conan
302
What kind of parents that would offer up their 5 to 12 year olds to be used as guinea pigs?
2 Likes
conan
303
NopeâŚalso not seeing outside independent source confirming any of those companies data either.
Are we suppose to take their word for it when theyâre exempt from any repercussions?
1 Like
Yes. It was approved. It even goes further stating that Pfizer (and Moderna) will continue to provide additional information for the approved groups:
Pfizer, Inc. will conduct post-authorization observational studies to evaluate the association
between Pfizer-BioNTech COVID-19 Vaccine and a pre-specified list of AESIs, along with
deaths and hospitalizations, and severe COVID-19. The study population should include
individuals administered the authorized Pfizer-BioNTech COVID-19 Vaccine under this EUA
in the general US population (16 years of age and older), populations of interest such as
healthcare workers, pregnant women, immunocompromised individuals, and subpopulations
with specific comorbidities. The study should be conducted in large scale databases with an
active comparator. Pfizer, Inc. will provide protocols and status update reports to the IND
19736 with agreed-upon study designs and milestone dates.
Of note, the Sponsor will submit plans for a clinical study to assess safety and
immunogenicity in pregnant women and has proposed active surveillance studies
designed to monitor vaccination during pregnancy within populations expected to receive
the vaccine under EUA.
In reference to the voting question, and prior to the committee members casting their votes
committee members asked FDAâs perspective on use of the vaccine in pregnancy. FDA
explained that data from the preclinical developmental and reproductive toxicity study for this
product are expected soon. Even though there are insufficient data to inform vaccine-associated
risks in pregnancy, there are also no data warranting a contraindication.
The EUA is for everyone 16 years of age and older. This includes pregnant women 16 years and older. They considered the vaccine in pregnancy and decided there were no contraindications. Thatâs why the EUA doesnât say âeveryone 16 years of age and older, except in pregnancy.â Pregnant women 16 and older are included. They go on to say that Pfizer (and Moderna) will continue to monitor and give information on specific populations, which includes pregnancy.
But please, continue to believe that the 140,000 pregnant women who were vaccinated while pregnant and registered with the CDC V-safe registry are in violation of the vaccine EUA. I guess a whole lot of people are going to be in trouble for vaccinating an unapproved population.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafepregnancyregistry.html
Parents who understand how vaccine trials work and feel that by participating they are providing a service to society at large.
1 Like
WuWei
306
Thatâs a lot of âsplaininâ for thisâŚ
6.4. Unknown Risks/Data Gaps Safety in certain subpopulations There are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals.
If itâs approved, why more studies?
1 Like
WuWei
308
Youâre tripping all over yourself. All Iâm looking for is âApproved for use by pregnant womenâ.
Not a fairy tale, not a story. Not some extrapolation. Not math.
Just a simple statement.
âApproved for use by pregnant womenâ.
From the EUA:
The review team therefore recommends issuance of an EUA for use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.
Pregnant women is a subset of âindividuals 16 years of age and older.â They did not make an exception for pregnancy. They even discussed pregnancy as I previously quoted. Or is the argument they should have included a list of every subset of the population who could receive the vaccine? Do you have a list of every medical condition or attribute which would cover everyone in âindividuals 16 years of age and older?â
WuWei
313
They singled them out in the paragraph I quoted. Also very clearly said why.
No.
In Pennsylvania pregnant women were given priority in getting the earliest doses of the vaccine.
The priority was based on CDC categories of risk groups:
Certain Medical Conditions and Risk for Severe COVID-19 Illness | CDC
This could be a disaster if there turns out to be unexpected effects on unborn children.
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How are you going to test me without invading my body against my will? If I donât want things put into my body, that doesnât mean only via a needle.
My body, my choice. Right?
conan
318
Can you imagine how libs would react if Trump wanted to mandate vaccine? 
3 Likes
No body is forcing you to get tested.
You volunteer to get tested or go home and donât draw a paycheck.
WW
1 Like
[quote=âWorldWatcher, post:319, topic:239786â]
So, a boss telling their employee, " Have sex with me or go home without pay until you do," is not forcing that employee to have sex with them?
1 Like
