Coronavirus COVID-19 - Global Health Pandemic #97

[ringbearer]

I was asking because Astra Zeneca is not manufactured in the US.

This is what I found:

FDA Approval is Required by Law
Federal law requires all new drugs in the U.S. be shown to be safe and effective for their intended use prior to marketing. However, some drugs are available in the U.S. even though they have never received the required FDA approval. Many health care professionals and patients are unaware that some of the drugs prescribed are not FDA approved.

FDA permits some unapproved prescription drugs to be marketed if:

• the drug is subject to an open drug efficacy study implementation (DESI) program proceeding,
• health care professionals rely on the drug to treat serious medical conditions when there is no FDA-approved drug to treat the condition,
• there is insufficient supply of an FDA-approved drug.

The law allows some unapproved prescription drugs to be lawfully marketed if they meet the criteria of generally recognized as safe and effective (GRASE) or grandfathered. However, the agency is not aware of any human prescription drug that is lawfully marketed as grandfathered.

Search Marketed Drugs Listed with FDA, Including Unapproved Drugs
Drugs marketed in the U.S., with or without FDA approval, can be identified in the following databases:

• National Drug Code (NDC) Directory publishes data derived from information submitted to the agency as part of drug listing requirements, including information on unapproved drugs. NDC numbers are provided for all listed drugs, regardless of approval status. Information in the directory does not indicate that FDA has verified the information provided.
• Drugs@FDA lists information on FDA-approved drugs since 1998, including patient information, labels and approval letters.
• Orange Book identifies FDA approved drugs.

Unapproved Drugs

 

[Betty P]

Yes, it's a pretty good system, similar to other developed nations.

Here's a list of unapproved drugs the FDA has attempted to remove from the market in the US. It can be difficult to do at times. Some of these are "alternative medicine" types of treatments. Some are benign, useless drugs, others can cause real harm. Some are variations of existing drugs that haven't been approved by the FDA.

FDA Actions to Remove Unapproved Drugs from the Market by Drug

 

[nhmemorymaker]

Lol, you got that right. It’s not just the migrants, rotf. I think the issue began when we were told it was “going to go away”, “it affects virtually nobody”, that it’s okay to hold unmasked, undistanced superspreader rallies, that mitigation measures and masks are a violation of people’s rights. Our baseline was up well before “migrants” lol, highest in the world. There’s been a problem in the States, much of which has nothing to do with migrants, and this is a fact. Shoot, there are probably more infections transmitted this past year in churches lol.

I appreciate you bringing this up. When someone posted it, I just felt "no...better stay away-too political" but your words are true.....
current government is really really trying to work vaccines at the border. AND with so many in the US NOT taking the vaccine, I think using vaccines at the border is a good thing.....

I know we had a posting a while back, showing how many vaccines had to be destroyed because of "shelf life". This just makes me so upset, when I think of how many parts of the world are desperate to get vaccines.

 

[musicaljoke]

My parents won't get vaccinated. My newborn woke me up in the middle of the night last night. All I could think of when I woke up was that maybe I could get my parents to wear N95 masks. So I found myself essentially panic buying N95 masks in the middle of the night like they weren't going to be there if I waited 5 minutes.

I was reading this thread before falling asleep. I figure the people in this thread will understand if anyone would. I need my parents to make it through this next wave. But my poor deluded father listens to Dr Mercola.

Congratulations on the safe arrival!! You've been in my mind and on my heart for these past few months.

 

[weepingangel]

'Kind of a heartbreak for all of us involved in science' | More than 600,000 doses of COVID-19 vaccine in NC could expire at the end of the month

Arkansas loses a third of its vaccine stockpile to an expiration date

Tens of thousands of coronavirus vaccines expired in Alabama as millions remain unvaccinated

Nebraska COVID-19 vaccination doses expiring in a few weeks

 

[musicaljoke]

I've bowed out of this thread, but I got an alert on your post and didn't want to be rude I'm not sure what you mean by the question, though. Every drug used in the US has to be FDA approved unless its approved for emergency use. There is no alternative I've ever heard of and, afaik, none of the covid shots have been approved yet.

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/pfizer-biontech.html#:~:text=Health%20Canada%20authorized%20this%20vaccine,to%20COVID%2D19.

About the Pfizer-BioNTech COVID-19 vaccine
The Pfizer-BioNTech COVID-19 mRNA vaccine (Tozinameran or BNT162b2) is used to protect against COVID-19.

The vaccine is approved for people who are 12 years of age and older. Its safety and effectiveness in people younger than 12 years of age have not yet been established.

Health Canada first authorized this vaccine with conditions on December 9, 2020, under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. On May 5, 2021, the authorization was expanded to include individuals aged 12 to 15.

 

[drama_farmer]

I appreciate you bringing this up. When someone posted it, I just felt "no...better stay away-too political" but your words are true.....
current government is really really trying to work vaccines at the border. AND with so many in the US NOT taking the vaccine, I think using vaccines at the border is a good thing.....

I know we had a posting a while back, showing how many vaccines had to be destroyed because of "shelf life". This just makes me so upset, when I think of how many parts of the world are desperate to get vaccines.

Makes sense to me, from a public health standpoint. Vaxxing the border towns is a smart thing to do. They are creating a "buffer zone*" of sorts, imo.

As for the undocumented migrants entering the US to work during the fall harvest and in processing plants, I have the same opinion.

Someone has to pick and process those crops that end up on our dinner tables. Even if there's a tiny chance our food supply can be compromised due to the collateral damage of COVID, it makes lots of sense to try to mitigate that possibility through vaccination.
IMO

 

[SouthAussie]

That is weird- what are they thinking is causing these respiratory illnesses or are they totally baffled?

From what I was reading last week, it is because the children have been quite protected from all the 'usual' illnesses for the past year and more. Due to social distancing, handwashing, and not being in crowded places. Now that things have opened up in the UK, the children have become susceptible again .... and susceptible as a large group, due to that year of protection of them all.


So why is RSV, considered a winter illness, peaking in the summer of 2021? Simply put, restrictions put in place for preventing the spread of COVID-19 held back other respiratory viruses too. As many countries are lifting these restrictions, many respiratory diseases are spreading again.
RSV is a common respiratory pathogen – so common in fact that nearly all of us are infected with it by the age of two.

..... in approximately one in three children, RSV can cause bronchiolitis, an inflammation of the bronchioles, the smallest tubes in our lungs.
In young children, this may result in refusing feeds and dry nappies for long periods. This is when many parents rightly make the decision to take their child to hospital. Very young children – those in their first months of life – are the most susceptible to hospitalisation due to having smaller airways.
RSV: what is it, and why are child cases surging in the wake of COVID?

 

[nhmemorymaker]

'Kind of a heartbreak for all of us involved in science' | More than 600,000 doses of COVID-19 vaccine in NC could expire at the end of the month

Arkansas loses a third of its vaccine stockpile to an expiration date

Tens of thousands of coronavirus vaccines expired in Alabama as millions remain unvaccinated

Nebraska COVID-19 vaccination doses expiring in a few weeks

All I can think about ...is how can we get them to where they are needed... super-quickly. Such a shame, shame, shame.

 

[CoverMeCagney]

From what I was reading last week, it is because the children have been quite protected from all the 'usual' illnesses for the past year and more. Due to social distancing, handwashing, and not being in crowded places. Now that things have opened up in the UK, the children have become susceptible again .... and susceptible as a large group, due to that year of protection of them all.


...

This is exactly what my doctor friend said. Our immune systems haven’t needed to fight as much lately, so they’re effectively a bit weaker than in a typical year.

I think, for the first time ever, I will get the flu jab this year. Never been offered it before but don’t want to risk a double whammy of illness when winter comes.

 

[SoCalDavidS]

Vocal anti-vaccine broadcaster dies from COVID-19 complications

WEST PALM BEACH, Fla. — Former South Florida talk show host Dick Farrel, known and beloved by fans for his over-the-top right-wing opinions, has died from complications from COVID-19.

On Facebook, Farrel advocated against getting the coronavirus vaccine and was skeptical of Dr. Anthony Fauci, Chief of the U.S. National Institute of Allergy and Infectious Disease, and his recommendations concerning the coronavirus. Friends said after contracting the virus he changed his point of view. Friends say Dick Farrel encouraged them to get the vaccine after he was infected

"COVID took one of my best friends! RIP Dick Farrel. He is the reason I took the shot. He texted me and told me to 'Get it!' He told me this virus is no joke and he said, "I wish I had gotten it!" said Farrel's close friend Amy Leigh Hair on her Facebook page. She told WPTV, "I was one of one the people like him who didn't trust the vaccine. I trusted my immune system. I just became more afraid of getting COVID-19 than I was of any possible side effects of the vaccine. I'm glad I got vaccinated."

https://www.wptv.com/lifestyle/tast...-broadcaster-dies-from-covid-19-complications

 

[Sundog]

KN95 have ear loops. Yes, they are more comfortable, presumably because with ear loops it's harder to achieve an airtight fit, so they likely let more air around the edges. Which is not really a good a thing for covid transmission. That said, for general population (not working with covid patients) KN95 are more user friendly, easier to take off and put back on, and so on.

I use a large paper clip to tighten the ear loops at the back of my head and then my KN95 masks have a very snug, tight fit. They are very comfortable that way, with no gaps.

 

[SouthAussie]

Vocal anti-vaccine broadcaster dies from COVID-19 complications

WEST PALM BEACH, Fla. — Former South Florida talk show host Dick Farrel, known and beloved by fans for his over-the-top right-wing opinions, has died from complications from COVID-19.

On Facebook, Farrel advocated against getting the coronavirus vaccine and was skeptical of Dr. Anthony Fauci, Chief of the U.S. National Institute of Allergy and Infectious Disease, and his recommendations concerning the coronavirus. Friends said after contracting the virus he changed his point of view. Friends say Dick Farrel encouraged them to get the vaccine after he was infected

"COVID took one of my best friends! RIP Dick Farrel. He is the reason I took the shot. He texted me and told me to 'Get it!' He told me this virus is no joke and he said, "I wish I had gotten it!" said Farrel's close friend Amy Leigh Hair on her Facebook page. She told WPTV, "I was one of one the people like him who didn't trust the vaccine. I trusted my immune system. I just became more afraid of getting COVID-19 than I was of any possible side effects of the vaccine. I'm glad I got vaccinated."

https://www.wptv.com/lifestyle/tast...-broadcaster-dies-from-covid-19-complications

We are definitely seeing more of these anti-vax 'personalities' passing away due to covid just lately. I wonder if this will go any way toward their avid followers deciding to get vaccinated.

 

[jjenny]

All I can think about ...is how can we get them to where they are needed... super-quickly. Such a shame, shame, shame.

We could start giving boosters to people who want it, for one.

 

[anneg]

We could start giving boosters to people who want it, for one.

Yes. I'd happily accept one of the NC shots expiring this month.

 

[beatrixpotter]

@beatrixpotter I have several N95 masks, and can't stand to wear them for 8 hours a day. So, any mask is better than no mask, hopefully they can find one tolerable for them.

Maybe the N95 masks we were issued at work are poorly manufactured. I felt like I was literally breathing in fiberglass particles.

Sorry you have all of this stress, with a new baby.

Thanks, Micky. I found it really hard to breath in one while pregnant. It seems easier now. While pregnant I ended up hospitalized and I found my oxygen levels were routinely 94-96% with no explanation why after lots of testing. I wasn't sure if it was the mask or me. But I never had to wear it all day. That would be a nightmare. My parents would only need one to go in stores and that sort of thing.

This is the N95 I bought for myself though. Maybe if the fabric has copper, zinc and citric acid it's harder to breath through? lol Either way I feel more reassured still with a mask that kills viruses on contact as well.

RespoKare N95 Surgical Respirator Mask With Antimicrobial/Antiviral Agent - FDA Cleared NIOSH Approved

 

[beatrixpotter]

I recently bought some more N95 and KN95 masks online. I think we'll need them through the winter, when we go out. I wish we didn't have to, but there it is.

I hope your parents wise up. It's best for everyone's health, especially the little ones who aren't old enough to get the vaccine. Myself and my DIL's mother will be taking care of our grandchild while my DIL goes back to work. I think her new workplace is requiring all employees to get the vaccine, so hopefully she won't be at too great risk of exposure.

ETA: Congrats on being a new mom! Our grandchild just celebrated her first birthday, so I know its stressful for new parents going through this pandemic. It's all working out ok, though. You have to be firm about keeping unvaccinated people away from the little one.

Thank you! Though I'm actually an old mom here at 44.

I talked to my mom today and she was immediately receptive about the masks and seemed happy I bought them for her. I went ahead and gave them a couple I already have on hand. I started sending her daily news stories recently to update her on what's going on and I think that's helping. I think it had been out of sight out of mind. She wasn't reading anything and didn't want to know how bad things were. Which made it easier to pretend she wasn't really at risk.

Several times in the conversation she made reference to "if I get vaccinated" which was totally different from two weeks ago when she said "I'm not getting vaccinated". The truth is she's scared of needles and has apparently not had one vaccine since childhood!

I think what we are going to offer to do is set the appointment up for her and offer to drive her there and stay with her. I'm even going to offer her an anxiety pill to help her handle it calmly. I really hope she will take us up on the offer.

She asked if she got the vaccine but my dad didn't would it really make any difference for her? I told her it would mean at the very least she would have a much milder case. Fingers crossed!

 

[beatrixpotter]

I used to read Dr. Mercola on his web site- he has gotten wackier as the years have gone one: haven't been to his web site or read his rantings in a long time. Too bad you have to deal with your father believing Dr. Mercola: you sure have your hands full. I wish you the best in dealing with all of this and congrats on being a new mom!!! How wonderful for you!

Thank you very much! This is not my first baby though. My oldest is actually 21 and I have several in between.

I had started reading Dr Mercola too many years ago. But back when it was just a newsletter and he wasn't actually selling something in response to all his newsletters. I actually stopped reading years ago because I realized it was all just fear based and telling me how doctors and medicine were out to get me. It just gave me a bunch of anxiety.

Apparently he's decided everyone is out to get him and he's deleting all his online articles and will only keep all his new ones up for 48 hrs at a time. He and his girlfriend have been hyping for years that the government is actually killing off alternative doctors. She keeps a running list of doctors who die in mysterious circumstances.

It's really pretty nuts. But he's been hyping up the fear for years. I don't know why my dad even reads him. He never does anything to improve his health with diet or exercise at all. He follows none of his suggestions and eats the same diet for decades.

 

[beatrixpotter]

That is weird- what are they thinking is causing these respiratory illnesses or are they totally baffled?

RSV has been super bad in the south especially. I've noticed online in the last month that there are tons of baby's who end up hospitalized. I've never before been in due date groups online where so many little ones end up sick like this.

But there are apparently some other really bad respiratory illnesses going around. I have a friend in Missouri whose whole family got some severe respiratory illness. I thought covid but the tests for that and flu were negative.

It's odd that all these fall and winter illnesses are going around now. Would mask wearing and social distancing really cause this? Because most people stopped wearing masks or social distancing months ago. It just seems odd. But the whole world is odd right now...

 

[beatrixpotter]

Did you see this article on Mercola this week? Maybe you could convince your dad that he has been called a "superspreader"

CNN tracked down a super-spreader of Covid-19 misinformation. See how he reacted - CNN Video

I had not read this! But I did hear he was removing all his articles. I read people in online health groups freaking out over it. It basically just all confirms their persecution complex though. They won't take it seriously that he spreads misinformation.

Oh, and get this! Our Aldi cashier yesterday actually asked my husband if he'd heard of Dr Mercola. I was shocked he immediately replied with: "I have and I'm not a fan."

She's also told him there are new studies showing a connection between COVID and 5G at a previous shopping visit. So the Aldi cashier is a straight up conspiracy theorist and is bringing it up with all the customers.

She also brought up the Weston A Price Foundation. I am familiar with them but went to see what they were saying about covid. Here's a good taste of what the crazies are reading out there.
Is Coronavirus Contagious? - The Weston A. Price Foundation