Covid-19 Vaccine Development

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Brave souls - hopefully from all age groups. My family would have a fit if I volunteered for this. Under the right circumstances, I’d do it, otherwise.

Yes I was talking about this today and I wouldn't mind having it.
Americans are very worried about vaccine safety in general, so circumventing standard protocols would lead to fewer people taking the upcoming vaccines. I suspect that what we’ll do is exactly what we’re already doing (fairly large third phase trials - in which up to 200,000 Americans will get an early vaccine). I might sign up for one myself, if there’s one close enough to where I live (they usually want to find places with higher positivity rates than where I live).

Russia and UK are doing similar things - doing the first two regular phases and then widening the third phase to include as many people as possible. However, it’s hard to imagine that the tracing of all these people would be as rigorous as in what the FDA expects in that phase.

Russia is interesting because most of the early vaccinations have occurred mostly in Moscow and St Petersburg and they are indeed keeping track on the recipients (Russia already has many ways of keeping track of citizens - workplace and state are not as divided as in other nations).

So it’ll be great if UK rushes through to open phase (instead of prolonged third phase) and keeps the data that we’ll all need to feel more confident. Keep in mind that UK already has two people with more serious side effects and IMO, until that’s published properly, I think people should be wary. Right now, there’s no way to know who, exactly, had those side effects (other than their age and sex, which has been published).

I’d bet a dozen donuts that the woman with the myelin issue had received the vaccine and was not in the control group (she was older, but myelin is known to be compromised due to COVID - and no where has it been published that this woman actually got CV, so I’m guessing she got the vaccine).

Americans are going to be slow to take any vaccine that is rushed through too quickly. We have too little trust in our government right now - particularly the HHS. But, our own pharma companies are being forthcoming about their protocols - Johnson and Johnson is my favorite, so far, but there are others.

I don’t think anyone cares if we’re a month or two behind UK or Russia in getting a vaccine. It will be no safer than wearing a mask, anyway, as no vaccine is 100%

For me, I just want a more moderate course of CV if I get it.

No needless deaths need to occur in either scenario nor will deaths drop dramatically in UK or Russia right away - it doesn’t work like that. It will take time to vaccinate millions of people...especially in the midst of the pandemic.

They said the last one was not down to the vaccine, but they would say that wouldn't they. I'll find the link to park here.

US trial of Oxford University's Covid-19 vaccine STILL on hold waiting on FDA decision | Daily Mail Online

Looks like the US are dragging their feet restarting the trial. It has been two weeks now.
 
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Americans are very worried about vaccine safety in general, so circumventing standard protocols would lead to fewer people taking the upcoming vaccines. I suspect that what we’ll do is exactly what we’re already doing (fairly large third phase trials - in which up to 200,000 Americans will get an early vaccine). I might sign up for one myself, if there’s one close enough to where I live (they usually want to find places with higher positivity rates than where I live).

Russia and UK are doing similar things - doing the first two regular phases and then widening the third phase to include as many people as possible. However, it’s hard to imagine that the tracing of all these people would be as rigorous as in what the FDA expects in that phase.

Russia is interesting because most of the early vaccinations have occurred mostly in Moscow and St Petersburg and they are indeed keeping track on the recipients (Russia already has many ways of keeping track of citizens - workplace and state are not as divided as in other nations).

So it’ll be great if UK rushes through to open phase (instead of prolonged third phase) and keeps the data that we’ll all need to feel more confident. Keep in mind that UK already has two people with more serious side effects and IMO, until that’s published properly, I think people should be wary. Right now, there’s no way to know who, exactly, had those side effects (other than their age and sex, which has been published).

I’d bet a dozen donuts that the woman with the myelin issue had received the vaccine and was not in the control group (she was older, but myelin is known to be compromised due to COVID - and no where has it been published that this woman actually got CV, so I’m guessing she got the vaccine).

Americans are going to be slow to take any vaccine that is rushed through too quickly. We have too little trust in our government right now - particularly the HHS. But, our own pharma companies are being forthcoming about their protocols - Johnson and Johnson is my favorite, so far, but there are others.

I don’t think anyone cares if we’re a month or two behind UK or Russia in getting a vaccine. It will be no safer than wearing a mask, anyway, as no vaccine is 100%

For me, I just want a more moderate course of CV if I get it.

No needless deaths need to occur in either scenario nor will deaths drop dramatically in UK or Russia right away - it doesn’t work like that. It will take time to vaccinate millions of people...especially in the midst of the pandemic.

There is a possibility that instead of a placebo they are giving another vaccination so that there is a reaction at the injection site. That could also have given a volunteer a reaction.
 
10,000 UK volunteers to take part in new COVID-19 vaccine trials

250,000 volunteers have signed up and this Novavax trial has begun in UK.

"Ten thousand UK volunteers will from today (Friday 25 September) be invited to join a leading phase 3 coronavirus vaccine trial, as the number of people who have signed up to take part in research hits 250,000.

The Phase 3 study will test the safety and effectiveness of a promising new vaccine, developed by US biotechnology company Novavax, across a broad spectrum of people, including those from a variety age groups and backgrounds. Phase 3 studies involve many thousands of people, giving researchers insights into the effects of a vaccine on a much larger population than phase 1 and 2 studies.

Calling on some of the thousands of volunteers who have joined the fight against coronavirus through the NHS Vaccine Registry, the phase 3 trials, which started yesterday (24 September), are the second to commence in the UK and will be undertaken at a number of National Institute for Health Research (NIHR) regional sites across the UK, including Lancashire, the Midlands, Greater Manchester, London, Glasgow and Belfast."

More at link.
 
Brave souls - hopefully from all age groups. My family would have a fit if I volunteered for this. Under the right circumstances, I’d do it, otherwise.

I have two friends here in the US in vaccine trials. I do consider them pretty brave. They are very provaccine. But I have a lot of health issues and medication allergies that make me inclined to wait till I'm sure it's safe. I admire and respect people willing to take that risk now for others though.
 
Indianapolis COVID-19 vaccine trial on hold after patient get sick | Fox 59

The coordinator states that they put healthy people into the trial (no known underlying conditions), but of course there are many things that can go undetected (just as in the larger population).

No word on if the symptoms are similar to the myelin issues in England, but it is the same vaccine (AstrZeneca).

This probably explains why US trials have not restarted. Under ordinary circumstances, this is taken up only by the top tier of scientists within the study (who can see who got what).
 
I think the Ebola vaccine was authorised for compassionate use long before the FDA approved it in Dec 2019. The EU did not approve it until this year.

Ebola vaccine - Wikipedia
I can't speak to that as I'm definitely learning all about this myself. In this writing, the bolded wording is done by him, not me. He is referencing the Anthrax vaccine. Not that it didn't happen with Ebola also, I just don't know enough about it all yet.

Trick or treat? A fact check on a COVID-19 Vaccine before Halloween

On August 26, U.S. Food & Drug Administration Commissioner Dr. Stephen Hahn tweeted that the FDA Vaccine Advisory Committee will be convened Oct. 22 to review COVID-19 vaccines.

On August 30 Dr. Hahn was reported in the Financial Times stating he would consider issuing an EUA — an Emergency Use Authorization — for a COVID-19 vaccine to be given to certain groups of persons even before the end of a Phase 3 efficacy trial.

Notably, no new unlicensed vaccine candidate has ever received an EUA from the FDA.

Thus, unlike hundreds of EUAs issued over the years for diagnostic tests and therapies, there is no new unlicensed vaccine precedent for an EUA. (The only EUA for a vaccine was in 2005 for the anthrax vaccine that had been licensed for over 30 years).
 
16 pharmaceutical companies and the Gates Foundation to scale up manufacturing of Covid-19 vaccines

The 16 pharmaceutical companies to sign this agreement are AstraZeneca; Bayer; bioMérieux; Boehringer Ingelheim; Bristol Myers Squibb; Eisai; Eli Lilly; Gilead; GSK; Johnson & Johnson; Merck & Co. (known as MSD outside the U.S. and Canada); Merck KGaA; Novartis; Pfizer; Roche; and Sanofi.

United Nations welcomes nearly $1 billion in recent pledges - to bolster access to lifesaving tests, treatments and vaccines to end COVID-19

The Bill & Melinda Gates Foundation has signed a new joint agreement, along with 16 pharmaceutical companies, to commit to scaling up manufacturing of Covid-19 vaccines at "an unprecedented speed" and making sure that approved vaccines reach broad global distribution as early as possible.


 
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Interesting and will have to watch what the result is from the EAU & FDA.

Regeneron REGN-COV2 monoclonal antibody reported better in (non-hospitalized) patients who lack their own antibodies to SARS-CoV-2

On Wednesday, Regeneron posted a “Statement on REGN-COV2 Emergency Use Authorization Request.”

How will FDA make its decision on this request for an EUA? Will it convene a meeting of outside expert advisors? In what time frame will the FDA announce its decision?

A second US company also requested an EUA for its monoclonal (single) antibody Wednesday.

Will the FDA make its decision on both companies’ requests at the same time?
 
Interesting and will have to watch what the result is from the EAU & FDA.

Regeneron REGN-COV2 monoclonal antibody reported better in (non-hospitalized) patients who lack their own antibodies to SARS-CoV-2

On Wednesday, Regeneron posted a “Statement on REGN-COV2 Emergency Use Authorization Request.”

How will FDA make its decision on this request for an EUA? Will it convene a meeting of outside expert advisors? In what time frame will the FDA announce its decision?

A second US company also requested an EUA for its monoclonal (single) antibody Wednesday.

Will the FDA make its decision on both companies’ requests at the same time?
They should do, as the study results have been good. I will post them on here. IMO it is as good as a vaccine for the time being.

Regeneron's REGN-COV2 Antibody Cocktail Reduced Viral Levels and Improved Symptoms in Non-Hospitalized COVID-19 Patients | Regeneron Pharmaceuticals Inc.

"The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally-occurring immune response. These patients were less likely to clear the virus on their own, and were at greater risk for prolonged symptoms. We are highly encouraged by the robust and consistent nature of these initial data, as well as the emerging well-tolerated safety profile, and we have begun discussing our findings with regulatory authorities while continuing our ongoing trials. In addition to having positive implications for REGN-COV2 trials and those of other antibody therapies, these data also support the promise of vaccines targeting the SARS-CoV-2 spike protein."

The descriptive analysis included the first 275 patients enrolled in the trial and was designed to evaluate anti-viral activity with REGN-COV2 and identify patients most likely to benefit from treatment; the next cohort, which could be used to rapidly and prospectively confirm these results, has already been enrolled. Patients in the trial were randomized 1:1:1 to receive a one-time infusion of 8 grams of REGN-COV2 (high dose), 2.4 grams of REGN-COV2 (low dose) or placebo. All patients entering the trial had laboratory-confirmed COVID-19 that was being treated in the outpatient setting. Patients were prospectively characterized prior to treatment by serology tests to see if they had already generated antiviral antibodies on their own and were classified as seronegative (no measurable antiviral antibodies) or seropositive (measurable antiviral antibodies). Approximately 45% of patients were seropositive, 41% were seronegative and 14% were categorized as "other" due to unclear or unknown serology status."

More technical details at the link.
 
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US pauses Covid vaccine trial due to ill volunteer

Johnson & Johnson has paused its Covid vaccine trial to investigate why one participant in the study fell ill.

The company said an independent review would check if the person's unexplained symptoms were related to the jab.

It has suspended recruitment to the phase three trial as a precaution.

It said in large trials, with tens of thousands of volunteers, it was to be expected that some may become unwell during the study period.

The company said that for privacy reasons, it could not give more details about the participant.

"We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information," it said in a statement.

It is not the first Covid vaccine trial to be suspended - a participant in the UK's Oxford University study had an unexplained illness too, but it has since been deemed safe to resume, except for in the US where regulators are still in discussions with manufacturer Astra Zeneca.
 
Covid-19 vaccine 90 percent effective in early analysis, Pfizer says

"Today is a great day for science and humanity," Albert Bourla, Pfizer's chairman and chief executive, said in a statement.

The drug company Pfizer said Monday that early analysis showed its candidate for Covid-19 is more than 90 percent effective in preventing infection.

It said no serious safety concerns were observed in the trial, and that it would apply for emergency use authorization to the U.S. Food and Drug Administration after a key safety hurdle was passed, likely in mid-November...
 
Data is in on Moderna vaccine. It's 94% effective. Also stable at room temperature, no need to keep it cold/frozen

Moderna's coronavirus vaccine is 94.5% effective, according to company data - CNN

In Moderna's trial, 15,000 study participants were given a placebo, which is a shot of saline that has no effect. Over several months, 90 of them developed Covid-19, with 11 developing severe forms of the disease.

Another 15,000 participants were given the vaccine, and only five of them developed Covid-19. None of the five became severely ill.

I think this is the vaccine that doesn't always prevent you getting COVID 19, but if you do, the symptoms are not severe. JMO, doesn't that mean it will help stop the spread of COVID 19 to others, but not completely.

We should be hearing more results in the coming days and weeks as the other vaccine trials were on a similar schedule.
 
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Data is in on Moderna vaccine. It's 94% effective. Also stable at room temperature, no need to keep it cold/frozen

Moderna's coronavirus vaccine is 94.5% effective, according to company data - CNN



I think this is the vaccine that doesn't always prevent you getting COVID 19, but if you do, the symptoms are not severe. JMO, doesn't that mean it will help stop the spread of COVID 19 to others, but not completely.

We should be hearing more results in the coming days and weeks as the other vaccine trials were on a similar schedule.

This is exciting news. Not only for Operation Warp Speed but for the future of medicine. :) JMO
 

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