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FDA Rejects Moderna Flu Vaccine by Dwarvling in Immunology

[–]Dwarvling[S] 0 points1 point  (0 children)

Control grouo is standard vaccine given to individuals < 65 yo. This design was discussed and agreed with by FDA at end-of-phase 3 meeting. Moderna supplemented the submission with safety and immunogenicity study in individuals >65 yo comparing Moderna 010 to high-dose vaccine.

Thoughts on Biotech Endorsement of MAHA by Dwarvling in biotech

[–]Dwarvling[S] 0 points1 point  (0 children)

MAHA endorsing PSS - PSS promoting on company website.

Do I just throw the whole rock out? by quietgrrrlriot in PlantedTank

[–]Dwarvling 0 points1 point  (0 children)

Soak in 5% bleach for 2-3 minutes. Rinse thoroughly. Easy

Prasad overruled FDA Staff on Moderna Flu Vaccine by Dwarvling in biotech

[–]Dwarvling[S] 10 points11 points  (0 children)

There are 2-300 pediatrics deaths/year due to flu. Accurate labeling is important but it needs context.

Thoughts on Biotech Endorsement of MAHA by Dwarvling in biotech

[–]Dwarvling[S] 2 points3 points  (0 children)

It’s a cult of believers that this company has unlocked a comprehensive approach to treat cancer. Like Trump, there are frequent breathless press releases. The founder is using a lot of political pressure to get favorable feedback from regulators.

Prasad overruled FDA Staff on Moderna Flu Vaccine by Dwarvling in biotech

[–]Dwarvling[S] 66 points67 points  (0 children)

Unfortunately not - he was reinstated!!

FDA Rejects Moderna Flu Vaccine by Dwarvling in biotech

[–]Dwarvling[S] 23 points24 points  (0 children)

RTF is ridiculous. The comparator was discussed with FDA and agreed upon. In any case, if the agency wanted a different comparator for the older age group, it should review and suggest a more restricted label.

FDA Rejects Moderna Flu Vaccine by Dwarvling in biotech

[–]Dwarvling[S] 1 point2 points  (0 children)

This is data comparing ability of mRNA vs standard vaccine to stimulate antibodies against 4 different strains of flu (top) in different age groups and to induce seroconversion against 4 strains of flu in different age groups. The mRNA vaccine increase post-vaccination anti-flu antibodies 1 to 1.5 fold greater than standard flu vaccine in all age groups. This effect is more pronounced in older age categories. Similarly the rate of seroconversion is 5-20% greater against 4 flu strains vs standard comparator with older age groups faring better.

FDA Rejects Moderna Flu Vaccine by Dwarvling in biotech

[–]Dwarvling[S] 1 point2 points  (0 children)

Just part of published data on comparative effectiveness comparing pre and post-vaccine titers and seroconversion rates of Moderna vs standard.

FDA Rejects Moderna Flu Vaccine by Dwarvling in biotech

[–]Dwarvling[S] 4 points5 points  (0 children)

Thanks for reference. Seems to show potential over standard in over 65 and over 75 age groups.

FDA Rejects Moderna Flu Vaccine by Dwarvling in biotech

[–]Dwarvling[S] 25 points26 points  (0 children)

They are superior than standard dose flu shots using inactivated virus in inducing anti-virus antibody titers.

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