Stock Groups

Moderna files for U.S. authorization of COVID shot for kids under 6 -Breaking

[ad_1]

© Reuters. FILE PHOTO : This illustration, taken January 16, 2022, shows a vial labelled “Moderna COVID-19 Vaccine.” REUTERS/Dado Ruvic/Illustration

Julie Steenhuysen and Michael Erman

(Reuters) – Moderna (NASDAQ:) Inc announced Thursday that it requested U.S. regulators authorize the COVID-19 vaccine to children below 6 years old. This would allow it to be the first available shot against coronavirus for kids under 5 years of age.

COVID-19 is available from Pfizer Inc (NASDAQ:), and BioNTech Se (NASDAQ:), are approved for children aged 5 years and over. Their trial data for children 2-4 years old showed a lower immune response than adults. Therefore, they extended the study to see if a third dose could be tested. Pfizer stated that April would bring the data.

Paul Burton, Moderna’s Chief Medical Officer, stated in an interview that “this does represent an area of important unmet need.”

Burton stated that there is no other treatment or vaccine available for these children. They can’t judge the data sufficient so I believe it is best to give the information to the children as fast as possible.

Moderna’s March trials data showed that the vaccine produced an identical immune response in young children and adults.

The Omicron version of coronavirus was dominant in the pediatric trial. This variant has been found to have evaded vaccine immunity when compared with older versions. Two doses of the drugmaker were found to be effective at preventing infection in children aged 6 months to 2 and 37% in kids between 2-and 5-years old.

Burton has not provided any information about the timeframe in which the U.S. Food and Drug Administration is expected to review the authorization request.

Interview with CNN: Dr. Anthony Fauci, a top U.S. expert in infectious disease, suggested last week that FDA will review Moderna and Pfizer/BioNTech data in order to determine if there are any issues.

The number of American parents who want their children to be vaccinated in this age bracket is unknown. In the United States, only 28% of children aged 5-11 are fully vaccinated. COVID-19 can often be milder in children than for adults.

Data released Tuesday by the U.S. Centers for Disease Control and Prevention showed that 75% of American children have evidence of COVID infected blood. Most of this was during Omicron surge, which took place from December to February.

Burton advised parents still to get their kids vaccinated.

COVID is considered a serious disease. “These variants of COVID are very transmissible,” said he.

I believe getting immunized now is the best way to protect your child. It will protect you from severe illness, hospitalizations, and protect you against long-term COVID effects. Burton said that it is sensible to be vaccinated.

Last week, the American Academy of Pediatrics urged that data be reviewed quickly in a Twitter post (NYSE:) by its members. They noted declines in masking and other protections.

We urge you to submit data as soon as possible to ensure that your children have a safe and effective vaccine.

[ad_2]