Don’t wanna speak for CNYskier but I did stay at Holiday Inn Express once upon a time.
The New Normal
- Thread starter Harvey
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Campgottagopee
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- Jul 20, 2020
At our worst we had 15 covid pos in our hospital. Yesterday we had 3. Today there is 6.
MarzNC
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- Jul 18, 2020
Back in 2020, the phrase "novel coronavirus" was seen a lot. Not so much in 2021. Very little was known about SARS-CoV-2 when it devastated northern Italy starting in late 2019. The first cases in Boston were seeded by a meeting of Biogen senior management in Feb 2020 that included execs from Italy. One man who attended then went to the Biogen office near Raleigh (where I live) before going home to the midwest. He exposed people in both places who tested positive after contact tracing was done. SARS, MERS, SARS-CoV-2 are the coronaviruses that have jumped to humans since 2000.
There are other coronaviruses that circulate among humans often. Common cold symptoms can be traced to coronaviruses known as HCoVs. Those presumably jumped into homo sapiens and mutated to cause mild symptoms a long, long, long time ago.
Warning . . . this got long. It's an attempt to explain why the development of the Moderna mRNA vaccine took much less time than usual back in 2020. Hard to condense the process of vaccine development and approval regulatory into a few paragraphs.
mRNA research has been around for 20 years or so. Mostly was focused on cancer. My immunologist ski buddy knew all about them in grad school. One reason Moderna could come up with a vaccine candidate so quickly in 2020 was that mRNA as a basis for a vaccine was what Moderna has been doing for a decade. They had the necessary genetic info about SARS-CoV-2 by Jan 2020, a candidate for Phase 1 testing in humans by Feb 2020. That's not possible as quickly with other approaches to vaccine development.
Usually vaccine development in the lab is followed by months and years of clinical trials (Phases 1, 2, 3). After approval by a regulatory agency like the FDA, then a company gears up for manufacturing. While they might start that towards the end of Phase 3 trials, would be too risky from a business standpoint to start much sooner. Obviously the pandemic in 2020 changed everything in terms of the importance of setting up manufacturing at the same time the Phase 3 trials were ongoing. The Phase 2 lab results made it clear that the vaccine candidate worked or else Phase 3 couldn't start. Big money from the federal government made it possible for Moderna and Pfizer to go ahead with manufacturing set up in 2020, probably other companies too.
Phase 3 vaccine trials require thousands of subjects. The volunteers go about their daily life and in 2020 that meant only a few would get exposed enough to catch COVID-19 during the efficacy study period (months, not weeks or years). Moderna needed about 30,000 for the primary trial in the U.S., with 15,000 getting placebo and 15,000 getting both shots of Moderna. Dosing was based on Phase 1/2 results. Need a big enough dose to see useful changes based on lab results, but still low enough to minimize adverse effects. The FDA bases approval on statistical evidence of "safety and efficacy" from at least one U.S. study. Fair to say that finding 30,000 volunteers and 40,000 volunteers for Pfizer in 2020 didn't take long. I think enrollment was completed in a few months, starting in March 2020. Studies in other countries are helpful for safety, and can support efficacy. With a novel coronavirus, testing in other countries can be helpful for variants that show up elsewhere before they get to the U.S.
For those who don't know me, my Ph.D. is in Biostatistics from the UNC-Chapel Hill School of Public Health. I worked in the pharma/biotech industry on clinical trials research for 15 years. I didn't write statistical analysis plans but know how to interpret one. I joined when Quintiles was still a startup right out of grad school. The CEO and co-founder was one of my professors before he started Quintiles as a small biostatistics and data management company in 1982. My first boss was one of the original 7 staff. Clinical services were added in 1988. Quintiles became a leading full-service international CRO after a successful IPO in 1993. That's why I could retire early to be a relaxed older parent and had time for online ski forums after my daughter got on skis in 2004.
There are other coronaviruses that circulate among humans often. Common cold symptoms can be traced to coronaviruses known as HCoVs. Those presumably jumped into homo sapiens and mutated to cause mild symptoms a long, long, long time ago.
Warning . . . this got long. It's an attempt to explain why the development of the Moderna mRNA vaccine took much less time than usual back in 2020. Hard to condense the process of vaccine development and approval regulatory into a few paragraphs.
mRNA research has been around for 20 years or so. Mostly was focused on cancer. My immunologist ski buddy knew all about them in grad school. One reason Moderna could come up with a vaccine candidate so quickly in 2020 was that mRNA as a basis for a vaccine was what Moderna has been doing for a decade. They had the necessary genetic info about SARS-CoV-2 by Jan 2020, a candidate for Phase 1 testing in humans by Feb 2020. That's not possible as quickly with other approaches to vaccine development.
Usually vaccine development in the lab is followed by months and years of clinical trials (Phases 1, 2, 3). After approval by a regulatory agency like the FDA, then a company gears up for manufacturing. While they might start that towards the end of Phase 3 trials, would be too risky from a business standpoint to start much sooner. Obviously the pandemic in 2020 changed everything in terms of the importance of setting up manufacturing at the same time the Phase 3 trials were ongoing. The Phase 2 lab results made it clear that the vaccine candidate worked or else Phase 3 couldn't start. Big money from the federal government made it possible for Moderna and Pfizer to go ahead with manufacturing set up in 2020, probably other companies too.
Phase 3 vaccine trials require thousands of subjects. The volunteers go about their daily life and in 2020 that meant only a few would get exposed enough to catch COVID-19 during the efficacy study period (months, not weeks or years). Moderna needed about 30,000 for the primary trial in the U.S., with 15,000 getting placebo and 15,000 getting both shots of Moderna. Dosing was based on Phase 1/2 results. Need a big enough dose to see useful changes based on lab results, but still low enough to minimize adverse effects. The FDA bases approval on statistical evidence of "safety and efficacy" from at least one U.S. study. Fair to say that finding 30,000 volunteers and 40,000 volunteers for Pfizer in 2020 didn't take long. I think enrollment was completed in a few months, starting in March 2020. Studies in other countries are helpful for safety, and can support efficacy. With a novel coronavirus, testing in other countries can be helpful for variants that show up elsewhere before they get to the U.S.
For those who don't know me, my Ph.D. is in Biostatistics from the UNC-Chapel Hill School of Public Health. I worked in the pharma/biotech industry on clinical trials research for 15 years. I didn't write statistical analysis plans but know how to interpret one. I joined when Quintiles was still a startup right out of grad school. The CEO and co-founder was one of my professors before he started Quintiles as a small biostatistics and data management company in 1982. My first boss was one of the original 7 staff. Clinical services were added in 1988. Quintiles became a leading full-service international CRO after a successful IPO in 1993. That's why I could retire early to be a relaxed older parent and had time for online ski forums after my daughter got on skis in 2004.
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Campgottagopee
Well-known member
- Joined
- Jul 20, 2020
I really appreciate you taking the time to share your thoughts and knowledge during this pandemic.
MarzNC
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- Joined
- Jul 18, 2020
All the news reports I've seen say that the FDA is pushing hard to finish the review for Pfizer by early September. What's not that obvious is the other stuff that has to be reviewed that has to do with manufacturing, not the "safety and efficacy" of the vaccine.
As I understand it, Moderna is not at the same stage in terms of providing data to the FDA.
The other important regulatory review coming up will be for the clinical trials for kids under 12. FDA asked that the trial enrollments be expanded a bit in order to have more safety data. Want to give as much chance as possible to detect adverse events. Those trials are much smaller in terms of how many subjects are included. Mostly checking that a lower dose is still effective and to assess safety (adverse events) in the different age groups.
MarzNC
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- Joined
- Jul 18, 2020
I know there are public university systems that are likely to require vaccination for students once there is full approval by the FDA. For NC, has to do with how the law is written. There are obviously vaccinations that are required, like for measles and other highly contagious diseases that are kept in check by vaccination.
The number of colleges requiring vaccination shot up over 700 in the last week. Mostly private colleges but there are a few public colleges too. In general, getting tested weekly is the alternative to being vaccinated.
According to the local news last night, Carolina has 85% of students attesting that they are vaccinated. Vaccination stats have been added to the Carolina Dashboard. But NC State down the road only had 55% yesterday as students started moving into dorms. Duke is requiring vaccination and says 99% of students, faculty, and staff are vaccinated. Meaning 1% were granted exemptions. Delta is clearly causing more breakthrough cases. Both Carolina and Duke have already had clusters identified where the students were vaccinated and only have mild symptoms. Two of the situations were for graduate students.
The number of colleges requiring vaccination shot up over 700 in the last week. Mostly private colleges but there are a few public colleges too. In general, getting tested weekly is the alternative to being vaccinated.
According to the local news last night, Carolina has 85% of students attesting that they are vaccinated. Vaccination stats have been added to the Carolina Dashboard. But NC State down the road only had 55% yesterday as students started moving into dorms. Duke is requiring vaccination and says 99% of students, faculty, and staff are vaccinated. Meaning 1% were granted exemptions. Delta is clearly causing more breakthrough cases. Both Carolina and Duke have already had clusters identified where the students were vaccinated and only have mild symptoms. Two of the situations were for graduate students.
Who said anything about endangering others, maybe I missed something
Canada closed their borders, if we were strong on that front as well things would be different, we have very weak leadership
jasonwx
Well-known member
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- Jul 22, 2020
I have 2 friends that work for Big Pharma.. One is a Phd the other MD.. All they want to do is develop drugs that help people.
We need these companies and they need to make a profit too. Yes they charge to much cause business can and do get greedy.
With out them most us older folks 50 + would be dead..
We need these companies and they need to make a profit too. Yes they charge to much cause business can and do get greedy.
With out them most us older folks 50 + would be dead..
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