Covid-19: Treatments, Cures, and Vaccines

This vaccine is not authorized for use. Phase 3 trials are not complete. There is not Phase 4 data yet. We are years away from seeing any of these vaccines be approved.

The FDA has authority to grant emergency use of any medication, treatment or preventative measure per their procedures, during a public health emergency.

In short, it is an "at-risk" approval since there is no lingterm safety and efficacy data to be evaluated. It may be revoked at any moment negative data says it should be....just like what happened with hydroxychloroquine.

 

Interesting research in animals on a truly effective anti-viral drug candidate.

Oral Antiviral Blocks Transmission, Multi-Organ Failure Mechanisms, Molecular Target for Lung Fibrosis: COVID-19 Updates

 

FDA review, ahead of independent, external review, gives thumbs up to the Moderna Vaccine. Data shows that it was 94.5% effective over all, with that number jumping up to 95.6% in those below 65, while still 86.4% in those older than 65.

I believe the independent review board meeting on Thursday the 17th and the FDA likely issues EUA order no later than the weekend if they also give their thumbs up.

Moderna COVID-19 vaccine passes FDA reviewers' test, but shares drop anyway

 

Johnson and Johnson expects to have its Phase III read out data available at the beginning of January. That would mean that they would be ready to apply for EUA by the end of January giving the US 3 vaccine suppliers by February, including the largest supply chain of all (Johnson and Johnson) if the data is as good as they hope.

AstraZeneca may also be ready to apply for EUA with the FDA by late January or early February.

2 more vaccine developers could seek FDA's green light by February

 

New York company receives ok to commence human trials on a vaccine delivered through nose drops. Pre-clinical results in animals suggest this vaccine candidate may produce a more robust and longer lasting anti-body response than the Pfizer or Moderna vaccines.

https://nypost.com/2020/12/15/ny-company-to-start-trials-of-nasal-drop-covid-19-vaccine/

 

Moderna receives EUA for their Corona Virus Vaccine. Expects to ship 20 million doses to the US Govt by the end of December.

Moderna scores FDA authorization for its COVID-19 vaccine, adding key 2nd shot as nationwide campaign ramps up

 

There is no image there for me to see. What was this supposed to show?

 

It was a meme but I haven't been having much luck with pictures lately, here is the text:

The order of vaccinations should have been:
1) Healthcare workers
2) The elderly and medically vulnerable
3) Essential workers
4) People who live with essential workers
5) Other people
6) Squirrels
7) Robocop
8) Dragons
9) The blue folks from Avatar
10) Marco Rubio

 

Even without seeing the image, it made me chuckle. Thanks for sharing.

 

11. People in Florida for the winter.

 

I would think that is covered by 2)

That being said, never understood the animosity towards one of the biggest industries in the state. Granted, I don't have to put up with it anymore but I would be curious what would happen to Florida if all the tourism went away.

 

Nothing at all against tourists and tourism. Just think they should be vaccinated in their state of residence.

 

State of residence shouldn’t matter. People spending half the year here aren’t “tourists”. They are part time residents. It’s irrational to think someone that lives here roughly half the year or more should have to head 1000+ miles away just to get a vaccine based on something arbitrary such as their state of primary residence.

It isn’t just retired people either, should a traveling nurse who works the season down here not get a vaccine here because their primary residence is somewhere else? I think it’s pretty obvious they should line up and get the vaccine along with all their colleagues based on their presence here at the time of vaccine distribution. The same logic should apply to the elderly part time residents. If they are already here they get the vaccine here.

Maybe if someone is just on a 2 week vacation or something I’d slightly agree with you, but then I tend to think people shouldn’t be “vacationing” during a pandemic in the first place - least of all 75 year olds.

 

Pfizer and BioNTech to launch controlled study to prove vaccine is effective against latest variant in UK. While I will probably get the technical terms incorrect, but one thing I recall reading is that the Pfizer vaccine targeted only part of the protein spike on the virus particle. The Moderna version addressed the entire spike.

Moderna is confident that their vaccine will be successful here as well. One thing that both companies pointed out is that the virus is very different now than a year ago when they started. They planned for significant future mutations since the amino acids used to copy the virus are apparently very prone replication errors.

Pfizer, Moderna urge calm as they launch tests of vaccines against mutated COVID-19

 

Separate article on my phone talked about phase 3 trials for this drug, MK-7110, an anti-viral pill that showed very good results in earlier, smaller studies for both reducing period of time of infection and reducing the risk of death due to severe respiratory infection.

Merck signs $356 million deal with U.S. government for experimental COVID-19 therapy

 

Novavax becomes the third company to take their vaccine candidate to Phase 3 trials. I am way outside my area here, but if I understand it, this is unlike any of the other vaccine candidates. It is made out of a synthetic protein subunit that mimics the spike protein of SARS-CoV-2. A proprietary adjuvant, or chemical to further encourage your immune system to produce anti-bodies is included. It is a tried and true method of making vaccines as most Flu, HPV and Hepatitis B vaccines are all made this way.

Novavax coronavirus vaccine becomes fifth to begin Phase 3 trials in United States - CNN

 

UK approves Oxford vaccine

Oxford/AstraZeneca vaccine: UK regulator approves another coronavirus vaccine - CNN

Previously, the team developing the vaccine said it had an "an average efficacy of 70%," with one dosing regimen showing an efficacy of 90%.
"Excitingly, we've found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply," Andrew Pollard, chief investigator of the Oxford Vaccine Trial, said in November.

 

Not sure how regulators approved it with all of the uncertainty around dosing, manufacturing control, ie you get what you think you are getting, etc.....

I am actually glad the US FDA delayed the US trial for over 7 weeks investigating the UK adverse reaction and gave the AZ team time to better sort themselves out. From what I have read Johnson and Johnson expects to be able to request approval (if their data is good) by end of January which is about 2-3 weeks ahead of what AZ could do in the US.

 

WHO-sponsored preliminary review indicates Ivermectin effectiveness

"Dr Andrew Hill of the Department of Pharmacology at the University of Liverpool (UK) is currently performing a WHO-sponsored review and meta-analysis of randomized controlled trials of ivermectin against covid. In the following 12-minute video, Dr Hill is presenting his preliminary results, which indicate a highly significant 83% reduction in covid mortality (95% CI 65%-92%).

This result is based on in-hospital trials, so it does not yet take into account early ambulatory and prophylactic treatment. The authors of the review intend to include three more trials, due to be published sometime in January, before providing a final conclusion. At the end of his presentation, Dr Hill describes ivermectin as a potentially “transformational treatment”."