Pfizer Submits Data to FDA For COVID-19 Vaccine in Children
Initial trial data found that the two-dose COVID-19 vaccine regimen in children elicited neutralizing antibody responses one month after the second dose.
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By - Pfizer and BioNTech recently submitted data to FDA from the Phase 2/3 clinical trial of their COVID-19 vaccine in children five to 11 years of age.
Last week, the companies announced that two doses of their COVID-19 vaccine elicited neutralizing antibody responses in pediatric patients five to 11 years of age in a Phase 2/3 trial.
In the trial, 2,268 patients received a 10-microgram dose of the vaccine in a two-dose regimen. The SARS-CoV-2-neutralizing antibody geometric mean titer was 1,197, demonstrating a strong immune response one month after the second dose.
These are the first results from a pivotal trial of a COVID-19 vaccine in this age group and were comparable to those recorded in a previous study in people 16 to 25 years of age.
FDA received data from the trials for initial review. But a formal submission to request emergency use authorization of the COVID-19 vaccine in children five to 11 years of age is expected to follow in the coming weeks.
Pfizer and BioNTech also plan to submit the data to the European Medicines Agency (EMA) and other regulatory authorities.
Topline immunogenicity and safety results for the other two age cohorts from the trial, including children two to five years of age and six months to less than two years of age, are expected as soon as the fourth quarter of this year.
Moderna Provides Peru 20M Doses of its COVID-19 Vaccine
Moderna recently announced a supply agreement with the government of Peru for 20 million doses of Moderna’s COVID-19 vaccine to begin delivery in the first quarter of 2022.
Currently, Peru has not approved COVID-19 Vaccine Moderna. But the company will work with regulators to gain necessary approvals before vaccine distribution, a Moderna spokesperson said.
“We appreciate the support from the government of Peru with this supply agreement for doses of the Moderna COVID-19 vaccine,” Corinne Le Goff, PharmD, MBA, chief commercial officer of Moderna, said in the announcement.
“We are committed to making our vaccine available around the world as we seek to address the pandemic with our COVID-19 vaccine,” Goff continued.
Thermo Fisher Launches Saliva Collection Kit for Research
Thermo Fisher Scientific recently launched the Thermo Scientific SpeciMAX Stabilized Saliva Collection Kit to safely collect saliva for research.
The SpeciMAX Stabilized Saliva Collection Kit preserves viral nucleic acids in a stabilization solution that inactivates common respiratory viruses for safer sample collection.
The kit includes a spill-resistant funnel, a screw cap to secure the sample after collection, and a standardized size tube that fits into viral RNA extraction automation workflows for high throughput sample processing.
The new kit complements Thermo Fisher’s recently launched SpeciMAX Saliva Collection Kit for raw saliva.
“Labs need a non-invasive and non-hazardous collection kit that works with their current instruments,” Ellie Mahjubi, vice president and general manager of sample preparation at Thermo Fisher Scientific, said in the announcement.
“SpeciMAX Stabilized Saliva Collection Kits are compatible with downstream automation workflows to help reduce the costs and time of viral research,” Mahjubi continued.
