Novartis today announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint(1). Initial data show there was no statistically significant reduction in the proportion of patients on ruxolitinib plus SoC therapy who experienced severe complications, including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) by Day 29, compared to SoC alone(1).

Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults. Phase 1/2 study interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of the FDA granting Emergency Use Authorization (EUA) for the companies’ COVID-19 mRNA vaccine (BNT162b2). There is one member of the Committee whose vote is not included in the 17 to 4 vote decision.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicine has published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. In the trial of 43,448 participants, who were 16 years and older, 21,720 of whom received BNT162b2 and 21,728 placebo, the two-dose regimen of 30 μg BNT162b2, which was given 21 days apart, was well-tolerated and demonstrated vaccine efficacy of 95% against COVID-19.

Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the first adolescent participants have been dosed in the Phase 2/3 study of mRNA-1273, the Company’s vaccine candidate against COVID-19, in adolescents ages 12 to less than 18.

Pfizer Canada and BioNTech SE (Nasdaq: BNTX) today announced that Health Canada has granted Authorization under Interim Order for the emergency use of their mRNA COVID-19 vaccine (BNT162b2). The distribution of the vaccine in Canada will be prioritized according to the populations identified in guidance from the National Advisory Committee on Immunizations (NACI).

Results of an interim analysis of the Phase III programme conducted by Oxford University with AZD1222, peer-reviewed and published in The Lancet today, demonstrated that the vaccine is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation. The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the Phase III UK and Brazil trials conducted by Oxford University.