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Moderna said Wednesday it will seek immediate authorization for a coronavirus vaccine for children younger than 6 years after interim results from its clinical trial showed volunteers in this age group had a similar immune response to young adults when given a quarter dose compared to younger adults. powerful.
However, the company has proven that the vaccine is only 44% effective in preventing symptomatic disease in children 6 months to 2 years old, and 37% effective in children 2 to 5 years old. The company is investigating the effectiveness of a booster vaccine, and one of its senior officials said it expects a booster will be necessary for this age group, as is the case with adults.
The firm’s senior vice president of infectious diseases, Dr. Jacqueline Miller said the relatively low level of protection demonstrates the ability of the Omicron variant to evade the shield of the vaccine. Still, “What we’ve seen is a successful trial,” she said in an interview.
“I would say 37.5 percent and 43.7 percent higher than zero,” he said. “If I were the parent of a young child, I would like to have some protection on board, especially if we see another wave of infections.”
The firm’s announcement comes shortly before Pfizer and BioNTech are expected to publish the results of a three-stage study for children under the age of five using doses that are one-tenth more potent than those aged 12 and over. These results are expected in April.
At the request of the Food and Drug Administration, Pfizer-BioNTech presented preliminary results of its trials last month; Regulators hoped that the data on the two doses would be strong enough to launch the vaccine campaign while awaiting the final results on the three doses.
However FDA changed its mind When new data collected during the Omicron surge convincingly showed that two doses did not adequately protect against symptomatic infection. Pfizer and BioNTech have not made the final results public, but in December they reported that two doses of their vaccine induced a strong immune response in children 6 months to 2 years old, but not 2 to 4 years old.
Children under the age of 5, a group of nearly 18 million, are still the only Americans ineligible for the vaccine.
Moderna’s CEO, Stéphane Bancel, said in a statement that the company will request emergency authorization for the two-stage vaccine for children ages 6 to 11, updating a similar request it submitted last summer for children ages 12 to 17. The request was put on hold as the Food and Drug Administration wanted to see more data on myocarditis, a rare side effect involving heart inflammation.
So far, Pfizer-BioNTech’s shot has been the only shot authorized for Americans 5 to 17.
About 6,900 children in the United States and Canada were enrolled in Moderna’s trial for under-6s. Moderna said there were no cases of serious illness, hospitalization or death in either the placebo or the vaccine arm. Most infections were mild.
The firm said that children who received the vaccine showed a comparable response at neutralizing antibody level as adults aged 18 to 25 years who met the primary endpoint set by the FDA for a successful trial.
Moderna said there was enough infection to also evaluate the vaccine’s efficacy against symptomatic disease because of the Omicron increase. The relatively low efficacy is in line with research on how well vaccines protect adults from the Omicron variant. Moderna is working on booster shots for all three age groups under 18.
Dr. “We definitely plan to give these kids a booster dose,” Miller said. “And recall that we found that we needed to give adults a booster dose to maintain high levels of vaccine efficacy against the Omicron variant.”
Most adverse events were mild or moderate, and fever rates were typical of current pediatric vaccines. The firm said several children — 0.2 percent of the study group — developed fevers of more than 104 degrees Fahrenheit.
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