Covid-19 Vaccine Development

According to the reporter in this video, this week was the deadliest week in the deadliest month for people in nursing homes and long care facilities. :(

Also, per Dr. Gottlieb, younger people receive some immunity from the first shot, but elderly populations really need that second booster. It will be some time before we see a reduction in mortality trends in the elderly population:

 
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Wanted to let you all know.... i received my 1st vaccine on Thursday and feel fine. Arm a little sore but otherwise fine with no fever, malaise etc. I work in healthcare so we started vaccinating last week. :)

awesome!
 
Today, the ingredients for the Moderna vaccine were released. I'm quoting my own post for Pfizer ingredients to have for later and to compare if needed by anyone.

4.1 Vaccine Composition, Dosing Regimen The Moderna COVID-19 Vaccine is a white to off-white, sterile, preservative-free frozen suspension for intramuscular injection. The vaccine contains a synthetic messenger ribonucleic acid (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of SARS-CoV-2 virus. The vaccine also contains the following ingredients: lipids (SM-102, 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.

Source: This is the document for this Thursday for the FDA for Moderna. https://www.fda.gov/media/144434/download

Bump for ingredients for both the Moderna and Pfizer, including the lipids differences for the nanoparticles. If you swim upstream by clicking the up arrow, there is more information in the previous posts about the ingredients I'm not posting here in this one. I kept looking to see if updated on the excipient site https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf for vaccines, and just now realized it won't be there for some time as now under EUA vs. "approved".
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Today, the ingredients for the Moderna vaccine were released. I'm quoting my own post for Pfizer ingredients to have for later and to compare if needed by anyone.

4.1 Vaccine Composition, Dosing Regimen The Moderna COVID-19 Vaccine is a white to off-white, sterile, preservative-free frozen suspension for intramuscular injection. The vaccine contains a synthetic messenger ribonucleic acid (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of SARS-CoV-2 virus. The vaccine also contains the following ingredients: lipids (SM-102, 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.


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Here, for instance, is what the US Food and Drug Administration says is in Pfizer’s vaccine:

  • Active Ingredient
    • nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2
  • Lipids
    • (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis (ALC-3015)
    • (2- hexyldecanoate),2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
    • 1,2-distearoyl-snglycero-3-phosphocholine (DPSC)
    • cholesterol
    • Salts
      • potassium chloride
      • monobasic potassium phosphate
      • sodium chloride
      • basic sodium phosphate dihydrate
    • Other
      • sucrose

Source: This is the document for this Thursday for the FDA for Moderna. https://www.fda.gov/media/144434/download
 
“Dr. Anthony S. Fauci, the nation’s top infectious disease expert, told CNN on Friday that the United States would not follow Britain’s lead in front-loading first vaccine injections, potentially delaying the administration of second doses.

Britain announced a plan this week to delay second shots of its two authorized vaccines, developed by Pfizer and AstraZeneca, in an attempt to dole out to more people the partial protection conferred by a single dose.

“I would not be in favor of that,” Dr. Fauci told CNN’s Elizabeth Cohen. “We’re going to keep doing what we’re doing.””

*more at link
Dr. Fauci advises against the British approach of delaying a second dose of vaccine.
 
Amid evolving strains, COVID-19 vaccines likely need updates every 3 years, former FDA chief Gottlieb says
Dec. 21, 2020

“Former Food and Drug Administration Commissioner Scott Gottlieb said Monday coronavirus vaccines will likely require updates every few years as surface proteins on the virus evolve to become unrecognizable to antibodies.

Gottlieb told CNBC co-hosts that while current COVID-19 vaccines and prior immunity are likely effective against the newly mutated strain of the virus rapidly circulating in the U.K., the evolving virus will necessitate surveillance by sequencing.

"We thought every two, or maybe three years, I was saying that probably 6-8 months ago, every three years, that might still be the case," Gottlieb said, referring to a potential timeframe for updated COVID-19 vaccines. "I don’t think this is something we need to update every season, but if it becomes easy to update it, you may do that, you may look at what the predominant strain is and try to update it more regularly."“



@SquawkCNBC
Dec 21, 2020
"Eventually we'll get into a framework with COVID--we'll accept that if a vaccine can induce a certain level of antibodies it is going to be effective and therefore allow updates based on antibody response," says
@ScottGottliebMD
. "That's how we'll be able to keep up with this."
 
Johnson & Johnson Initiates Second Global Phase 3 Clinical Trial of its Janssen COVID-19 Vaccine Candidate | Johnson & Johnson

“November 15, 2020 -- The Phase 3 ENSEMBLE study of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enroll and vaccinate study participants. ENSEMBLE is proceeding to enroll up to 60,000 participants worldwide.

In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. ENSEMBLE 2 is a complementary, planned, pivotal, large-scale, multi-country Phase 3 trial that will study the safety and efficacy of a two-dose regimen of the investigational Janssen vaccine candidate for the prevention of COVID-19 in up to 30,000 participants worldwide. The ENSEMBLE and ENSEMBLE 2 trials will run in parallel.

While a potentially safe and effective single-dose preventive COVID-19 vaccine would have significant benefits, particularly in a pandemic setting, Janssen’s COVID-19 vaccine program has been designed to be extremely thorough and driven by science. As such, we are investigating multiple doses and dosing regimens to evaluate their long-term efficacy.”
 
DH and I both received emails from Beaumont Health this morning indicating that we are eligible for the Covid vaccine. Beaumont is the largest hospital group in Michigan, so there were likely thousands of email recipients who are now trying to access their current Beaumont charts or set up a Beaumont chart which is the only way to schedule an appointment for the vaccine. We want to discuss the vaccine with our respective primary care physicians before we set up appointments. We both have previously-scheduled appointments with our doctors at which time we will seek their advice on which vaccine would be best for each of us.
 
DH and I both received emails from Beaumont Health this morning indicating that we are eligible for the Covid vaccine. Beaumont is the largest hospital group in Michigan, so there were likely thousands of email recipients who are now trying to access their current Beaumont charts or set up a Beaumont chart which is the only way to schedule an appointment for the vaccine. We want to discuss the vaccine with our respective primary care physicians before we set up appointments. We both have previously-scheduled appointments with our doctors at which time we will seek their advice on which vaccine would be best for each of us.
Good news if you should decide at least you are able. It is a big decision and you are wise to seek trusted medical advice.

I received my first vaccine Wednesday. It happened much sooner than I thought. I did get a chance to discuss it with my doctor prior.

I have a feeling I was able to receive it sooner because many people in my health system refused. My group was estimated to be up in May or June! I am not in a high risk job, age or medical group. I am considered an essential employee, though.

I hope I made the right decision!
 
US coronavirus: More states report climbing Covid-19 numbers as CDC chief warns US Capitol riot was a likely 'surge event' - CNN

“Fauci: Second Covid-19 vaccine dose 'critical'
Receiving the second dose of the Moderna of Pfizer Covid-19 vaccine is essential for optimal protection, Dr. Anthony Fauci said on Friday.
"The second dose is absolutely critical," he said. One dose of either vaccine, Fauci added, "has not been proven to be efficacious to the degree that we want, and we don't know how long the protection lasts."
"Whatever you're hearing, one dose of the Moderna and one dose of the Pfizer is not optimal," he said. "Optimal is one dose of Pfizer, followed in 21 days by the boost. Or one dose of Moderna followed in 28 days with a boost if you want optimal protection and optimal durability."“
 
Good news if you should decide at least you are able. It is a big decision and you are wise to seek trusted medical advice.

I received my first vaccine Wednesday. It happened much sooner than I thought. I did get a chance to discuss it with my doctor prior.

I have a feeling I was able to receive it sooner because many people in my health system refused. My group was estimated to be up in May or June! I am not in a high risk job, age or medical group. I am considered an essential employee, though.

I hope I made the right decision!

Congratulations! :)
 
Congratulations! :)
Thanks, @margarita25 ! I appreciate the the smiley and your congrats. I was really on the fence. I didn’t expect to get the vaccine until summer. I work in health care and was deemed essential. Had I not worked for a major health system it may have been summer before I qualified. My health system is really hoping we take the vaccine. It is difficult to run a hospital with 30% absentee rates due to Covid. ( that is what we were running as of a couple weeks ago).

That said, my dear 80+ year old parents still await theirs. Skipping this vaccine would not have given them one any sooner, I know this.

I was also scared! This type vaccine, the speed or roll out...I am still scared. I swore up and down that I was waiting until a few months passed to see how the vaccine was tolerated. To bring it back to relevance for this thread, I was hoping to wait for the Johnson and Johnson vaccine or another type. Maybe one that only required one shot. There are many vaccines in development and I hope I made the right choice by not waiting.

In the end I did it. I was offered and felt it wrong inside not to do my part to stop this awful virus.

With all that is happening in the country, I have been a little down. Your congrats and smile made me feel good. Thank you!
 

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