Covid-19 roundup: Biden plans for early November rollout of vaccines for kids; EMA evaluates Regeneron's antibody combo
The Biden administration on Wednesday announced plans for a quick rollout of the Pfizer/BioNTech Covid-19 vaccine to kids ages 5 to 11 early next month, pending FDA authorization.
The administration plans to initiate community partnerships with clinics, pharmacies and hospital systems if that EUA happens.
The announcement comes as Pfizer’s vaccine has shown 93% effectiveness in preventing hospitalizations among adolescents aged 12 to 18, according to the CDC analysis of real-world data released on Tuesday.
The analysis of data from 19 US pediatric hospitals, which was conducted while the Delta variant was at its peak from June through September, showed that among the 179 children who were hospitalized for Covid-19, all but six were unvaccinated. And of the 29 patients hospitalized with severe enough Covid-19 to require life support, none were vaccinated. Two of those patients died.
While the Pfizer/BioNTech vaccine is currently authorized for children as young as 12, the FDA has scheduled an adcomm to evaluate and weigh the data on the younger children on Oct. 26. And the CDC’s independent advisory committee will meet on Nov. 2-3.
EMA starts evaluation of Roche/Regeneron monoclonal antibody combo
The European Medicines Agency has begun evaluating Roche’s application for marketing authorization for the monoclonal antibody combo Ronapreve from Roche and Regeneron.
The agency will assess Ronapreve, which has won an EUA in the US and brought in billions in sales, on a shorter timeline and could issue an opinion within two months, the EMA says.
EMA’s safety committee also completed its first assessment of Roche’s risk management plan to identify, characterize and minimize Ronapreve’s risks. There is also data in the works on how the antibody combination can be developed and studied for use in children, according to the EMA’s pediatrics committee.
The EMA also said it will work with the European Commission to fast track marketing authorizations in all EU and EEA member states.