Pfizer and BioNTech have requested FDA an EUA for a bivalent vaccine, on 8/22/2022, containing the original Pfizer-BioNTech COVID-19 vaccine and a new Omicron BA.4/BA.5 variant vaccine. When approved, the companies are ready to start shipping the vaccine. Moderna requested an EUA for a similar bivalent vaccine a day later. Neither vaccine has any clinical trial data available, instead the NDA are based on preclinical and manufacturing data, as well as human studies of vaccines that incorporated the BA.1 omicron strain. The FDA authorized EUAs for bivalent vaccines from Moderna and Pfizer-BioNTech on 8/31/2022. The Moderna COVID-19 Vaccine is approved for patients 18 years and older. The Pfizer-BioNTech COVID-19 Vaccine, is approved for patients 12 years of age and older. The vaccines are given as a single booster dose at least two months following primary or booster vaccination. ACIP voted 13-1 to recommend the updated COVID-19 vaccine boosters, on 9/1/2022, and the CDC agreed and endorsed the vaccines the same day.
A review of data for 109,254 non-hospitalized, high-risk, COVID-19 patients found that use of nirmatrelvir reduced hospitalization in patients 65 and older (14.7 cases vs 58.9 cases per 100,000 person-days). However, in patients 40 to 64, there was no reduction (15.2 cases vs 15.8 cases per 100,000 person-days). Mortality was also reduced in older patients, but not in younger patients.
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