COVID-19 updates
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COVID-19 Vaccines
Pfizer and BioNTech announced immunology data from a 140 patient, Phase II/III trial, where a booster dose of their COVID-19 vaccine, given six-months after the initial series, produced a six-fold increase in antibodies one month after the booster compared to antibody titers one month after the second dose in children 5 through 11 years of age. A sub-analysis of 30 patients found that the Omicron variant was neutralized by the antibodies. A pre-print draft describes an 895 patient, open-label, Phase II/III trial, where a bivalent COVID-19 vaccine developed by Moderna was tested against its approved vaccine. The bivalent vaccine consisted of the original vaccine with the addition of mRNA for the Beta variant spike proteins. Compared to original vaccine, the bivalent vaccine elicited increased antibody titers for the original virus and Beta, Omicron and Delta variants after 28 days. Antibody titers levels were still elevated for the bivalent vaccine at 180 days for the original Beta, Omicron variants. The bivalent vaccine was given as a booster about nine months after the primary series. Moderna is also developing a bivalent vaccine that combines the original vaccine with mRNA for the Omicron variant spike proteins. A blinded randomized trial for this vaccine will be reported in 2Q22. Moderna feels the Omicron bivalent vaccine will be chosen for use as a booster in the fall. A systematic review and meta-analysis of 29 studies involving 11,713 solid organ transplant patients identified risk factors for decreased antibody titers. The risk factors included older age, recent transplantation, deceased donor status, active use of antimetabolites, and recent exposure to antithymocyte globulin or rituximab. Receiving additional doses of an mRNA vaccine increased the chance of developing higher antibody titers. British researchers analyzed the vaccine effectiveness (VE) for the Omicron variant for COVID-19 vaccines from Pfizer-BioNTech and AstraZeneca.
COVID-19 Antibodies In the six-month, 5,197 patient, Phase III, PROVENT trial (NCT04625725), 0.3% of patients who received a prophylactic dose of tixagevimab plus cilgavimab developed symptomatic COVID-19 compared to 1.8% who received placebo in adults at increased risk of an inadequate response to COVID-19 vaccination. COVID-19 Vaccines
The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) did not develop a plan for COVID-19 vaccine booster composition or timing of additional boosters. In addition to attempting to predict which variant will be dominant, half of the U.S. population has not received a booster dose, so how to optimize protection for everyone will be more of a challenge. VRBPAC members agreed the goal for booster doses should be prevention of hospitalization and death in at least 80% of patients. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said the fourth dose vaccine dose was a reasonable approval until a new booster, that would preferably have longer-lasting protection, was available. He felt frequent use of boosters was not a strategy that should be continued. VRBPAC will meet again to discuss more specific details of a booster program for COVID-19. The CDC endorsed the FDA’s approval of a second booster vaccination and recommended certain immunocompromised individuals and people over the age of 50 who received an initial booster dose at least 4 months be eligible for a second booster (fourth dose) or an mRNA COVID-19 vaccine. A CDC analysis of COVID-19 vaccine effectiveness (VE) from 12/16/2021 to 3/7/2022 found that for preventing emergency department/urgent care visits VE was 24% for one J&J vaccination, 54% after two J&J doses, 79% after one J&J vaccination followed by one mRNA dose, and 83% after three mRNA doses. VE for the same vaccine regimens to prevent COVID-19 associated hospitalizations was 31%, 67%, 78%, and 90% respectively. In a 2,812 patient, case–control, test-negative trial, vaccine effectiveness (VE), of the Pfizer-BioNTech COVID-19 vaccine, for the Omicron variant was 20% for non-critical COVID-19, 40% to prevent COVID-19 hospitalizations and 79% for critical COVID-19 in adolescents 12 to 18 years of age with a median interval since vaccination of 162 days. VE was 68% to prevent COVID-19 hospitalizations in children 5 to 11 years of age, with a median interval since vaccination of 34 days. A CDC analysis of EHR data from 40 health systems found the risk for myocarditis, pericarditis, or multisystem inflammatory syndrome to be 2 to 6 times higher in 12 to 17 year old boys who experienced a COVID-19 infection compared to receiving an mRNA COVID-19 vaccine. In young men 18 to 29 years, the risk is 7 to 8 times higher with infection over vaccination. An analysis of EHR data from 1,252,331 Israeli patients, who were 60 and older, found that a fourth vaccination with an mRNA COVID-19 vaccine lowers the risk by half for a confirmed infection. But the protection wanes and only lasts about eight weeks. Protection against severe cases of COVID-19 were three times lower and did not appear to decrease over time. The study was too short to estimate the duration of protection against severe disease. NIH Outpatient Treatment Update 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):
Alternative Therapies if nirmatrelvir boosted with ritonavir or remdesivir are not available or an inappropriate choice for the patient, then one of the following therapies can be used.
COVID-19 Antibodies The FDA no longer authorizes sotrovimab to treat COVID-19 in the U.S. due to the Omicron BA.2 sub-variant becoming the dominant variant. The CDC reports that BA.2 now accounts for 72.2% of all COVID-19 cases with BA.1.1 accounting for most of the remaining cases. In a 28-day, 1,181 patient, Phase II trial (NCT04373460), 2.9% of patients treated with high titer convalescent plasma were hospitalized for COVID-19 compared to 6.3% with placebo in outpatients with recent onset of COVID-19. COVID-19 Antivirals In the 28-day, 3,515 patient, Phase III, TOGETHER trial (NCT04727424), treatment with ivermectin did not reduce COVID-19 hospitalizations or urgent-care visits compared to placebo in high-risk Brazilian outpatients with COVID-19. The FDA placed a partial hold on leronlimab HIV trials and a full hold on leronlimab COVID-19 trials in the United States. At the same time, CytoDyn decided to place a hold on its leronlimab COVID-19 Brazilian trial pending review of two cardiac events by the data safety monitoring board. |
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