Category: medical care

Pfizer vaccine update

My spouse B, daughter T, and I are participating in the Pfizer/BioNTech coronavirus vaccine trial. My most recent update on our personal experience is here, but I wanted to share an open letter from Pfizer which you can find here.

President Trump has been intimating that a vaccine would be available under emergency authorization by election day November third, which has led to fears that the companies might compromise the science in order to meet that deadline. The companies, though, have been trying to reassure the public that they will adhere to sound scientific and public health principles.

The letter from Pfizer’s chairman and CEO Albert Bourla explains that there are three necessary components for vaccine approval: effectiveness, for which they expect data by the end of October; safety, for which they will have data in the third week of November; and manufacturing data to ensure consistent quality. If there are good results confirmed by outside experts, Bourla believes that Pfizer will be able to apply for emergency use authorization from the United States Food and Drug Administration shortly after the safety data are available in the third week of November.

Even if the emergency and final authorization is approved, Pfizer will continue its study for two years in order to monitor safety and longevity of effectiveness.

I appreciate Pfizer’s transparency of their process and truly hope that their vaccine will be shown to be safe and effective so that we can begin to protect first our most vulnerable and eventually everyone from COVID-19. I also hope that lots of other companies in the US and around the world will also produce safe and effective vaccines so we can end the pandemic as soon as possible.

JC’s Confessions #16

In the first few seasons of The Late Show, Stephen Colbert did a recurring skit, now a best-selling book, called Midnight Confessions, in which he “confesses” to his audience with the disclaimer that he isn’t sure these things are really sins but that he does “feel bad about them.” While Stephen and his writers are famously funny, I am not, so my JC’s Confessions will be somewhat more serious reflections, but they will be things that I feel bad about. Stephen’s audience always forgives him at the end of the segment; I’m not expecting that – and these aren’t really sins – but comments are always welcome.

JC

I should be watching the Senate Judiciary committee’s hearings on the nomination of Amy Coney Barrett to the United States Supreme Court right now.

I can’t bring myself to do it.

There are a lot of reasons.

First, it renews my sorrow at the loss of Ruth Bader Ginsburg.

Second, it is difficult to cope with the nomination going forward under the current circumstances. There is the proximity to the election with voters already casting their ballots and the hypocrisy of the Republicans in moving forward with the confirmation process when they would not allow a hearing for President Obama’s nominee in 2016 many months before the election. There is also the fact that the Senate is not in session due to several senators being COVID positive; if it isn’t safe to be in session, in-person hearings should not be held, either.

Third, I’m leery of how the subject of religion will be handled. Like me, Judge Barrett is Roman Catholic, as are five current members of the Supreme Court with a sixth having been raised Catholic. In a country that is predominantly Protestant, it seems odd to have so many Catholics on the Court. I realize that justices make determinations on the basis of the law, but there are times that some of the arguments made in cases cross into religious belief and the Catholic hierarchy sometimes makes arguments that are factually incorrect. For example, some recent cases have upheld employers’ refusal to offer birth control in the medical insurance of women employees on the grounds that birth control is abortifacient, which, while taught by the Catholic bishops, is not medically true. Likewise, you see arguments that same-sex marriage is an assault on religious freedom even though it is a civil law; while some religions choose to offer ceremonies for same-sex couples, no religion is compelled to do so.

Fourth, I remain suspicious of the originalist/textualist bent that Judge Barrett exhibits. That judicial philosophy fails to account for how the meaning of words changes over time. In my view, one of the strengths of our Constitution and laws is that it can be interpreted in the light of new circumstances. Let’s face facts: many of the men who wrote the Constitution were slaveholders who never envisaged that one day Blacks, women, and people who don’t own property would be voters. Many modern issues could not have been imagined by people in the 18th century.

However, some issues that were clearly spelled out in the legal writings of the 18th century are ignored by originalists when it suits them. For example, the second amendment very clearly places the right to bear arms in the context of a “well-regulated militia” but originalists often ignore that part of the text and original intent. It’s also very clear that the Founders understood that corporations are not people; a future Supreme Court may someday strike down the Citizens United ruling on that basis.

I don’t know what will happen with this nomination or with the Court in the coming years, but, right now, I can’t bear to watch.

looking for antibodies

Last week, B, T, and I had our third visit in the Pfizer/BioNTech coronavirus vaccine trial.

The main purpose of the visit was to draw blood to analyze for the presence of antibodies and other factors involved in viral immunity. Because the study is placebo-controlled and blinded, neither we nor the researchers will know our individual results, but the data will be important in determining how quickly and how well the vaccine works.

Our next appointments aren’t until March when more blood work will be done to check on antibody levels again and to see if they have remained and/or declined. In the meantime, we will continue to check in weekly through a phone app which asks about possible COVID symptoms. We will also contact the office if any of us develop symptoms that could be COVID, so that we can be tested.

The Pfizer phase III trial data will be evaluated when a certain number of COVID cases develop among the participants. When these case benchmarks are reached, the researchers will be able to determine how much protection the vaccine group exhibited compared to the placebo group. That percentage helps to determine if the vaccine will be approved.

If the vaccine is approved, Pfizer may decide to end the trail early so that the placebo group members can receive a vaccine to protect themselves. They would continue to follow the vaccine group from the trial for two years as planned, collecting data on how durable the immunity is and any side effects that might not be evident immediately.

We have also passed the window of time after the second injection in the trial when one couldn’t receive any other vaccines, so all three of us have now gotten our seasonal flu shots. We do always get flu vaccines every year, but public health experts are particularly strong in their recommendations that everyone get a flu shot this year. They are afraid of having a bad flu season on top of the coronavirus pandemic, which would make the fall and winter even more dangerous.

Please, all the Northern Hemisphere folks reading this, make arrangements to receive a flu vaccine, if you haven’t already done so.

for the archives

A few weeks ago, a poet-and-church friend who is a faithful reader of Top of JC’s Mind asked if I would like to get in touch with a friend of hers who is involved with a local historical society. Their historical society is joining with others in New York State to assemble an archive related to the pandemic. My friend thought that my posts about being in the vaccine trial might be appropriate for the archive.

It turned out that the archiving project was interested in my vaccine trials posts and any others that dealt with living in the time of COVID. I had sent the vaccine posts first. Then, I worked my way through my blog archive, copying the links to other pandemic related posts.

I knew that I wrote about the impact of COVID-19 quite a lot, but I was surprised at how long the list of posts was – fifty-six posts, from late February through September 11, in addition to the handful of vaccine ones. I joked with the archivist about it being either “an embarrassment of riches or just an embarrassment!” Since then, any time I write about our pandemic experiences I send her the link.

I had asked her how they were preserving the archive. She said that, while they do keep links on their computer, they are printing the materials for posterity. Archival technologies tend to come and go but paper lasts for a very long time.

It’s humbling to think that, decades from now, some future historian might stumble across some of my posts and be able to glean some insights about what it has been like dealing with these fraught times in our communities in upstate New York. First person contemporaneous accounts are highly sought sources for historians and documentarians and I would be honored if my posts are able to assist someone with their research some-year in the future.

scatter-brained

I’ve been wanting to write a post for several days, but have felt too scattered to do it.

I’m still feeling too scattered, but am determined to do it now regardless, ignoring the fact that I have unread email messages going back to Sunday, although I think I’ve caught all the important ones, and a long to-do list of other tasks.

Our national drama and the pandemic continue to demand an outsize share of my thoughts. The president’s behavior and rhetoric are increasingly bizarre, possibly as a result of the high-dose steroids he is taking for COVID. There are over two dozen known cases among White House and campaign personnel and cases and quarantine of the Joint Chiefs of Staff, our highest ranking military officers. The president is planning to resume public campaigning, even though he is most likely still infectious. The medical information that has been released publicly is at best incomplete and at worst misleading.

Yesterday, arrests were made as a result of a plot to kidnap and possibly kill Michigan governor Gretchen Whitmer. I’m grateful that the governor and her family are safe but appalled that a self-styled right-wing militia was planning such a horrible attack. Gov. Whitmer, like many other governors around the country, has enacted executive orders to address the pandemic. She has been vilified by protesters, some of whom were armed, Republican legislators, and the president. She has been publicly threatened with violence and been subjected to sexist slurs. Still, it was shocking to learn that there was a serious plot to kidnap her and “try her for treason” before the November election. Instead of expressing support for her yesterday after the news broke, the president tweeted criticism of her and her policies, along with mischaracterizations of her and other Democrats.

In local COVID news, there has been an uptick in cases here in Broome County and we are officially on yellow alert, which sets lower limits on gatherings and increased testing for schools. Our county executive had already asked residents to stay at home as much as possible, so there isn’t much additional impact on daily life, but the official recognition by New York State has reminded me to be even more cautious with outings.

I am also getting increasingly anxious about our upcoming trip to the UK to visit daughter E and her family. The UK has also had an increasing number of COVID cases recently and has tightened restrictions. B, T and I are going for the month of November because we will need to quarantine for the first two weeks. Then, we will have two weeks to visit, although it’s unclear if we will be able to all congregate at their home as gatherings of more than six are prohibited. We are also hoping to celebrate JG’s baptism, but aren’t sure how many will be allowed to attend. After we return home to New York, we will need to quarantine for two weeks, bringing us to mid-December. The airline has already changed our flights once and I’m hoping that no additional travel restrictions go into effect this month.

Part of what is stressing me out is trying to plan and prepare for six weeks of travel and quarantine. Besides B, T, and me, I need to have plans in place for Paco and for the house, where my sisters and brother-in-law in various constellations will be holding down the fort in our absence. This is turning into a major re-jiggering and re-stocking effort indoors, while a long-awaited landscaping project has been going on outdoors.

Meanwhile, in my continuing quest to catch up with personal preventive health measures, I had a COVID test this morning in advance of a colonoscopy next week. Because of some pre-existing conditions, my prep is a bit more complicated than for most people, so I’m hoping I can get through it with a minimum of repercussions. Maybe I’ll write a post next week while I’m waiting for the remnants of the sedation and medications to wear off. That could be, um, interesting?

On the poetry front, I got another chapbook rejection. It was a debut chapbook competition that had drawn over 200 entries, a detail I’m including as it gives people an idea of the odds, and this contest was relatively small. On the unexpectedly happy news side, I received notification of acceptance to an anthology called Lullabies and Confessions: Poetic Explorations of Parenting Across the Lifespan from University Professors Press. I had submitted to the anthology over four years ago and had assumed my poem had been rejected although I hadn’t gotten an email about it, but the project had instead been delayed and my poem will be included. Publication is expected in print and ebook early next year.

I’m still feeling scattered, as though there is something else I’m supposed to be saying, but I want to get this out. Stay safe and be well!

DT and COVID

As I’m sure the whole world knows, the president of the United States is hospitalized with COVID-19. It’s been a bit difficult to get the straight facts on his condition, but it is increasingly looking like his case is on the more severe side.

He does have multiple risk factors, including his age, gender, and weight. He is being treated aggressively by his medical team, including with an experimental antibody treatment and with remdesivir. These are both given early in the course of the disease to help the body fend off the virus.

Today, though, it was revealed that the president is being given the steroid dexamethasone, which is usually given only to more severe cases later in the disease course, when there are significant lung complications and/or the need for a ventilator.

The medical team is even talking about the possibility of discharging him back to the White House, which does have its own sophisticated medical unit, tomorrow.

This doesn’t seem to add up. If his condition warrants dexamethasone, it would seem best to keep him in the hospital for close observation.

Another concern is that days seven through ten of COVID often see an exacerbation of symptoms. The president is only on day four. It seems it would be much safer to keep him in the hospital. It’s not as though he is cramped for space or lacking amenities in the presidential suite at Walter Reed; besides medical care, it also has its own secure conference room and kitchen/dining space.

I also wish that the president would temporarily sign over powers to Vice-president Pence in accordance with Article 25 of the Constitution. We know that the president has suffered with a high fever and times when his blood oxygen level has dropped below normal. COVID is nothing if not unpredictable. Foreign powers could take a provocative action, surmising that the president would not be well enough to respond appropriately. I think it would be safer for the country to have the vice-president, as long as he remains well, exercise the presidential powers until the president is fully recovered. Pence can always confer with president when his symptoms are well-controlled, but he would have the power to respond on his own if the president were to be unwell when a crisis arose.

The president and First Lady’s illness with COVID would be problematic enough, but a number of senators and other government and campaign staff and advisors have also been infected or exposed. Because the incubation period can extend to fourteen days, there are many people who should be in quarantine to make sure they don’t expose others while pre-symptomatic or asymptomatic. Somehow, despite the seriousness of the situation, Sen. Mitch McConnell plans to push ahead with the confirmation hearing of Amy Coney Barrett to the Supreme Court. He considers that worth the risk, while he won’t put the latest House-passed coronavirus relief package up for a vote.

Voters, pay attention to how candidates on your ballot are handling this health and governmental crisis. Are they prioritizing your and the country’s health and well-being or their own power?

200,000

The number of known COVID-19 deaths in the United States is over 200,000.

It’s hard for me to grasp the total, knowing that each of these was someone’s child, parent, sibling, co-worker, neighbor, friend.

A few days ago when I was working on this post, I needed to look up the population of Broome County, New York, where I live.

It’s about 190,000.

I am imagining the city of Binghamton empty, the University and all the other schools without students and staff, all the towns and villages without people, just the wild creatures and birds alive.

It’s sobering.

In reality, Broome County has lost 85 residents to COVID, each person a loss to their family and community. Somehow, though, my thought experiment in concentrating the loss to our country as the obliteration of our entire county has given me a sense of scale and of grief that the statistics alone did not elicit.

What does 200,000 deaths mean to you?

unmasked

Last week, I needed to bring one of our vehicles to a dealership for a recall. The one we usually use wasn’t certified to work on the electrical/battery system of our hybrid, so we made the appointment at another dealer in a neighboring county. We live near the county line, so it’s just a couple of towns to our west.

Tioga County is a rural county; Broome, where I live is a mix of rural, urban, and suburban, although Binghamton is a small city by most standards with a population of about 46,000. Broome County’s population is about 190,000 in 716 square miles; Tioga’s is 48,000 in 523 square miles.

Your geography trivia for the day!

So, I arrive at the service department of the dealership, wearing my mask. There is a sign on the door that face coverings are optional for customers but required for staff, which seemed a bit odd as New York State rules are to wear a mask whenever people are closer than six feet (2 meters). I was surprised to walk up to the service desk to find that there was no plexiglass barrier to protect the employee and he was not wearing a mask.

I tried to maintain distance as best I could. I checked in, walked past unmasked customers in line, and sat in the waiting area with unmasked customers while unmasked employees walked through several times. When the repair was complete, the employee doing checkout hastily put on a mask after the window that separated her desk from the hallway was opened.

The experience left me feeling not endangered, because I was masked and maintained social distance most of the time, but disrespected. While the business knew that its employees should be masked when in proximity to another employee or a customer, they were not complying.

As the designated shopper in our house, I’m used to visiting businesses which have implemented careful measures to keep their employees and customers as safe as possible. The result has been that our infection rate in the state has remained very low as we methodically re-open businesses and services. If I am ever in a similar situation that I have to use this car dealership, I’ll make arrangements to drop the car off the evening before so that I only need to go inside to do the final paperwork when it’s ready.

I hope that there won’t be any outbreaks from the disregard that I witnessed at the car dealership, which, presumably, was considered acceptable to others in that community. For me, it seemed a small taste of what I hear on the news from other states, that folks don’t believe that masks and distancing help prevent COVID infections or that masks infringe on their liberties or that COVID doesn’t exist, all of which contribute to the appalling rates of illness and death in the United States.

At least I know that no one there will have contracted COVID from me.

September 11

Nineteen years ago today, terrorists, most of whom were from Saudi Arabia, attacked the United States, killing thousands of people and destroying airplanes and buildings in New York City, Arlington, Virginia, and Shanksville, Pennsylvania. I remember those killed, the many who acted valiantly to try to save lives, often at the cost of their own, those who worked in the aftermath of the disaster, many of whom suffered illness as a result, and the many thousands, both military and civilian, who were impacted by the wars in Afghanistan and the rest of the Middle East that sprang from the 9/11 attacks.

Nine years ago, my area was suffering from a record flood of the Susquehanna River, brought on by the remnants of tropical storm Lee. What many people don’t realize is how long it takes to recover from such an event – and that some things aren’t recoverable. It took years to repair homes that could be and tear down those that couldn’t. There are neighborhoods with patches of grassland where homes once stood, interspersed with homes that managed to survive. Those neighborhoods have changed character, with fewer older folks in them as they were the most likely to move to higher ground or leave the area after the flood. Our own home was not flooded, but there was standing water three blocks away and significant basement flooding one block away. We had long carried flood insurance on our house, although it isn’t required by the (still outdated) flood maps; we will continue to do so, hoping that we never have to use it while realizing that the increased strength of weather systems and changes to the upper-level wind patterns brought on by global warming may someday send us another record-breaking flood that will reach our home.

Despite these prior events, September 11, 2020 feels even more fraught. The global pandemic has exacted a terrible toll on the United States. We are over six million cases and closing in on 200,000 fatalities. The economic impact, especially on those on the lower end of the socioeconomic spectrum, has been severe, with rising rates of hunger and housing crisis. The pandemic also made more prominent existing problems with the health care system, racism, environmental degradation, education, infrastructure, jobs, wealth, taxation, and social programs. While some of the effects have been buffered by living in New York State, where Governor Andrew Cuomo has been leading an effective response to the crisis, I am appalled by the lack of leadership from the president and the callous intransigence of Senate Majority Leader Mitch McConnell, which are prolonging and deepening the suffering in the country as a whole. Because the Senate hasn’t passed the HEROES Act which the House passed in May, additional federal assistance to households, state and local governments, the post office, and the election system isn’t available. As a result of the national inaction, states are going to have to lay off front-line personnel and the vote count in November’s elections will take a long time.

To make matters worse, this week has seen new evidence that the president’s failure to address the pandemic was not due to lack of understanding the crisis. A just-released recorded interview on February 7 with Bob Woodward makes clear that the president knew that the virus was highly contagious, deadly, and spread through the air, yet he continued to intentionally downplay the threat rather than mount an effective and protective response. If the president had lead the nation in the kind of efforts that Governor Cuomo did in New York, there would have been millions fewer cases of the virus and thousands upon thousands fewer deaths. There would be widespread testing and contact tracing. The test positivity rate would be below one percent, as it has been in New York State for over a month. Businesses and schools would be thoughtfully and carefully re-opening, ready to re-adjust if cases start to rise. Instead, Dr. Fauci, director of the National Institute of Allergies and Infectious Diseases, is telling the United States to “hunker down and get through this fall and winter, because it’s not going to be easy.” I only hope that people take the advice to heart in their own lives and at the state and local level, because Trump and McConnell are still not helping us mount a national response.

The Trump/Bob Woodward interview I mentioned above was just released because Woodward has a book coming out, part of a spate of books about Donald Trump being published with less than two months to go before the presidential election. These books reveal information that, while perhaps suspected, had not previously been confirmed about the president and his staff. The picture isn’t pretty. While there is some straight-up incompetence and inexperience at play, there is even more corruption, selfishness, greed, and disregard for the Constitution and laws, morals, ethics, and the common good.

Time for the pitch. Make a plan and vote! We need there to be a President Biden in January 2021 in order to have any hope of reclaiming our democracy.

Which brings me to another fear. While there is widespread and credible polling both nationally and in battleground states showing that Biden is leading Trump by several percentage points, the election process itself is under threat. The most frightening is that the Russians, along with several other countries, are once again attempting to interfere with election. This week, a whistleblower came forward with evidence that the administration is knowingly tamping down revealing the extent of the Russian interference, in particular. At the same time, the administration and the Republicans are filing lawsuits to disrupt mail-in voting. The postal service is slowing mail delivery, which could make ballots arrive too late to be counted. The president keeps saying that mail-in ballots lead to widespread fraud, which is absolutely a lie; states and local election boards have numerous, proven safeguards in place to prevent fraud. It is true that the final vote tally will take longer, especially in states that don’t count mail-in votes until days after Election Day. (Of course, some of the delays could have been averted if the Senate had acted on the HEROES Act which would have provided more training, machinery, and personnel to count ballots more quickly.) People need to be aware that we may not have final election results for a couple of weeks. This does not mean there is fraud; it means that election bureaus are diligently following their procedures to report an accurate tally.

Nineteen years ago, despite sorrow and shock, the people of the United States pulled together to help us get through the crisis. Nine years ago, our local community drew together to assist those impacted by the flood. Unfortunately, I don’t see that same sense of solidarity in the country as we face the pandemic, government corruption, and economic catastrophe, along with the long-standing problems of racism, lack of equal access to good-quality education and health care, environmental ruin, and other injustices. Granted, it’s a lot, but we can improve our lives and our nation if we act together. When we say in the Pledge of Allegiance “with liberty and justice for all”, we have to mean it.

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.