Moderna says its low-dose COVID-19 vaccine works for children under 6

NEWSCENTER 5 AT 5:30. JESSICA: MODERNA SAYS IT鈥橲 COVID VACCINE HAS BEEN AUTHORIZED IN CANADA FOR AGES SIX TO 11. THE TWO-DOSE VACCINE WAS RECENT CLELYARED FOR USE IN ATTH YOUNG AGE GROUP IN THE EUROPEAN UNION AND AUSTRALIA, BUT NOT YET HERE IN THE U.S. PFIZER IS THE ONLY SHOT AVAILABLE HERE FOR KIDS UNDER THE AGE OF 18. ERIKA: A NEW CDC REPORT FINDS, THE PFIZER VACCINE OFFERS LESS PROTECTION AGAINST THE OMICRON VARIANT TO YOUNGER CHILDREN THAN IT DOES TO OLDER AGE GROUPS. HERE TO ANSWER QUESTIONS IS DR. KRISTIN MOFFITT, AN INFECTIOUS DISEASE SPECIALIST AT BOSTON CHILDREN鈥橲 HOSPITAL. GREAT TO HAVE YOU WITH US. >> GOOD TO SEYOE U TOO. JESSICA: OMICRON IS THE PREVALANT VARIANT OUT THERE RIGHT NOW, SO THIS DATA IS REALLY IMPORTANT. HOW BIG IS THEIF DFERENCE BETWN EEPROTECTION LEVS?EL >> THIS STUDY YOU ARE REFERENCING THAT CAME OUT OF THE CDC SHOWED THE VACCINE EFFECTIVENESS AGAINST ASYMPTOMATIC OR MILD INFECTION IN FIVE TO 11-YEAR-OLDS WAS OVER 30%. WHILE IT WAS CLOSER TO 60% AGAINST THE SAME IN 12-YEAR-OLDS TO 15-YEAR-OLDS. IT IS IORMPTANT TO KEEP THAT DATA AND PERSPECTIVE. THAT IS STUDY THAT INCLUDED SAMPLING, EVEN ASYMPTOMATIC AND MILDLY INFECTED PEOPLE, ON A WEEKLY BASIS ACROSS THE FOUR STATES. MOSTLY SOUTHERN STATES. THERE WAS A LARGER STUDY THAT CAME OUT A COUPLE WEEKS AGO THAT LOOKED AT COVID-19 HOSPITALIZATIONS DURING THE OMICRON SURGE. ACROSS 10 DIFFERENT STATES THAT SHOWED THE VACCINE鈥橲 EFFECTIVENESS WAS MUCH BETTER AGAINST SEVERE ILLNESS. IT WAS AUTBO 74% EFFECTIVE AT PREVENTING HOSPITALIZATIONS FROM -- FOR FIVE TO 11-YEARLD-OS. IT IS IMPORTANT TO KEEP THOSE NUMBERS IN PERSPECTIVE. WHILE THE VACCINE EFFECTIVENESS AGAINST MILDER, ASYMPTOMATIC INFECTIOISN DISAPPOINTING, IT IS VERY ENCOURAGING THAT ITS EFFECTIVENESS IN THAT AGE GROUP IS STILL VERY GOOD. ERIKA: IT IS MOST IMPORTANT OBVIOUSLY. WHY WOULD A COVID VACCINE BE LESS EFFECTIVE IN YOUNGER DSKI THAN IT WOULD BE IN TEENAGERS? A DOSAGE THING? >> I THINK THE MOST LIKELY EXPLANATION IS THE DOSE. YOU WILL RECALL FIVE TO 11-YEAR-OLDS ARE GETTING ABOUT ONE THIRD OF THE DOSE OF WHAT CHILDREN 12 AND OLDER HAVE BEEN- RECEIVING.2 AND OLDER HAVE BEEN- WHETHER OR NOT THERE ARE OTHER FACTORS CONTRIBUTING FOR SOMETHING THATS I UNDER EVALUATION. ANOTHER THING UNDER EVALUATION, WE KNOW PFIZER IS STUDYING THE EFFECTIVENESS AND SAFETY OF A THIRD DOSE IN FIVE TO 11-YEAR-OLDS, WHICH WILL BE INTERESTING TO SEE IF THAT IMPRESOV VACCINE EFFECTIVENESS IN FIVE TO 11-YEAR-OLDS AS HAS BEEN SHOWN FOR BOOSTERS IN TSEHO OVER 12. ERIKA: I WANT TO ASK YOU SOMETHING ABOUT MASKING. MOST PUBLIC SCHOOLS NO LONGER REQUIRE FACE MASKS INDOORS. WHAT ARE YOUTHR OUGHTS ON THIS? DO THINK THAT NEEDS TO CHANGE FOR ELEMENTARY SCHOOLS? >> IT IS A GREAT QUESTION. I STILL THINK AT THE CURRENT LEVELS OF TRANSMISSION ACROSS MOST COMMUNITIES, WHICISH RELATIVELY LOW, THAT CLASOOSRMS SHOULD STILL BE QUITE A SAFE PLACE IN THOSE LOW TRANSMISSION SETTINGS. SUCH THAT HAVING CHILDNRE UNMASKED SHODUL STILL BE VYER LOW RISK FOR INFECTION. I THINK THAT IS A DIFFERENT CALCULATION FOR COMMUNITIES WHERE TRANSMISSIONS I HIGHER AND MASKING SHOULD BE RECONSIDERED IN THOSE SETTINGS. >> AND ALSO, HOW ABOUT FOR FAMILIES THAT MAY BE HAVE A PARENT OR A CHILD WHO IS IMMUNO-COMPROMISED OR AT HIGH-RISK? I IMAGINE THAT ADVICE WOULD CH ANGE IN THAT CASE ASEL WL. >> EXACTLY. I THINK THE RISK ASSESSMENT FOR THOSE FAMILIES WOULD BE DIFFERENT AS WELL. AND FOR THOSE FAMILIES, MAYBE EVEN IN COMMUNITIES WHERE TRANSMISSION IS LOW, THE RISK OF BRINGING COVID-19 INTO THE HOUSEHOLD IS STILLOO T HIGH. SUCH THAT IN ADDITION TO MAKING SURE EVERYBODY IN THE FAMILY IS AS VACCINATED AS THEY CODUL BE, THOSE FAMILIES MIGHT ALSO CONSERID HAVING EVERYONE IN THE HOUSEHOLD MASK UP WHEN THEY ARE INDOORS, EVEN IN LOW TRANSMISSION SETTINGS TO REALLY KEEP THE HOUSEHOLD AS SAFE AS POSSIBLE. JESSA:IC ALL RIGHT, WE THANK YOU SO MUCH FOR YO

Moderna鈥檚 COVID-19 vaccine works in babies, toddlers and preschoolers the company announced Wednesday 鈥� and if regulators agree, it could mean a chance to finally start vaccinating the littlest kids by summer.Moderna said in the coming weeks it would ask regulators in the U.S. and Europe to authorize two small-dose shots for youngsters under 6. The company also is seeking to have larger-dose shots cleared for older children and teens in the U.S.The nation鈥檚 18 million children under 5 are the only age group not yet eligible for vaccination. Competitor Pfizer currently offers kid-sized doses for school-age children and full-strength shots for those 12 and older.But parents have anxiously awaited protection for younger tots, disappointed by setbacks and confusion over which shots might work and when. Pfizer is testing even smaller doses for children under 5 but had to add a third shot to its study when two didn't prove strong enough. Those results are expected by early April.Vaccinating the littlest 鈥渉as been somewhat of a moving target over the last couple of months,鈥� Dr. Bill Muller of Northwestern University, an investigator in Moderna鈥檚 pediatric studies, said in an interview before the company released its findings. 鈥淭here鈥檚 still, I think, a lingering urgency to try to get that done as soon as possible.鈥漈he younger the child, the smaller the dose being tested. Moderna said a quarter of the dose it uses for adults worked well for youngsters under age 6.Moderna enrolled about 6,900 tots in a study of the 25-microgram doses. Early data showed after two shots, youngsters developed virus-fighting antibody levels just as strong as young adults getting regular-strength shots, the company said in a press release.Moderna said the small doses were safe, and the main side effects were mild fevers like those associated with other commonly used pediatric vaccines.Once Moderna submits the data to the FDA, regulators will debate whether to authorize emergency use of the small doses for tots. If so, the Centers for Disease Control and Prevention then will decide whether to recommend them.While COVID-19 generally isn鈥檛 as dangerous to youngsters as to adults, some do become severely ill. The CDC says about 400 children younger than 5 have died from COVID-19 since the pandemic鈥檚 start. The omicron variant hit children especially hard, with those under 5 hospitalized at higher rates than at the peak of the previous delta surge, the CDC found.COVID-19 vaccines in general don鈥檛 prevent infection with the omicron mutant as well as they fended off earlier variants 鈥� but they do still offer strong protection against severe illness.Moderna reported that same trend in the trial of children under 6, conducted during the omicron surge. While there were no severe illnesses, the vaccine proved just under 44% effective at preventing any infection in babies up to age 2, and nearly 38% effective in the preschoolers.Moderna said also said Wednesday it will ask the Food and Drug Administration to clear larger doses for older children.While other countries already have allowed Moderna鈥檚 shots to be used in children as young as 6, the U.S. has limited its vaccine to adults. A Moderna request to expand its shots to 12- to 17-year-olds has been stalled for months.The company said Wednesday that, armed with additional evidence, it is updating its FDA application for teen shots and requesting a green light for 6- to 11-year-olds, too.Moderna says its original adult dose 鈥� two 100-microgram shots 鈥� is safe and effective in 12- to 17-year-olds. For elementary-age kids, it鈥檚 using half the adult dose.But the FDA never ruled on Moderna鈥檚 application for teen shots because of concern about a very rare side effect. Heart inflammation sometimes occurs in teens and young adults, mostly males, after receiving either the Pfizer or Moderna vaccines. Moderna is getting extra scrutiny because its shots are a far higher dose than Pfizer's.The risk also seems linked to puberty, and regulators in Canada, Europe and elsewhere recently expanded Moderna vaccinations to kids as young as 6.鈥淭hat concern has not been seen in the younger children,鈥� said Northwestern鈥檚 Muller.

Moderna said in the coming weeks it would ask regulators in the U.S. and Europe to authorize two small-dose shots for youngsters under 6. The company also is seeking to have larger-dose shots cleared for older children and teens in the U.S.

The nation鈥檚 18 million children under 5 are the only age group not yet eligible for vaccination. Competitor Pfizer currently offers kid-sized doses for school-age children and full-strength shots for those 12 and older.

But parents have anxiously awaited protection for younger tots, disappointed by setbacks and confusion over which shots might work and when. Pfizer is testing even smaller doses for children under 5 but had to add a third shot to its study when two didn't prove strong enough. Those results are expected by early April.

Vaccinating the littlest 鈥渉as been somewhat of a moving target over the last couple of months,鈥� Dr. Bill Muller of Northwestern University, an investigator in Moderna鈥檚 pediatric studies, said in an interview before the company released its findings. 鈥淭here鈥檚 still, I think, a lingering urgency to try to get that done as soon as possible.鈥�

The younger the child, the smaller the dose being tested. Moderna said a quarter of the dose it uses for adults worked well for youngsters under age 6.

Moderna enrolled about 6,900 tots in a study of the 25-microgram doses. Early data showed after two shots, youngsters developed virus-fighting antibody levels just as strong as young adults getting regular-strength shots, the company said in a press release.

Moderna said the small doses were safe, and the main side effects were mild fevers like those associated with other commonly used pediatric vaccines.

Once Moderna submits the data to the FDA, regulators will debate whether to authorize emergency use of the small doses for tots. If so, the Centers for Disease Control and Prevention then will decide whether to recommend them.

While COVID-19 generally isn鈥檛 as dangerous to youngsters as to adults, some do become severely ill. The CDC says about 400 children younger than 5 have died from COVID-19 since the pandemic鈥檚 start. The omicron variant hit children especially hard, with those under 5 hospitalized at higher rates than at the peak of the previous delta surge, the CDC found.

COVID-19 vaccines in general don鈥檛 prevent infection with the omicron mutant as well as they fended off earlier variants 鈥� but they do still offer strong protection against severe illness.

Moderna reported that same trend in the trial of children under 6, conducted during the omicron surge. While there were no severe illnesses, the vaccine proved just under 44% effective at preventing any infection in babies up to age 2, and nearly 38% effective in the preschoolers.

Moderna said also said Wednesday it will ask the Food and Drug Administration to clear larger doses for older children.

While other countries already have allowed Moderna鈥檚 shots to be used in children as young as 6, the U.S. has limited its vaccine to adults. A Moderna request to expand its shots to 12- to 17-year-olds has been stalled for months.

The company said Wednesday that, armed with additional evidence, it is updating its FDA application for teen shots and requesting a green light for 6- to 11-year-olds, too.

Moderna says its original adult dose 鈥� two 100-microgram shots 鈥� is safe and effective in 12- to 17-year-olds. For elementary-age kids, it鈥檚 using half the adult dose.

But the FDA never ruled on Moderna鈥檚 application for teen shots because of concern about a very rare side effect. Heart inflammation sometimes occurs in teens and young adults, mostly males, after receiving either the Pfizer or Moderna vaccines. Moderna is getting extra scrutiny because its shots are a far higher dose than Pfizer's.

The risk also seems linked to puberty, and regulators in Canada, Europe and elsewhere recently expanded Moderna vaccinations to kids as young as 6.

鈥淭hat concern has not been seen in the younger children,鈥� said Northwestern鈥檚 Muller.

糖心vlog