The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Dec. 10, 2020 to review a request for an emergency use authorization (EUA) Pfizer’s and BioNTech’s COVID-19 vaccine. The FDA plans to do a live broadcast of the meeting.
Moderna and NIAID initiated an NIAID funded, 30,000 patient, Phase III, COVE trial (NCT04470427) for COVID-19 vaccine candidate mRNA-1273 on July 27. The vaccine is administered as two 100 mcg immunizations given 28 days apart. Moderna announced final results from the COVE trial on 11/30/2020. The efficacy of mRNA-1273 was 94.1% based on 196 cases of COVID-19 that developed in the study population. The study population included 7,000 patients over the age of 65 and 5,000 under 65 at increased risk for severe COVID-19 due to co-morbidities. The study population also included 37% with diverse backgrounds, including 6,000 participants who identify as Hispanic or LatinX, and 3,000 who identify as Black or African American. The most common adverse effects were injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. There was an increase in frequency and severity of adverse effects after the second immunization. Moderna submitted a request for an Emergency Use Authorization (EUA) from the FDA and EMA on 11/30/2020. When approved, Moderna will have 20 million vaccine doses available in 2020 and up to 1 billion doses in 2021. Moderna announced that mRNA-1273 is stable for 30 days at 2 to 8 C and for six-months at -20 C. This will make the vaccine easier to ship and use in pharmacies, clinics and small hospitals.
Novavax plans to enroll 30,000 patients in a Phase III, Operation Warp Speed sponsored trial, in the U.S. and Mexico (NCT04611802). Due to difficulties in scaling up vaccine manufacturing, the initiation of the trial has been delayed a second time and is expected to begin at the end of December. Novavax initiated a 15,000 patient, Phase III trial to evaluate two doses of NVX-CoV2373 given 21-days apart for the prevention of COVID-19 in the United Kingdom (NCT04583995). At least 25% of trial participants will be 65 or older. Novavax completed enrollment in November 2020 and expects the first interim data to be reported in 1Q21. Novavax is evaluating two doses of NVX-CoV2373 given 21-days apart for the prevention of COVID-19 in South Africa in a 4,422 patient, Phase IIb trial (NCT04533399). The trial includes 245 medically stable, HIV-positive participants.
AstraZeneca is designing a new trial to evaluate the efficacy of the half-strength initial dose/full strength second dose regimen that demonstrated 90% efficacy in a small subpopulation in a 22,690, Phase III trial.
Gamaleya is evaluating Gam-COVID-Vac in the prevention of COVID-19 in the 40,000 patient Phase III (RESIST) trial (NCT04530396). Two doses of Gam-COVID-Vac will be given 21 days apart in the trial. The Russian National Research Center for Epidemiology and Microbiology announced results from a second interim analysis of the Sputnik V vaccine, where efficacy was estimated to be 91.4%, 28 days after the first dose and seven days after the second dose, based on the distribution of 39 cases of COVID-19 among 18,794 patients. (Note: Pfizer based their 95% efficacy on 170 cases distributed among 41,135 patients and Moderna reported 94.1% efficacy after 196 cases of COVID-19 occurred in over 30,000 patients). The Russian sovereign wealth fund announced the COVID-19 vaccine, Sputnik V, will be available internationally beginning in January 2021 as a two-dose regimen priced less than $20.
In a 30-day, 333 patient trial (NCT04383535), there was no difference in 30-day clinical status between treatment with convalescent plasma and placebo in Argentinian hospitalized patients with COVID-19. Most patients in the trial also received a glucocorticoid.