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GreekReporter.comGreek NewsModerna Says Vaccine Safe for Teens, Will Submit to FDA

Moderna Says Vaccine Safe for Teens, Will Submit to FDA

Angeline Mitchell, registered nurse and American Red Cross volunteer, prepares shots of the Moderna COVID-19 vaccine for the inoculations of critical medical staff and first responder volunteers onboard Naval Air Station Sigonella, on Jan. 9, 2021. The Moderna vaccine has passed its trials for teenagers and will now be placed before the FDA for approval. Credit: U.S. Navy photo by Mass Communication Specialist 1st Class Kegan E. Kay.

The Moderna pharmaceutical company, headquartered in Cambridge, Massachusetts, announced on Tuesday that its mRNA vaccine, now only given to adults, is “highly effective” in adolescents.

The firm stated that its Covid-19 vaccine has shown itself to be extremely effective in 12- to 17-year-olds. It now plans to apply for F.D.A. authorization for emergency use.

If the F.D.A. authorizes such use, the inoculation will become only the second vaccine used by teenagers after the Pfizer/BioNTech shot, which was authorized in early May and has now been given to a total of 4.1 million teenagers in the US. According to CDC director Dr. Rochelle Walensky, this includes her own 15-year-old son.

Initially, the Pfizer vaccine was tested on, and authorized for, only those who were 16 years of age and above. The Moderna product has only been given to those who were 18 and older outside of these trials.

The astonishing success of the vaccine rollout, especially for those who are teenagers, has enabled the country to begin planning for a return to a normal school year for 2021/2022.

New York City Mayor Bill de Blasio announced this week that all public school students in the City — which comprises the largest school system in the entire United States — would be going back to school as normal in the Fall.

Vaccine shows astonishing efficacy in teens

Other states, including Connecticut, Illinois, Massachusetts and New Jersey, will restrict at-home learning, according to recent statements made by their governors and other officials.

The Moderna announcement was based on the results of a clinical trial that tested a total of 3,732 teens, from 12 to 17, two-thirds of whom received a total of two vaccine doses.

According to Moderna, there were zero cases of symptomatic Covid-19 in the teens who were fully vaccinated.

This finding, of course, means that the vaccine’s efficacy is an astounding 100 percent — a level of success that has rarely, if ever, been reached by any other vaccine.

That is, outside of the Pfizer/BioNTech product, which reported the exact same efficacy in a trial of their vaccine in 12- to 15-year-olds.

Dr. Kristin Oliver, a pediatrician and vaccine expert, told the New York Times in an interview “These look like promising results. The more vaccines we have to protect adolescents from Covid, the better.”

In another striking finding, Moderna also reported that one single dose of its product showed an astounding 93 percent efficacy against symptomatic Covid-19.

“Those cases that did occur between the two doses were mild, which is also a good indicator of protection against disease,” said Saskia Popescu, an infectious disease epidemiologist at George Mason University, in the Times report.

There were some mild side effects, according to Moderna — which were to be expected, and in line with reports from adults who also received the Moderna and other inoculations, including pain at the site of the injection, headache, fatigue, muscle pain and chills.

Moderna noted in its statement that “No significant safety concerns have been identified to date.”

The teens who took part in the study will be monitored for an entire year after their second dose of the Moderna product.

The company’s news release did not contain detailed data from the clinical trial.

According to Dr. Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan, explained that the vaccines’ efficacy can be more difficult to evaluate in children, because they are normally less likely to develop symptomatic disease than adults.

Notwithstanding that, however, she states that the Moderna trial results are in line with what scientists expected. In short, she says, they mean “that adolescents respond to the vaccine comparably to adults who receive it.”

Moderna said that it now plans to submit the data from its trials on teens for publication in a peer-reviewed journal.

The United States is finally seeing a long-awaited decrease in the number of its new cases, with the numbers from May 24 showing that there were a total of 25,595 new cases, representing a decrease of –37% over the last two weeks. There were 416 deaths yesterday, which was a decrease of –13% over those recorded two weeks ago.

As of May 25, a total of 131 million, or 39.8%, of Americans, are fully vaccinated.

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