The Covid vaccines really do work

[robinson]

Really

[Pyrrho]

The FDA has officially authorized Pfizer/BioNTech and Moderna booster shots for vaccinated adults.

https://www.npr.org/sections/coronaviru ... u-s-adults

"The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one."

[Pyrrho]

I'll make use of whatever advantage I can get to avoid severe illness and/or hospitalization.

[Pyrrho]

I'm old, I have risk factors, I'm getting my useless booster on Wednesday, being not manly enough to withstand the "common cold" that is putting people on respirators, etc.

[Pyrrho]

FDA Advisory Committee meeting discussing the Merck COVID-19 pill is today, starting at 9:00 am. Merck slide presentations are now available:

https://www.fda.gov/advisory-committees ... 1-11302021

They haven't posted the webcast link yet.

https://www.youtube.com/user/USFoodandDrugAdmin

edited to add:

They did post the link to the YouTube live stream...inside a PDF. Tell me this isn't a government operation.



Advisory committees are a glimpse into "how the sausage is made". Not the whole picture but you get the picture what is a picture.

Make sure you have enough popcorn and caffeinated soft drinks.

[Pyrrho]

Good questions about the mutations aspect of the medication.

[Pyrrho]

Hildreth is hammering them a bit on the mutagenesis.

[Pyrrho]

Pfizer wants the FDA to approve booster shots of its vaccine for 16-17 year-olds.

https://www.npr.org/sections/health-sho ... -year-olds

[Pyrrho]

NYT visualization. Superb work.

https://www.nytimes.com/interactive/202 ... ation.html

[Pyrrho]

Got my booster, got my flu shot, got my mile-long CVS receipt.

[Ben Trovado]

Not really enthused about the booster.

I need to read more, but the entire debate has gotten so polarized and political that it is hard to trust what you locate as background statistics, etc.

[Pyrrho]

Not really enthused about the booster.

I need to read more, but the entire debate has gotten so polarized and political that it is hard to trust what you locate as background statistics, etc.

Yeah, it's crazy. I tend to look at the advisory committee materials on these things because they do tend to publish actual data, with the understanding that the data are provided by the pharma companies. There does tend to be more data available from the FDA AdCom sites than what might be available in a journal article...but even then, what is made available is a fraction of the reams of data collected. What's written for us commoners, aka "plain language summary" is often simplified to an extent that it's still not understandable.

Even so, clinical trials have to follow certain protocols and the FDA and the external experts on the advisory committees do look at those data. I wouldn't want the AstraZeneca vaccine, myself, but that one's not approved in the USA anyway. I got the booster but I'm also not running around thinking I'm immune because of it.

[Pyrrho]

Article about the Novavax vaccine:

https://www.npr.org/sections/health-sho ... dy-to-roll

These new vaccines are what's called protein subunit vaccines. They work by injecting people with a tiny portion of the virus. In the case of the COVID-19 vaccine, that tiny portion is the so-called spike protein critical for the virus to enter cells.

An advantage of protein subunit vaccines is they tend to be very stable, so they don't require freezers for storage. A regular refrigerator is adequate. This makes distributing the vaccine much easier.

...
Large studies of the vaccine have shown that it works extremely well, and so far there are no safety concerns.

Novavax has begun filing for emergency use authorization with various regulatory agencies.

[Pyrrho]

Also, today, post-booster, post-flu shot, I feel like I got shot at and missed, shit at and hit.

[Pyrrho]

https://www.npr.org/sections/coronaviru ... id-vaccine

A committee of advisers to the Centers for Disease Control and Prevention has voted unanimously to recommend the use of the Moderna and Pfizer-BioNTech COVID-19 vaccines over the Johnson & Johnson jab, following growing concerns about rare blood clots.

The advisers said Thursday that vaccines from Pfizer- and Moderna should be preferred by all adults, who may be at greater risk for developing severe blood clots from the J&J vaccine than those under age 18. Some committee members said the J&J vaccine should remain available for people who prefer it.

[robinson]

Because some people prefer blood clots over heart problems!

[Pyrrho]

The J&J is the "traditional" vaccine.

https://www.cdc.gov/coronavirus/2019-nc ... nssen.html

[Doctor X]

Should have gone with the Cadillac Vaccine.

This what you get when you choose a Ford.

– J.D.

[robinson]

https://twitter.com/2rachelled/status/1 ... 57314?s=21

[robinson]

Imagine if the vaccines were worse than useless

[robinson]

Since there are now 100% vaccinated populations

The cases and deaths should be going down

Not up

[Anaxagoras]

Evidences:

https://ourworldindata.org/grapher/unit ... =~All+ages

[robinson]

https://www.health.com/condition/infect ... d-shutdown

[robinson]

""While faculty and staff case numbers currently remain low,"

Hahahahaha

One out of every 26 infected, in a week, and they describe the number as low.

[robinson]

These are fully vaccinated people. It's impossible to deny the vaccinated are spreading the virus.

Which means all the vaccinated medical staff can be infecting their patients.

Worst vaccine ever

[Anaxagoras]

https://www.health.com/condition/infect ... d-shutdown

However, he added, "we have not seen evidence of significant disease in our students to date."

So the news is that they are testing positive, but no-one is getting seriously ill.

They still work at preventing illness and death.

[robinson]

August 26, 2021
The CDC defines it as a “product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.”

Now the CDC claims

a vaccine is a “preparation that is used to stimulate the body’s immune response against diseases.”

[robinson]

I told you, you just have to redefine what “vaccine” means

[Pyrrho]

https://www.ideastream.org/news/the-omi ... tive-tests

In a statement, officials said one-third of tests conducted at the hospital system are coming back positive, partially due to the rapid spread of the omicron variant. More specifically, the Clinic is testing about 3,000 people per day and 1,000 of those tests are positive, according to officials.

“We estimate half of those positive samples are due to omicron,” Cleveland Clinic spokesperson Halle Bishop said in a statement.

...

More research is needed to determine if the variant causes more severe disease, he added. Early studies indicate the current COVID-19 vaccines provide some protection against omicron, but booster shots are thought to provide the best defense, Rhoads said.

“They say two doses of the mRNA vaccine give about 30 percent protection at preventing symptomatic infection, and then three doses, which is where a lot of us are now with the boosters, gives about 75 percent protection,” he said.

...
“We know [omicron] is here, and currently the majority of our hospitalizations are unvaccinated – 80 percent,” Bishop of the Clinic said. “The vast majority of vaccinated patients hospitalized because of COVID have underlying health issues. As we go through this wave we'll learn more.”

[Pyrrho]

https://www.npr.org/sections/coronaviru ... g-children

Pfizer-BioNTech announced Friday that they will expand ongoing clinical trials of their COVID-19 vaccine in children to include a third dose for participants as young as 6 months old.
...
The companies said two doses did not produce a robust immune response in kids 2 to 5 years old.
...

"The study will now include evaluating a third dose of 3 [micrograms] at least two months after the second dose of the two-dose series to provide high levels of protection in this young age group," the companies said in a statement.

"No safety concerns were identified and the 3 [microgram] dose demonstrated a favorable safety profile in children 6 months to under 5 years of age," they said.

Press release, best taken with 12 ounces of water, or Budweiser, same difference.

https://www.pfizer.com/news/press-relea ... s-covid-19

[robinson]

It’s always about the money

[Pyrrho]

https://ohiocapitaljournal.com/2021/12/ ... pass-2020/

Gov. Mike DeWine is deploying more than 1,000 national guard troops to Ohio hospitals ahead of a busy holiday season that could swell the number of COVID-19 patients. The state is also in talks with a hospital staffing agency that could bring in additional workers from out of state.

“This will allow for Ohio hospitals to bring in qualified nurses and other medical personnel from out of state to fill needed positions and help ease some of the pressure on hospitals and their staff over the critical holiday period,” DeWine explained.

The governor’s move comes as the state faces a sobering reality: More people have died of COVID-19 this year than last despite widely available and effective vaccines. Many residents have stubbornly refused to get vaccinated, and the arrival of the highly contagious delta variant has underscored the consequences of their collective inaction. The nearly 14,000 Ohioans who have died this year were almost exclusively — about 95% — unvaccinated individuals.

Now, with the even more contagious omicron variant spreading, hospitals are bracing for yet another wave of the virus. According to Mike Abrams who heads up the Ohio Hospital Association, facilities around the state are teetering.

“In recent weeks hospitals have had to make difficult decisions to ensure hospital services were available including postponing elective surgeries, transferring patients to other facilities and diverting EMS services,” Abrams said in an emailed statement. “We are also seeing an increase in influenza cases. The ongoing workforce challenges facing our members coupled with latest surge of COVID-19 patients has created an urgent need for workforce assistance.”

[Pyrrho]

https://www.scientificamerican.com/arti ... s-not-low/

I am a science journalist and I have followed COVID news closely to protect my family. Based on extensive reading of trusted sources, I judged the risk of COVID transmission from a vaccinated person to be “very limited,” or “rare.” I allowed my son to be around my vaccinated, unmasked friends indoors.

I was particularly interested in whether asymptomatic vaccinated people could spread the virus, since media coverage last summer suggested that at the time there were no known cases. If this held true, we could continue socializing with vaccinated friends. All fall, I could not find a single news story showing that asymptomatic vaccinated people transmitted the virus.

And then, on November 15, my son tested positive. In my shock and grief, rather than relying only on news reports, I dug into the science myself.

I must emphasize that vaccinated people are several times less likely to be infected by Delta than unvaccinated people. As a result, they must still be less likely to transmit COVID than an unvaccinated person. Once infected, however, it appears to be a different story.

and

A peer-reviewed study of 162 Delta-infected index cases and their 231 household contacts—who were tracked and tested every day for up to 20 days, regardless of symptoms—found that once infected, the vaccinated were just as likely to transmit COVID to people in their own households as the unvaccinated: about a quarter of both did so. They also found that the asymptomatic infection rate among vaccinated and unvaccinated participants was similar: around 30 percent. This was published in Lancet Infectious Disease.

The Lancet Infectious Disease article:

https://www.thelancet.com/journals/lani ... 4/fulltext

Vaccination reduces the risk of delta variant infection and accelerates viral clearance. Nonetheless, fully vaccinated individuals with breakthrough infections have peak viral load similar to unvaccinated cases and can efficiently transmit infection in household settings, including to fully vaccinated contacts. Host–virus interactions early in infection may shape the entire viral trajectory.

[Pyrrho]

Link: https://twitter.com/ScienceMagazine/status/1473506112406269955

[robinson]

Link: https://twitter.com/ScienceMagazine/status/1473506112406269955

There was, and is, an old method of testing vaccines to see if they work. And are safe. Especially a novel method, and especially to see if there are side effects, especially long term ones.

It used to be done before testing on people.

If animal studies and testing had been done on the mRNA treatments, none of the current shit would be that surprising, shocking or mysterious.

[robinson]

It's just basic science. You see if it can be done, does it work, and if it is safe, on animals first.






Before you inject several billion kids with it.

[Pyrrho]

https://twitter.com/VincentRK/status/14 ... 8937260042

[Pyrrho]

https://www.fda.gov/news-events/press-a ... t-covid-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

[Pyrrho]

A bit more info:

https://www.fda.gov/news-events/press-a ... t-covid-19

The primary data supporting this EUA for Paxlovid are from EPIC-HR, a randomized, double-blind, placebo-controlled clinical trial studying Paxlovid for the treatment of non-hospitalized symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2 infection. Patients were adults 18 years of age and older with a prespecified risk factor for progression to severe disease or were 60 years and older regardless of prespecified chronic medical conditions. All patients had not received a COVID-19 vaccine and had not been previously infected with COVID-19. The main outcome measured in the trial was the proportion of people who were hospitalized due to COVID-19 or died due to any cause during 28 days of follow-up. Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88% compared to placebo among patients treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment. In this analysis, 1,039 patients had received Paxlovid, and 1,046 patients had received placebo and among these patients, 0.8% who received Paxlovid were hospitalized or died during 28 days of follow-up compared to 6% of the patients who received placebo. The safety and effectiveness of Paxlovid for the treatment of COVID-19 continue to be evaluated.

It seems that the clinical trial is ongoing. The "primary" study ended on December 9--and I don't know what "primary" means in this context--with full study completion expected in April 2022. This pill was not reviewed by an advisory committee of experts. The FDA apparently considered that to be unnecessary. I'd have preferred that an advisory committee take a look at it, because then the public gets a chance to get a glimpse of some of the data.

https://clinicaltrials.gov/ct2/show/NCT04960202

Paxlovid is a combination of Pfizer's drug and an existing antiretroviral drug, Ritonavir:

https://en.wikipedia.org/wiki/Ritonavir

Ritonavir was patented in 1989 and came into medical use in 1996.[7][8] It is on the World Health Organization's List of Essential Medicines.[9] Ritonavir capsules were approved as a generic medication in the United States in 2020.[10]

Pfizer's drug:

https://en.wikipedia.org/wiki/Nirmatrelvir

Nirmatrelvir was developed by modification of the earlier clinical candidate lufotrelvir,[15][16] which is also a covalent 3CL protease inhibitor but its warhead is a phosphate prodrug of a hydroxyketone. Lufotrelvir needs to be administered intravenously limiting its use to a hospital setting. Stepwise modification of the tripeptide protein mimetic led to nirmatrelvir, which is suitable for oral administration.[2] Key changes include a reduction in the number of hydrogen bond donors, and the number of rotatable bonds by introducing a rigid bicyclic non-canonical amino acid, which mimics the leucine residue found in earlier inhibitors. This residue had previously been used in the synthesis of boceprevir.[17] Tert-leucine used in the P3 position of nirmatrelvir was identified first as optimal non-canonical amino acid in potential drug targeting SARS-CoV-2-Mpro using combinatorial chemistry (Hybrid Combinatorial Substrate Library technology).[18][19]

Here's the "fact sheet" for doctors. I imagine that this drug will be given to patients who have risk factors that might plant them in the hospital with severe COVID-19. It comes down to a benefit:risk situation, because this pill ain't your daily multivitamin. There are a lot of contraindications and drug interactions.

https://www.fda.gov/media/155050/download

[Pyrrho]