Moderna, a biotech corporation based in the United States, said that it had submitted a request for an emergency use authorization in the United States for its COVID vaccination for children aged six months to under six years.
In the United States and most other nations, only very young children are eligible for the COVID-19 vaccination, which is causing alarm among many parents.
“We think (this vaccine) will be able to safely protect young children against SARS-CoV-2, which is critical in our ongoing fight against COVID-19 and will be especially appreciated by parents and carers,” said firm CEO Stephane Bancel in a statement.
The business released trial findings in March, revealing that the two-shot regimen was safe and produced a significant immunological response.
Two doses of 25 micrograms given to newborns, toddlers, and preschoolers produced comparable levels of antibodies as two doses of 100 micrograms given to young individuals aged 18-25, indicating equal levels of protection against severe instances of the virus.
The study included 4,200 children aged two to six years, as well as 2,500 newborns aged six months to two years.
The side effects were mainly minor and comparable to those observed in older age groups.
The business did, however, discover projected relatively poor effectiveness, despite the fact that its experiment took place during the Omicron variant wave.
The current series of vaccinations was developed to combat the virus’s initial strain.
When only instances verified positive on a positive PCR test were included in the research, vaccine effectiveness was 51% in children aged six months to two years, and 37% in children aged two to five years.
Moderna stated that they were comparable to vaccination effectiveness estimates in adults during Omicron, and the company is also investigating booster doses for all paediatric groups.
Pfizer makes a mistake
The Food and Drug Administration (FDA) postponed a meeting of a panel to discuss the Pfizer-BioNTech COVID vaccination for children under the age of five in February, stating that it needed to review data on how three doses worked before making a decision.
When given in two doses of three micrograms to children aged six months to two years, Pfizer’s vaccine evoked antibodies comparable to the entire 30 micrograms given to persons aged 16-25, but this was not true for children aged two to four.
In an interview this week, Pfizer CEO Albert Bourla stated that if regulators agree, the vaccinations should be available by June.
The situation is exacerbated further by the fact that Moderna’s vaccine is presently only approved for adults aged 18 and up in the United States, but Pfizer’s is available to children aged five and up. Moderna is requesting permission for older children separately.
In an interview with CNN+ this week, Anthony Fauci, the White House’s senior medical adviser, proposed that the FDA might analyse data from both firms for small children at the same time in order to avoid “confusion.”
Scientists investigating a newborn vaccination must carefully assess the risk-benefit ratio.
Children under the age of five are at extremely low risk of serious illness even if they are unvaccinated. According to official records, there have only been 476 fatalities in this age range in the United States since the pandemic began.
There have also been nearly 8,000 occurrences of MIS-C, a post-viral inflammatory syndrome that has killed 66 infants in the United States.
Despite the mediocre-sounding effectiveness estimates, Brigham and Women’s Hospital emergency physician Jeremy Faust tweeted that Moderna’s results were really encouraging news.
“What these vaccinations have been demonstrated to do repeatedly is guard against severe illness and hospitalisation, which have long-term repercussions,” he said, adding that immune response results indicated success on these metrics.
“I’ll feel perfectly at ease getting my four-year-old vaccinated with Moderna.”