Novavax will delay requesting an EUA until October 2021 to complete FDA requirements for its manufacturing process. Novavax plans to seek approval in September 2021 in the U.K., Canada and Australia. The company has already sought approval in India, Indonesia and the Philippines.
Novavax announced preliminary data demonstrating that a single booster dose of NVX-CoV2373, given six months after the initial two-dose regimen resulted in a 4.6-fold increase in antibody titers.
ACIP met to review the safety of the three COVID-19 vaccines that have received an EUA. The group recommended that the benefits of vaccination outweigh the risks for Guillain-Barré syndrome and thrombosis with thrombocytopenia syndrome after Janssen COVID-19 vaccination and myocarditis after mRNA (Pfizer-BioNTech and Moderna) COVID-19 vaccination.
In the 3,732 patient, Phase II/III TeenCOVE trial (NCT04649151), no cases of COVID-19 were reported among adolescents ages 12 to 17 years that received two doses of the Moderna COVID-19 vaccine compared to four cases in the placebo group in the adult Phase III COVE study. Efficacy was 93% when measured 14 days after the first dose. The vaccine was well tolerated with no serious adverse events.
In a four-month, 120 patient, Phase IV trial (NCT04885907), 55% of patients that received a third dose of the Moderna COVID-19 vaccine achieved at least 100 U/ml of anti–receptor-binding domain (RBD) compared to 18% that received only two doses in solid organ transplant patients that did not have a previous diagnosis of Covid-19. The percent virus neutralization was 71% in the three-dose group compared to 13% in the two-dose group.
The FDA amended the EUAs for both mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) to allow for the use of a third dose in certain immunocompromised individuals.
The 14-day, 263 patient, Phase III, ACTION trial (NCT04332107) was terminated early after an interim analysis failed to find an improvement in the number of ambulatory COVID-19 patients that were symptom free. There was also no difference in hospitalizations at 21-days.
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