AR
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Moderna has announced that its COVID-19 vaccine is effective for children under the age of 6 years. According to the pharma giant, if regulators give the approval to its vaccine, the company could start inoculating babies, toddlers and preschoolers by summer.
Moderna added that in the coming weeks it would be seeking the approval of regulators in the US and Europe for its two small-dose vaccine for youngsters under 6 years. The company is also looking forward to receiving approval for larger doses for older children and teens in the U.S.
Early results from the study conducted by the pharma giant found that the young kids developed high levels of antibodies from its vaccine to fight the Coronavirus. The vaccine given to kids contained a quarter of the dose given to adults. However, the vaccine proved less effective against the highly-contagious Omicron variant of COVID-19.
Speaking with the media, Moderna president Dr. Stephen Hoge, underlined that the vaccine provides the same level of protection against COVID-19 in young kids as it does in adults.
Moderna's competitor Pfizer is currently offering kid-sized doses for school-age children and full-strength doses for youngster aged 12 and above.
Significantly, experts have expressed concern that Moderna has revealed only limited data about its vaccine's efficiency for kids. Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief, noted that the vaccine doses could be helpful for the youngest children.
Parents across the world have been waiting to enhance protection for their younger children against COVID-19. Pfizer is also testing smaller doses for children under 5. However, the pharma had to add a third dose to its study when two doses did not prove strong enough for protection of children against the disease. The final results of Pfizer study are expected by early April.
According to Dr. Bill Muller of Northwestern University, who is helping study Moderna's pediatric doses, vaccinating the youngest children has been a "moving target" for experts over the last couple of months.
“There’s still, I think, a lingering urgency to try to get that done as soon as possible," Dr Muller noted.
Companies are testing smaller doses for younger children. As part of its research, Moderna enrolled about 6,900 kids under 6, including babies as young as 6 months, to given a 25-microgram dose of its COVID-19 vaccine.
The children developed levels of antibodies just as strong as young adults who get full-strength shots, the company said in its announcement.
Moderna conducted its study in tots during the Omicron surge. An interesting trend was seen among children: at a time when there were no severe illnesses, the vaccine proved about 44% effective in preventing milder infections in babies up to the age of 2. Similarly, it was nearly 38% effective in preschoolers.
Goodman added that higher levels of antibodies among children should be seen as higher vaccine efficacy against severe infections.
Modern added that small doses proved safe and displayed limited side-effects such as mild fevers, like those associated with other common peadiatric vaccines.
Amid the ongoing fight against COVID-19, booster doses have proven critical among adults in fighting Omicron. Currently, Moderna is testing booster doses for children, either a third shot of the original vaccine or an extra dose that contains a combination of protection against the original virus and the Omicron variant.
The FDA will be determining the authorisation of emergency use of the vaccine doses after Moderna submits its full data. Furthermore, the Centers for Disease Control and Prevention would be suggesting the age group of the recipients.
According to the CDC, about 400 children younger than 5 have died from COVID-19 since the onset of the pandemic. The Omicron variant has also impacted children with those under the age of 5 hospitalised at higher rates than at the peak of previous Delta surge.
While other countries are already allowing Moderna vaccine doses to be used in children as young as 6, the US has limited its inoculation to adults. Moderna's request for expanding its vaccine doses to children between 12-17 years has been halted for months now.
Last week, the company underlined that it is updating its FDA application with additional evidence for teen doses and requesting for an approval for doses for children between the ages of 6-11 years.
Hoge has expressed optimism in his company's ability to offer its vaccine “across all age groups in the United States by the summer.”
The company had added that its original adult vaccine regime consisting of two 100-microgram doses is safe and effective in 12- to 17-year-olds. On the other hand, for elementary-age children, the company is using half the adult dose.
Reportedly, FDA has yet not approved Moderna's application for teen vaccine doses over concerns about a very rare side effect. Teens and young adults, mostly males, can experience heart inflammation after receiving either the Pfizer or Moderna vaccines. Moderna is getting extra scrutiny, noting that its doses are a far higher quantity than Pfizer.
Meanwhile Hoge said that about A1.5 million adolescents have received the Moderna vaccine in other countries and there has been a very reassuring safety among them.
Experts are linking the heart risk to puberty and regulators in Canada, Europe and other regions recently expanded Moderna vaccinations to children as young as 6.
Northwestern’s Muller maintained that the concern has not been yet seen in the younger children.
SOURCE: Khaleej Times