Category: medical care

vaccine trial – injection 2

This week, B, T, and I are receiving our second injections of the Pfizer/BioNTech experimental COVID vaccine or placebo, three weeks after the first round. There is COVID testing and general health screening but no blood draw, which will wait for the next visit to see the antibody response. Throughout the two years of the trial, we will continue with a weekly diary of possible COVID symptoms, although we would contact the trial staff immediately if we suspected we had COVID. We each have an emergency test kit at home to collect samples if we are directed to do so by study personnel.

The possible date of vaccine approval in the United States has become a hot topic. The president has intimated that a vaccine could become available before Election Day, November third. Local health departments around the country are supposed to have plans in place for distribution by November first.

However, that timeline doesn’t jibe with the amount of time needed for preliminary Phase III trial results. Yesterday, Pfizer, BioNTech, and seven other drug companies involved in COVID vaccine development signed a joint pledge to uphold their rigorous testing measure and not request authorization without the requisite data showing safety and efficacy.

I’m pleased that they made this commitment to the public. When vaccines do become available, it is vital that billions of people around the world receive them so that we can end the pandemic. If only a small fraction of the world’s population receive it, the pandemic will not end because there will still be a large pool of potential victims for the virus. Some of those victims will be people who were vaccinated, as no vaccine is 100% effective. The vaccine should lessen the severity in those people who do contract it, as we see with current flu vaccines. It’s important to remember, though, that part of the way vaccines work is by creating herd immunity so that a pathogen can’t create an outbreak. Vaccines offer a safer, less lethal path to herd immunity than just allowing vast swaths of the population to be infected.

I suppose it’s possible that a vaccine might receive emergency use authorization this fall so that it could be used by front-line medical workers and extremely vulnerable individuals before long-term safety and efficacy could be established, but widespread vaccination isn’t possible until next year, at the earliest.

The wisdom of moving forward scientifically and methodically was illustrated this week by AstraZeneca, which put their COVID vaccine trial on hold in order to investigate a possible adverse reaction. It may be that the reaction had another cause, but, until that can be determined, they don’t want to risk the health of their participants. Rushing the swine flu vaccine out to the public in 1976 caused enough serious complications that it had to be suspended after ten weeks; no one wants to repeat that experience with COVID.

Meanwhile, our family will keep doing our small part in advancing the science in hopes that COVID-19 can be brought under control, saving as many people as possible from illness, disability, and death.

COVID vaccine trial update

Last week, B, T, and I each had our initial visit for the Pfizer/BioNTech vaccine trial for COVID-19. There was a lengthy informed consent document, medical history and physical exam, COVID test, blood draw, and injection with either the trial vaccine or placebo. Two of us had some mild side effects and one of us did not, so we are surmising that one of us received the placebo, but the study is triple-blind (participant, care provider, investigator) so we don’t know for sure if that is the case.

The Pfizer/BioNTech vaccine is a messenger RNA vaccine; this type of vaccine has not previously been approved for widespread use. It works by enclosing a strip of messenger RNA in a lipid shell. When it gets into cells, it manufactures the spike protein that the SARS-CoV-2 has on its exterior, so that the body recognizes it and makes antibodies and T-cells to combat it.

The phase I data looks promising, so I hope that this vaccine will be found effective. RNA vaccines are able to be manufactured quickly, which will be a plus if they are approved for use. I am hoping that a number of vaccines will be able to complete Phase III trials and earn approval, so that we can get as many people around the world vaccinated as quickly as possible. It’s the only way to gain herd immunity without a horrifying level of illness and loss.

The Pfizer/BioNTech trial is expected to finish its primary collection of data needed for approval in mid-April 2021, although the trial will continue to follow participants through November 2022 to see how well antibodies and T-cells persist.

Science takes time and the COVID vaccine is being developed at a blindingly fast rate in terms of past vaccine development. Remember that we are still looking at months before approval, not weeks. Even when one or more vaccines are approved, people will need to keep up with distancing, masks, sanitizing, etc. to keep the disease at bay while vaccination production and distribution campaigns occur.

Please, everyone, do your part to keep yourself, your family, and your neighbors as safe as possible, while vaccines and effective treatments are developed. I’ll post more information about our trial as time goes on.

SoCS: check-up

One of the many things that got deferred in 2019 while we were dealing with the final months of my mom’s life and the first months without her was going to the doctor for a check-up. I wasn’t being totally health-delinquent as I had other reasons to visit the doctor’s office, but I didn’t have the standard wellness exam that someone my age would usually have every year.

Next month, I am going to have a check-up, though, preceded by lab work so we can go over the results at my appointment. I may also need to have a bone density scan. I have crossed over into a diagnosis of osteopenia, which isn’t surprising. At 59, I don’t expect to have the same bone density as a woman in her twenties. I’m hoping that I can avoid taking Fosamax or some other bone-builder medication, at least for now. I prefer to save that until I actually develop osteoporosis, if I ever do. One can only take those types of medications for a limited amount of time and I don’t want to use up my quota too soon.

I also know that I should be thinking about getting a new shingles vaccine. I have had a bout of shingles and have had the older vaccine, but the new one is supposed to be much, much more effective. I will probably need to wait longer to get it, though, because, in the next few weeks, B, T, and I are all scheduled to participate in a coronavirus vaccine trial. The trial is supposed to last for two years, but I’m sure there will be a window for me to get the shingles vaccine at a time when it won’t interfere with the trial.

I’m sure I’ll be posting about the trial when it begins.

2019-2020 SoCS Badge by Shelley

Linda’s prompt for Stream of Consciousness Saturday this week is “check/cheque/Czech.” Join us! Find out more here: https://lindaghill.com/2020/07/24/the-friday-reminder-and-prompt-for-socs-july-25-2020/

Sad stats

The horror show that is the United States and coronavirus continues.

My state, New York, was the world epicenter in the early spring. Through good leadership informed by science and metrics and residents who took the policies seriously, we were able to get the pandemic under control. Through a careful, phased, and data-driven process, we have also been able to keep our transmission rate low as we have opened more of our economy.

Still, when the map of case numbers would be released every day, New York, the fourth most populous state, showed the highest number of total cases, over 400,000, because our initial outbreak had been so severe.

Until this week.

California, which is the most populous state, passed New York this week on confirmed COVID case numbers. (All the public health experts agree that the actual case numbers are much higher, but the official count uses only testing results and death certificates.) While California had had early success in containing the virus, it re-opened businesses too quickly and many people abandoned needed precautions like masks. Hence, their caseload is soaring. I’m hoping that New York will continue to keep the virus from resurging so that we never again reach the top number of cases, but Texas and Florida, second and third most populous states, are also in the midst of major outbreaks and might surpass California’s numbers in the coming weeks.

It’s appalling.

What saddens me is that it didn’t have to happen this way. New York and some of our partner states in the Northeast learned a lot of lessons through our experiences this spring and, in the absence of a national program, have been offering to help other states deal with the virus and the economic/social fallout. This has resulted in some positive news in the states being hard-hit now, for example, the mortality rate is lower, in part because of improved treatments for the severely ill. Most of the news, though, is bad: overwhelmed hospitals, people not wearing masks and attending large gatherings, bodies being stored in refrigerated trucks because mortuaries are backlogged, more and more states where the number of cases is rising.

Meanwhile, there is still no national plan. The House of Representatives, led by the Democrats and Speaker Nancy Pelosi, passed the Health and Economic Recovery Omnibus Emergency Solutions Act or the HEROES Act in mid-May, which would address some of the current problems with testing, contact tracing, and treatment of COVID, as well as a host of economic and social impacts on individuals, families, businesses, agencies, and state and local governments. The Senate, under the leadership of Republican Majority Leader Mitch McConnell, didn’t act on the bill this spring and just returned from a three-week break without their own version of a bill and, after a week’s work, they still don’t have a Republican proposal, much less a bill that has been negotiated with the Democratic and Independent senators so that it is ready for debate and vote.

Meanwhile, people are sick and dying, out of work, not knowing how they are going to be able to pay their bills, scared, and bewildered about their country’s dysfunctional state. The United States has become an object of pity around the world.

I’m disappointed that, even when the crisis is monumental, the Republican leadership can’t muster the will and/or competence to do their job and govern for the good of the people. If they had integrity, they would resign to make way for leaders who can and will serve the people and the Constitution. Resignations would be less disruptive than the current inaction.

a vaccine trial

Our family physicians’ practice has a research department that works in conjunction with national trials. I have done several studies with them in the past, including vaccines for seasonal flu and adult RSV (respiratory syncytial virus).

I got a call the other day because they are signing people up for a SARS-CoV-2 vaccine trial. This is the virus that causes COVID-19. It will be a two-year study looking at the effectiveness of the study vaccine. I qualified and enrolled in the study, as did spouse B and daughter T.

We don’t know whether this vaccine will prove to be effective or for how long, but we are committed to being part of the process to find out. Even if it isn’t protective, that information will be helpful in the search for finding a vaccine that is.

They are looking for more participants. If you are in the Binghamton NY area and are interested, please contact me for a referral to the researchers who can provide full information about the study. You may leave a message in the comments so we can work out how to communicate privately or contact me through Facebook Messenger or email if we are already connected.

SoCS: New York State re-opening

I live in the Southern Tier region of New York State (USA), where we are undertaking a methodical re-opening of businesses after we successfully drastically lowered our number of COVID-19 cases.

Every day, I listen to the press briefings from Governor Cuomo. He has been very transparent on what the state is doing and what the role of the public is in protecting public health during our stay-at-home period and now our phased re-opening.

The Southern Tier region is about to enter Phase 3. One of the services that is allowed in phase 3 is nail salons. Hair salons were allowed to resume, with masks and other safeguards in place in phase 2, but nail salons had to wait for phase three as it involves longer face-to-face interaction.

I don’t do manicures, but I do have an appointment for a haircut in a couple of weeks. After that, I’ll be able to go without the headband that has become part of my wardrobe in order to keep my bangs out of my eyes.

Long bangs is an infinitesimal price to pay for what has been great news for New York State. Unlike other states that were less careful about re-opening businesses, our infection rates have continued to decline. The numbers are constantly monitored with widespread testing and contact tracing for positive tests so that we know we are not starting an outbreak. As soon as the numbers in a region start to creep up, there are plans in place to cut back on the re-opening until the infection rate is under control again.

I’m proud of everyone in New York and our leadership team for the thoughtful, caring, science-based, and successful way we have tackled this challenge. I hope that more states and countries, seeing our approach working so well, will follow our lead and be able to save their people from further suffering from the pandemic.
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Linda’s prompt for Stream of Consciousness Saturday this week is “nail.” Join us! Find out how here: https://lindaghill.com/2020/06/12/the-friday-reminder-and-prompt-for-socs-june-13-2020/

2019-2020 SoCS Badge by Shelley!
 https://www.quaintrevival.com/

Memorial Day 2020

Today, the United States observes Memorial Day. It originated as a day to honor Union soldiers who died during the Civil War, but expanded over time to include service members who died in any armed conflict.

I am also thinking today of all the civilians who lose their lives in wars. Perhaps, this is because I just finished watching World on Fire on Masterpiece, which is about people from various countries in World War II Europe.

As the country continues its struggle with the COVID-19 pandemic, we often hear politicians and media describe it as a war. The medical personnel, first responders, and caregivers are called the front line, a term that is sometimes also applied to other essential workers, such as transit, delivery, and grocery workers. I am confused, though, by the use of the term “warrior.” Sometimes, it seems that the general public are considered warriors, serving others by staying at home to avoid spreading the virus further. Others are using the term warriors to describe those who are giving up on stay-at-home orders and going back to “normal” whether or not the public health officials say it is wise.

I am extraordinarily grateful to be living in New York State, where our governor and other leaders are methodically working to expand economic activity while safeguarding public health. National news reports have shared data that twenty-four states are re-opening their economies with the rate of infection still increasing, even though the national guideline is that at least two weeks of declining infections is required first.

While I remain unsure of who the “warriors” are, I am painfully aware of who the casualties are in this war. As I write this, there are 98,000+ confirmed COVID-19 deaths in the United States. The number will surely reach 100,000 within the next two days. Over these last few months, the United States has lost more lives to coronavirus that it has service personnel in all the wars since the end of World War II combined.

Today, I am commemorating all the service members and civilians who died in war and all the pandemic victims. May their memories strengthen us to serve others.

SoCS: re-opening?

I want to believe that our region’s re-opening of some businesses will not spark more cases of COVID-19.

I wrote earlier in the week about our area of New York State qualifying to re-open certain businesses. As of yesterday, non-essential retail can be open for curbside pick-up. Some construction and manufacturing can start up with appropriate precautions to protect workers. Plans have to be filed with our regional commission to make sure that they comply with CDC and state guidelines. This is stage one of four. All seven metrics that govern re-opening have to be met at all times. If something slips, signalling a possible outbreak, businesses will have to close again until conditions improve.

It’s bothering me that the media are lumping New York State in with the other 47 states that are ending stay-at-home policies. The vast majority of those states have not met the CDC guidelines for two weeks of declining cases, making public interaction much more dangerous. Those states are not trying to contain the virus but to mitigate it.

New York is putting in place a much different strategy. Only those areas of the state that have the virus contained are eligible. There is a requirement to do a certain number of tests weekly and there are contact tracers, so many for every thousand residents, so that if a case is detected, they can quarantine all contacts that have been close to the infected person so that we don’t get community spread. We hope that the testing, tracing, and monitoring will keep the virus contained, allowing more businesses and services to re-open over the coming weeks and months, while protecting public health. If the program is effective, we won’t need to back off and go back to stay-at-home, but we can if infection rates go up. More importantly, we would know that infection rates are climbing before they get out of control. It turns out that the reason New York had so many cases is that the virus was already out in the community months before anyone realized, coming into New York/New Jersey airports from Europe when everyone was thinking that it was only travel to China that was worrisome. Even now, the downstate region is still under stay-at-home for at least another month. The other area of the state that is still under stay-at-home is western New York, including Buffalo.

Because New York State’s plan is so well-thought-out and relies on science and the experiences of other countries in re-opening, I am hopeful that we will be able to protect public health while gradually getting more people back to work.

I am very afraid for the states that are re-opening more haphazardly, which is, sadly, most of them. They didn’t even follow the CDC guideline to have two weeks of declining infection rates before opening businesses. Many places also opened high-risk businesses, such as hair salons and bars, where social distancing is impossible. The experts who model suspected outcomes have all raised their estimates for infections and fatalities because so many states are taking such a risky path.

I’m sad and scared.

I want New York’s path to work. If it does, I want other states to adopt similar plans, so that we can save as many people as possible from illness and death.

Is that too much to ask?
*****
Linda’s prompt for Stream of Consciousness Saturday is using the word “want” within the first three words of the post. Join us! Find out more here:  https://lindaghill.com/2020/05/15/the-friday-reminder-and-prompt-for-socs-may-16-2020/

2019-2020 SoCS Badge by Shelley!
https://www.quaintrevival.com/

New York’s reopening plan

I’ve posted several times about how my state is handling the pandemic. Unlike many other states, New York State has taken a methodical, metric-based approach.

The whole state has been under a program called PAUSE, which is a stay-at-home order for all but essential workers and shopping for necessities. Starting on May 15th, certain regions of the state that have met the criteria will be moving into phase one of four for re-opening certain businesses.

My region, the Southern Tier, is qualified to re-open companies with worker and customer safety plans in place in construction, manufacturing, delivery/curbside pick-up retail, wholesale, agriculture, forestry, fishing, and hunting. The region needs to continue to meet the criteria each week, including testing and having contact tracers available. If criteria continue to be met, other businesses will open in phases. If the statistics show an outbreak is developing, the phased-in businesses will close until all the criteria are again met.

The state has a website called New York Forward, which has up-to-date information about the plan and the current status of each region. There is more information about the phase-in of businesses here. For those who would like more detail, there are many different pages and sections available on different aspects of the plan from the New York Forward main page link above, as well as a 50 page book, which includes some history, the basics of the plan itself, and future goals.

While there are no certainties in dealing with the pandemic, I am reassured that there is a detailed plan with metrics based on science and the experiences of other places dealing with the virus. It’s also good to know that there is continuous monitoring of the situation so that we can adapt the implementation as needed.

For the good of our state and the health and well-being of our residents, I hope the plan works well. If it does, I hope other governments will be able to use it as a template for their own plans.

We are better off if we make thoughtful, science-based decisions. This pandemic has shown how connected the world is. We all need to cooperate if we are ever going to end this diesase.

New York State and plans

Every day, I listen to Governor Andrew Cuomo of New York give his daily coronavirus briefing and take questions from the press.

I am definitely not alone.

I often watch through Facebook Live, so there is a comment stream during the briefing. While some of the people are, like me, New York residents, many others tune in from other states and countries. While there are some trolls, many people thank Governor Cuomo for his candid, factual presentation and his compassion. There are always some calls for him to run for president. I admit to having the occasional, totally improbable political fantasy that both the nominating conventions decide to choose a governor who has handled the pandemic as well as possible to run for president, so that instead of Trump versus Biden, we would have, say, Hogan versus Cuomo. Not going to happen, but I, for one, would breathe easier if it did.

This is a big week for New York State. Our current stay-at-home order expires May 15 and it is expected that some regions, including the Southern Tier where I live, will qualify to enter phase one (of four) for expanding what businesses and services may be opened and under what circumstances. There are a number of criteria to meet before being eligible, including at least a two-week decline of new cases, hospital and intensive care unit availability, and testing and contact tracing capabilities. All the businesses have to have plans in place for safe working conditions and customer delivery protocols. If COVID-19 cases start to increase, the state will go back to its prior level of operations until conditions improve again. The New York plan is based on medical science and the experiences of other countries and cities around the world as they try to increase economic and social activities after outbreaks of the virus. For reference, businesses like hair salons and dine-in restaurants don’t re-open until phase three.

Because of the planning and vigilance of our state government, I feel relatively secure that New York will be able to protect public health while gradually opening more and more public and private entities. I remain very worried, however, about the majority of states who are re-opening without even having had a decline in the number of cases. Indeed, right now, if you take New York out of the national statistics, you find that while New York’s infection rate is on a steady decline, the rest of the country is still on the increase. In addition, some countries that had contained the outbreak, such as Germany and South Korea, are having to back off with some of their re-opening of businesses because their case numbers are rising again.

I am hopeful that our region and other New York State regions that qualify will be able to move forward with our slow and thoughtful plans while still protecting public health. If that happens, I hope other states and countries will study our approach and adapt it to their regions.

With over four million confirmed cases world-wide, we need the best practices devised and enacted as soon as possible around the world.