Johnson & Johnson is in discussions with US authorities including the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) regarding using its Covid-19 vaccine for booster dosing. A formal recommendation is expected to be made after assessment of new data. In July this year, Johnson & Johnson shared data that showed that its single-shot Covid-19 vaccine generated strong immune response against the Delta variant and other mutations. A Phase 1/2a study showed that the immunity did not fade for at least eight months.
The US National Institutes of Health (NIH) have announced that the Clinical Trial of Covid-19 Convalescent Plasma in Outpatients (C3PO) failed to reach its primary endpoint. The agency noted that Covid-19 convalescent plasma could not prevent disease progression in a high-risk group of outpatients with Covid-19. The study was stopped in February 2021. Covid-19 convalescent plasma is the blood plasma procured from patients who have recovered from Covid-19. The research team expected that administering plasma in patients within the first week of their symptoms would lead to at least 10% reduction in disease progression. However, the figure was observed to be less than 2% in the study.
NRx Pharmaceuticals has provided a positive safety update on Zyesami (aviptadil), which is being tested in hospitalised patients with acute respiratory failure due to Covid-19. The ACTIV-3 Critical Care Phase III study is sponsored by the National Institutes of Health. After reviewing 140 patients, an independent Data Safety Monitoring Board identified no new safety concerns in the trial and recommended continued enrolment. Zyesami is a synthetic version of vasoactive intestinal peptide, which can deliver lung-protective, anti-viral and anti-inflammatory effects.