New York (AP) – A government advisory board approved a second brand of COVID -19 vaccine for school children and teens on Tuesday.
External experts from the Food and Drug Administration unanimously agree that the Moderna vaccine is sufficiently safe and effective for children ages 6 to 17. If the FDA agrees, it will be the second option for this child who joined the Pfizer vaccine.
Moderna’s COVID-19 vaccine has long been available to adults in the United States and elsewhere, and more than three dozen countries also offer it to older children. If the FDA allows the modernized vaccine for adults and young children, the Centers for Disease Control and Prevention will decide whether to formally recommend the vaccine.
The company is seeking permission in Massachusetts to take two doses and plans to offer an enhancer later. Tuesday’s vote was mostly just two doses: full strength for 12-17 and half dose for 6-11.
“The data show that the benefits outweigh the risks for both doses in both age groups,” said CDC panel member Melinda Wharton.
“I believe this will give families an important option” and could be especially important for families living in areas where the coronavirus is on the rise, said another panel member, Drs. Ofer Levy of Boston Children’s Hospital.
The FDA kept the modern vaccine in adolescence for several months before investigating a rare side effect, inflammation in the heart. This is a major risk for teens and young men and can also occur with the Pfizer vaccine. Moderna received further investigation because its shots had a higher dose.
In their review, FDA scientists said there were no confirmed cases of heart disease in studies of Moderna children. But experts say the studies may have had very few participants to show similar extraordinary effects.
“We need to look at it clearly as we expand vaccine use,” said Dr. Mark Sawyer, panel member at the University of California, San Diego Medical School.
For other side effects, FDA officials said there was nothing to worry about, mainly arm pain, headaches, and fatigue.
An FDA review concluded that two doses of Moderna were effective in preventing symptomatic COVID-19 disease in adults and young children, with levels of antiviral antibodies comparable to those developed in adolescents.
The vaccine’s effectiveness is estimated at 93 percent for adults and 77 percent for younger, according to an FDA review. However, the study was conducted at a time when previous versions of the coronavirus caused more infections in the United States than more contagious. This is also based on the limited number of COVID-19 cases, which makes the estimates relatively rough.
The studies added an amplification shot and the data is expected to be around next month, Moderna officials said. Amplification shots are recommended by Pfizer for vaccinated children as well as for all adults.
One of the panel members, Dr Paul Ofit, noted that the effectiveness of the vaccine has been reduced against new variants of the coronavirus. Ofit, of Philadelphia Children’s Hospital, said he only supports Moderna’s proposals because he expects to offer the third dose he says is needed before anyone can be considered fully vaccinated.
It is not known how many requests there will also be for the two Moderna shots. Adults were eligible for the Pfizer vaccine last year using the same technology, and only 60% received two doses. Shooting for the younger ones began in November; According to the CDC, nearly 29 percent are fully vaccinated.
If the FDA allows a modern vaccine for teens and students, a CDC spokesman said the agency has no plans to review the vaccine by the end of this month.
The Associated Press Department of Health and Science receives support from the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.
Source: Huffpost
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