COVID-19 Update #101 for 9/24/2021

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COVID-19 Vaccine Booster doses
 
On 9/22/2021, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow a booster dose, given at least six months after completion of the second dose to patients 65 years and older or who are at high risk for severe COVID-19, which includes healthcare professionals, frontline workers and people that live in group settings. On 9/23/2021, ACIP recommended a booster dose of the Pfizer-BioNTech vaccine for patients 65 years and older, residents of long-term care facilities and 50 to 64 years patients at high risk for severe COVID-19. Patients who at 18 to 49 at high risk for severe COVID-19 infection may receive one, if the patient wants one. ACIP did not recommend a booster dose for health care professionals, other front-line workers or people that live in group settings. The CDC agreed with ACIP on recommending a booster dose for patients 65 years and older, residents of long-term care facilities and patients at high risk for severe COVID-19, but also added a recommendation for health care professionals, other front-line workers or people that live in group settings. Neither the FDA nor CDC has recommended booster doses of the Moderna or Johnson & Johnson COVID-19 vaccines. No recommendation was made regarding use of the Pfizer-BioNtech vaccine as a booster dose for patients that originally received the Moderna or Johnson & Johnson COVID-19 vaccines.
 
J&J announced that in the 31,836 patient, Phase III, ENSEMBLE 2 trial (NCT04614948), a booster dose of the J&J COVID-19 vaccine given 56 days after the initial immunization produced vaccine effectiveness of 100% against severe/critical COVID-19, 75% against symptomatic infections globally and 94% in the U.S. 
 
COVID-19 Vaccines
 
A study of 36 women, who received an mRNA vaccine during pregnancy, found that antibodies were passed on to infants.
 
A pre-publication draft of a retrospective review of data from 1,914,670 patients in an insurance claims database estimated the vaccine effectiveness, for the J&J COVID-19 vaccine in states with high Delta variant incidence, at 78% for infections and 85% to prevent hospitalizations.
 
COVID-19 Antivirals
 
Gilead Sciences announced that in the 28-day, 562 patient, Phase III, PINETREE trial (NCT04501952), 0.7% of patients treated with three intravenous infusions of remdesivir were hospitalized or died compared to 5.3% with placebo in non-hospitalized COVID-19 patients at high risk for disease progression. Enrollment for this trial was stopped, in April 2021, prior to fulfilling the 1,264 patient enrollment due to a change in epidemiology and adoption of additional treatment options at the time. The Delta variant became the dominant variant in the summer of 2021.