Moderna says that its vaccine is effective for 12- to 17-year-olds and that it will seek F.D.A. auth

[BumRushDaShow]

Last edited Tue May 25, 2021, 10:42 AM - Edit history (1)

Source: New York Times

Moderna said on Tuesday that its coronavirus vaccine, authorized only for use in adults, was powerfully effective in 12- to 17-year-olds, and that it planned to apply to the Food and Drug Administration in June for authorization to use the vaccine in adolescents. If approved, it vaccine would become the second Covid-19 vaccine available to U.S. adolescents. Federal regulators authorized the Pfizer-BioNTech vaccine this month for 12- to 15-year-olds. The Pfizer shot was initially authorized for use in people 16 and older, while Moderna’s has been available for those 18 and up.

Proof of the vaccines’ efficacy and safety for adolescents is helping school officials and other leaders as they plan for the fall. On Monday, Mayor Bill de Blasio said that all public school students in New York City, the largest school system in the United States, would return to in-person learning in the fall. New York’s move comes as several states have indicated that they will restrict remote learning, including Connecticut, Illinois, Massachusetts and New Jersey.

The Moderna results are based on a clinical trial that enrolled 3,732 people ages 12 to 17, two-thirds of whom received two vaccine doses. There were no cases of symptomatic Covid-19 in fully vaccinated adolescents, the company reported. That translates to an efficacy of 100 percent, the same figure that Pfizer and BioNTech reported in a trial of their vaccine in 12- to 15-year-olds. “These look like promising results,” said Dr. Kristin Oliver, a pediatrician and vaccine expert at Mount Sinai Hospital in New York. “The more vaccines we have to protect adolescents from Covid, the better.” Moderna also reported that a single dose of its vaccine had 93 percent efficacy against symptomatic disease.

“Those cases that did occur between the two doses were mild, which is also a good indicator of protection against disease,” Saskia Popescu, an infectious disease epidemiologist at George Mason University, said in an email. The side effects were consistent with what has been reported in adults: pain at the site of the injection, headache, fatigue, muscle pain and chills. “No significant safety concerns have been identified to date,” the company said. The adolescents in the study will be monitored for a year after their second dose.

Read more: https://www.nytimes.com/2021/05/25/science/moderna-vaccine-teens-efficacy.html

---

ETA - full headline: Moderna says that its vaccine is effective for 12- to 17-year-olds and that it will seek F.D.A. authorization.

[Texin]

1. Yesterday on NPR, they reported that there have been cases of myocarditis reported

within this age group. It's affecting a small number of boys who have received the MRNA (Moderna and Pfizer vaccs), but the cases were mild and treatable. Yet another apparent vaccine-related inflammatory reaction.

It makes one wonder what an actual infection of Covid-19 would have precipitated in individuals who've had an inflammatory reaction to the vaccine.

[OnlinePoker]

2. Not necessarily the vaccine that's causing it.

Since this occurs without the vaccine and the number of cases are so low, I would wait until the CDC makes it official. They're still investigating.

[Texin]

4. Hyper inflammatory reaction to the virus itself causes the body

to attack itself in the attempt to fight the virus. The medical professionals indicated they believe that the kids who developed the heart inflammation post-vaccine probably had some sort of inflammatory response that was triggered by the vaccine.

I was vaccinated - and I believe firmly in vaccines. That said, I too had an inflammatory response following the second Moderna jab. I developed pneumonitis about 10 days subsequent to receiving the vaccine. This was in all absence of any underlying lung infection. No prior symptoms of any kind. I am an asthmatic, and my lungs become inflamed by environmental triggers that without medication would cause an asthmatic attack. I take an inhaled steroid medication. I had no symptoms of asthma and no other indicators of an infection: no fever, no malaise, etc. I didn't know anything was wrong until I started to cough - a loose, untroubling cough. I didn't think anything of it until I coughed up a kleenex full of bloody congestion. Again and again over about three hours. I went to the hospital emergency department and after all kinds of tests, I was cleared to go home with a prescription antibiotic and a diagnosis of pneumonitis.

[dalton99a]

3. Kick

[Rhiannon12866]

5. Good news!

I saw some young teens (with their moms) coming out of the state-run local clinic when I took my brother for his second shot last week - they got the Pfizer. Kids definitely need to be vaccinated in time for summer vacation - and especially before the start of school next fall.

[BumRushDaShow]

6. One of the things I also heard

was that the Pfizer vaccine was recently authorized to be stored (and can remain viable) for up to 30 days at regular refrigerator temps (vs the requirement for storage in ultra-low freezers) - https://www.fda.gov/news-events/press-announcements/fda-brief-fda-authorizes-longer-time-refrigerator-storage-thawed-pfizer-biontech-covid-19-vaccine

That now opens the door for personal physicians to stock the vaccine, which will be a benefit for getting it to pediatricians for the young ones (where the children would be more comfortable with a shot from their own doctor who would have given them other ones in the past)!