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05-07-2021, 10:12 AM #49Hall Of Fame Poster
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Re: New Jersey program offers free beer to those who get Covid-19 vaccine.
And they tested over 30,000+ patients and monitored them and are continuing to monitor possible side effects.
Which is why it was emergency approved. Once they have data over time, then they will approve approve. I mean seriously on the one hand you complain its not approved, but then insist on long term studies for approval
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05-07-2021, 10:27 AM #51
Re: New Jersey program offers free beer to those who get Covid-19 vaccine.
Blah doesn’t realize he is cheering on the Medical community’s Fire, Ready, Aim procedure with this.
I too believe it’s a real request for the Us government(FDA) to approve the use of a privy before they require and enforce its use. The fact that the same body trying to require us all to genetically modify our. Bodies, won’t outwardly tell us it is safe first.
Our corporate oligarchy wants it that way. They can make billions peddling something they aren’t sure is safe with immunity from repercussions if it is not.
All this for an illness that 995/1000 people survive with no last effects.
I’d be curious to see, have more people had COViD symptoms from the vaccine or the virus?
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Re: New Jersey program offers free beer to those who get Covid-19 vaccine.
I saw 25% of Pfizer's first quarter revenue came from the vaccine. That's a lot of motivation for people to get vaccinated...
Also, everyone I know who got it has had side effects. Some randomly for a few weeks after the first dose and have decided against the second because of it.
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05-07-2021, 10:48 AM #53
Re: New Jersey program offers free beer to those who get Covid-19 vaccine.
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05-07-2021, 12:01 PM #54Hall Of Fame Poster
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Re: New Jersey program offers free beer to those who get Covid-19 vaccine.
Moderna COVID-19 Vaccine VRBPAC Briefing Document
1. Executive Summary
On November 30, 2020, ModernaTX (the Sponsor) submitted an Emergency Use Authorization (EUA) request to FDA for an investigational COVID-19 vaccine (mRNA-1273) intended to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vaccine is based on the SARS-CoV-2 spike glycoprotein (S) antigen encoded by RNA and formulated in lipid nanoparticles (LNPs). The proposed use under an EUA is for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The proposed dosing regimen is 2 doses, 100 μg each, administered 1 month apart.
The EUA request includes safety and efficacy data from an ongoing Phase 3 randomized, double-blinded and placebo-controlled trial of mRNA-1273 in approximately 30,400 participants. The primary efficacy endpoint is the reduction of incidence of COVID-19 among participants without evidence of SARS-CoV-2 infection before the first dose of vaccine in the period after 14 days post-dose 2. In an interim analysis conducted using a data cutoff of November 7, 2020, a total of 27,817 participants randomized 1:1 to vaccine or placebo with a median 7 weeks of follow-up post-dose 2 were included in the per-protocol efficacy analysis population of participants without evidence of SARS-CoV-2 infection prior to vaccination. Efficacy in preventing confirmed COVID-19 occurring at least 14 days after the second dose of vaccine was 94.5.0% (95% CI 86.5%, 97.8%) with 5 COVID-19 cases in the vaccine group and 90 COVID-19 cases in the placebo group. Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19. Secondary efficacy analyses suggested benefit of the vaccine in preventing severe COVID-19 (11 protocol-defined severe COVID-19 cases in the placebo group vs. 0 cases in the vaccine group), in preventing COVID-19 following the first dose, and in preventing COVID-19 in individuals with prior SARS-CoV-2 infection, although available data for some of these outcomes did not allow for firm conclusions. Efficacy data from the final scheduled analysis of the primary efficacy endpoint (data cutoff of November 21, 2020, with a median follow-up of >2 months post-dose 2) demonstrated a VE of 94.1% (95% CI 89.3%, 96.8%), with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group and was consistent with results obtained from the interim analysis. The VE in this analysis when stratified by age group was 95.6% (95% CI: 90.6%, 97.9%) for participants 18 to <65 years of age and 86.4% (95% CI: 61.4%, 95.5%) for participants ≥65 years of age. A final secondary efficacy analysis also supported efficacy against protocol-defined severe COVID-19, with 30 cases in the placebo group vs. 0 cases in the vaccine group.
Safety data from a November 11, 2020 interim analysis of approximately 30,350 participants ≥18 years of age randomized 1:1 to vaccine or placebo with a median of 7 weeks of follow-up after the second dose supported a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA. These safety data are the primary basis of FDA’s safety review. On December 7, 2020, the Sponsor submitted additional follow-up data from these participants with a cutoff of November 25, 2020, which represents a median of 9 weeks (>2 months) of follow-up post-dose 2. Key safety data from this later submission, including death, other serious adverse events, and unsolicited adverse events of interest were independently verified and confirmed not to change the safety conclusions from the interim safety analys
https://www.fda.gov/media/144434/download
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05-07-2021, 12:31 PM #55
Re: New Jersey program offers free beer to those who get Covid-19 vaccine.
Experimental in the it is NOT FDA approved. LOL, I am not making this up.
Do I really want somebody else's MRNA in my body if not necessary?
I had COVID somewhere along the line. I have the antibodies. I have the same protection as somebody getting an unapproved vaccine.
And it wasn't just tested on 30,000 people. It is hundreds of millions and rising by the day. Again, it is still in the experimental stage. That's fact.
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05-07-2021, 12:34 PM #56
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05-07-2021, 12:35 PM #57
Re: New Jersey program offers free beer to those who get Covid-19 vaccine.
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05-07-2021, 12:38 PM #58
Re: New Jersey program offers free beer to those who get Covid-19 vaccine.
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05-07-2021, 12:46 PM #59
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05-07-2021, 12:47 PM #60Hall Of Fame Poster
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Re: New Jersey program offers free beer to those who get Covid-19 vaccine.
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