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Borg
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I have seen news reports that the vaccine will be free for everyone but you could still get charged an "administrative fee" by your insurance company.
Borg said:I have seen news reports that the vaccine will be free for everyone but you could still get charged an "administrative fee" by your insurance company.
Is anyone's state/city announcing vaccination sites/protocols yet? I've only heard that we will have some for medical workers this month. They are first in line, along with nursing home residents.The accelerated timeline comes after President Trump’s chief of staff threatened the F.D.A. head’s job if he didn’t get it done on Friday. The Trump Administration will buy another 100 million doses of Moderna vaccine.
The Food and Drug Administration authorized Pfizer’s Covid-19 vaccine for emergency use on Friday, clearing the way for millions of highly vulnerable people to begin receiving the vaccine within days.
Pfizer has a deal with the U.S. government to supply 100 million doses of the vaccine by next March. Under that agreement, the shots will be free to the public.
I'm not surprised. They love to pass costs down to the average person here in the U.S. I'm glad the vaccine is free and hope the fee is less than $200.bhobba said:That is surprising. Here in Aus it is freely supplied by the government for anyone that wants it, subject to supply. We got 10 million doses of the Pfizer vaccine being rolled out in the UK. Since we now have it well under control the government has decided to wait until the UK rollout is well underway before using the Pfizer vaccine - expected in about a month or two's time. But of the 25 million in Australia this is only enough for 5 million people so will be rationed.
kyphysics said:I might actually prefer to be in Australia's situation vs. U.S. You guys had 28 days of no cases until very recently (mentally/emotionally, I think that'd feel amazing). In the U.S., we've had 28+ days of 100,000 or more (recently many 200,000 case days) cases. Sort of the exact opposite. Only good thing is we're getting that 100 million doses.
Ivan Seeking said:I am not clear on the meaning of herd immunity if the spike protein antibodies do not provide general immunity. If you are immune to infection but can still be a carrier and spread the disease, does the concept of herd immunity even apply?
If we find that the Pfizer vaccine does prevent spread, great. But we don't know yet and they keep talking about herd immunity as if it's a given [assuming enough people get vaccinated, which is another issue]. This seems inconsistent to me.
https://www.jhsph.edu/covid-19/articles/achieving-herd-immunity-with-covid19.htmlWhat is herd immunity?
When most of a population is immune to an infectious disease, this provides indirect protection—or herd immunity (also called herd protection)—to those who are not immune to the disease.
For example, if 80% of a population is immune to a virus, four out of every five people who encounter someone with the disease won’t get sick (and won’t spread the disease any further). In this way, the spread of infectious diseases is kept under control. Depending how contagious an infection is, usually 50% to 90% of a population needs immunity to achieve herd immunity.
Ivan Seeking said:But we don't know yet and they keep talking about herd immunity as if it's a given [assuming enough people get vaccinated, which is another issue]. This seems inconsistent to me.
bhobba said:I think the standard of reporters has dropped alarmingly. Yes it is inconsistent. We will not know about herd immunity until we know more about the vaccines.
Ivan Seeking said:Nobody discusses what the Covid world looks like if mRNA vaccines don't prevent spread. Another big problem is that of testing additional vaccines. Is it ethical to give a test subject a placebo when we have an effective vaccine?
See the discussion about this in this other thread:Ivan Seeking said:Another big problem is that of testing additional vaccines. Is it ethical to give a test subject a placebo when we have an effective vaccine?
Ivan Seeking said:Nobody discusses what the Covid world looks like if mRNA vaccines don't prevent spread.
Under this scenario, people whose immune systems have been primed to recognize and fight the virus — whether through infection or vaccination — could contract it again in the future. But these infections would be cut short as the immune system’s defenses kick into gear. People infected might not develop symptoms or might have a mild, cold-like infection.
The journal Science published a piece discussing this subject (also linked to in the thread that @berkeman cited): https://science.sciencemag.org/content/370/6522/1277.fullIvan Seeking said:Another big problem is that of testing additional vaccines. Is it ethical to give a test subject a placebo when we have an effective vaccine?
I recall reading somewhere about a protocol in which a placebo is NOT used, and instead an existing medication or vaccine is used. The intent is to determine which is better, the old or the new, or whether there are individual patient characteristics that make one more effective than the other for people with such characteristics. For example, a person with high blood pressure might benefit more from A than B, while person with normal blood presure would benefit more from B.Ivan Seeking said:Another big problem is that of testing additional vaccines. Is it ethical to give a test subject a placebo when we have an effective vaccine?
Buzz Bloom said:I recall reading somewhere about a protocol in which a placebo is NOT used, and instead an existing medication or vaccine is used. The intent is to determine which is better, the old or the new, or whether there are individual patient characteristics that make one more effective than the other for people with such characteristics. For example, a person with high blood pressure might benefit more from A than B, while person with normal blood presure would benefit more from B.
It may be that since at the present time there is no currently av ailable effective vaccine, this protocol has not been discussed.
https://www.biocentury.com/article/631294“If the availability of a COVID-19 vaccine proven to be safe and effective precludes ethical inclusion of a placebo control group, that vaccine could serve as the control treatment in a study designed to evaluate efficacy with non-inferiority hypothesis testing.”
It is far from clear, however, that non-inferiority trials of COVID-19 vaccines would be feasible. Moreover, the difficulty of doing this could preface pressure on FDA to accept external control arms or real-world data as controls.
Demonstrating non-inferiority to an effective intervention can require very large trials or the acceptance of large confidence intervals around the results. The placebo-controlled Phase III COVID-19 trials already include at least 30,000 participants, and there will be little acceptance of uncertainty about the efficacy of a vaccine to prevent a life-threatening disease.
I have a question here that you may have been thinking but didn't really ask: has there been any thought toward antibody or infection testing people prior to vaccinating them? I haven't seen anything, so my guess is no. I don't understand why they wouldn't do that, as vaccinating everyone would seem to waste a significant fraction of the available vaccines and substantially delay reaching the herd immunity threshold.kyphysics said:Is anyone's state/city announcing vaccination sites/protocols yet? I've only heard that we will have some for medical workers this month. They are first in line, along with nursing home residents.
Here's a question:
US Population: ~330 million
US Positively Tested COVID cases: 16 million
Possible Real US COVID count (conservative 5x): 80 million
Possible Real US COVID count (moderate 10x): 160 million
...
However, there's no guarantee you won't have an overlap of people who've already had COVID and never got tested and those who get a vaccine shot. Obviously, there will be some overlap, so you won't get the full 180 million immune individuals. Nonetheless, any thoughts on how fast we could get some sort of herd immunity?
I haven't heard of that - do you have a source where you heard it? It doesn't make sense to me; if a person is immune, that means their body isn't mass-producing the virus, doesn't it? Is there any evidence that people can be long-term asymptomatic carriers?Ivan Seeking said:I am not clear on the meaning of herd immunity if the spike protein antibodies do not provide general immunity. If you are immune to infection but can still be a carrier and spread the disease, does the concept of herd immunity even apply?
No, I hadn't thought of that question, but it's a fair one.russ_watters said:I have a question here that you may have been thinking but didn't really ask: has there been any thought toward antibody or infection testing people prior to vaccinating them? I haven't seen anything, so my guess is no. I don't understand why they wouldn't do that, as vaccinating everyone would seem to waste a significant fraction of the available vaccines and substantially delay reaching the herd immunity threshold.
russ_watters said:I haven't heard of that - do you have a source where you heard it? It doesn't make sense to me; if a person is immune, that means their body isn't mass-producing the virus, doesn't it? Is there any evidence that people can be long-term asymptomatic carriers?
Diseases that we think of as “one-and-done” infections induce such a robust and durable immune response in a single encounter that we cannot be reinfected. In general terms, measles fits into this category, although there are rare reports of people contracting measles more than once.
The bad news is that viruses that infect via the mucus membranes of the nose and throat, like SARS-2, typically don’t induce sterilizing immunity.
“Sterilizing [immunity] in my view is out of the question, as with any respiratory virus,” said Marion Koopmans, head of virology at Erasmus Medical Center in Rotterdam, the Netherlands. Stanley Perlman, a Coronavirus researcher at the University of Iowa, called this option “not so likely.”
But Florian Krammer, a professor of vaccinology at the Icahn School of Medicine at Mount Sinai Hospital in New York, does believe some people will develop sterilizing immunity after a bout of Covid-19.
One last observation about sterilizing immunity: If infection doesn’t trigger it, there is reason to be concerned that vaccines may not either. Peiris noted that so far most of the experimental vaccines, when tested in primates, protect the lungs from severe disease but don’t block replication of virus in the upper airways.
If the primates predict how the vaccines will work in people, these studies would suggest that people may still be able to be infected and they may emit viruses that potentially could infect others, but the type of Covid-19 disease that lands people in ICUs and that sometimes kills them would be prevented.
russ_watters said:Thanks.
Totally separate issue/question: Why isn't every able pharma company on the planet now manufacturing the Pfizer or Moderna vaccine?
https://www.statnews.com/2020/12/11...ps-slipping-experts-say-it-will-change-again/Another challenge for those making predictions about vaccine availability is that manufacturing capacity is a closely guarded secret, and companies are unlikely to reveal precise details even to major buyers such as the U.S. government, said Lee.
“Vaccine manufacturers hold their production capacity pretty close to their vest because it’s a point of a negotiation.” he said. Companies want to have flexibility in their contracts so they can balance production of various drugs and vaccines. “These companies are businesses and want to maximize their revenue. They’ll continue to make other products they can sell while manufacturing their vaccine.”
Even during a medical emergency, companies won’t reveal this information, said Mark Capofari, who was director of global logistics at Merck from 1995 to 2007 and currently lectures on supply chain management at Penn State University. During the AIDS crisis, when Merck made a key treatment drug, Crixivan, production capacity wasn’t shared outside the company, he said.
https://www.nature.com/articles/s41586-020-2798-3For the vaccines in clinical trials for which phase I/II data are available, we observe both an immunogenicity and a reactogenicity gradient. In terms of immunogenicity, inactivated and AdV5-based vaccines seem to rank the lowest, followed by ChAdOx1-based vaccines and mRNA vaccines, and finally adjuvanted, protein-based vaccines, which show the best performance. Reactogenicity seems to be lowest in inactivated and protein-based vaccines, followed by mRNA vaccines, with vectored vaccines having the highest rate of side effects. It is highly likely that the vaccine candidates from AstraZeneca, Moderna and Pfizer—which have progressed the furthest in clinical trials in the USA and Europe—will all show sufficient efficacy and will be licensed if they are shown to be sufficiently safe. However, it might also be the case that these vaccines will be replaced at a later date by newer candidates that show similar efficacy but have more tolerable reactogenicity profiles. In addition, it is difficult to predict how availability and production capacity will shape the global landscape of SARS-CoV-2 vaccines. Although they might not be licensed in the USA and Europe, it is very likely that AdV5-based and inactivated vaccines produced in China—as well as other vaccine candidates produced in India and elsewhere—will have a major role in satisfying the global demand for vaccines against SARS-CoV-2.
The first part is probably part of the answer I was looking for; the second part isn't what I meant. Several/many pharma companies maintain federally funded, idle vaccine factories for the explicit purpose of pandemic response. One client of my company is Sanofi Pasteur, who maintains such a facility in Pennsylvania. They make seasonal flu vaccines in addition to maintaining the empty factory. About all I know of their technology is they grow it in eggs, by the millions. I'm sure that's a more conventional vaccine technology, and I don't know how easy it would be to re-tool to the new technology -- maybe not that easy.Ygggdrasil said:mRNA vaccines are a very new technology, so it would probably take substantial investment of time and capital for a company to put into place the proper systems for manufacturing an mRNA vaccine...
Why aren't all the companies now going to make the Pfizer or Moderna vaccine now that we know it works?
1) People still need drugs for other conditions. You can't stop making insulin to start making a Coronavirus vaccine.
That shouldn't be a relevant issue. It is a problem the governments of the world could easily choose to make go away, when faced with the worst economic crisis since the great depression. The US could spend a trillion dollars on it ($3,000 per inoculation) and it would still be worth it.2) Vaccines aren't that profitable compared to other drugs...
Fair enough, but I 'd suggest that "fastest" matters a lot here too. Sanofi/GSK predict their vaccine may not be ready until the second half of 2021. I'd suggest that that's too late and if they have capacity to manufacture an inferior vaccine sooner, we should make it happen.3) It's still not clear whether the Pfizer and Moderna vaccines are the best or safest options...
Would you bet the entire world's pharma [vaccine] manufacturing capacity on this one technology?
Sure. What I'm suggesting here is a technology sharing and prioritization effort. I've seen no indication that such a thing is in the works, and that bothers me. Heck, if a manufacturing plant is capable of it, they could manufacture the Pfizer or Moderna vaccine while the R&D arm of a company was still working on their own vaccine.There are plenty of vaccines in development that could have potential advantages over the Pfizer and Moderna vaccines. For example, both vaccines require the vaccine to be shipped and stored frozen (-20°C for the Moderna vaccine and -70°C for the Pfizer vaccine). This poses challenges for distribution in developed nations (e.g. in rural areas of the US), not to mention developing nations. In contrast, other vaccines in development can be transported and stored at normal refrigerator temperature (4°C, like other vaccines), which would allow transport, distribution and storage using normal vaccine distribution channels. Similarly, vaccines manufactured using more conventional technologies (e.g. recombinant protein vaccines) could be more easily adapted to existing biopharma manufacturing capacity than the new mRNA vaccine technologies. I doubt that mRNA vaccines will contribute the majority of Coronavirus vaccinations worldwide.
Another technology in Q1 could be good from a timing perspective, especially if they can start manufacturing it before approval. But it's not so much as putting all the eggs (pun?) in one basket that I'm after, as it is using that basket for something else while we're waiting on the chickens.I, for one, have high hopes for the recombinant protein vaccine being produced by Novavax. Phase I/II data for this vaccine look promising, and the https://ir.novavax.com/news-releases/news-release-details/novavax-announces-covid-19-vaccine-clinical-development-progressthat interim results from its phase III trial in the UK could be available in early Q1 2021. Analysis of early clinical data and experimental studies in animals suggests that the recombinant protein vaccines might have higher efficiency and lower side effects than the other vaccine technologies (though some recombinant protein vaccines have already reported failures).
The mRNA vaccines from Pfizer and Moderna certainly look safe and effective, and deserve emergency use authorization for distribution. However, I would not yet put all the eggs in one basket for those two vaccines.
That's an interesting issue/twist, but not one that I'm particularly concerned with. The math on the transportation containers is straightforward, and what it says is that there's no real issue shipping huge quantities of the cryogenic vaccine. But they just haven't made smaller containers to distribute smaller quantities. That really doesn't bother me: for the time being and to get the most bang for our buck/limited supply, shipping thousands at a time to cities is a better deal than trying to ship dozens at a time to small, rural communities.Ygggdrasil said:For example, both vaccines require the vaccine to be shipped and stored frozen (-20°C for the Moderna vaccine and -70°C for the Pfizer vaccine). This poses challenges for distribution in developed nations (e.g. in rural areas of the US), not to mention developing nations.
russ_watters said:Several/many pharma companies maintain federally funded, idle vaccine factories for the explicit purpose of pandemic response. One client of my company is Sanofi Pasteur, who maintains such a facility in Pennsylvania. They make seasonal flu vaccines in addition to maintaining the empty factory. About all I know of their technology is they grow it in eggs, by the millions. I'm sure that's a more conventional vaccine technology, and I don't know how easy it would be to re-tool to the new technology -- maybe not that easy.
https://www.sanofi.us/en/about-us/our-stories/our-response-to-covid-19
https://www.statnews.com/2020/12/11...setback-in-development-of-a-covid-19-vaccine/
kyphysics said:Is anyone's state/city announcing vaccination sites/protocols yet? I've only heard that we will have some for medical workers this month. They are first in line, along with nursing home residents.
Tom.G said:From memory of 'a few days ago', Los Angeles published this priority list:
Medical workers
1) First responders (paramedics, fire, [police?])
2) Nursing Homes, residents and staff
3) High-risk members of the public (co-morbidities and age >65)
4) High-risk members of the public (co-morbidities)
5) High-risk members of the public (age>65)
6) General public
Items 4) and 5) may have been combined with the 'or' operator.
(further research turned up these)
Here is a link to the California Dept of Health recommended priorities:
https://www.cdph.ca.gov/Programs/CI...-Vaccine-During-Phase-1A-Recommendations.aspx
The California Governor announced:
https://calmatters.org/health/coronavirus/2020/12/california-priorities-first-covid-vaccines/
https://infogram.com/california-vaccine-priorities-1hxj48pp5qrkq2v
Buzz Bloom said:I recall reading somewhere about a protocol in which a placebo is NOT used, and instead an existing medication or vaccine is used.
russ_watters said:Totally separate issue/question: Why isn't every able pharma company on the planet now manufacturing the Pfizer or Moderna vaccine?
https://www.statnews.com/2021/01/13...r-jjs-one-dose-covid-vaccine-will-measure-up/In the study, participants had neutralizing antibodies, measured in a unit called a geometric mean titer, of 224 to 354, on day 29 after their first vaccine dose; those levels reached 288 to 488 by day 57. These levels could be enough to produce immunity. But there was a big benefit to giving the participants a booster dose. It doubled or tripled their levels of neutralizing antibodies. The question is whether the antibody levels induced by the first dose are indeed enough, or if there are other types of immunity spurred by the vaccine that lead to protection.
“Just because it’s higher in neutralizing response doesn’t necessarily mean it’s more efficacious,” said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “It may be that the immune response induced by the first dose is enough and that more is not necessarily better.”
The answer to the question, of course, will come from Phase 3 clinical trial results. Said Carlos del Rio, a distinguished professor of medicine at the Emory University School of Medicine: “The proof is in the pudding.”
https://www.politico.com/news/2021/01/13/johnson-johnson-vaccine-production-458941Johnson & Johnson has fallen behind on production of its Covid-19 vaccine, a delay that could put it as much as two months behind schedule, a person briefed on the matter told POLITICO.
The company had originally pledged to deliver 12 million doses by the end of February, with plans to reach 100 million over the next four months.
But Johnson & Johnson has since warned officials that it could take until the end of April to catch up to its original projections, the person briefed on the matter said.
Ygggdrasil said:...
Unfortunately, these positive phase 1/2 data are tempered by news that production of the J&J vaccine is two months behind schedule, so even if approved soon, the vaccine may not be able to make an impact for a few more months:
What evidence do you have that in the UK, for example, the vaccine is being given only to a few rich old people?stefan r said:Its not O.K. to vaccinate a few rich old people and then pretend everything is fine.
PeroK said:What evidence do you have that in the UK, for example, the vaccine is being given only to a few rich old people?
https://en.wikipedia.org/wiki/COVID-19_vaccination_programme_in_the_United_Kingdom
The People's Vaccine Alliance says nearly 70 lower-income countries will only be able to vaccinate one in 10 people.
At least 90% of people in 67 low income countries stand little chance of getting vaccinated against Covid-19 in 2021 because wealthy nations have reserved more than they need and developers will not share their intellectual property, says the People’s Vaccine Alliance, which includes Amnesty International, Frontline AIDS, Global Justice Now, and Oxfam.1
“Unless something changes dramatically, billions of people around the world will not receive a safe and effective vaccine for Covid-19 for years to come,” said Anna Marriott, Oxfam’s health policy manager.
Rich countries with only 14% of the world’s population have bought up 53% of the eight most promising vaccines, the alliance said, including all of the Moderna vaccine doses expected to be produced over the next year and 96% of the Pfizer-BioNTech vaccine doses.
WHO's director said only 25 vaccine doses have been provided in a single poor country, while over 39 million doses have been administered in nearly 50 richer nations