Biotechnology company Moderna said on Wednesday it will apply to FDA regulators for authorization of its COVID-19 mRNA vaccine for children age six months to under two years, and two years to under six years of age..The company hopes to gain emergency-use authorization for its SPIKEVAX mRNA vaccine based on data generated by its KidCOVE pediatric clinical trials showing the vaccine generated a similar immune response to adults..Moderna is pioneering messenger RNA (mRNA) therapeutics and vaccines, and announced Wednesday positive interim data from the Phase 2/3 study of its COVID-19 vaccine for children..The study’s authors concluded the jab induced a “robust” immune response. The statistics tell a different story, however. The Omicron variant was predominant during Moderna’s trial, and the biotech company said two doses were around 38% effective in preventing infections in children age two to five, and 44% effective for children ages six months to two years..According to Moderna, these results are consistent with the lower effectiveness seen with two doses of Omicron in adults..The US Food and Drug Administration will receive a request from the biotechnology company to authorize a two-dose injection “in the coming weeks,” Moderna said. The dose will be 25 micrograms in each shot, which equals 25% of the two doses for adults the company said in a statement..“Given the need for a vaccine against COVID-19 in infants and young children, we are working with the US FDA and regulators globally to submit these data as soon as possible,” Moderna CEO Stéphane Bancel said in the statement..“Additionally, after consultation with the US FDA, we have initiated a submission for emergency-use authorization of our COVID-19 vaccine in children ages six to 11 years old and are updating our submission to the FDA for emergency use authorization of mRNA-1273 in adolescents ages 12 to 17 years with additional follow-up data. We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages,” she said..Moderna claimed few adverse reactions resulted in the children in the study..“Rates of fever greater than 38°C among vaccine recipients were consistent with other commonly used and recommended pediatric vaccines and were 17.0% and 14.6% in the six months to under-two years and the two-to-under-six-years age groups, compared to 23.9% in the six-to-under-12 years age group, which received a 50 µg two-dose primary series. Fever greater than 40°C was seen in only a few children,” Modern said..Long-term safety data is not available on the vaccine Moderna hopes to put into manufacture. Mortality and adverse reaction data will be collected in the post-market pharmacovigilance phase of the trials following the anticipated authorization of the vaccine..“All participants will be monitored for 12 months after their second injection to assess long-term protection and safety. These data are subject to change based on ongoing data collection. The company plans to submit these data to a peer-reviewed publication,” Moderna said regarding the ongoing trials..Approximately 6,700 children aged six months to six years took part in the study, which was conducted in the United States and Canada..Amanda Brown is a reporter with the Western Standard.,.abrown@westernstandardonline.com.,.Twitter: @WS_JournoAmanda
Biotechnology company Moderna said on Wednesday it will apply to FDA regulators for authorization of its COVID-19 mRNA vaccine for children age six months to under two years, and two years to under six years of age..The company hopes to gain emergency-use authorization for its SPIKEVAX mRNA vaccine based on data generated by its KidCOVE pediatric clinical trials showing the vaccine generated a similar immune response to adults..Moderna is pioneering messenger RNA (mRNA) therapeutics and vaccines, and announced Wednesday positive interim data from the Phase 2/3 study of its COVID-19 vaccine for children..The study’s authors concluded the jab induced a “robust” immune response. The statistics tell a different story, however. The Omicron variant was predominant during Moderna’s trial, and the biotech company said two doses were around 38% effective in preventing infections in children age two to five, and 44% effective for children ages six months to two years..According to Moderna, these results are consistent with the lower effectiveness seen with two doses of Omicron in adults..The US Food and Drug Administration will receive a request from the biotechnology company to authorize a two-dose injection “in the coming weeks,” Moderna said. The dose will be 25 micrograms in each shot, which equals 25% of the two doses for adults the company said in a statement..“Given the need for a vaccine against COVID-19 in infants and young children, we are working with the US FDA and regulators globally to submit these data as soon as possible,” Moderna CEO Stéphane Bancel said in the statement..“Additionally, after consultation with the US FDA, we have initiated a submission for emergency-use authorization of our COVID-19 vaccine in children ages six to 11 years old and are updating our submission to the FDA for emergency use authorization of mRNA-1273 in adolescents ages 12 to 17 years with additional follow-up data. We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages,” she said..Moderna claimed few adverse reactions resulted in the children in the study..“Rates of fever greater than 38°C among vaccine recipients were consistent with other commonly used and recommended pediatric vaccines and were 17.0% and 14.6% in the six months to under-two years and the two-to-under-six-years age groups, compared to 23.9% in the six-to-under-12 years age group, which received a 50 µg two-dose primary series. Fever greater than 40°C was seen in only a few children,” Modern said..Long-term safety data is not available on the vaccine Moderna hopes to put into manufacture. Mortality and adverse reaction data will be collected in the post-market pharmacovigilance phase of the trials following the anticipated authorization of the vaccine..“All participants will be monitored for 12 months after their second injection to assess long-term protection and safety. These data are subject to change based on ongoing data collection. The company plans to submit these data to a peer-reviewed publication,” Moderna said regarding the ongoing trials..Approximately 6,700 children aged six months to six years took part in the study, which was conducted in the United States and Canada..Amanda Brown is a reporter with the Western Standard.,.abrown@westernstandardonline.com.,.Twitter: @WS_JournoAmanda
