COVID-19 Update #116 for 1/4/2022
NIH recommend that nonhospitalized patients with mild to moderate COVID-19 who are at high risk of disease progression, be treated with (in order of preference):
The FDA expanded the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a single booster dose for patients 12 through 15 years of age. Boosters for all patients 12 years and older can now be given as soon as five months after completion of primary series. Patients who are 5 through 11 years, who have undergone solid organ transplantation or are immunocompromised to an equivalent level are also now eligible for a booster dose. The interval between the primary series and a booster dose remains unchanged at six months for the Moderna COVID-19 vaccine and two months for the J&J vaccine.
South African researchers examined the results of 133,437 COVID-19 PCR tests and found the effectiveness of the Pfizer-BioNTech COVID-19 vaccine to be 70% after two doses in preventing hospitalizations for COVID-19 during a period when Omicron variant was the dominant strain compared to 93% when the Delta variant was the dominant strain.
In a second study, South African researchers compared the COVID-19 neutralization ability for the Beta, Delta, and Omicron variants with serum from 20 patents that had received two vaccinations with the Pfizer-BioNTech COVID-19 vaccine to a group of 20 patients that had received three injections. The researchers found that a third dose of the vaccine increased neutralization efficiency by a factor of 100 against the Omicron variant, but neutralization was lower by a factor of four against the omicron variant compared to the delta variant.
Rockefeller University researchers tested plasma from a variety of patients and found that recovered COVID-19 patients and patients that had received a third (booster) vaccination had enhanced protection against the Omicron variant.
CDC researchers reviewed data from VAERS and V-Safe voluntarily surveillance systems for children ages 5 to 11 years from 11/3/2021 to 12/19/2021. The researchers found the most common adverse reactions were injection site pain, fatigue and headache. ADR were mostly mild, and few cases of myocarditis were reported. It was estimated that 8.7 million doses were given during this time period to children 5 to 11 years.
A retrospective analysis of maternal and umbilical cord blood samples from 1,359 vaccinated pregnant women found that COVID-19 immunization before and throughout pregnancy resulted in detectable antibodies at delivery. The highest maternal and umbilical cord antibody levels were found in mothers who had received a complete vaccination course, had a prior history of COVID-19, or received a third-trimester booster dose.
The FDA issued an emergency use authorization (EUA) for convalescent plasma, on 8/23/2020, for the treatment of hospitalized patients with COVID-19. The original EUA was granted for any convalescent plasma product collected at FDA registered blood establishments. In February 2021, the FDA narrowed the EUA to high-antibody-titer convalescent plasma. The FDA no longer authorizes the use of plasma with low SARS-CoV-2 antibody titers. In December 2021, the FDA narrowed the EUA to treatment of COVID-19 in inpatients or outpatients who have an immunosuppressive disease or who are receiving immunosuppressive treatment. Fact sheets have been created for health care providers and patients. The Fact Sheet for HCPs has been revised to reflect the changes in the EUA. The documents include dosing instructions and potential adverse effects, such as allergic reactions, transfusion-associated circulatory overload, and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections.
Kiniksa Pharmaceuticals announced that in a 29-day, 582 patient, Phase II/III trial (NCT0444746), treatment with mavrilimumab did not decrease the percentage of patients that required mechanical ventilation or died compared to placebo in patients with severe COVID-19 pneumonia and systemic hyperinflammation.
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