6 ms·

Would like to add that the adcom meeting that happened yesterday wasn't unanimous even though efficacy data was strong because of they were asked to approve it

by wyxuan 6y ago

Would like to add that the adcom meeting that happened yesterday wasn't unanimous even though efficacy data was strong because of they were asked to approve it for 17 and 16 year olds as well even though the data for these age groups was lackluster. This likely didn't matter much to FDA because 16 and 17 year olds aren't likely to receive any doses before the full throated approval because they by and large aren't in the people first in line for the vax (1st line workers, vulnerable groups, old people).

Exmoor 6y ago
And the concerns about 16-17 weren't that it wasn't effective or safe, but that given that age group has a very low incidence of serious symptoms or death that the bar for risks needed to be much higher since they compromised a relatively small part of the study group.
cwwc 6y ago
Interestingly, this seems to also be the case with pregnant women (unless I’m missing something). I’m guessing they’ll be ahead of teens but still low enough in the priority scheme to mostly not receive it?
- IfOnlyYouKnew 6y ago
  Pregnancy is a "generic" risk factor for any medical intervention, as is young age. There is no reason to believe the vaccine is particular harmful in these groups. But since it's eminently possible to avoid the risk by vaccinating most people around them, that option is (slightly) more attractive.
  - divbzero 6y ago
    The Society for Maternal-Fetal Medicine advocates for the inclusion of pregnant women in vaccine trials and just released a statement applauding FDA’s decision to allow pregnant women access to the vaccine. [1] [2] US FDA’s decision deviates from UK MHRA’s decision to hold off on finalizing their advice for women who are pregnant. [3] [1]: https://www.smfm.org/covidclinical https://www.smfm.org/covidclinical [2]: https://s3.amazonaws.com/cdn.smfm.org/media/2632/FDA_final.pdf https://s3.amazonaws.com/cdn.smfm.org/media/2632/FDA_final.p... [3]: https://www.gov.uk/government/publications/covid-19-vaccination-women-of-childbearing-age-currently-pregnant-planning-a-pregnancy-or-breastfeeding/covid-19-vaccination-a-guide-for-women-of-childbearing-age-pregnant-planning-a-pregnancy-or-breastfeeding https://www.gov.uk/government/publications/covid-19-vaccinat...
TedDoesntTalk 6y ago
Why did 4 people vote against recommending approval?
- divbzero 6y ago
  It was likely due to disapproval over the inclusion of people age 16 and 17. At least two of the four dissenting votes have confirmed that this was their reason and they would otherwise have given their wholehearted approval. [1] As GP points out few in that age group will be in line to get the vaccine early anyway. [1]: https://www.statnews.com/2020/12/11/podcast-pfizer-covid-19-vaccine-debate-details-distribution/ https://www.statnews.com/2020/12/11/podcast-pfizer-covid-19-...
Abishek_Muthian 6y ago
Considering this going to be the strategy all over the world, I think children should get the vaccines ASAP provided the vaccine is proven safe as missing a year of school is going to have profound impact on their life and society. Many students from marginalized society, especially from poor countries might never go to school again as they have been employed by their parents for meager sum. But I think definition of who's 'vulnerable' is what going to be contentious, apart from obvious front-line workers and elderly whom would you decide are vulnerable? Immunity compromised individuals? I'm myself house ridden for over 2 years now due to spine surgery and so likely immunity compromised but there's no way that could be informed to the Govt. I just hope my elderly parents get their vaccine.
- birken 6y ago
  Children are low on the priority list because they get severe symptoms at a much, much lower rate than adults and especially older adults. And the schools are not closed right now because of the fear that younger children are going to get the virus. Schools are closed because teachers are (rightly) concerned about getting the virus, and families are (rightly) concerned that their children might pick up the virus at school and bring it home with them and infect more at-risk individuals. If the teachers and family members are vaccinated, then I think it is pretty clear the risk/benefit analysis would highly suggest sending children back to school, even if they aren't vaccinated yet. Schools in the US have already opened in many places before there is a vaccine, so I don't doubt schools are going to be opening ASAP, and that is almost certainly before most children are vaccinated.
  - scoopertrooper 6y ago
    I'd be worried creating a viral reservoir in schools even if the adult population were completely vaccinated. It'd be an excellent environment for the virus to mutate and become endemic.
    - ch4s3 6y ago
      As far as we know young children don’t spread COVID. There aren’t any confirmed cases of children under ten spreading it to other people. It’s super odd, but that’s what the evidence suggests at this point.
deleted 6y ago
[deleted]

by wyxuan 6y ago

Exmoor 6y ago

And the concerns about 16-17 weren't that it wasn't effective or safe, but that given that age group has a very low incidence of serious symptoms or death that the bar for risks needed to be much higher since they compromised a relatively small part of the study group.

cwwc 6y ago

Interestingly, this seems to also be the case with pregnant women (unless I’m missing something). I’m guessing they’ll be ahead of teens but still low enough in the priority scheme to mostly not receive it?

IfOnlyYouKnew 6y ago
Pregnancy is a "generic" risk factor for any medical intervention, as is young age. There is no reason to believe the vaccine is particular harmful in these groups. But since it's eminently possible to avoid the risk by vaccinating most people around them, that option is (slightly) more attractive.
- divbzero 6y ago
  The Society for Maternal-Fetal Medicine advocates for the inclusion of pregnant women in vaccine trials and just released a statement applauding FDA’s decision to allow pregnant women access to the vaccine. [1] [2] US FDA’s decision deviates from UK MHRA’s decision to hold off on finalizing their advice for women who are pregnant. [3] [1]: https://www.smfm.org/covidclinical https://www.smfm.org/covidclinical [2]: https://s3.amazonaws.com/cdn.smfm.org/media/2632/FDA_final.pdf https://s3.amazonaws.com/cdn.smfm.org/media/2632/FDA_final.p... [3]: https://www.gov.uk/government/publications/covid-19-vaccination-women-of-childbearing-age-currently-pregnant-planning-a-pregnancy-or-breastfeeding/covid-19-vaccination-a-guide-for-women-of-childbearing-age-pregnant-planning-a-pregnancy-or-breastfeeding https://www.gov.uk/government/publications/covid-19-vaccinat...

TedDoesntTalk 6y ago

Why did 4 people vote against recommending approval?

divbzero 6y ago
It was likely due to disapproval over the inclusion of people age 16 and 17. At least two of the four dissenting votes have confirmed that this was their reason and they would otherwise have given their wholehearted approval. [1] As GP points out few in that age group will be in line to get the vaccine early anyway. [1]: https://www.statnews.com/2020/12/11/podcast-pfizer-covid-19-vaccine-debate-details-distribution/ https://www.statnews.com/2020/12/11/podcast-pfizer-covid-19-...

Abishek_Muthian 6y ago

Considering this going to be the strategy all over the world, I think children should get the vaccines ASAP provided the vaccine is proven safe as missing a year of school is going to have profound impact on their life and society. Many students from marginalized society, especially from poor countries might never go to school again as they have been employed by their parents for meager sum. But I think definition of who's 'vulnerable' is what going to be contentious, apart from obvious front-line workers and elderly whom would you decide are vulnerable? Immunity compromised individuals? I'm myself house ridden for over 2 years now due to spine surgery and so likely immunity compromised but there's no way that could be informed to the Govt. I just hope my elderly parents get their vaccine.

birken 6y ago
Children are low on the priority list because they get severe symptoms at a much, much lower rate than adults and especially older adults. And the schools are not closed right now because of the fear that younger children are going to get the virus. Schools are closed because teachers are (rightly) concerned about getting the virus, and families are (rightly) concerned that their children might pick up the virus at school and bring it home with them and infect more at-risk individuals. If the teachers and family members are vaccinated, then I think it is pretty clear the risk/benefit analysis would highly suggest sending children back to school, even if they aren't vaccinated yet. Schools in the US have already opened in many places before there is a vaccine, so I don't doubt schools are going to be opening ASAP, and that is almost certainly before most children are vaccinated.
- scoopertrooper 6y ago
  I'd be worried creating a viral reservoir in schools even if the adult population were completely vaccinated. It'd be an excellent environment for the virus to mutate and become endemic.
  - ch4s3 6y ago
    As far as we know young children don’t spread COVID. There aren’t any confirmed cases of children under ten spreading it to other people. It’s super odd, but that’s what the evidence suggests at this point.

deleted 6y ago

[deleted]