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The Omicron variant was predominant during Moderna’s pediatric trial, and the drugmaker claims two doses were around 38% effective in preventing infections in 2 to 5-year-olds and 44% effective for children aged 6 months to 2 years.
Its request comes after drug company suggested two-doses of its vaccine provided a comparable protection in young children to that of adults.
A clinical trial of around 6,700 kids found two quarter doses of the COVID-19 shot in children aged 6 and under generated an immune response similar to that of young adults who also received two full shots.
Moderna plans to submit an application to the FDA for the authorization of its COVID-19 vaccine among kids between the ages of six months to five years (file photo)
Children who got the shot only experienced mild side effects. None developed severe Covid-19.
Despite the application, Moderna still needs to send in its final batch of data to the FDA, according to Politico and it is not likely to do so until May 4.
The filing essentially means that Moderna can start to plan how it would go about distributing the shot, but a final decision to approving the jab is likely to still be several weeks away.
The FDA has so far not commented on the possible application.
Peter Marks, the top FDA vaccine regulator, told lawmakers that a more specific timeline would be released next week which would likely stipulate when the agency planned to give the shots the green light.
Peter Marks, the top FDA vaccine regulator, told lawmakers that a more specific timeline would be released next week stipulating when the agency planned to give the shots the green light
‘Just remember that we can’t actually finish our reviews until we actually have complete applications in the FDA,’ Marks testified to the Senate HELP Committee.
‘We will proceed with all due speed, once we have complete applications, some of these are complicated because they are relatively covering larger swaths of the pediatric population than others,’ he added.
Last week, Pfizer said a third dose of the COVID-19 vaccine produced significant protection against the Omicron variant in healthy children from ages 5 to 11 while earlier in the year the FDA authorized a third dose of the Pfizer/BioNTech vaccine for children ages 12 to 15 and those aged 5 through 11 who are immunocompromised.
It is unclear how much demand there is for a third vaccine dose in the age group.
Just 28% of children aged 5 to 11 years – around 8.2 million – are fully vaccinated, according to data from the CDC.
There has also been some skepticism on the need for boosters in younger children given the reduced risk of severe infection and hospitalization in the age group.
Moderna’s trial involving 6,700 children found two doses were around 38% effective in 2 to 5-year-olds and 44% effective for kids aged 6 months to under 2 years
Pfizer has filed for the clearance of a 10-microgram booster dose for children 5 to 11 years. Adults receive a 30-microgram dose of the vaccine.
The primary two-dose COVID-19 shot from Pfizer and BioNTech was authorized in the United States for children 5 to 11 years in October.
Moderna’s filing will further pile pressure on the FDA for them to authorize the vaccine after it was revealed how the agency was delaying until Pfizer put forward its filing for a similar shot.
Federal regulators believed that the release of vaccines from both companies at the same time would make it easier to roll them out to the public and cut down on confusion, but it might result in a delay until June.
‘Let me be very clear, being thorough absolutely does not mean we are delaying review of these vaccines,’ Marks said in a video on Tuesday. ‘We’re going to move with all expediency without sacrificing our standards to complete our evaluations.’
Currently, the only Covid-19 vaccine available for children ages 5-11 is made by Pfizer and BioNTech (file photo)
Source: Daily Mail