Pfizer and BioNTech announced that in a 2,260 patient, Phase III trial, no cases of COVID-19 developed in patients immunized with their COVID-19 vaccine compared to 18 cases in the placebo group for 100% efficacy in patients 12 to 15. The companies plan to submit the data to the FDA to expand the EUA to this age group.
Pfizer and BioNTech provided an update for their COVID-19 vaccine trial (NCT04368728) after 927 symptomatic cases of COVID-19 developed after up to six-months of follow-up for 91.3% efficacy. For prevention of symptomatic infection, the vaccine was 100% effective using CDC criteria and 95.3% effective using FDA criteria. There were 800 patients from South Africa in the trial and nine infections developed, six of which were caused by the B.1.351 (South African) variant. All infections developed in the placebo group, suggesting good efficacy, but based on limited data.
A preprint article of a 100 patient study found the Pfizer-BioNTech vaccine elicited high titers of antibodies that provided robust neutralization of the original SARS-CoV-2 virus and the P.1 (Brazilian) variant in healthy patients 80 to 96 years.
In an 8,534 patient, Phase III trial (NCT04400838), 520 patients developed COVID-19. The virus was sequenced in 301 patients. Efficacy in preventing symptomatic infection with the AstraZeneca COVID-19 vaccine was 70.4% against the B.1.1.7 (U.K.) variant and 81.5% against the original SARS-CoV-2 viruses. The vaccine was less efficacious for asymptomatic infection with 28.9% efficacy for B.1.1.7 compared to 69.7% for original viruses.
Novavax has added crossover arms to its studies to allow trial participants that received placebo to get the vaccine without unblinding the trials. A second round of vaccines will be offered for participants in the 15,000 patient, U.K. trial (NCT04583995) and the 30,000 patient, Phase III, PREVENT-19 trial (NCT04611802) in the U.S. and Mexico. Patients that received the vaccine will receive placebo and placebo patients will receive the vaccine. In the 2,905 patient, South African trial (NCT04533399), placebo patients will receive the vaccine, while the original vaccine patients will receive a booster to determine if a booster will improve efficacy for the B.1.351 (South African) variant.
The CoVIg-19 Plasma Alliance (CSL Behring, Takeda, BioPharma Plasma, Biotest, GC Pharma, LFB, National Bioproducts Institute, Octapharma and Sanquin) announced that in the 7-day, 600 patient, Phase III, ITAC trial (NCT04546581), adding anti-coronavirus hyperimmune intravenous immunoglobulin (H-Ig) to remdesivir did not reduce disease progression compared to remdesivir alone in hospitalized patients with COVID-19 who had symptoms for 12 days or fewer without life-threatening organ dysfunction or end-organ failure. NIH sponsored the trial.
The WHO recommended against the use of ivermectin due to inconclusive evidence and felt the drug should only be used to treat COVID-19 as part of a clinical trial.
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