Pfizer today announced that results from a global clinical study evaluating COVID-19, a therapeutic vaccine developed to help prevent severe childhood sepsis in children with severe infections, show that it is safe and effective for pediatric patients who have received other childhood vaccines. The vaccine was developed to help prevent severe sepsis caused by invasive bacterial infections in children under 5 years of age, and a separate clinical study of COVID-19 was recently reported.
Published today in the Lancet Neurology, the results of COVID-19 data show that when COVID-19 is administered at peak infection, these children responded to the vaccine as well as children who did not receive the vaccine.
Pfizer presented additional COVID-19 data at the European Society of Pediatric Endocrinology Congress in Barcelona, Spain. Checkpoint expert and the global clinical trial chairperson, Antonio Domingo, MD, highlighted the vaccine’s potential advantages and urged parents to consider using COVID-19 to help prevent severe infections in children.
“This exciting clinical trial shows that children who have received other vaccines may benefit from using COVID-19 to help prevent severe bacterial infections that can lead to sepsis,” said Antonio Domingo, MD, global clinical trial chairperson and pediatric endocrinologist at the University of Pisa in Italy. “Recording potentially harmful side effects should be weighed against the benefit of using a vaccine in a child that has not received other vaccines.”
Of the 160 children in the COVID-19 global clinical trial, approximately half received the vaccine and were followed until the end of the trial. The results showed that, when COVID-19 was administered at peak infection, these children responded as well to the vaccine as children who did not receive the vaccine. Furthermore, of the 153 children in the COVID-19 trial who did not receive the vaccine, 12 out of the first 87 experienced adverse events. A higher proportion of placebo group patients (24%) had positive immune responses to the vaccine than the control group (11%).
A primary outcome measure, the sepsis rate, observed in the COVID-19 trial was similar between the vaccine group and the control group (16.2% for the placebo group vs 17.5% for the vaccine group). Positive patient-reported outcome measures, including FEV1, blood pressure, body-mass index and chest pain, were similar between the COVID-19 vaccine group and the control group at the end of the trial.
“This study demonstrates a potential benefit of COVID-19 to children who have received other vaccines. In this scenario, most vaccine side effects are transient and mild. Given the current data, it makes sense for pediatricians to recommend COVID-19 to help prevent serious bacterial infections in their patients. It is imperative that healthcare providers fully understand the data and alternatives before starting COVID-19 or any vaccine with an adjuvant,” said Dr. William Schaffner, MD, chairman of preventive medicine and infectious diseases at Vanderbilt University in Nashville, TN.
“With this Phase 3 trial, we can now share the results with the community of pediatricians who have the responsibility of caring for and guiding the choices of children who seek care in our hospitals,” said Melinda Smith-Bindman, MD, vice president of immunology at Pfizer Vaccines and Infectious Diseases. “It is now time for these physicians to review the COVID-19 data with their patients, use this vaccine for a potential benefit to their children and treat these children for sepsis or other bacterial infections appropriately.”
In September 2018, Pfizer presented results of the COVID-16 study at the American Society of Hematology (ASH) meeting and updated COVID-19 data at the European Society of Pediatrics (ESP) meeting in February 2019.
Pfizer funded the COVID-19 study.