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Covid-19 - Treatments & Vaccines

So either (1) doctors (and nurses), who obviously can think for themselves and are seemingly at high risk, are ducking the vaccine for whatever reason. Yet everyone else is supposed to literally bend over and take it. Or, (2) the doctors (and nurses) are dumb enough to be duped by Facebook-inspired misinfo about medicine, yet per Rafi the institutional stooge we are supposed to follow their medical advice. Which is it? This is such a clusterfuck of epic proportions.

I just know that I’m gonna do the opposite of whatever Turftoe says I should do.
 
Now that the vaccine is approved, the FDA can get back to the real important work

 
FDA has released a briefing document following the Vaccine Advisory Committee meeting about the Moderna vaccine. There are a bunch of related materials at the link as well.

Vaccine Advisory Committee Moderna
 
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FDA Vaccine Advisory Committee Ex Summary

FDA Vaccine Advisory Committee Ex Summary It is long, but just over a page from a 54 page document. Those who want it all can get it at the link posted above.

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 analysis.

The most common solicited adverse reactions associated with mRNA-1273 were injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%); severe adverse reactions occurred in 0.2% to 9.7% of participants, were more frequent after dose 2 than after dose 1, and were generally less frequent in participants ≥65 years of age as compared to younger participants. Among unsolicited adverse events of clinical interest, which could be possibly related to vaccine, using the November 25, 2020 data cutoff, lymphadenopathy was reported as an unsolicited event in 173 participants (1.1%) in the vaccine group and 95 participants (0.63%) in the placebo group. Lymphadenopathy (axillary swelling and tenderness of the vaccination arm) was a solicited adverse reaction observed after any dose in 21.4% of vaccine recipients <65 years of age and in 12.4% of vaccine recipients ≥65 years of age, as compared with 7.5% and 5.8% of placebo recipients in those age groups, respectively. There was a numerical imbalance in hypersensitivity adverse events across study groups, with 1.5% of vaccine recipients and 1.1% of placebo recipients reporting such events in the safety population. There were no anaphylactic or severe hypersensitivity reactions with close temporal relation to the vaccine. Throughout the safety follow-up period to date, there were three reports of facial paralysis (Bell’s palsy) in the vaccine group and one in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of adverse events (including other neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to mRNA-1273.

The frequency of serious adverse events was low (1.0% in the mRNA-1273 arm and 1.0% in the placebo arm), without meaningful imbalances between study arms. The most common SAEs in the vaccine group which were numerically higher than the placebo group were myocardial infarction (0.03%), cholecystitis (0.02%), and nephrolithiasis (0.02%), although the small numbers of cases of these events do not suggest a causal relationship. The most common SAEs in the placebo arm which were numerically higher than the vaccine arm, aside from COVID-19 (0.1%), were pneumonia (0.05%) and pulmonary embolism (0.03%).

With the exception of more frequent, generally mild to moderate reactogenicity in participants <65 years of age, the safety profile of mRNA-1273 was generally similar across age groups, genders, ethnic and racial groups, participants with or without medical comorbidities, and participants with or without evidence of prior SARS-CoV-2 infection at enrollment.

This meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is being convened to discuss and provide recommendations on whether, based on the totality of scientific evidence available, the benefits of the mRNA-1273 COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older. The committee will also discuss what additional studies should be conducted by the vaccine manufacturer following issuance of the EUA to gather further data on the safety and effectiveness of this vaccine.
 
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Yes, thanks for posting.
Now let's get that sucker out to the population.
 
Yes, thanks for posting.
Now let's get that sucker out to the population.

Look for the Emergency Use Authorization to be issued in a day or two. Then there are about 6 million doses ready to go.

This Moderna vaccine only needs a regular freezer to keep for months. Much easier distribution logistics.
 
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FDA has issued an Emergency Use Authorization for the Moderna vaccine. The first doses should start moving this weekend. Now 20 million people could get initial doses before the end of the year.

https://www.washingtonpost.com/health/2020/12/17/covid-fda-moderna-vaccine-2/

ETA: The simpler storage requirements of the Moderna vaccine make the distribution much easier. It can be stored for months in ordinary freezer conditions an for up to a month at refrigerator temperature. The U.S. is getting 200 million doses in its first order.
 
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Why the are these politicians getting vaccines before people directly caring for COVID patients. None of those assholes that have attended maskless meetings and engagements should get a single vaccine before all healthcare workers and staff have received them.
 
Why the are these politicians getting vaccines before people directly caring for COVID patients. None of those assholes that have attended maskless meetings and engagements should get a single vaccine before all healthcare workers and staff have received them.

Some 100% need it for continuity of government.
 
Why the are these politicians getting vaccines before people directly caring for COVID patients. None of those assholes that have attended maskless meetings and engagements should get a single vaccine before all healthcare workers and staff have received them.

Just because “rich people” isn’t physically written on the rollout list doesn’t mean it shouldn’t be implied.
 
Politicians, especially republican politicians, getting the vaccine and making a big show of it is a good idea when something like 40% of the country are saying they won’t be getting it because they don’t trust it.
 
Politicians, especially republican politicians, getting the vaccine and making a big show of it is a good idea when something like 40% of the country are saying they won’t be getting it because they don’t trust it.

Exactly. If the country is to get to a high enough fraction vaccinated to stop the spread, a big majority of Trumps 74 million voters have to take the vaccine.

Pence, McConnell et al are a good start. Trump himself along with Ivanka, Melania and Jared also need to be public about getting the vaccine.

Tucker Carlson and others on Fox also need to be public about their vaccinations. Preferably once it is no longer "Trumps's vaccine." Because most of the country will get vaccinated after Trump's term is over. All the MAGA hat wearers need to get the two jabs.
 
I think that’s bullshit. There are plenty of people that want it now. They can put on their show after all the people taking care of COVID patients get theirs. We are struggling now to staff COVID floors and it is getting worse. If we get to the point that we have extra vaccine people don’t want, let them do their show then. They don’t need the vaccine to do their job. They just need to make better decisions to lower their risk.
 
Why would doctors believe a cardiology fellow spreading misinformation?
I'm guessing that fear really messes with people's critical thinking skills. It was that rumor about placenta complications that was apparently freaking out women.

Not sure that there were other doctors convinced by the fellow -- mostly nurses. I think the fellow was one of the persons being yelled at, so probably why I included that category.

Anyways, just quickly typed that post as it was reported to me bc I thought it was interesting. I wouldn't recommend anyone (especially 2&2) drawing any conclusions about the world from my story
 
Sinclair owned TV station

 
I don't think Trump would ever get the vaccine on TV. that would require taking off his jacket and rolling up his sleeve which he would never, ever do because it's not classy.
 
CDC has endorsed fans with germicidal UV lights as effective for ridding indoor air of Covid. Supposed to be effective in closed spaces like school classrooms
Big Ass Fans is the only company making fans with UV lights. Supposed to take about an hour to clean the air in a school classroom size space.
 
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