Modern Inc. said on Wednesday it would ask regulators to authorize its COVID-19 vaccine in children under the age of 6, based on data that showed it had similar immunity to adults in its clinical trial. generated a reaction.
The Omicron version of COVID-19 was dominant during Moderna’s pediatric trial, and the drugmaker said the two doses were about 38% effective in preventing infection in children aged 2 to 5 years and those from 6 months to less than 2 years of age. 44% were effective for children.
It said these figures were in line with the reduced effectiveness against Omicron seen in adults who received two doses of its vaccine.
Moderna’s vaccine may be the first authorized shot for children under the age of 5 in the United States, and many parents of young children are waiting for a vaccine.
an opponent’s shot made by Pfizer Inc. and BioNTech SE of Germany is authorized for use in children 5 years of age and older. But their test results for children 2 to 4 years old showed a weaker immune response than in adults, prompting the trial to expand to testing a third dose. The result is expected in April.
“We are working together to address the need for a vaccine against COVID-19 in infants and young children. US FDA and to submit these data to regulators globally as quickly as possible,” Moderna Chief Executive Stefan Bansel said in a statement.
Dr. Jacqueline millmanA top Moderna scientist told Reuters the company was “a few weeks away” from applying for authorization for age groups in the United States, Europe and elsewhere.
generally well tolerated
It is not clear how many American parents will vaccinate their children in that age group. Only 27% of 5-11 year olds in the country are fully vaccinated, and COVID-19 is generally milder in children than in adults.
There were no serious cases for vaccine or placebo participants in Moderna’s pediatric trial.
Moderna said the shots, taken at four-week intervals, were generally well tolerated across the age group and most of the side effects experienced were mild or moderate.
The dose size tested was 25 micrograms — a quarter of the dose that adults get for each of their first two shots.
There are some concerns about dosage size. By comparison, the dosage of pfizer and BioNTech’s vaccine – which uses the same messenger royal army Technology – was 10 micrograms for children ages 5 to 11. They are testing a 3 microgram dose for children under the age of 5.
“The FDA asked us to evaluate a lower dose and we intend to do so,” Moderna’s Miller said. “However, we believe that the current data actually supports the dosage selection we have made in this age group … we are confident in the dosage that we have chosen.”
Moderna’s vaccine is approved by the FDA for use in adults 18 years of age and older. But it has not yet been approved for children ages 6 to 17 in the United States, despite having received approval for that age group in Australia, Canada and the European Union. The United Kingdom and Switzerland have allowed the vaccine to be used in children aged 12-17 years. US regulators have asked for more safety data from the company and the FDA also said that additional time is needed to evaluate the risk of a type of heart inflammation called myocarditis after vaccination in the age group, a rare side effect that is mainly mainly affects young men.
Moderna says it plans to update its emergency use authorization filing with more data on 12-17-year-olds, and has begun the process for 6- to 11-year-olds.
The company also said that it plans to study a booster dose for all pediatric populations, including a booster designed to combat the Omicron version of the virus alongside its original COVID-19 vaccine. Combined vaccine.
The Omicron version of COVID-19 was dominant during Moderna’s pediatric trial, and the drugmaker said the two doses were about 38% effective in preventing infection in children aged 2 to 5 years and those from 6 months to less than 2 years of age. 44% were effective for children.
It said these figures were in line with the reduced effectiveness against Omicron seen in adults who received two doses of its vaccine.
Moderna’s vaccine may be the first authorized shot for children under the age of 5 in the United States, and many parents of young children are waiting for a vaccine.
an opponent’s shot made by Pfizer Inc. and BioNTech SE of Germany is authorized for use in children 5 years of age and older. But their test results for children 2 to 4 years old showed a weaker immune response than in adults, prompting the trial to expand to testing a third dose. The result is expected in April.
“We are working together to address the need for a vaccine against COVID-19 in infants and young children. US FDA and to submit these data to regulators globally as quickly as possible,” Moderna Chief Executive Stefan Bansel said in a statement.
Dr. Jacqueline millmanA top Moderna scientist told Reuters the company was “a few weeks away” from applying for authorization for age groups in the United States, Europe and elsewhere.
generally well tolerated
It is not clear how many American parents will vaccinate their children in that age group. Only 27% of 5-11 year olds in the country are fully vaccinated, and COVID-19 is generally milder in children than in adults.
There were no serious cases for vaccine or placebo participants in Moderna’s pediatric trial.
Moderna said the shots, taken at four-week intervals, were generally well tolerated across the age group and most of the side effects experienced were mild or moderate.
The dose size tested was 25 micrograms — a quarter of the dose that adults get for each of their first two shots.
There are some concerns about dosage size. By comparison, the dosage of pfizer and BioNTech’s vaccine – which uses the same messenger royal army Technology – was 10 micrograms for children ages 5 to 11. They are testing a 3 microgram dose for children under the age of 5.
“The FDA asked us to evaluate a lower dose and we intend to do so,” Moderna’s Miller said. “However, we believe that the current data actually supports the dosage selection we have made in this age group … we are confident in the dosage that we have chosen.”
Moderna’s vaccine is approved by the FDA for use in adults 18 years of age and older. But it has not yet been approved for children ages 6 to 17 in the United States, despite having received approval for that age group in Australia, Canada and the European Union. The United Kingdom and Switzerland have allowed the vaccine to be used in children aged 12-17 years. US regulators have asked for more safety data from the company and the FDA also said that additional time is needed to evaluate the risk of a type of heart inflammation called myocarditis after vaccination in the age group, a rare side effect that is mainly mainly affects young men.
Moderna says it plans to update its emergency use authorization filing with more data on 12-17-year-olds, and has begun the process for 6- to 11-year-olds.
The company also said that it plans to study a booster dose for all pediatric populations, including a booster designed to combat the Omicron version of the virus alongside its original COVID-19 vaccine. Combined vaccine.