Column from WSZIO by Sandi Lusk
Before I begin, we would like to say that we have deliberately refrained from inserting politics into our columns. The poison, lies, and vitriol that has passed as political discourse over the past 4 years has been unprecedented. We strongly feel that this has no place in a civic center column, but is better expressed as a letter to the editor.
We have not written in a long time, as our programs have been suspended due to COVID 19 this past year, and we do not know when they will resume. However, there are a few pertinent things to say about the crazy times we live in that directly relate to the COVID situation.
The message for today: There have been a lot of lies and half-truths being spread about COVID prevention, testing, and vaccines. We would like to say a few words about this.
First, there is no doubt that wearing a mask (or masks) helps protect against COVID:
“CDC recommends that everyone wear a mask over their nose and mouth when in public, including on public transportation and in transportation hubs such as airports and stations. Masks slow the spread of COVID-19 because they help keep people who are infected from spreading respiratory droplets to others when they cough, sneeze, or talk. Medical masks and N-95 respirators are for healthcare workers and other first responders, as recommended by current CDC guidance.” Feb 2, 2021.
From the FDA: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/face-masks-including-surgical-masks-and-respirators-covid-19#:~:text=Masks%20may%20help%20prevent%20people,from%20spreading%20the%20virus.
This is not a political or “freedom of expression” issue. This should never have been politicized in the first place, that was highly irresponsible. We are in the middle of a massive pandemic. This is a public health issue. Nearly 500,000 lives have been lost in the United States alone. Each one of us has a responsibility and a duty to ourselves and the community to help stop the transmission of this deadly disease. Please wear the mask for all our sakes.
Vaccines: As of now, 2 vaccines are being given in NYC, the Pfizer vaccine and the Moderna vaccine. There are others on the horizon: From the CDC website:
Currently, two vaccines are authorized and recommended to prevent COVID-19:
As of December 28, 2020, large-scale (Phase 3) clinical trials are in progress or being planned for three COVID-19 vaccines in the United States:
Both Pfizer and Moderna vaccines work the same way: mRNA vaccines contain material from the virus that causes COVID-19 that gives our cells instructions for how to make a harmless protein that is unique to the virus. After our cells make copies of the protein, they destroy the genetic material from the vaccine. Our bodies recognize that the protein should not be there and build T-lymphocytes and B-lymphocytes that will remember how to fight the virus that causes COVID-19 if we are infected in the future.
In other words, the vaccine is giving your immune system a suit of armor to deal with the virus, because your immune system will already have antibodies that can recognize the COVID virus and attack it if you become infected.
These vaccines have gone through the FDA required clinical trials: phases 1,2,3 and we really now are in phase 4. To see how this works you can view this slide presentation:
https://www.youtube.com/watch?v=dsfPOpE-GEs&feature=emb_title.
Phase 1 studies of a new drug are usually the first that involve people. Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects. Although the treatment has been tested in lab and animal studies, the side effects in people can’t be known for sure. These studies also help to decide on the best way to give the new treatment.
Phase 2 clinical trials: Does the treatment work? If a new treatment is found to be safe in phase 1 clinical trials, a phase 2 clinical trial is done to see if it works against the specified disease.
Phase 3 clinical trials: Is it better than what’s already available? Treatments that have been shown to work in phase 2 clinical trials must succeed in one more phases before they’re approved for general use. Phase 3 clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment (in this case though, there was none, so vs placebo).
Because doctors do not yet know which treatment is better, study participants are often picked at random (called randomized) to get either the standard treatment or the new treatment. When possible, neither the doctor nor the patient knows which of the treatments the patient is getting. This type of study is called a double-blind study.
Phase 4 clinical trials: What else do we need to know? Drugs approved by the FDA are often watched over a long period of time in phase 4 studies. Even after testing a new medicine on thousands of people, all the effects of the treatment may not be known. Some questions may still need to be answered.
This information is from this site: https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html.
Although there was expedited approval, these vaccines have gone through the above steps. Please take the vaccines, it can be a matter of life and death, literally.
It is not easy getting an appointment for the vaccine. I took me 2 weeks of getting on the computer everyday at 7 am to get an appointment, and I finally got my first shot a week ago. You can go to this link to search for an appointment: https://vaccinefinder.nyc.gov/locations. Eligibility has recently been expanded, please check if you are eligible.
One caveat: Even after you are fully vaccinated, you should still follow CDC precautions, eg, mask and social distancing, until most of us gain immunity.
We are sharing this information with you in the hope it will help keep all of you healthy and safe during this trying time. We are all in this together. This is not politics; it is a matter of being a responsible member of the community.
With the crazy weather lately, our thoughts have turned to Texas; part of the editorial team I work with at my job had been without water, power, and heat much of last week. My thoughts are with them, and I was reflecting on how things are changing. The South may have to adapt to colder weather, just as we up North may have to adapt to much hotter weather in the summer. The only thing certain besides death and taxes in this world is change.
So, in closing, we look forward to a better year, and we will hopefully meet again on the other side of this pandemic. Take care, so we can.
TTFN.
Before I begin, we would like to say that we have deliberately refrained from inserting politics into our columns. The poison, lies, and vitriol that has passed as political discourse over the past 4 years has been unprecedented. We strongly feel that this has no place in a civic center column, but is better expressed as a letter to the editor.
We have not written in a long time, as our programs have been suspended due to COVID 19 this past year, and we do not know when they will resume. However, there are a few pertinent things to say about the crazy times we live in that directly relate to the COVID situation.
The message for today: There have been a lot of lies and half-truths being spread about COVID prevention, testing, and vaccines. We would like to say a few words about this.
First, there is no doubt that wearing a mask (or masks) helps protect against COVID:
“CDC recommends that everyone wear a mask over their nose and mouth when in public, including on public transportation and in transportation hubs such as airports and stations. Masks slow the spread of COVID-19 because they help keep people who are infected from spreading respiratory droplets to others when they cough, sneeze, or talk. Medical masks and N-95 respirators are for healthcare workers and other first responders, as recommended by current CDC guidance.” Feb 2, 2021.
From the FDA: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/face-masks-including-surgical-masks-and-respirators-covid-19#:~:text=Masks%20may%20help%20prevent%20people,from%20spreading%20the%20virus.
This is not a political or “freedom of expression” issue. This should never have been politicized in the first place, that was highly irresponsible. We are in the middle of a massive pandemic. This is a public health issue. Nearly 500,000 lives have been lost in the United States alone. Each one of us has a responsibility and a duty to ourselves and the community to help stop the transmission of this deadly disease. Please wear the mask for all our sakes.
Vaccines: As of now, 2 vaccines are being given in NYC, the Pfizer vaccine and the Moderna vaccine. There are others on the horizon: From the CDC website:
Currently, two vaccines are authorized and recommended to prevent COVID-19:
- Pfizer-BioNTech COVID-19 vaccine
- Moderna’s COVID-19 vaccine
As of December 28, 2020, large-scale (Phase 3) clinical trials are in progress or being planned for three COVID-19 vaccines in the United States:
- AstraZeneca’s COVID-19 vaccine
- Janssen’s COVID-19 vaccine
- Novavax’s COVID-19 vaccine
Both Pfizer and Moderna vaccines work the same way: mRNA vaccines contain material from the virus that causes COVID-19 that gives our cells instructions for how to make a harmless protein that is unique to the virus. After our cells make copies of the protein, they destroy the genetic material from the vaccine. Our bodies recognize that the protein should not be there and build T-lymphocytes and B-lymphocytes that will remember how to fight the virus that causes COVID-19 if we are infected in the future.
In other words, the vaccine is giving your immune system a suit of armor to deal with the virus, because your immune system will already have antibodies that can recognize the COVID virus and attack it if you become infected.
These vaccines have gone through the FDA required clinical trials: phases 1,2,3 and we really now are in phase 4. To see how this works you can view this slide presentation:
https://www.youtube.com/watch?v=dsfPOpE-GEs&feature=emb_title.
Phase 1 studies of a new drug are usually the first that involve people. Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects. Although the treatment has been tested in lab and animal studies, the side effects in people can’t be known for sure. These studies also help to decide on the best way to give the new treatment.
Phase 2 clinical trials: Does the treatment work? If a new treatment is found to be safe in phase 1 clinical trials, a phase 2 clinical trial is done to see if it works against the specified disease.
Phase 3 clinical trials: Is it better than what’s already available? Treatments that have been shown to work in phase 2 clinical trials must succeed in one more phases before they’re approved for general use. Phase 3 clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment (in this case though, there was none, so vs placebo).
Because doctors do not yet know which treatment is better, study participants are often picked at random (called randomized) to get either the standard treatment or the new treatment. When possible, neither the doctor nor the patient knows which of the treatments the patient is getting. This type of study is called a double-blind study.
Phase 4 clinical trials: What else do we need to know? Drugs approved by the FDA are often watched over a long period of time in phase 4 studies. Even after testing a new medicine on thousands of people, all the effects of the treatment may not be known. Some questions may still need to be answered.
This information is from this site: https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html.
Although there was expedited approval, these vaccines have gone through the above steps. Please take the vaccines, it can be a matter of life and death, literally.
It is not easy getting an appointment for the vaccine. I took me 2 weeks of getting on the computer everyday at 7 am to get an appointment, and I finally got my first shot a week ago. You can go to this link to search for an appointment: https://vaccinefinder.nyc.gov/locations. Eligibility has recently been expanded, please check if you are eligible.
One caveat: Even after you are fully vaccinated, you should still follow CDC precautions, eg, mask and social distancing, until most of us gain immunity.
We are sharing this information with you in the hope it will help keep all of you healthy and safe during this trying time. We are all in this together. This is not politics; it is a matter of being a responsible member of the community.
With the crazy weather lately, our thoughts have turned to Texas; part of the editorial team I work with at my job had been without water, power, and heat much of last week. My thoughts are with them, and I was reflecting on how things are changing. The South may have to adapt to colder weather, just as we up North may have to adapt to much hotter weather in the summer. The only thing certain besides death and taxes in this world is change.
So, in closing, we look forward to a better year, and we will hopefully meet again on the other side of this pandemic. Take care, so we can.
TTFN.
