Why was Pfizer approved before Moderna?

I am hearing that Moderna will likely not receive approval anytime soon. The Myocarditis issue is going to be getting a much closer review. The clinician that told me this has close ties to the FDA and said don't expect either Moderna or J&J to receive full approval in the next 6 months.

Another interesting note: Moderna has never received FDA approval on any drug they've ever created.

t - cam said:

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Diet Cokehead said:

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I am hearing that Moderna will likely not receive approval anytime soon. The Myocarditis issue is going to be getting a much closer review. The clinician that told me this has close ties to the FDA and said don't expect either Moderna or J&J to receive full approval in the next 6 months.

Another interesting note: Moderna has never received FDA approval on any drug they've ever created.

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I though that threat was larger with Pfizer while being extremely small either way.

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I had thought the same, but the clinician i spoke to said they are seeing more dangerous issues with Moderna. She thinks it might because it's a more potent dose than Pfizer, but that was just speculation.

Quote:

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As of June 30, 2021, approximately 141 million second mRNA COVID-19 vaccine doses had been administered in the United States to persons aged 18 years. Within VAERS, 497 reports of myocarditis after the second mRNA COVID-19 vaccine dose were received for persons aged 18 years. The reporting rate of myocarditis overall among adults was 3.5 cases per million second doses of mRNA COVID-19 vaccine administered. In subgroup analyses by age and sex, the reporting rate was highest among males aged 1829 years (24.3 cases per million mRNA COVID-19 vaccine second doses administered). Reports of cases in persons aged 1829 years were individually reviewed and confirmed to meet case definitions, whereas reports of cases in persons aged 30 years were received and processed but not individually reviewed. There were no confirmed myocarditis-associated deaths.

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https://www.cdc.gov/mmwr/volumes/70/wr/mm7032e4.htm?s_cid=mm7032e4_w#T1_down

Moderna is 3 weeks away.

Moderna for 18+ is within a month.

The myocarditis issue is a legit concern in 12-18 and they are investigating different doses to evaluate efficacy and to see if that decreases the risk of adverse effects.

Next up for Covid vaccines: kids under 12 (msn.com)

how are they even going to be able to end the vax study for 5-11 year olds?

you can show relative safety, but how are you going to show strong efficacy?

cone said:

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how are they even going to be able to end the vax study for 5-11 year olds?

you can show relative safety, but how are you going to show strong efficacy?

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unfortunately, Delta isn't like the OG and it is sending more kids to the hospital. With a big enough trial you should definitely get hospitalizations in the placebo.

cone said:

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how are they even going to be able to end the vax study for 5-11 year olds?

you can show relative safety, but how are you going to show strong efficacy?

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I expect it will take years.

The main efficacy they can prove is to correlate certain Ig levels to decreased risk of infections and hospitalizations in adults then extrapolate that data to kids based on Ig levels post vaccination.

The efficacy will have to be based on ig levels since hospitalization is such a rare outcome under the age of 12. Heck even under the age of 20.

KidDoc said:

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erube said:

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cone said:

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how are they even going to be able to end the vax study for 5-11 year olds?

you can show relative safety, but how are you going to show strong efficacy?

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unfortunately, Delta isn't like the OG and it is sending more kids to the hospital. With a big enough trial you should definitely get hospitalizations in the placebo.

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Hospitalization rate is still very low as a percentage of cases. Especially compared to RSV or Flu.

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It's also about 1/3 covid cases of what the 2018 flu was for children. Learn that from the media......

KidDoc said:

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erube said:

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cone said:

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how are they even going to be able to end the vax study for 5-11 year olds?

you can show relative safety, but how are you going to show strong efficacy?

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unfortunately, Delta isn't like the OG and it is sending more kids to the hospital. With a big enough trial you should definitely get hospitalizations in the placebo.

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Hospitalization rate is still very low as a percentage of cases. Especially compared to RSV or Flu.

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This is also what my kid's pediatrician said (I have an 8 month old). I still try to be careful and don't take him to indoor restaurants (my vaxxed wife and I still go, he stays with his nanny at home), so I think it's important not to be an idiot and unnecessarily expose them, especially with RSV going around too, but right now I think pediatricians are most worried about RSV and coming flu season (my kid is getting the flu shot as soon as it's available), really COVID is exacerbating care for RSV and flu because it is so widespread that it across a macro population it's eating into pedi ICU beds. But, for most kids, I think RSV and to an extent the flu, are the biggest worry right now. KidDoc, can you confirm?

That said, I'll still be vaccinated my kid once the COVID vaccine is available (assuming his pediatrician recommends it, which I assume she will). Statistically I realize there is likely a very low chance of an adverse effect either way (COVID or Vax), but assuming adverse vaccine reaction rates hold true, the vaccine will likely be a better bet than COVID.

how big is the trial?

cone said:

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how big is the trial?

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Not sure but the latest delay from FDA was "to recruit more patients".

The pfizer teen approval was only 1000 patients and didn't catch any myocarditis. I think that is one of the main reasons why they are pushing the brakes a bit and requiring larger studies and looking at different dosage schedules.

KidDoc said:

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erube said:

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cone said:

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how are they even going to be able to end the vax study for 5-11 year olds?

you can show relative safety, but how are you going to show strong efficacy?

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unfortunately, Delta isn't like the OG and it is sending more kids to the hospital. With a big enough trial you should definitely get hospitalizations in the placebo.

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Hospitalization rate is still very low as a percentage of cases. Especially compared to RSV or Flu.

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Some might find this helpful to see how Covid hospitalization/admission rates break out by age.

https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html




Caveats:
This is based on sampling from a subset of counties in a subset of states. It is not a count of all the cases in the country. The data lag means the dip in the most recent week may not reflect reality.

Any thoughts on whether to get Moderna or Pfizer or are they about the same?

It'd be nice if they used colors that were different