COVID-19 Vaccines
A 19,109 patient, British observational study described the effectiveness of COVID-19 vaccines against the Delta variant. The effectives of the Pfizer-BioNTech COVID-19 vaccine was estimated to be 88% after two doses and 67% with two doses of the AstraZeneca vaccine. An analysis of data by Israeli researchers found the effectiveness of the Pfizer-BioNTech COVID-19 vaccine to be 91% to prevent severe disease and 88% to prevent hospitalizations. The vaccine had an estimated effectiveness of 41% to protect against symptomatic disease and 39% to prevent infection due to the Delta variant compared to an estimated 64% effectiveness at the beginning of July. COVID-19 Anti-Inflammatories Mesoblast announced that in a 60-day, 222 patient, Phase III trial (NCT04371393), treatment with remestemcel-L added to standard of care (SOC) did not reduce all-cause mortality compared to SOC in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. In a pre-specified analysis of 123 patients under age 65, remestemcel-L reduced mortality by 46% by day 60, but not in 94 patients 65 or older. The Data Safety Monitoring Board (DSMB) recommended the trial be stopped when an interim analysis of 30-day data for 180 patients found it unlikely the trial would achieve a 43% reduction in mortality at the target enrollment of 300 patients. The DSMB recommended the trial be completed with the 222 patients already enrolled. COVID-19 Vaccines
The World Health Organization’s Global Advisory Committee on Vaccine Safety found the benefits of mRNA COVID-19 vaccines outweigh the risksin reducing hospitalizations and deaths from COVID-19. The risk for myocarditis and pericarditis is very low. The estimate in patients 12 to 29 is 40.6 cases per million second doses among males and 4.2 cases per million among females. In patients over 30, the rate drops to 2.4 per million second doses in males and one per million second doses in females in patients. The FDA has added Guillain-Barre syndrome to the Warning section of the Fact Sheet for the Johnson & Johnson COVID-19 vaccine. Most cases occurred within 42 days after vaccination. The occurrence is very low at 100 cases per 12.5 million doses. The FDA, CDC, and NIH have issued a joint statement that a booster vaccination is not currently needed for people that are fully vaccinated for COVID-19. A retrospective analysis of the outcomes of 15,060 pregnant women in an Israeli database found the estimated effectiveness of the Pfizer-BioNTech COVID-19 vaccine to be 78%. Updated NIH Treatment Summary Current treatment recommendations from NIH are organized by severity of disease in an easy-to-use graphic.
NIH found there is insufficient evidence to recommend either for or against the use of GM-CSF inhibitors (lenzilumab, otilimab, or mavrilimumab) for the treatment of hospitalized patients with COVID-19. COVID-19 Antivirals An analysis of oropharyngeal specimens from 181 patients that were collected during the Norwegian arm of the WHO Solidarity study did not find a decrease in SARS-CoV-2 viral load with remdesivir or hydroxychloroquine compared to standard of care. COVID-19 Vaccines
Researchers have examined the incidence of myocarditis after mRNA COVID-19 vaccine immunization.
Researchers from NIAID and their academic partners found that while virus neutralization from antibodies from 15 persons who had received the Moderna COVID-19 vaccine and 10 persons who had received the Pfizer–BioNTech vaccine were reduced the antibodies retained 79% of activity against the B.1.617.1 (India) variant and 96% of activity against the B.1.617.2 (India, Delta) variant. COVID-19 Anti-inflammatories A meta-analysis, by the World Health Organization, of 27 trials involving 10,930 patients, evaluated IL-6 inhibitors in the treatment of COVID-19. At 28-days the mortality risk in tocilizumab or sarilumab patients was 22% compared to 25% with usual care or placebo. The mortality benefit was maintained in patients receiving corticosteroids (21% vs 25%). The data supporting tocilizumab was more robust than sarilumab due to the larger patient population and the trials being conducted later in the pandemic, when use of corticosteroids became more common. There was not enough data (one trial) to estimate the effect of using siltuximab. Based on the data, the WHO now recommends that either tocilizumab or sarilumab be added to corticosteroids for the treatment of severe or critical COVID-19 infections. |
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