The COVID-19 Science and Medicine Question Thread

[Roccus7]

A third vaccine has reported good news today, a vaccine from Oxford-AstraZeneca. It's also a 2-dose regime, a low-dose initial vaccination, followed by a higher dose second dose one month later. Here's my personnel list of Pros and Cons...

• Pros
  • It may be more effective in preventing transmission when the recipient is exposed to the virus
  • Production of the altered, attenuated virus is easier
  • Refrigerated storage
  • Graduated dosages means the critical reagents can be stretched further
• Cons
  • They're still debating about the dosage scheme, but there's probably enough data to clear this up
  • This vaccine is using a different, old school, but proven technology than the others in that it uses weakened (attenuated), but live, adenoviruses to infect the cells of a vaccine recipient and get them to produce the COVID-19 spike protein
  • US is not high on the first introduction list

Let me clarify that final "Con". Don't get me wrong, there's nothing wrong with using attenuated viruses to inject nucleic acids into host cells. Up to this point it's been the standard way of making vaccines that introduce nucleic acids into a recipient. If you think about it, that's what a virus does, invading a cell to get its nucleic acids introduced so it can hijack a host cell and make more virus. Needless to say when viruses are used in this way, there are many steps and safeguards implemented to ensure we're not injecting folks with a virus that can wreck havoc on its own.

Although it's a new and never before used in a vaccine technique, the Pfizer and Moderna vaccines do not use any virus or virally-produced components of their vaccines. The Messenger RNA that they use, the code that gets incorporated into a vaccine recipients cells and results in the production of the COVID Spike Protein, is synthesized in a test tube, never being "touched" by a virus. In essence, this is a "virus free system" because the vaccine introduces the mRNA into a recipient by enclosing it in chemical-synthesized lipid nanoparticles and injecting these LNPs into patients where the muscle cells absorb these particles and the cells' normal protein synthesis system starts pumping out the Spike Proteins which get released from the cells so the immune system can kick in and make antibodies. Researchers have been using LNPs to introduce nucleic acid sequence into cells for many years now, but this will be their inaugural vaccine introduction

The biggest logistic problem with the mRNA-LNP vaccines is they must be stored frozen, with the Pfizer one needing -70°C (-90°F) storage. The biggest manufacturing problem is scaling up the mRNA synthesis, lots of expensive synthesizers will be needed.

It's my personal and professional opinion that now that we have a better and safer "mousetrap" we might as well use it. Since Nature can "find a way" to change, if you don't need to inject people with a virus, why do it now that it looks like the mRNA-LNP technology can beat this beastie?

IF the attenuated adenovirus vaccine from AstraZeneca was the only game in town, my sleeve would immediately get rolled up, but IF I'm presented with an option I'll use the "Why have hamburger when you can get fillet mignon?" logic for either one the mRNA-LNP vaccines.

 

[jpd]

The Coronavirus Is Airborne Indoors. Why Are We Still Scrubbing Surfaces? (Published 2020)

Scientists who initially warned about contaminated surfaces now say that the virus spreads primarily through inhaled droplets, and that there is little to no evidence that deep cleaning mitigates the threat indoors.

www.nytimes.com

 

[Roccus7]

The Coronavirus Is Airborne Indoors. Why Are We Still Scrubbing Surfaces? (Published 2020)

Scientists who initially warned about contaminated surfaces now say that the virus spreads primarily through inhaled droplets, and that there is little to no evidence that deep cleaning mitigates the threat indoors.

www.nytimes.com

I'm loathe to try to present these data to the Admiral. She's gonna keep wiping until we use up our sanitizing wipe inventory, of which there is plenty...

 

[jpd]

WOW.

....turns out that the Moderna vaccine, which was just shown to be 95 percent effective, was actually developed by the company in just two days in January 2020.

That’s right, they developed the vaccine in two days in January, but then needed to spend the following ten months performing tests in order to meet the FDA’s standards for vaccine safety and efficacy.

During those ten months, 1.3 million people, including a quarter million Americans, have died from the coronavirus.

Politics, Science and the Remarkable Race for a Coronavirus Vaccine (Published 2020)

The furious race to develop a coronavirus vaccine played out against a presidential election, between a pharmaceutical giant and a biotech upstart, with the stakes as high as they could get.

www.nytimes.com

 

[Roccus7]

WOW.

....turns out that the Moderna vaccine, which was just shown to be 95 percent effective, was actually developed by the company in just two days in January 2020.

That’s right, they developed the vaccine in two days in January, but then needed to spend the following ten months performing tests in order to meet the FDA’s standards for vaccine safety and efficacy.

During those ten months, 1.3 million people, including a quarter million Americans, have died from the coronavirus.

Politics, Science and the Remarkable Race for a Coronavirus Vaccine (Published 2020)

The furious race to develop a coronavirus vaccine played out against a presidential election, between a pharmaceutical giant and a biotech upstart, with the stakes as high as they could get.

www.nytimes.com

Key words, SAFETY & EFFICACY. In 2 days they made it, but didn’t have a clue IF it worked. No politics, just basic science. And when you read the linked article they say it!!

If the systems worked, designing a vaccine would be done in days. The task remaining would include time-consuming trials to ensure the vaccine worked and was safe, a process that brooked no shortcuts.

I'm not sure where you got the summary you put in bold above, but here's the only paragraph in the article that cites "1.3 million" and that is the TOTAL number of WW deaths from COVID-19.

Both companies ultimately completed the crucial stages of their human trials this month and reported spectacular initial results, vaccines that appear to be about 95 percent effective against a virus that has killed 1.3 million people, a quarter million of them in the United States.

Your quote makes it sound like the 10 months time to develop needlessly killed 1.3 million people. These vaccines are coming out in record time and that quick turnaround will save millions of lives. Misquotes like the one you posted can be misconstrued and piss all over a major accomplishment that all involved should be proud of.

Crap I’ve made assays in an afternoon, but that’s the easy part. Making sure it works, figuring out how to make millions of units, stability, and if it’s safe takes time, but that's the name of the game...

 

[Roccus7]

Rut-roh, seems that the AstraZeneca vaccine's clinical data have a bit of a haze shrouding the study. I've just pulled my sleeve back down, even it was the only game in town, at least until they figure out WTH really went on.

Hope anyone who bought AstraZeneca stock took a quick profit run. Don't forget all the other world markets will be open today so it'll be quite ugly out there on the NYSE tomorrow...

AstraZeneca manufacturing error clouds vaccine study results​

pressherald.com/2020/11/25/astrazeneca-manufacturing-error-clouds-vaccine-study-results/

By DANICA KIRKAAssociated PressNovember 26, 2020

A researcher in a laboratory at the Jenner Institute in Oxford, England, works on the coronavirus vaccine developed by AstraZeneca and Oxford University. University of Oxford/John Cairns via AP R7 Note - gotta love discontinuous gradient centrifugation separations...

LONDON — AstraZeneca and Oxford University on Wednesday acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine.

A statement describing the error came days after the company and the university described the shots as “highly effective” and made no mention of why some study participants didn’t receive as much vaccine in the first of two shots as expected.

In a surprise, the group of volunteers that got a lower dose seemed to be much better protected than the volunteers who got two full doses. In the low-dose group, AstraZeneca said, the vaccine appeared to be 90% effective. In the group that got two full doses, the vaccine appeared to be 62% effective. Combined, the drugmakers said the vaccine appeared to be 70% effective. But the way in which the results were arrived at and reported by the companies has led to pointed questions from experts.

The partial results announced Monday are from large ongoing studies in the U.K. and Brazil designed to determine the optimal dose of vaccine, as well as examine safety and effectiveness. Multiple combinations and doses were tried in the volunteers. They were compared to others who were given a meningitis vaccine or a saline shot.

DID RESEARCHERS MEAN TO GIVE A HALF-DOSE?
Before they begin their research, scientists spell out all the steps they are taking, and how they will analyze the results. Any deviation from that protocol can put the results in question.

In a statement Wednesday, Oxford University said some of the vials used in the trial didn’t have the right concentration of vaccine so some volunteers got a half-dose. The university said that it discussed the problem with regulators, and agreed to complete the late stage trial with two groups. The manufacturing problem has been corrected, according to the statement.

WHAT ABOUT THE RESULTS THEMSELVES?
Experts say the relatively small number of people in the low dose group makes it difficult to know if the effectiveness seen in the group is real or a statistical quirk. Some 2,741 people received a half dose of the vaccine followed by a full dose, AstraZeneca said. A total of 8,895 people received two full doses.

Another factor: none of the people in the low-dose group were over 55 years old. Younger people tend to mount a stronger immune response than older people, so it could be that the youth of the participants in the low-dose group is why it looked more effective, not the size of the dose.

Another point of confusion comes from a decision to pool results from two groups of participants who received different dosing levels to reach an average 70% effectiveness, said David Salisbury, and associate fellow of the global health program at the Chatham House think tank.

“You’ve taken two studies for which different doses were used and come up with a composite that doesn’t represent either of the doses,″ he said of the figure. “I think many people are having trouble with that.″

WHY WOULD A SMALLER FIRST DOSE BE MORE EFFECTIVE?
Oxford researchers say they aren’t certain and they are working to uncover the reason.

Sarah Gilbert, one of the Oxford scientists leading the research, said the answer is probably related to providing exactly the right amount of vaccine to trigger the best immune response.

“It’s the Goldilocks amount that you want, I think, not too little and not too much. Too much could give you a poor quality response as well,’’ she said. “So you want just the right amount and it’s a bit hit and miss when you’re trying to go quickly to get that perfect first time.”

WHAT ARE THE NEXT STEPS?
Details of the trial results will be published in medical journals and provided to U.K. regulators so they can decide whether to authorize distribution of the vaccine. Those reports will include a detailed breakdown that includes demographic and other information about who got sick in each group, and give a more complete picture of how effective the vaccine is.

Moncef Slaoui, who leads the U.S. coronavirus vaccine program Operation Warp Speed, said Tuesday in a call with reporters that U.S. officials are trying to determine what immune response the vaccine produced, and may decide to modify the AstraZeneca study in the U.S. to include a half dose.

“But we want it to be based on data and science,” he said.

 

[Roccus7]

Here's a bit of the NYTimes' report on the AstraZeneca "Oopsie". This is sad, but a very telling reason why it takes a long time to evaluate vaccine clinical trials. Dosage is firmly established by Phase 2 trials and having the wrong dose given to some recipients in Phase 3 is a blazing klaxon that there was a BIG screw up!!

You can read the entire article here: After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine

After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine​

Some trial participants only got a partial dose of AstraZeneca’s vaccine. Experts said the company’s spotty disclosures have eroded confidence.

AstraZeneca and Oxford “get a poor grade for transparency and rigor when it comes to the vaccine trial results they have reported,” said Natalie Dean, a biostatistician at the University of Florida. Credit...Andrew Testa for The New York Times

By Rebecca Robbins and Benjamin Mueller

The announcement this week that a cheap, easy-to-make coronavirus vaccine appeared to be up to 90 percent effective was greeted with jubilation. “Get yourself a vaccaccino,” a British tabloid celebrated, noting that the vaccine, developed by AstraZeneca and the University of Oxford, costs less than a cup of coffee.

But since unveiling the preliminary results, AstraZeneca has acknowledged a key mistake in the vaccine dosage received by some study participants, adding to questions about whether the vaccine’s apparently spectacular efficacy will hold up under additional testing.

Scientists and industry experts said the error and a series of other irregularities and omissions in the way AstraZeneca initially disclosed the data have eroded their confidence in the reliability of the results.

Officials in the United States have noted that the results were not clear. It was the head of the flagship federal vaccine initiative — not the company — who first disclosed that the vaccine’s most promising results did not reflect data from older people.


The upshot, the experts said, is that the odds of regulators in the United States and elsewhere quickly authorizing the emergency use of the AstraZeneca vaccine are declining, an unexpected setback in the global campaign to corral the devastating pandemic.

“I think that they have really damaged confidence in their whole development program,” said Geoffrey Porges, an analyst for the investment bank SVB Leerink.

 

[BennyV]

Here's a bit of the NYTimes' report on the AstraZeneca "Oopsie". This is sad, but a very telling reason why it takes a long time to evaluate vaccine clinical trials. Dosage is firmly established by Phase 2 trials and having the wrong dose given to some recipients in Phase 3 is a blazing klaxon that there was a BIG screw up!!

You can read the entire article here: After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine

After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine​

Some trial participants only got a partial dose of AstraZeneca’s vaccine. Experts said the company’s spotty disclosures have eroded confidence.

AstraZeneca and Oxford “get a poor grade for transparency and rigor when it comes to the vaccine trial results they have reported,” said Natalie Dean, a biostatistician at the University of Florida. Credit...Andrew Testa for The New York Times

By Rebecca Robbins and Benjamin Mueller

The announcement this week that a cheap, easy-to-make coronavirus vaccine appeared to be up to 90 percent effective was greeted with jubilation. “Get yourself a vaccaccino,” a British tabloid celebrated, noting that the vaccine, developed by AstraZeneca and the University of Oxford, costs less than a cup of coffee.

But since unveiling the preliminary results, AstraZeneca has acknowledged a key mistake in the vaccine dosage received by some study participants, adding to questions about whether the vaccine’s apparently spectacular efficacy will hold up under additional testing.

Scientists and industry experts said the error and a series of other irregularities and omissions in the way AstraZeneca initially disclosed the data have eroded their confidence in the reliability of the results.

Officials in the United States have noted that the results were not clear. It was the head of the flagship federal vaccine initiative — not the company — who first disclosed that the vaccine’s most promising results did not reflect data from older people.


The upshot, the experts said, is that the odds of regulators in the United States and elsewhere quickly authorizing the emergency use of the AstraZeneca vaccine are declining, an unexpected setback in the global campaign to corral the devastating pandemic.

“I think that they have really damaged confidence in their whole development program,” said Geoffrey Porges, an analyst for the investment bank SVB Leerink.

Interesting read. Unfortunately I think this is not going to be the first or last time something like this happens, which is pretty unfortunate considering some people are already uneasy about taking any vaccine.

 

[pequa1]

Moderna ?

 

[Roccus7]

Moderna ?

Moderna and Pfizer, the mRNA vaccines, still on track.

 

[TonySmjc]

Of no relevance to me

I didn’t buy any of their stock
And I have no intention of getting a Flu shot or a covid shot at anytime in the future

I’m by no Strech of the imagination an anti vaccination guy

I simply don’t believe you can vaccinate against this any more than you can effectively vaccinate against the flu or common cold

I’ll keep my sleeves down and my pants up

bring on the barbs and insults

 

[pequa1]

Read somewhere that people may need proof of vaccinations for some travel

 

[TonySmjc]

You get one shot at an opinion, this was the second strike. Take your legal musings to the other thread.

 

[Roccus7]

Read somewhere that people may need proof of vaccinations for some travel

Coming soon to a airport boarding gate, cruise ship dock, train station, bus depot and immigration counter, "No Shots, No Service!" I still remember the smallpox vaccine certificate for foreign travel...

 

[pequa1]

Coming soon to a airport boarding gate, cruise ship dock, train station, bus depot and immigration counter, "No Shots, No Service!" I still remember the smallpox vaccine certificate for foreign travel...

Party boats and charters too ?

 

[TonySmjc]

More drivel

 

[TonySmjc]

More drivel

 

[Roccus7]

Party boats and charters too ?

Who knows?

 

[TonySmjc]

Obviously you're bucking for a time out. Present some real DATA and you may post away. Since you've yet to provide anything from a scientific standpoint, feel free to post all conjecture and opinion on the other COVID thread.

BTW, how's the "numerical value" for your COVID-19 Antibody Test result you swore your doctor would get to you??? We're still waiting with baited breath...

 

[TonySmjc]

Drivel and drool. You got some science to share, we're all ears. You got nothing, then take your soapbox to the other thread and pontificate away...