Moderna's COVID-19 vaccine 100 percent effective in 12-17 age group: Trial study
Moderna had conducted clinical trials on at least 3,732 participants aged between 12 and 17 years. No cases of COVID-19 were observed in any of the vaccinated participants and "no significant safety concerns" were identified, as per study results.
Moderna announced on May 25, 2021 that various studies have shown that its COVID-19 vaccine is 100 percent effective in preventing COVID-19 infection among adolescents aged between 12 and 17 years.
The drugmaker plans to submit its findings to the US Food and Drug Administration (FDA) and global regulators in a couple of days and request for emergency use authorisation.
Moderna CEO Stephane Bancel said that they are encouraged to see that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. He said it is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection.
When will Moderna apply for emergency use approval for vaccination of 12-17-year-olds?
Moderna CEO Stephane Bancel informed that the company will submit its study results to the US FDA and global in early June and request for emergency use authorisation. She added saying that the company remains committed to doing its part to help end the COVID-19 pandemic.
Clinical Trials: Key Highlights
•Moderna had conducted clinical trials on at least 3,732 participants aged between 12 and 17 years.
•The study results revealed that no cases of COVID-19 were observed among any of the vaccinated participants. There was also no significant safety concerns.
•The vaccine was seen to be 93 percent effective after two weeks of the first dose and 100 percent effective after the second dose.
US FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents
•The US Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine on May 10, 2021 to include adolescents aged between 12 and 15 years.
•The FDA amended the emergency use authorisation given initially to the vaccine manufacturer in December 2020 for administration in individuals aged 16 years and older.
•An advisory panel of the Centres for Disease Control and Prevention had also recently recommended the use of the Pfizer-BioNTech COVID vaccine for children aged between 12 and 15 years.
The World Health Organisation had listed the Moderna COVID-19 vaccine (mRNA 1273) for emergency use on April 3-, 2021, becoming the fifth vaccine to receive WHO's emergency validation.
The WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines before including them in the list. It is a prerequisite for COVAX Facility vaccine supply.
WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) had reviewed the vaccine earlier in January 2021 and had recommended the vaccine for all aged 18 years and above in its interim recommendations.
Moderna's COVID vaccine had received emergency use authorization from the US Food and Drug Administration on December 18, 2020. The European Medicines Agency had granted the vaccine a marketing authorisation that would be valid throughout the European Union on January 6, 2021.
Vaccinating children and adolescents has become a prime focus now, as according to experts it will help in raising the overall immunity of the country given that herd immunity is unlikely to be achieved due to rising COVID-19 variants.