Vaccines
Peter Marks will serve as acting director of the Office of Vaccines Research and Review at the U.S. FDA following the resignation of two top officials at the agency.
The initiative marks a milestone in the biopharmaceutical industry’s COVID-19 response efforts as it now seeks to protect not just those who had contracted the virus but also those who are around them.
On Wednesday, the company said that its adjuvanted protein-based COVID-19 vaccine candidate, dubbed SCB-2019 (CpG 1018/Alum), hit the primary and secondary efficacy endpoints in a Phase II/III clinical trial.
The survey of 20,699 Americans found that the unvaccinated – 35% of respondents – didn’t trust that the vaccines were safe or effective.
As the COVID-19 pandemic hit a grim milestone, marking more U.S. deaths than were reported in the 1918–19 Spanish flu pandemic, research and breakthroughs continue.
The Phase II/III trial showed a favorable safety profile and “robust” neutralizing antibody responses in children five to 11 years old who received two 10 µg doses of the vaccine at 21 days apart.
COVID-19 remains relentless in challenging the community as it continues to evolve. Here are some of the top news for the week.
FDA external advisors will meet to consider Pfizer and BioNTech data in support of booster shots. The two companies also expect to file for Vaccine Authorization for children in the coming months.
CureVac NV is downsizing its European mRNA production network due to decreased demand for vaccines after the first wave of vaccinations.
Takeda announced that the company plans to grow its vaccines business. CEO Christophe Weber discussed this today in an interview at Reuters Events’ Pharma Japan 2021 conference.
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