITT) were provided by a study published by NEJM on Aug. 11. It looked at 170 definite and 50 probable cases of VITT in the U.K. Patients presented five to 48 days (median, 14 days) after vaccination and had no identifiable medical risk factors. Mortality was 22% overall and was highest among patients with a low platelet count and intracranial hemorrhage.

In other COVID-19 news, ACP recently cosigned a statement from leading medical organizations strongly urging all pregnant individuals—along with those who are recently pregnant, planning to become pregnant, or lactating—to be vaccinated against COVID-19. In light of rising cases as a result of the delta variant, pregnant individuals are at increased risk of severe COVID-19 infection, including death, and should protect themselves by being vaccinated, the statement noted.

A study published by JAMA Network Open on Aug. 11 reported the effects of COVID-19 during childbirth. It compared 18,715 women who gave birth with COVID-19 to 850,364 without COVID-19 and found significantly higher rates of preterm birth (16.4% vs. 11.5%) and in-hospital mortality (0.1% vs. <0.01%) associated with infection.

For high-risk outpatients with COVID-19, budesonide appeared to improve outcomes, according to a randomized trial published by The Lancet on Aug. 10. Patients were all age 65 years or older or age 50 years or older with comorbidities and had been unwell for up to 14 days with suspected COVID-19 before being randomly assigned to budesonide (n=1,073), usual care alone (n=1,988), or other treatments (n=1,639). The budesonide group had earlier self-reported recovery (11.8 days vs. 14.7 days) and lower rates of hospital admission or death (6.8% vs. 8.8%) than the usual care group. “Inhaled budesonide improves time to recovery, with a chance of also reducing hospital admissions or deaths (although our results did not meet the superiority threshold), in people with COVID-19 in the community who are at higher risk of complications,” the study authors concluded. They did note that this was an open-label trial and that inhalers have been previously shown to have placebo effects in chronic respiratory conditions, possibly affecting the findings on self-reported recovery time.