Washington: Biotech Company US Moderna said Monday the covid vaccine was safe and produced a strong immune response to children aged 6-11, adding it would soon submit test data to the global regulator.
The news came as a government advisory panel was preparing to meet on Tuesday on the question whether to authorize the Pfizer vaccine in children aged 5-11, with an infectious disease top Anthony Fauci predicts it will be available in mid-November.
“We are driven by the Immunogenicity Profile and Safety of MRNA-1273 in children aged 6 to 12 years and are happy that this research fulfills its main immunogenicity endpoint,” said Chief Executive Moderna Stephane Bancel in a statement.
Temporary analysis of mid-stage clinical trials to the end of 4,753 children show that two vaccine doses produce a high level of antibodies that neutralize – y-shaped proteins that are binding to the Coronavirus and blocking them into human cells.
This vaccine is a dose of 50 micrograms, which are half of what is used among adults, but still produced an average of 1.5 times more antibodies in children as they are doing in higher adults.
The majority of bad events are light or moderate, including fatigue, headaches, fever, and injection site pain.
This initial result, released through a press statement, does not include estimates of vaccine efficacy, which may be expected at the time after the case must still be paid.
News Moderna came when Food and Drug Administration (FDA) was preparing to hold an advisor panel to vote whether to wash the pfizer lamp for younger children, paving the way for 28 million Americans to vaccinate.
A briefing document posted on the FDA website shows the agency believes the benefits are greater than the most worrying side effects for this age group, namely myocarditis, or heart inflammation.
“The overall analysis estimates that the number of results related to Covid-19 are clinically prevented clearly will be greater than the number of cases of myocarditis associated with vaccines,” said the document.
But it acknowledges that the risk calculus of benefits will be different when community transmission is very low, as in the United States in June 2021.
The FDA also uploaded Pfizer’s efficacy analysis, with the company estimating the vaccine of two doses in 10 micrograms of more than 90 percent effective in preventing symptomatic disease.
Overall, more than 150 children aged 5 to 11 years have died of Covid in the United States since the start of Pandemi, according to official data.
“If everything goes well, and we get regulatory approval and recommendations from the CDC, it is very possible, if not too possible, the vaccine will be available for children from 5 to 11 in one or two weeks the first November,” Fauci told ABC News Sunday.