Moderna says COVID-19 vaccine safe, effective in kids 6 to 11

[Yo_Mama_Been_Loggin]

Source: The Hill

Moderna's COVID-19 vaccine generated a strong immune response in children and was generally well-tolerated, the company announced Monday.

In its study, Moderna determined that children aged 6 to 11 years old, who were vaccinated with two 50 microgram doses, had 1.5 times higher antibody levels than those observed among vaccinated young adults.

The dosage used for the children is half of the 100 micrograms used for the initial two adult shots, but the same amount authorized for the booster shot.

With the vaccine, these children showed a "robust neutralizing antibody response" and a "favorable safety profile" consistent with adolescent and adult response, the company noted.



Read more: https://www.msn.com/en-us/news/politics/moderna-says-covid-19-vaccine-safe-effective-in-kids-6-to-11/ar-AAPW6qz?li=BBnbfcQ

[OnlinePoker]

1. What does the FDA say? n/t

[CountAllVotes]

2. +1

I'd like an answer to that question as well!

[BumRushDaShow]

4. Moderna will be submitting their 6 - 11 age study data to FDA & CDC for an eventual EUA

in the near future.

From the OP article -

(snip)

The company said it plans to submit data to the Food and Drug Administration (FDA) and other regulators, including in Europe, "in the near term."

Moderna CEO Stéphane Bancel said the company is "encouraged" by the results showing effectiveness and safety.

"We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages," she said.

Moderna released a summary of the results, which have not yet been published in a peer-reviewed journal.

(snip)

https://www.msn.com/en-us/news/politics/moderna-says-covid-19-vaccine-safe-effective-in-kids-6-to-11/ar-AAPW6qz?li=BBnbfcQ

It will take a couple months to get a final nod once that is done.

I had heard on the radio (news) earlier today that they had something like 5000 (juvenile) participants in their trials.

[70sEraVet]

3. I read the article, now I'm confused about things I thought I knew.

"The vaccine manufacturer previously requested the FDA grant emergency use authorization for the vaccine to be administered to 12- to 17-year-olds in June, but the agency has not yet acted on that application."
I thought 12-17 year-olds have been getting vaccinated!

[OnlinePoker]

5. They are here in BC. n/t

[BumRushDaShow]

6. The only COVID-19 vaccine currently approved for ages less than 18 (under an EUA) is Pfizer's

Moderna is still waiting for their tween/teen EUA approval (I think the agency had requested a larger number of trial participants so they could capture any instances of adverse events like myocarditis, which seems to be more prevalent in the younger age groups.

Pfizer's request for the age 5-11 (not approved yet) will begin discussions tomorrow Oct. 26 (during FDA's VRBPAC meeting) and Nov. 2nd - 3rd (during CDC's ACIP meeting). There is an expectation that EUA approval of Pfizer's vaccine for ages 5-11 might come as soon as the end of that first week in November, assuming that both agency Committees approve, along with the agency heads.

Normally the general public does not see all of these processes because they are... well... mundane and boring to the lay person.

It's just that COVID-19 has been such a nightmare for almost 2 years and trying to get it controlled has ratcheted up the interest a thousand fold.

[cadoman]

7. congratulations Moderna!

Glad to see them dotting their "i"s and crossing their "t"s. One step closer to 100% vaccination!

[Rhiannon12866]

8. I got my second Moderna shot in March and I'm still here!

[riversedge]

9. Now we will have to go through the ordeal of parents who will not vaccinate their kids

against the Covid.