Pfizer Sees 'Mostly Mild to Moderate' Safety Profile in Phase 3 COVID-19 Vaccine Study - COVID-19 Clinical Trial
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Pfizer Sees ‘Mostly Mild to Moderate’ Safety Profile in Phase 3 COVID-19 Vaccine Study

As Pfizer moves ahead in COVID-19 vaccine research at record speeds, executives on Tuesday detailed a “mostly mild to moderate” safety profile, with rare instances of severe or grade 4 side effects. In phase 3 data through Aug. 27, trial participants who’d received only the first dose experienced mostly fatigue and headache, with other cases of muscle pain, diarrhea, chills and joint pain reported, according to a presentation from an investor event (slides 23 and 24).

Pfizer is advancing the vaccine in partnership with BioNTech, which developed the mRNA program. The data remain blinded; only the independent data monitoring board knows how the side effect reports stack up between the placebo and vaccine groups. But the board would notify Pfizer if any safety concerns arose, the company’s head of vaccine research Kathrin Jansen said Tuesday. The safety data disclosure comes after AstraZeneca, another drugmaker in phase 3 COVID-19 vaccine testing, had to pause its high-profile trial after a suspected case of transverse myelitis, according to reports. The trial has resumed in some countries, but not the U.S., where NIH officials said they were “concerned” about the case. On Tuesday, NIAID director Anthony Fauci told CNN it was a “matter of time” until the trial starts back up.

Lilly Links COVID-19 Antibody to Reduced Hospitalization Rate

Eli Lilly has linked its anti-SARS-CoV-2 antibody to a lower rate of hospitalization in patients recently diagnosed with mild to moderate cases of COVID-19. However, two of the three doses, including the highest studied in the phase 2 trial, failed to beat placebo in terms of reducing viral load by Day 11. The study, BLAZE-1, assessed the effect of three doses of LY-CoV555 and placebo in 452 patients with mild to moderate COVID-19 symptoms and a positive SARS-CoV-2 test based on a sample taken no more than three days before dosing. Lilly’s primary endpoint looked at the change in viral load from baseline to Day 11. 

Only the 2800-mg dose met the primary endpoint. The other two doses—700 mg and 7000 mg—did no better than placebo by that yardstick. Typically, the highest dose of a drug has the biggest effect.  Lilly is yet to share data or statistical analyses for the primary endpoint, making it impossible to get a handle on what it saw in the trial. The mixed primary endpoint data may partly be explained by the fact that most patients in all arms, including the placebo cohort, had nearly complete viral clearance by Day 11. 

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