Covid-19 Vaccine Development

[PayrollNerd]

I have struggled to keep up with this thread but wanted to drop in a few articles from my cousin, a professor of infectious diseases at Georgetown University Medical Center. This latest one is very informative.

Q&A: Dr. Daniel Lucey ’77 on the dangers of new COVID-19 variants | The Dartmouth

Snips:
We should also be concerned because some of these new variants can reinfect people who are already infected and have recovered. That is very, very bad news because for individual patients, they may become more ill and/or die with a reinfection from a variant.

As of Wednesday, the U.K. variant is in 33 U.S. states, so it’s more than half the states where this variant from the U.K. has been found.

 

[PayrollNerd]

These are some good insights over the past month related to Covid variants. Author: Daniel Lucey, M.D. MPH, FIDSA, FACP

UK data on a “realistic probability” of increased risk of death due to variant B.1.1.7 | Science Speaks: Global ID News (sciencespeaksblog.org)

Nosocomial COVID spread by variants: A Berlin hospital stops admissions and puts staff under “shuttle quarantine” | Science Speaks: Global ID News (sciencespeaksblog.org)

Bivalent COVID vaccines: When will studies begin in order to stay ahead of the multiple known (and unknown) variants? | Science Speaks: Global ID News (sciencespeaksblog.org)

South Africa COVID vaccine results cause Novavax to begin work immediately on ”a booster and/or combination bivalent vaccine” | Science Speaks: Global ID News (sciencespeaksblog.org)

 

[margarita25]

 

[margarita25]

These are some good insights over the past month related to Covid variants. Author: Daniel Lucey, M.D. MPH, FIDSA, FACP

UK data on a “realistic probability” of increased risk of death due to variant B.1.1.7 | Science Speaks: Global ID News (sciencespeaksblog.org)

Nosocomial COVID spread by variants: A Berlin hospital stops admissions and puts staff under “shuttle quarantine” | Science Speaks: Global ID News (sciencespeaksblog.org)

Bivalent COVID vaccines: When will studies begin in order to stay ahead of the multiple known (and unknown) variants? | Science Speaks: Global ID News (sciencespeaksblog.org)

South Africa COVID vaccine results cause Novavax to begin work immediately on ”a booster and/or combination bivalent vaccine” | Science Speaks: Global ID News (sciencespeaksblog.org)

Thanks, PayrollNerd. Added to Variants thread:
SARS-CoV-2 Variants - Coronavirus COVID-19 **NO DISCUSSION**

 

[dixiegirl1035]

J&J info has been published for day after tomorrows meeting with FDA. I cannot find the ingredients/composition though. darn... I was looking for such. If anyone can find, TIA.

VRBPAC February 26, 2021 Meeting Announcement

https://www.fda.gov/media/146217/download

https://www.fda.gov/media/146219/download

ETA: Nevermind, I found the ingredients in the second link.

The Janssen Ad26.COV2.S v accine is a colorless to slightly yellow, clear to very opalescent sterile suspension for intramuscular injection. The vaccine consists of a replication-incompetent recombinant adenovirus type 26 (Ad26) vector expressing the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein in a stabilized conformation. The vaccine also contains the following inactive ingredients: citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate 80, sodium chloride, sodium hydroxide, and hydrochloric acid.The Ad26 vector expressing the SARS-CoV-2 S protein is grown in PER.C6® TetR Cell Line, in media containing amino acids and no animal-derived proteins. After propagation, the vaccine is processed through several purification steps, formulated with inactive ingredients and filled into vials

 

[PayrollNerd]

Here's another blurb about the Covid-19 multvalent but to be honest, I don't even understand what this means. My accounting brain just can't absorb some of this science speak. I'm learning, slowly.

Moderna to test a “multivalent” COVID vaccine as well as single-valent boosters | Science Speaks: Global ID News (sciencespeaksblog.org)

Snip:
Of note, however, the updated guidance for COVID-19 vaccines from the FDA Feb. 22 focusing on virus variants in appendix 2 explicitly pertained to single-valent booster candidate vaccines. On page 18 of 21 of this guidance, FDA stated (my boldtype added): “This document also does not address considerations for multivalent COVID-19 vaccines”. Thus, further FDA guidance on multivalent vaccine candidates is anticipated.

Snip:

• A third dose of mRNA-1273, the Moderna COVID-19 Vaccine, as a booster at the 50 µg dose level. The Company has already begun dosing this cohort with the booster.”

 

[BetteDavisEyes]

Biden to announce Merck will help make Johnson & Johnson's coronavirus vaccine (nbcnews.com)

The agreement between the two major pharmaceutical companies could help speed up vaccinations across the country.

WASHINGTON — President Joe Biden will announce Tuesday that Merck & Co. will help manufacture Johnson & Johnson’s single-shot coronavirus vaccine, a senior administration official confirmed to NBC News.

The agreement could boost supply of the vaccine, which is being delivered to states this week after gaining federal approval for distribution to the public.

The deal between the two major pharmaceutical companies, first reported by The Washington Post, was brokered by the Biden administration after officials found out that Johnson & Johnson had fallen behind in the production of its vaccine...

 

[dixiegirl1035]

Here's another blurb about the Covid-19 multvalent but to be honest, I don't even understand what this means. My accounting brain just can't absorb some of this science speak. I'm learning, slowly.

Moderna to test a “multivalent” COVID vaccine as well as single-valent boosters | Science Speaks: Global ID News (sciencespeaksblog.org)

Snip:
Of note, however, the updated guidance for COVID-19 vaccines from the FDA Feb. 22 focusing on virus variants in appendix 2 explicitly pertained to single-valent booster candidate vaccines. On page 18 of 21 of this guidance, FDA stated (my boldtype added): “This document also does not address considerations for multivalent COVID-19 vaccines”. Thus, further FDA guidance on multivalent vaccine candidates is anticipated.

Snip:

• A third dose of mRNA-1273, the Moderna COVID-19 Vaccine, as a booster at the 50 µg dose level. The Company has already begun dosing this cohort with the booster.”

Perhaps think of it this way as a comparison when thinking of the multi-valent. Are you familiar with how the flu vaccine is made? It's a combination of different flu variations as no one knows which strain each year will be the one that comes out in force the most. It's an educated guess. So what the drug companies do is make a blend of more than one variation, hoping that it encompasses the strains expected to be most prevalent in the upcoming *flu season*. Some years, they miss the mark and we have a bad flu season (I think it was 2017 - 2018 season that happened?).

The mRNA strains are even more targeted. They are pieces of the coding at the spike site. So if antigenic drift there at those targets, it's a miss. One reason why some folks think that the other vaccines that are based on the "whole" virion can hold up better to the new variants.

If that helps, or is as clear as mud? I'll try to keep up with MedCram and Dr. Campbell to share one on this subject and state such focus in the post.

 

[dixiegirl1035]

@PayrollNerd, it was you who I promised to update if I found a MedCram or Dr. Campbell video on variants and vaccines.

Here is one that I missed last week. 10:47 long video speaking to such. Skip to 4:40 if you want to focus on such. HTH

 

[PayrollNerd]

@PayrollNerd, it was you who I promised to update if I found a MedCram or Dr. Campbell video on variants and vaccines.

Here is one that I missed last week. 10:47 long video speaking to such. Skip to 4:40 if you want to focus on such. HTH

Oh thank you! I’ve been very busy with home maintenance this past week. Time to relax and learn!

 

[margarita25]

 

[margarita25]

Pfizer/BioNTech says its Covid-19 vaccine is 100% efficacious and well tolerated in adolescents - CNN

The Pfizer-BioNTech Vaccine Is Said to Be Powerfully Protective in Adolescents

Pfizer vaccine: How one company makes its millions of Covid-19 vaccine doses - CNN

 

[margarita25]

Army’s own vaccine that could fight COVID variants begins clinical trials

 

[margarita25]

The big hole in America's plan to fight Covid-19 variants

“The global scramble to produce enough Covid-19 vaccine for 7 billion people is about to get even tougher, as drugmakers and countries ready a second round of shots to combat the growing threat of virus variants.

Finding vaccines that can ward off more contagious or virulent strains is only half the battle. The United States has virtually no capacity to manufacture revised vaccines or booster shots alongside the original versions, according to a half-dozen vaccine experts and Biden administration health officials. Setting up additional facilities could take months or even years.“

 

[anneg]

The big hole in America's plan to fight Covid-19 variants

“The global scramble to produce enough Covid-19 vaccine for 7 billion people is about to get even tougher, as drugmakers and countries ready a second round of shots to combat the growing threat of virus variants.

Finding vaccines that can ward off more contagious or virulent strains is only half the battle. The United States has virtually no capacity to manufacture revised vaccines or booster shots alongside the original versions, according to a half-dozen vaccine experts and Biden administration health officials. Setting up additional facilities could take months or even years.“

Not really what I wanted to hear!!

 

[margarita25]

Upon a quick google of “covid booster”:

3 days ago:

National Geographic:
Why we need booster shots against variants to help end the pandemic

Medscape:
Clinical Trials Mix Vaccine Types to Boost COVID Protection

COVID Vaccine Booster Shots Are Coming — Here’s What To Know

Moderna says its booster shot against COVID-19 variants is on the way
Moderna’s Chief Medical Officer Tal Zaks on Wednesday said the company should be able to supply booster shots by the end of 2021.

—

2 days ago:

In-Depth: The four leading COVID booster shot strategies

—

Yesterday:

Will you need a COVID-19 vaccine booster? Doctors weigh in

 

[margarita25]

 

[margarita25]

Chinese official acknowledges low effectiveness of Covid vaccines.

“A senior Chinese official said that the country’s vaccines may need to be administered in greater doses or in concert with other shots because of their low overall effectiveness.“

[...]

“Officials in Brazil said in January that the efficacy rate for the CoronaVac vaccine from the Beijing-based company Sinovac was just over 50 percent. By comparison, Moderna and Pfizer-BioNTech were found to be 90 percent effective in real world conditions, researchers said last month.

Last month the distributor in the United Arab Emirates of vaccines from China’s Sinopharm said it was offering a third dose in addition to the standard two-dose regimen for a “very small number” of people who were “not really responsive” to the vaccine.“

 

[margarita25]

1 week ago

 

[BetteDavisEyes]

FDA recommends pause for Johnson & Johnson COVID vaccine after extremely rare blood clotting cases (clickondetroit.com)

FDA: ‘Right now, these adverse events appear to be extremely rare’

United States health officials are calling for the immediate pause of the Johnson & Johnson (J&J) single-dose COVID-19 vaccine after six recipients developed a rare blood clot disorder.

The FDA and CDC announced Tuesday morning that they are recommending a pause in the use of the J&J vaccine “out of an abundance of caution.”...

US recommends 'pause' for J&J vaccine over clot reports (detroitnews.com)