As Rollout Nears, Small Practices and Rural Clinics Anticipate Challenges Storing and Administering COVID-19 Vaccines
A much-awaited COVID-19 vaccine comes with many logistical caveats.
A much-awaited COVID-19 vaccine comes with many logistical caveats.
The analysis of the primary outcomes was based on 170 confirmed cases of COVID-19.
The placebo-controlled COVE study is investigating the efficacy and safety of mRNA-1273 at the 100mcg dose (given intramuscularly in a 2-dose series, approximately 28 days apart) in more than 30,000 adults aged 18 years and older.
The trial will continue as planned and final analysis is expected when the number of confirmed COVID-19 cases reaches 164.
To estimate the association between attribute level and probability of choosing and receiving a vaccine, the study authors calculated the average marginal component effects sizes as well as marginal means.
In a statement, the Company noted that the actions being taken are considered “routine” when an unexplained illness is reported in a clinical trial.
Pfizer and BioNTech have selected a coronavirus disease 2019 (COVID-19) vaccine candidate and have initiated their phase 2/3 safety and efficacy trial.
The trial, which is the first to be implemented under Operation Warp Speed, is expected to enroll around 30,000 adults and will be conducted at multiple clinical research sites across the US.
The US Department of Health and Human Services and the Department of Defense have agreed to receive 100 million doses of BNT162, a vaccine for SARS-CoV-2, once the manufacturers obtains approval or emergency use authorization (EUA) from the Food and Drug Administration.
If effective, vaccine could be available for emergency use in the United States as early as September.