OT: COVID Science - Pfizer/Moderna vaccines >90% effective; Regeneron antibody cocktail looks very promising in phase II/III trial and more

[Knight Shift]

Need to see the data on efficacy and safety on all of them to compare and we haven't seen all that yet. But if I could get one today, I'd get either mRNA vaccine in a heartbeat. But I'll have to wait 3-4 months and by then we'll have much more data.

Is it true what I read somewhere--it was a JAMA-affiliated website that this is the first commercial vaccine using mRNA technology? Is that correct, and if so, no reservations?

This is a naive (perhaps dumb) question-- people who get vaccinated-- can they still be carriers and infect others?

The Pfizer vaccine is safe and very effective. The side effect profile that I posted above is very clean. Assuming that the J&J vaccine has similar data, I would ask for that one just since it is only one shot. However, I'm not going to turn down the Pfizer vaccine just to wait for J&J.

Is the concern about mRNA is that the protection won't last as long as a normal vaccine?

I still believe a lot of this "pandemic" is hype, but it's time to end this crap. Everyone needs to get the vaccine ASAP.

Concern, is that there is very little (if any) commercial experience with mRNA vaccines.
I'm not anti-vax. I just got the shingles vaccine, and it kicked by ass both times. Another reason I may just wait for J&J single shot.

I have not heard anything yet, and not sure if volunteer first responders are counted as essential workers. If yes, I may wait for J&J if it is not available when the vaccines are offered.

 

[RU848789]

Is it true what I read somewhere--it was a JAMA-affiliated website that this is the first commercial vaccine using mRNA technology? Is that correct, and if so, no reservations?

This is a naive (perhaps dumb) question-- people who get vaccinated-- can they still be carriers and infect others?


Concern, is that there is very little (if any) commercial experience with mRNA vaccines.
I'm not anti-vax. I just got the shingles vaccine, and it kicked by ass both times. Another reason I may just wait for J&J single shot.

I have not heard anything yet, and not sure if volunteer first responders are counted as essential workers. If yes, I may wait for J&J if it is not available when the vaccines are offered.

Yes, no MRNA vaccine has made it beyond clinical trials, to date, which is why I was been skeptical from February until we saw the initial phase I human data showing excellent immune response and minimal side effects. But every great breakthrough has to have a first time.

Given the spectacularly good data in phase III trials - and assuming there's no new concerns raised when the entire data set is reviewed by the FDA this week (there's a lot of data we haven't seen yet, but presumably if there had been any red flags we'd have heard about it), I wouldn't hesitate to get the vaccine. If I were in your position, there's no effing way in hell I'd wait if I could get it now.

It's likely that the small percentage of people who were vaccinated and became infected with the virus and became symptomatic would be at least somewhat infectious, but that hasn't been fully evaluated yet, i..e, I don't know that they've revealed the viral loads in those patients who became infected.

We also don't know how many people might have become infected but were asymptomatic, since they only tested people who were symptomatic - and that means we have no idea if they might have been even transiently infectious. The vaccine will absolutely greatly reduce illness (to close to zero, given 1 serious infection from the two mRNA trials combined), but it's likely going to only significantly decrease, but not stop transmission.

https://www.businessinsider.com/una...coronavirus-vaccine-what-we-dont-know-2020-11

 

[richthedentist]

Need to see the data on efficacy and safety on all of them to compare and we haven't seen all that yet. But if I could get one today, I'd get either mRNA vaccine in a heartbeat. But I'll have to wait 3-4 months and by then we'll have much more data.

Have you heard anything about when you get the vaccine if you can actually give someone Covid ie are we infectious when we get it? The Moderna CEO seemed to implicate he was not sure of this which as a health care provider this would be a big problem

 

[RU848789]

Do some math. The EU is already approved the vaccine. People will be getting the first shots tomorrow. Keep being a homer idiot.

Wrong. The EU has not approved any COVID vaccines, only the UK has, as their "FDA" is independent from the EU. The EU is likely to grant emergency use at the end of December, about 2-3 weeks after the US.

https://apnews.com/article/europe-regulator-covid-19-vaccine-dec-29-8700be24e4fbdb1cbdcc78532b3a5d15

 

[RU848789]

Have you heard anything about when you get the vaccine if you can actually give someone Covid ie are we infectious when we get it? The Moderna CEO seemed to implicate he was not sure of this which as a health care provider this would be a big problem

I have no idea why anyone would even suggest this. There is no "virus" associated with any of the current vaccines, so the vaccine can't "give" anyone else the virus. In theory, "live virus" vaccines (one of the Chinese vaccines is based on this) can give someone an infection, but that's extremely rare.

 

[RU848789]

So why do the numbers not support it. From a 100 million doses from Pfizer turns into less than 25% . Just 20 million max in the US by the end of this year. Yet they will be vaccinating people tomorrow in Europe. This isn't an Olympic event. It a world wide event with worldwide companies controlling distribution.

The reduction in projected doses by the end of the year, which was made about a month ago, so I'm not sure why you keep harping about it, was 50% from 100MM to 50MM, of which half go to the US (25MM for 12.5MM patients), which along with the Moderna allotment gets us to roughly about 20MM patients vaccinated by around the end of this year, as I said eariler.

Neither Pfizer nor Moderna have cut projected production for 1Q21, which I provided in great detail above also. Could that happen? Sure, many things can happen, but from what I've read and heard from at least one source at Pfizer, they expect to meet these projections. And, as I also just posted, the UK is the only country in Europe (not counting Russia) deploying any vaccines; the EU won't approve until the end of December. You really need to research your posts better.

 

[ArminRU]

Just to add a bit more detail to this, after the 23MM health care workers and LTC residents, who will get the vaccine first, the next groups are going to be the 87MM "essential" workers, the 100MM people with underlying conditions and the 53MM people over 65. That sounds like 263MM people (including the 23MM in the first wave), but there's overlap (many over 65 and/or essential workers also have underlying conditions), so maybe that's 200MM overall (this is a WAG). The link below outlines all of this.

As I said above, I think we'll have doses for 150-200MM people (these are US doses) by the end of March, assuming AZ/J&J come through with approved vaccines by the end of January. The other factor is only 58% of people say they're going to get a vaccine, which I believe is a significant underestimate, as people will want the vaccine more, once they see it's safe and effective and many people are getting it. Even if 70% getting vaccines is the "right" number, that means maybe only 70% of those 200MM prioritized people (considering the overlaps) or 140MM will actually get the vaccine.

That's why I believe vaccines will start becoming available by the end of March for everyone else who wants one, given I think we'll have doses for 150-200MM people by the end of March. Of course, not all of the rest of the 70MM heathy people will be able to get vaccines all at once, but I'm guessing they will be able to by the end of April (upside is by late March if AZ/J&J come through by late Jan; downside May if they don't and/or there are any other major delays).

https://www.cnet.com/how-to/who-get...rst-cdc-priority-and-everything-else-we-know/

I think there will be a large amount of people who previously tested positive and won’t get the vaccine immediately. Of the people I know who have been infected, none of them plan on getting the vaccine anytime soon because they feel comfortable with their natural immunity.

 

[ArminRU]

The Pfizer vaccine is safe and very effective. The side effect profile that I posted above is very clean. Assuming that the J&J vaccine has similar data, I would ask for that one just since it is only one shot. However, I'm not going to turn down the Pfizer vaccine just to wait for J&J.

Is the concern about mRNA is that the protection won't last as long as a normal vaccine?

I still believe a lot of this "pandemic" is hype, but it's time to end this crap. Everyone needs to get the vaccine ASAP.

The more I read about mRNA vaccines, the more I feel comfortable with them from a safety standpoint. Short term obviously looks good.

Long term is a bit of an unknown. However, they are not toxic, do not alter your DNA, and they break down very quickly after entering your body. I just can’t see how this could cause any sort of neurological disease years down the road. On top of that, it is very very rare for any vaccine to cause any sort of long term issues.

 

[bac2therac]

I have no idea why anyone would even suggest this. There is no "virus" associated with any of the current vaccines, so the vaccine can't "give" anyone else the virus. In theory, "live virus" vaccines (one of the Chinese vaccines is based on this) can give someone an infection, but that's extremely rare.

it suggested by cnn, gupta, and a asian female doctor on anderson cooper last week

 

[Knight Shift]

The more I read about mRNA vaccines, the more I feel comfortable with them from a safety standpoint. Short term obviously looks good.

Long term is a bit of an unknown. However, they are not toxic, do not alter your DNA, and they break down very quickly after entering your body. I just can’t see how this could cause any sort of neurological disease years down the road. On top of that, it is very very rare for any vaccine to cause any sort of long term issues.

Do you have any backup or links on your safety statement, toxicity and alteration of DNA.

There are dangers and concerns on the EUA with respect to trial participants:

Why emergency COVID-vaccine approvals pose a dilemma for scientists

Immunizations are speeding towards approval before clinical trials end, but scientists say this could complicate efforts to study long-term effects.

www.nature.com

"But if too many people cross over, the trials might not have sufficiently large control groups to gather statistically significant results for some long-term goals, says Stöhr. These include ruling out any long-term safety issues, and conclusively establishing whether the vaccine prevents people getting infected with SARS-CoV-2, or whether it simply protects infected people from getting the disease."


There also seem to be a lot of unkowns:

How safe are the new COVID-19 vaccines? And how do mRNA vaccines work?

Creating two vaccines in less than a year is an astonishing achievement, experts say, but the next task could prove even more difficult — convincing Americans that it’s safe to take vaccines developed at such a breakneck pace.

www.chicagotribune.com

"But the fact that these are the first two broadly available vaccines based on bits of genetic material called messenger RNA will prompt additional scrutiny regarding long-term effects, experts added."

“What turns it off? What makes it so it is no longer making coronavirus spike protein anymore?” Offit said. “If you look at the animal model studies, mice for example, you would assume that goes on for about 10 days. But what happens in humans, I don’t know. We will find that out, I think, over time.”

 

[ArminRU]

Do you have any backup or links on your safety statement, toxicity and alteration of DNA.

There are dangers and concerns on the EUA with respect to trial participants:

Why emergency COVID-vaccine approvals pose a dilemma for scientists

Immunizations are speeding towards approval before clinical trials end, but scientists say this could complicate efforts to study long-term effects.

www.nature.com

"But if too many people cross over, the trials might not have sufficiently large control groups to gather statistically significant results for some long-term goals, says Stöhr. These include ruling out any long-term safety issues, and conclusively establishing whether the vaccine prevents people getting infected with SARS-CoV-2, or whether it simply protects infected people from getting the disease."


There also seem to be a lot of unkowns:

How safe are the new COVID-19 vaccines? And how do mRNA vaccines work?

Creating two vaccines in less than a year is an astonishing achievement, experts say, but the next task could prove even more difficult — convincing Americans that it’s safe to take vaccines developed at such a breakneck pace.

www.chicagotribune.com

"But the fact that these are the first two broadly available vaccines based on bits of genetic material called messenger RNA will prompt additional scrutiny regarding long-term effects, experts added."

“What turns it off? What makes it so it is no longer making coronavirus spike protein anymore?” Offit said. “If you look at the animal model studies, mice for example, you would assume that goes on for about 10 days. But what happens in humans, I don’t know. We will find that out, I think, over time.”

Article explaining DNA is not changed and the mRNA only lasts a couple hours within the body. These are non-replicating mRNA vaccines, I read that too but can’t remember where.

Experts: mRNA vaccine for COVID-19 does not alter DNA

CLAIM: The new vaccine for COVID-19 will be the first of its kind ever. It will be an "MRna vaccine" which will literally alter your DNA. It will wrap itself into your system. You will essentially become a genetically modified human being. AP’S ASSESSMENT: False. Experts say mRNA vaccines do...

apnews.com

 

[RU848789]

it suggested by cnn, gupta, and a asian female doctor on anderson cooper last week

I'd need to see that, since it makes zero sense. I could see a non-scientist saying something incorrect, but not Gupta, as he's pretty good.

 

[RU848789]

Do you have any backup or links on your safety statement, toxicity and alteration of DNA.

There are dangers and concerns on the EUA with respect to trial participants:

Why emergency COVID-vaccine approvals pose a dilemma for scientists

Immunizations are speeding towards approval before clinical trials end, but scientists say this could complicate efforts to study long-term effects.

www.nature.com

"But if too many people cross over, the trials might not have sufficiently large control groups to gather statistically significant results for some long-term goals, says Stöhr. These include ruling out any long-term safety issues, and conclusively establishing whether the vaccine prevents people getting infected with SARS-CoV-2, or whether it simply protects infected people from getting the disease."


There also seem to be a lot of unkowns:

How safe are the new COVID-19 vaccines? And how do mRNA vaccines work?

Creating two vaccines in less than a year is an astonishing achievement, experts say, but the next task could prove even more difficult — convincing Americans that it’s safe to take vaccines developed at such a breakneck pace.

www.chicagotribune.com

"But the fact that these are the first two broadly available vaccines based on bits of genetic material called messenger RNA will prompt additional scrutiny regarding long-term effects, experts added."

“What turns it off? What makes it so it is no longer making coronavirus spike protein anymore?” Offit said. “If you look at the animal model studies, mice for example, you would assume that goes on for about 10 days. But what happens in humans, I don’t know. We will find that out, I think, over time.”

Been talking about these concerns for months and they're real. The problem is it's essentially unethical to approve an EUA for use prior to formal approval, as is likely being done this week in the US, without offering the placebo arm volunteers the vaccine, when they would be eligible (i.e. if they're healthy and under 65, they could get the vaccine when that group does or if they're a health care worker they could get the vaccine ASAP; some think the volunteers should go to the head of the line, but most don't). They've done their part and should be allowed to do this.

This was always going to be a risk to obtaining long term clinical trial information, which is usually never an issue as EUAs don't get issued much and certainly not within weeks of doing interim analyses. It's a classic risk-benefit analysis, though, since the upside of starting vaccinations, even without long-term safety/efficacy data, far outweighs the risks, especially for people at high risk from the virus and when any serious risks that would affect more than a tiny percent of the population should have been uncovered already.

For example, let's say there's a serious risk that escaped detection so far, meaning it's likely less than a 1 in 15-20K risk (the number of people vaccinated in the trials so far; let's say 1 in 20K for easier math). 1 in 20K is 50 in 1MM, which is significantly more than the risks of serious adverse events from most vaccines, which rarely have any serious events that are more than 1 in 1MM. But I'm pretty sure almost all would agree that having a few dozen serious adverse events (if that's the number - we just don't know - that's likely the worst case) is acceptable if the vaccines are saving probably a few hundred thousand lives (just talking US here). It's also pretty rare that there are significant long-term adverse events that aren't seen in the first few months of any vaccine trial, but that's not a guarantee either.

https://www.usatoday.com/story/news...vid-19-trials-put-volunteers-risk/6473436002/

 

[Knight Shift]

Been talking about these concerns for months and they're real. The problem is it's essentially unethical to approve an EUA for use prior to formal approval, as is likely being done this week in the US, without offering the placebo arm volunteers the vaccine, when they would be eligible (i.e. if they're healthy and under 65, they could get the vaccine when that group does or if they're a health care worker they could get the vaccine ASAP; some think the volunteers should go to the head of the line, but most don't). They've done their part and should be allowed to do this.

This was always going to be a risk to obtaining long term clinical trial information, which is usually never an issue as EUAs don't get issued much and certainly not within weeks of doing interim analyses. It's a classic risk-benefit analysis, though, since the upside of starting vaccinations, even without long-term safety/efficacy data, far outweighs the risks, especially for people at high risk from the virus and when any serious risks that would affect more than a tiny percent of the population should have been uncovered already.

For example, let's say there's a serious risk that escaped detection so far, meaning it's likely less than a 1 in 15-20K risk (the number of people vaccinated in the trials so far; let's say 1 in 20K for easier math). 1 in 20K is 50 in 1MM, which is significantly more than the risks of serious adverse events from most vaccines, which rarely have any serious events that are more than 1 in 1MM. But I'm pretty sure almost all would agree that having a few dozen serious adverse events (if that's the number - we just don't know - that's likely the worst case) is acceptable if the vaccines are saving probably a few hundred thousand lives (just talking US here). It's also pretty rare that there are significant long-term adverse events that aren't seen in the first few months of any vaccine trial, but that's not a guarantee either.

https://www.usatoday.com/story/news...vid-19-trials-put-volunteers-risk/6473436002/

And this is why some people may be a bit wary and may decide to wait a bit before getting vaccinated. Some don't care how many former Presidents get vaccinated together (did not see President Carter, and he's a scientist/engineer!!!). That does not make them bad people or anti-vaxers, they just may want to wait to see how the first groups of people do with the vaccines.

 

[RU848789]

And this is why some people may be a bit wary and may decide to wait a bit before getting vaccinated. Some don't care how many former Presidents get vaccinated together (did not see President Carter, and he's a scientist/engineer!!!). That does not make them bad people or anti-vaxers, they just may want to wait to see how the first groups of people do with the vaccines.

I understand wary, although if I were on the front lines or behaving in a risky manner, I'd have zero issue getting either mRNA vaccine, as soon as the FDA approves the EUA and presumably shares more details from the ongoing clinical trials (they have to) and assuming those data don't raise any red flags. For me even a 1 in 20K chance of a serious adverse event (and it should be far less than that, with 1 in 20K being the absolute worst case, since there were no serious adverse events, due to the vaccine, so far) is not worth the 72 in 20K risk of dying for people aged 50-64 (43K deaths from COVID for ~12MM people, assuming ~20% infected so far; that's about 8X the death rate from flu for that age group) and about the 500-1000 per 20K chance of a serious illness.

Perhaps for young, healthy people, the comparison isn't as clear cut, although if the risk of death and serious adverse events are actually more like 1 in 500K or more, as one would expect given the data so far and comparison to past history of other vaccines (and we'll know this better in about a month after 10MM+ are vaccinated), then getting the vaccine still would make sense to me, as the chances of dying for 25-34 year olds are 0.022% or 4.4 in 20K or 110 in 500K (2037 COVID deaths over 20% of 46MM people). It would also be helpful to confirm if vaccinated people are less likely to transmit the virus (should be the case, but not proven yet), as that's another reason to get the vaccine.

Having said all that, I'm not a high priority, so I'll have to wait and I'm ok with waiting, as we're very conservative on contact with anyone and I'm ok with people at much greater risk of infection getting the vaccine before me. That will also give us the luxury of knowing a fair amount more about the vaccines and their efficacy/safety by the time we get vaccinated.

With regard to side effects, another angle we're going to need to consider is the media frenzy/scare angle, which we know is real. Derek Lowe has a nice blog article on this from Friday, where he talks about the fact that any sample of 10MM people, vaccinated or not, is going to have quite a few deaths (14K) and many other medical maladies and there will be reports about some of these being "due to" the vaccine and that will likely scare some people away from getting the vaccine, unfortunately. This is not the same as the flawed argument circulating that deaths from COVID aren't really due to COVID, as those deaths are signed off on by doctors and the 300K+ excess deaths so far this year is an independent check that the 275K deaths we've seen from COVID are truly due to COVID.

https://blogs.sciencemag.org/pipeline/archives/2020/12/04/get-ready-for-false-side-effects

Bob Wachter of UCSF had a very good thread on Twitter about vaccine rollouts the other day, and one of the good points he made was this one. We’re talking about treating very, very large populations, which means that you’re going to see the usual run of mortality and morbidity that you see across large samples. Specifically, if you take 10 million people and just wave your hand back and forth over their upper arms, in the next two months you would expect to see about 4,000 heart attacks. About 4,000 strokes. Over 9,000 new diagnoses of cancer. And about 14,000 of that ten million will die, out of usual all-causes mortality. No one would notice. That’s how many people die and get sick anyway.

But if you took those ten million people and gave them a new vaccine instead, there’s a real danger that those heart attacks, cancer diagnoses, and deaths will be attributed to the vaccine. I mean, if you reach a large enough population, you are literally going to have cases where someone gets the vaccine and drops dead the next day (just as they would have if they *didn’t* get the vaccine). It could prove difficult to convince that person’s friends and relatives of that lack of connection, though. Post hoc ergo propter hoc (after this, therefore because of this) is one of the most powerful fallacies of human logic, and we’re not going to get rid of it any time soon. Especially when it comes to vaccines. The best we can do, I think, is to try to get the word out in advance. Let people know that such things are going to happen, because people get sick and die constantly in this world. The key will be whether they are getting sick or dying at a noticeably higher rate once they have been vaccinated.

No such safety signals have appeared for the first vaccines to roll out (Moderna and Pfizer/BioNTech). In fact, we should be seeing the exact opposite effects on mortality and morbidity as more and more people get vaccinated. The excess-death figures so far in the coronavirus pandemic have been appalling (well over 300,000 in the US), and I certainly think mass vaccination is the most powerful method we have to knock that back down to normal.

That’s going to be harder to do, though, if we get screaming headlines about people falling over due to heart attacks after getting their vaccine shots. Be braced.

 

[bac2therac]

 

[WhiteBus]

There is a great new mask being worn in Philly. It reads
"THIS MASK IS AS USELESS AS OUR MAYOR" 😂
So true!

 

[Greg2020]

Almost none of those things happen on plane rides but its ok, I don't need your deflection. I get it, and will stop asking you questions since your lack on response is actually revealing enough. Just to be clear, in no way have any of my posts or questions been "fear mongering", so take that label and stick it with all the other nonsense you spew.

I am pretty sure Bac has never been on a plane.

 

[RU848789]

Here's an interesting sampling of articles from today, highlighting related elements of the pandemic.

The first one is from the Atlantic, discussing how we've reached the peak in deaths we saw in the spring and how brutal the next 2 months will be before vaccines start to make a difference by late January. I've talked about all of this frequently and think we'll see up to 2500-3000 deaths/day (a bit more than the ~2200/day in the spring) assuming we end up with a bit over 2X the hospitalizations of this summer. We're getting near 2X now and some think we'll see 3000-4000 deaths/day - I don't, but 2500-3000 is no picnic either - and Christmas gatherings could actually bump things up over 3000/day, sadly.

https://www.theatlantic.com/.../covid-deaths.../617318/

The second is another example of a superspreader event from rural Washington, which involved health care workers attending a 300-person, packed indoor wedding, violating state restrictions, with mask-wearing optional, and then likely being the source of death for 6 LTC patients where they work. It's yet another example of how so many are still not following masking/distancing guidances privately, especially indoors, where the risks are highest, despite more public evidence of mask compliance.

https://www.seattletimes.com/.../17-cases-two-covid-19.../

The third is an interesting story from Slovakia, where they instituted lockdowns and massive, frequent, and rapid antigen testing of the entire population (something many have talked about being a way out of the pandemic if it could be scaled up), resulting in over an 80% reduction in cases in just 2 weeks. Surely some of the reduction was due to the lockdown, but much of it is also likely due to rapid identification and isolation of positives, early in their infections, when they're most infectious.

https://www.lshtm.ac.uk/.../mass-testing-short-period...

And finally, the fourth one is a sad reminder of what could have been if we and other countries had taken this potential pandemic as seriously as Taiwan did in the beginning, which is the most important time to stop a pandemic. It's an interview with their leading infectious disease doctor, who traveled to Wuhan in mid-January and saw for himself how bad this could be, as it was obvious there was out of control human-to-human transmission going on. He returned and helped drive adoption of strict travel restrictions and quarantines of any positive cases and contacts (supported by aggressive early testing). This country of 24MM, located right next to China, where it all started, has had 7 deaths...

https://www.theguardian.com/.../a-year-after-wuhan-alarm...

 

[RU848789]

Fantastic article on the speed of development of the Moderna vaccine and how we actually could've gone far faster in hindsight. I love the part about pre-developing vaccines for a host of virus classes now and doing the animal and then early clinical testing in healthy volunteers and then manufacture at least millions of doses at risk, so that if it looks like one of these viruses could take off in a pandemic, we could be ready to do phase III trials very soon after the risk was identified.

https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.html

For COVID, if this approach had been taken, it's possible we could've had the vaccine ready for rollout in April. Most of us have been just amazed at even getting to emergency approval in 11 months vs. the typical 4+ years, but reading this makes it clear we can go even faster - if we pre-invest, which is not something we tend to do well, unfortunately. The article also reiterates something I've tried to remind people of - that without doing the fundamental research on viruses, genetics, vaccines, immunology, etc., as well as how those all applied to SARS and MERS (where vaccines were developed but never deployed as the outbreaks died out), there's simply no way we would've gotten this and other vaccines developed in anywhere near a year.

I also love the story of how Dr. Fauci and his staff at NAIAD were talking to Moderna R&D leads within a day after first getting the genetic sequence of the virus from the Chinese and saying they needed to get an mRNA vaccine going ASAP. I think a lot of people don't really know what a distinguished scientific leader Fauci is. I've read a few of his papers and he's done some amazing work.

https://www.contagionlive.com/view/anthony-fauci-how-covid19-vaccines-progressed-quickly-safely

The Chinese published the sequence of SARS-CoV-2 in a public database on January 10,” he explained. “I got my team together on the 11th (of January) and said, ‘We’ve got to partner with Moderna and put this in an mRNA platform.’ By the 15th, we started doing it. Sixty-five days later, we were in a phase 1 trial. And 7 months later, we’re in a phase 3 trial. That process would normally take a few years, but we didn’t compromise anything.”

 

[rutgersdave]

I'd need to see that, since it makes zero sense. I could see a non-scientist saying something incorrect, but not Gupta, as he's pretty good.

I watched CNN and it basically said there was no virus in the vaccine so you wouldn’t be able to get the coronavirus from the vaccine.

 

[RU_DIO]

Fantastic article on the speed of development of the Moderna vaccine and how we actually could've gone far faster in hindsight. I love the part about pre-developing vaccines for a host of virus classes now and doing the animal and then early clinical testing in healthy volunteers and then manufacture at least millions of doses at risk, so that if it looks like one of these viruses could take off in a pandemic, we could be ready to do phase III trials very soon after the risk was identified.

https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.html

For COVID, if this approach had been taken, it's possible we could've had the vaccine ready for rollout in April. Most of us have been just amazed at even getting to emergency approval in 11 months vs. the typical 4+ years, but reading this makes it clear we can go even faster - if we pre-invest, which is not something we tend to do well, unfortunately. The article also reiterates something I've tried to remind people of - that without doing the fundamental research on viruses, genetics, vaccines, immunology, etc., as well as how those all applied to SARS and MERS (where vaccines were developed but never deployed as the outbreaks died out), there's simply no way we would've gotten this and other vaccines developed in anywhere near a year.

I also love the story of how Dr. Fauci and his staff at NAIAD were talking to Moderna R&D leads within a day after first getting the genetic sequence of the virus from the Chinese and saying they needed to get an mRNA vaccine going ASAP. I think a lot of people don't really know what a distinguished scientific leader Fauci is. I've read a few of his papers and he's done some amazing work.

https://www.contagionlive.com/view/anthony-fauci-how-covid19-vaccines-progressed-quickly-safely

The Chinese published the sequence of SARS-CoV-2 in a public database on January 10,” he explained. “I got my team together on the 11th (of January) and said, ‘We’ve got to partner with Moderna and put this in an mRNA platform.’ By the 15th, we started doing it. Sixty-five days later, we were in a phase 1 trial. And 7 months later, we’re in a phase 3 trial. That process would normally take a few years, but we didn’t compromise anything.”

Hey,

Wanted to say thank you for all the data you provide. I just wanted to ask your opinion on one thing. You retired from Merck and are now consulting. Your company decided to forego fast tracking a vaccine and decided to use the traditional method to create a vaccine which will take them 4 years or so to do. I've been told by a good friend who works at Merck that this was done to insure that their virus would have no long term affects on people. So my question is why are you so confident in these quickly made vaccines when your own company is against speeding up the process?

 

[ejgonz]

Hey,

Wanted to say thank you for all the data you provide. I just wanted to ask your opinion on one thing. You retired from Merck and are now consulting. Your company decided to forego fast tracking a vaccine and decided to use the traditional method to create a vaccine which will take them 4 years or so to do. I've been told by a good friend who works at Merck that this was done to insure that their virus would have no long term affects on people. So my question is why are you so confident in these quickly made vaccines when your own company is against speeding up the process?

I worked at Merck for 15 years before taking a career opportunity elsewhere. Merck ALWAYS plays the long game and does not rush. I would bet they end up with the safest, most durable vaccine in the end and 5 years from now will quietly have one of, if not the, top selling vaccine.

 

[RU_DIO]

I worked at Merck for 15 years before taking a career opportunity elsewhere. Merck ALWAYS plays the long game and does not rush. I would bet they end up with the safest, most durable vaccine in the end and 5 years from now will quietly have one of, if not the, top selling vaccine.

Do you have any concerns about the vaccines that are about to be rolled out to the general public? Most people I talk to do not have any desire to take the vaccine. And no one I've spoken to wants to get the vaccine for their children.

 

[T2Kplus10]

I worked at Merck for 15 years before taking a career opportunity elsewhere. Merck ALWAYS plays the long game and does not rush. I would bet they end up with the safest, most durable vaccine in the end and 5 years from now will quietly have one of, if not the, top selling vaccine.

No, Sanofi will end up with the top vaccine once the dust settles. They are by far the world leader in vaccines and theirs will come out in a few months. They are batting clean up vs. the coronavirus:

1. Pfizer
2. Moderna
3. J&J
4. Sanofi

Game over. Merck wasn't quick enough and is still sitting in the dugout.

 

[T2Kplus10]

Do you have any concerns about the vaccines that are about to be rolled out to the general public? Most people I talk to do not have any desire to take the vaccine. And no one I've spoken to wants to get the vaccine for their children.

Known technology, clean trials, clinical trail patients will continue to be tracked, etc. FYI, the concern about AEs for vaccines are acute, not chronic. Any of this would show up very quickly.

 

[ejgonz]

Do you have any concerns about the vaccines that are about to be rolled out to the general public? Most people I talk to do not have any desire to take the vaccine. And no one I've spoken to wants to get the vaccine for their children.

I work in clinical research and there isn’t enough data today for me to feel assured. But my wife and I work at home 100% now and my kids are fully virtual for school. We don’t have any preexisting conditions, so we’re good to sit tight for a while and wait for more data. But the way things are trending I will take one of the front runner vaccines if things continue to look good.

I also think I want my near 90 year old grandmother and 65+ father to get vaccinated early on. The Pfizer vaccine has the best safety profile so far it seems.

 

[RU848789]

Hey,

Wanted to say thank you for all the data you provide. I just wanted to ask your opinion on one thing. You retired from Merck and are now consulting. Your company decided to forego fast tracking a vaccine and decided to use the traditional method to create a vaccine which will take them 4 years or so to do. I've been told by a good friend who works at Merck that this was done to insure that their virus would have no long term affects on people. So my question is why are you so confident in these quickly made vaccines when your own company is against speeding up the process?

Thanks! With regard to Merck vaccines, that wasn't my primary area, but I did do some work in that area several years ago and I'm quite familiar with COVID vaccine efforts at Merck and can tell you that Merck is in phase I clinical trials for both vaccines and that it won't take anywhere near 4 years to launch these (your friend at Merck is wildly misinformed on that). Merck is not "against" getting vaccines to market fast - it's just that the CEO has questioned whether there should be more focus on better vaccines - I'm sure there are some high level MK execs who are now wondering if Merck should have been more aggressive on vaccine development...

Anyway, with regard to the vaccines, one is based on a tried and true measles vaccine vector (Merck bought Themis for this) and the other is based on vesicular stomatitis viruses (partnering with IAVI), the same approach Merck used to produce its successful Ebola vaccine; both use these viral vectors to deliver spike protein genes (similar to how the AZ/Oxford and J&J adenovirus vector vaccines work - just using different virus delivery systems).

Merck is usually pretty quiet on announcements, but I recall reading somewhere that their expectation was to be able to complete phase III trials for the measles vector vaccine by April-ish and the VSV one by late spring. These will certainly be later than the first wave of vaccines, but I think Merck's hope is that these vaccines will be better (single dose, no need for freezing, and the VSV one is in pill form), but that obviously remains to be seen. There is still most of the world to vaccinate next year and beyond.

The NY Times tracker has info on each (under the "viral vectors" section) and the Merck timeline in the 2nd link shows all of Merck's COVID efforts at a high level. In addition, the timeline link shows that Merck also has an antiviral (molnupiravir) in phase II/III trials now, which will be available in tablet form (unlike remdesivir which requires injection) - timing likely to be in the spring. And Merck also just bought an anti-inflammatory antibody treatment for COVID (and other uses) from OncoImmune, which has shown impressive results in seriously ill patients in a small phase III clinical trials.

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

https://www.merck.com/wp-content/uploads/sites/5/2020/10/MRK_Timeline_COVID_D08_VF.pdf

 

[RUBOB72]

it suggested by cnn, gupta, and a asian female doctor on anderson cooper last week

CNN ,Gupta and “an Asian female doctor” ... on Anderson Cooper. Now that is a trio of experts.

 

[T2Kplus10]

Getting close to approval:

FDA says Pfizer Covid vaccine provides some protection after first dose, meets success criteria

FDA says Pfizer Covid vaccine provides some protection after first dose, meets success criteria

The FDA said data from Pfizer's coronavirus vaccine trials was "consistent" with recommendations put forth by the agency for an emergency use authorization.

www.cnbc.com

The Food and Drug Administration said Tuesday data from Pfizer’s coronavirus vaccine trials was consistent with recommendations put forth by the agency for an emergency use authorization, adding the vaccine was highly effective and did not raise any specific safety concerns.

In briefing documents published ahead of an advisory meeting Thursday to review Pfizer’s vaccine, FDA staff also said data submitted appeared to show the vaccine provided protection after the first dose. Pfizer’s vaccine requires two doses about three weeks apart. The agency added that two doses of the vaccine were “highly effective” in preventing confirmed cases of Covid-19 at least seven days following the second dose.

“As such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the agency wrote in documents posted on its website.

The FDA is expected to decide on whether to authorize Pfizer’s vaccine within days.

 

[RU_DIO]

I work in clinical research and there isn’t enough data today for me to feel assured. But my wife and I work at home 100% now and my kids are fully virtual for school. We don’t have any preexisting conditions, so we’re good to sit tight for a while and wait for more data. But the way things are trending I will take one of the front runner vaccines if things continue to look good.

I also think I want my near 90 year old grandmother and 65+ father to get vaccinated early on. The Pfizer vaccine has the best safety profile so far it seems.

I have a cousin who was a director at Merck and now is a director at J&J. He says he will take the vaccine after it's been out for a few months.

I have no problem with my parents taking the vaccine as they are in their 70's. I just do not think my children need to take the vaccine as the chances of them being affected by the virus is very small. Not sure why it appears people will be required to take the vaccine in order to get out there and live their lives again. I feel let those who want to take the vaccine take it and then open up the nation again.

 

[RU848789]

No, Sanofi will end up with the top vaccine once the dust settles. They are by far the world leader in vaccines and theirs will come out in a few months. They are batting clean up vs. the coronavirus:

1. Pfizer
2. Moderna
3. J&J
4. Sanofi

Game over. Merck wasn't quick enough and is still sitting in the dugout.

Not true at all. GSK is first in worldwide vaccine sales, Merck is a close 2nd, and Sanofi is not far behind Merck. Whether Merck is too late to the party (and Sanofi, as they're not ahead of Merck on either of their two vaccine candidates) is up for debate and not a given.

Link to vaccine sales by company

 

[T2Kplus10]

I work in clinical research and there isn’t enough data today for me to feel assured. But my wife and I work at home 100% now and my kids are fully virtual for school. We don’t have any preexisting conditions, so we’re good to sit tight for a while and wait for more data. But the way things are trending I will take one of the front runner vaccines if things continue to look good.

I also think I want my near 90 year old grandmother and 65+ father to get vaccinated early on. The Pfizer vaccine has the best safety profile so far it seems.

I've posted the AE data a few times and while the Pfizer vaccine looks better, I still haven't found the actual AE reporting protocol (which can make a very big difference on the number of reported AEs). Obviously, since it is not H2H, be careful with comparing.

 

[T2Kplus10]

Not true at all. GSK is first in worldwide vaccine sales, Merck is a close 2nd, and Sanofi is not far behind Merck. Whether Merck is too late to the party (and Sanofi, as they're not ahead of Merck on either of their two vaccine candidates) is up for debate and not a given.

Link to vaccine sales by company

Sanofi is the world leader in vaccines and its tech. Not even close. The best and brightest scientists go there to work on vaccines.

 

[RobertG]

Here's an interesting sampling of articles from today, highlighting related elements of the pandemic.

The first one is from the Atlantic, discussing how we've reached the peak in deaths we saw in the spring and how brutal the next 2 months will be before vaccines start to make a difference by late January. I've talked about all of this frequently and think we'll see up to 2500-3000 deaths/day (a bit more than the ~2200/day in the spring) assuming we end up with a bit over 2X the hospitalizations of this summer. We're getting near 2X now and some think we'll see 3000-4000 deaths/day - I don't, but 2500-3000 is no picnic either - and Christmas gatherings could actually bump things up over 3000/day, sadly.

https://www.theatlantic.com/.../covid-deaths.../617318/

The second is another example of a superspreader event from rural Washington, which involved health care workers attending a 300-person, packed indoor wedding, violating state restrictions, with mask-wearing optional, and then likely being the source of death for 6 LTC patients where they work. It's yet another example of how so many are still not following masking/distancing guidances privately, especially indoors, where the risks are highest, despite more public evidence of mask compliance.

https://www.seattletimes.com/.../17-cases-two-covid-19.../

The third is an interesting story from Slovakia, where they instituted lockdowns and massive, frequent, and rapid antigen testing of the entire population (something many have talked about being a way out of the pandemic if it could be scaled up), resulting in over an 80% reduction in cases in just 2 weeks. Surely some of the reduction was due to the lockdown, but much of it is also likely due to rapid identification and isolation of positives, early in their infections, when they're most infectious.

https://www.lshtm.ac.uk/.../mass-testing-short-period...

And finally, the fourth one is a sad reminder of what could have been if we and other countries had taken this potential pandemic as seriously as Taiwan did in the beginning, which is the most important time to stop a pandemic. It's an interview with their leading infectious disease doctor, who traveled to Wuhan in mid-January and saw for himself how bad this could be, as it was obvious there was out of control human-to-human transmission going on. He returned and helped drive adoption of strict travel restrictions and quarantines of any positive cases and contacts (supported by aggressive early testing). This country of 24MM, located right next to China, where it all started, has had 7 deaths...

https://www.theguardian.com/.../a-year-after-wuhan-alarm...

Wikipedia has a timeline of events on what Taiwan did in the early days of the Pandemic which included mobilizing the Armed Forces.

Before first case reported[edit]
On 31 December 2019, Taiwan Centers for Disease Control (CDC) implemented inspection measures for inbound flights from Wuhan, China in response to reports of an unidentified outbreak.[109] The passengers of all such flights were inspected by health officials before disembarking.[109] Taiwan's Central News Agency reported that Luo Yi-jun, deputy director for Taiwan's Centers for Disease Control, had been reading on PTT in the early hours of New Year's Eve when a thread about an unknown disease causing pneumonia in Wuhan caught his attention. He saw a post including screenshots from a group chat with Li Wenliang. He immediately emailed colleagues and put the country on alert.[110][111]

A six-year-old passenger who arrived in Taiwan on 31 December after transferring in Wuhan and developed a fever was closely monitored by the CDC.[112] At this time, there were 27 reported cases of the new pneumonia in Wuhan.[112]

By 5 January 2020, the Taiwan CDC began monitoring all individuals who had traveled to Wuhan within fourteen days and exhibited a fever or symptoms of upper respiratory tract infections. Said people were screened for 26 known pathogens, including SARS and Middle East respiratory syndrome; those testing positive were quarantined.[9]

On 20 January, the government deemed the risk posed by the outbreak sufficient to activate the Central Epidemic Command Center (CECC).[113][114][115] Originally established as a level 3 government entity,[114] the CECC was promoted to level 1 on 28 February.[116] The CECC has coordinated government responses across areas including logistics for citizens on the Diamond Princess, disinfection of public spaces around schools, and providing briefings with Chen Shih-chung, the Minister of Health and Welfare.[9]

After first case reported[edit]
On 21 January, the same day that Taiwan's CDC reported the first confirmed case of the novel coronavirus in Taiwan, a level 3 travel alert to Wuhan was issued, recommending avoidance of all non-essential travels to the city.[117]

On 26 January, Taiwan suspended all air travel to and from China, and put in place quarantine measures for passengers who flew from China.[118]

On 24 January, the Taiwanese government announced a temporary ban on the export of face masks for one month to secure a supply of masks for its own citizens.[119][120] The ban was extended twice; on 13 February until the end of April,[121] and on 13 April until the end of June.[122] On 6 February, the government instituted a mask rationing system, requiring citizens to present their National Health Insurance card.[123][124] Prior to its implementation, the system was extended to holders of the Alien Resident Certificate, and people with valid entry permits.[125] People with odd-numbered identity documents were permitted to buy masks on Mondays, Wednesdays, and Fridays; those with even-numbered identity documents were to buy masks on Tuesdays, Thursdays, and Saturdays; anyone is allowed to buy masks on Sundays. Adults were allowed to buy two masks each visit and children four, with the restriction that a minimum of seven days must elapse since the last purchase. The date restriction for children under thirteen years of age was revoked on 27 February.[126][127] Starting on March 5, adults were permitted to buy three masks weekly; the children's quota was raised to five.[128] After March 12, masks were available for preorder online.[129] In April, the mask rationing system was revised, so that adults could buy nine masks every two weeks. From 9 April, the specific date restrictions are to be removed. In addition, Taiwanese nationals can send 30 masks every two months overseas to first or second-degree relatives.[130][131] Taiwan's Ministry of Foreign Affairs assumed responsibility for distribution of masks to families of diplomats.[132]

With population of 24 million, Taiwan has been producing more than 13 million masks per day since March,[133] later increasing the output to 20 million.[134]
On 2 February 2020, Taiwan's Central Epidemic Command Center postponed the opening of primary and secondary schools until 25 February (originally 11 February).[135][136] In early February 2020, Taiwan's "Central Epidemic Command Center" requested the mobilization of the Taiwanese Armed Forces in both containing the spread of the virus and in building up defenses against it. Soldiers were dispatched to the factory floors of major mask manufacturers to help staff the 62 additional mask production lines that were being set up at the time.[137] In early March, Taiwan's average production of surgical face masks reached 9.2 million per day.[138] By the end of March, the daily production of surgical face masks reached 13 million.[133]

Also I read a story that a traveler who was quarantined in his hotel and stepped into the hallway for 8 seconds and was fined $3500.

 

[RU848789]

Sanofi is the world leader in vaccines and its tech. Not even close. The best and brightest scientists go there to work on vaccines.

Since you're being obstinate on this, here's the graphic on 2019 global sales. I rest my case. And your "best and brightest" comment is just silly. All 4 of the top companies below are highly competitive in attracting top vaccine talent and innovating in the vaccine space.

 

[ArminRU]

Let’s see how fast antivaxxers run with the Bell’s Palsy thing from the FDA report...

 

[RU_DIO]

Let’s see how fast antivaxxers run with the Bell’s Palsy thing from the FDA report...

I had that 15 years ago. Not a fun thing to get. Fortunately it went away after 3 weeks of accupuncture or stimulus.

 

[RU848789]

Wikipedia has a timeline of events on what Taiwan did in the early days of the Pandemic which included mobilizing the Armed Forces.

Before first case reported[edit]
On 31 December 2019, Taiwan Centers for Disease Control (CDC) implemented inspection measures for inbound flights from Wuhan, China in response to reports of an unidentified outbreak.[109] The passengers of all such flights were inspected by health officials before disembarking.[109] Taiwan's Central News Agency reported that Luo Yi-jun, deputy director for Taiwan's Centers for Disease Control, had been reading on PTT in the early hours of New Year's Eve when a thread about an unknown disease causing pneumonia in Wuhan caught his attention. He saw a post including screenshots from a group chat with Li Wenliang. He immediately emailed colleagues and put the country on alert.[110][111]

A six-year-old passenger who arrived in Taiwan on 31 December after transferring in Wuhan and developed a fever was closely monitored by the CDC.[112] At this time, there were 27 reported cases of the new pneumonia in Wuhan.[112]

By 5 January 2020, the Taiwan CDC began monitoring all individuals who had traveled to Wuhan within fourteen days and exhibited a fever or symptoms of upper respiratory tract infections. Said people were screened for 26 known pathogens, including SARS and Middle East respiratory syndrome; those testing positive were quarantined.[9]

On 20 January, the government deemed the risk posed by the outbreak sufficient to activate the Central Epidemic Command Center (CECC).[113][114][115] Originally established as a level 3 government entity,[114] the CECC was promoted to level 1 on 28 February.[116] The CECC has coordinated government responses across areas including logistics for citizens on the Diamond Princess, disinfection of public spaces around schools, and providing briefings with Chen Shih-chung, the Minister of Health and Welfare.[9]

After first case reported[edit]
On 21 January, the same day that Taiwan's CDC reported the first confirmed case of the novel coronavirus in Taiwan, a level 3 travel alert to Wuhan was issued, recommending avoidance of all non-essential travels to the city.[117]

On 26 January, Taiwan suspended all air travel to and from China, and put in place quarantine measures for passengers who flew from China.[118]

On 24 January, the Taiwanese government announced a temporary ban on the export of face masks for one month to secure a supply of masks for its own citizens.[119][120] The ban was extended twice; on 13 February until the end of April,[121] and on 13 April until the end of June.[122] On 6 February, the government instituted a mask rationing system, requiring citizens to present their National Health Insurance card.[123][124] Prior to its implementation, the system was extended to holders of the Alien Resident Certificate, and people with valid entry permits.[125] People with odd-numbered identity documents were permitted to buy masks on Mondays, Wednesdays, and Fridays; those with even-numbered identity documents were to buy masks on Tuesdays, Thursdays, and Saturdays; anyone is allowed to buy masks on Sundays. Adults were allowed to buy two masks each visit and children four, with the restriction that a minimum of seven days must elapse since the last purchase. The date restriction for children under thirteen years of age was revoked on 27 February.[126][127] Starting on March 5, adults were permitted to buy three masks weekly; the children's quota was raised to five.[128] After March 12, masks were available for preorder online.[129] In April, the mask rationing system was revised, so that adults could buy nine masks every two weeks. From 9 April, the specific date restrictions are to be removed. In addition, Taiwanese nationals can send 30 masks every two months overseas to first or second-degree relatives.[130][131] Taiwan's Ministry of Foreign Affairs assumed responsibility for distribution of masks to families of diplomats.[132]

With population of 24 million, Taiwan has been producing more than 13 million masks per day since March,[133] later increasing the output to 20 million.[134]
On 2 February 2020, Taiwan's Central Epidemic Command Center postponed the opening of primary and secondary schools until 25 February (originally 11 February).[135][136] In early February 2020, Taiwan's "Central Epidemic Command Center" requested the mobilization of the Taiwanese Armed Forces in both containing the spread of the virus and in building up defenses against it. Soldiers were dispatched to the factory floors of major mask manufacturers to help staff the 62 additional mask production lines that were being set up at the time.[137] In early March, Taiwan's average production of surgical face masks reached 9.2 million per day.[138] By the end of March, the daily production of surgical face masks reached 13 million.[133]

Also I read a story that a traveler who was quarantined in his hotel and stepped into the hallway for 8 seconds and was fined $3500.

Yep, this is what a highly proactive government and a populace willing to sacrifice a bit for the common good look like. One can debate whether Taiwan's approach could have worked here, but it wasn't even considered, much less tried. I'm convinced that universal masking in East Asian countries is the biggest reason they've all done so well. It doesn't hurt that most of them also have had aggressive testing to identify emerging hotspots and isolating to prevent those from growing. Talked about a lot of this way back in March...

https://rutgers.forums.rivals.com/t...es-interventions-and-more.191275/post-4455708

https://rutgers.forums.rivals.com/t...ventions-and-more.191275/page-16#post-4451746

 

[tom1944]

I work in clinical research and there isn’t enough data today for me to feel assured. But my wife and I work at home 100% now and my kids are fully virtual for school. We don’t have any preexisting conditions, so we’re good to sit tight for a while and wait for more data. But the way things are trending I will take one of the front runner vaccines if things continue to look good.

I also think I want my near 90 year old grandmother and 65+ father to get vaccinated early on. The Pfizer vaccine has the best safety profile so far it seems.

Same here