Coronavirus: Thread

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Moderna Asks FDA To Authorize Covid Vaccine For Children Under 6

Moderna on Thursday became the first Covid-19 vaccine manufacturer to
ask the Food and Drug Administration (FDA) to approve its jab for
children under 6, less than six months after the agency delayed
approval for adolescents as young as 12-years-old over the risk of
dangerous heart inflammation in younger patients.

The development comes after the company announced positive results in
late March for a phase 2/3 study for children aged 6 months to under 6
years - which found that the vaccine had "lower efficacy" against the
Omicron strain.

    "Using the Phase 3 COVE study COVID-19 definition, vaccine
efficacy in children 6 months to 2 years was 43.7% and vaccine
efficacy was 37.5% in the 2 to under 6 years age group."

And while the New York Times says that "Parents of the roughly 18
million youngest Americans" have been "waiting for months for
pediatric doses," a CDC study revealed that throughout the entire
pandemic up until January 31, 2022, there were just 2,562 children up
the age of four years-old who were hospitalized with Covid-19, and
just 16 deaths (2 of them from Omicron).

https://www.cdc.gov/mmwr/volumes/71/wr/mm7111e2.htm?s_cid=mm7111e2_w#T1_down

So Moderna wants approval for a jab with efficacy as low a 37.5%, for
a demographic which has a 0.000142% hospitalization rate and generally
mild (to no) symptoms without vaccination.

    Moderna’s clinical trial data showed that the antibody response of
the youngest children compared favorably with that of adults ages 18
to 25, meeting the trial’s primary criterion for success. Although the
trial was not big enough to measure vaccine effectiveness, Moderna
said Thursday the vaccine appeared to be 51 percent effective against
symptomatic infection among those younger than 2, and 37 percent
effective among those 2 to 5. -NYT

Moderna's chief medical officer, Dr. Paul Burton, said that the
Omicron variant accounted for 80% of cases in the study group, which
explains the low efficacy rate.

For now, Moderna's vaccine has only been cleared for adults - and the
company has also requested authorization of its Covid vaccine for
those aged 6-11 and 12-17, which the company will submit data for in
around two weeks.

The FDA's head of vaccine regulation, Dr. Peter Marks, hinted at a
Tuesday Senate oversight hearing that the agency may consider
Moderna's applications for all children as a whole.

    Moderna and Pfizer-BioNTech have both been developing doses for
the youngest children since last year. Moderna is proposing a two-dose
regimen for children from 6 months to 5 years old, using one-fourth
the strength of an adult dose. Pfizer and BioNTech are working on a
three-dose regimen for those 6 months to 4 years old, at one-tenth the
strength of the adult dose. Pfizer has not yet submitted a request for
F.D.A. authorization, but is expected to do so soon. -NYT

Last week, White House adviser Dr. Anthony Fauci suggested that the
agency wants to review data for Moderna and Pfizer simultaneously in
order to directly compare the two.

Regulators aren't expected to act on Moderna's application before
June, while federal officials will ask the agency's outside advisory
panel of experts to review the data before authorizing any vaccine for
the least vulnerable.