Category: medical care

Unmasked!

As my more frequent readers may recall, spouse B, daughter T, and I are all participants in the Pfizer/BioNTech coronavirus vaccine trial. The vaccine received emergency use authorization in the United States in December 2020. Pfizer is now unmasking people in the placebo group and offering to make them part of the vaccine group for further study as they plan to follow participants for two years to gather data on long-term efficacy.

Earlier this week, I received a call saying that I was in the placebo group, which B, T, and I had long suspected as they both had side effects after our injections but I did not. I will receive my first injection with the real vaccine in early February, timed to coincide with the end of the waiting period after the shingles vaccine I had this month. I am grateful for the opportunity to receive the vaccine and to contribute to the data which will help keep more people from suffering the worst consequences of COVID and eventually end the pandemic.

While we will still need to mask and distance, I’m hoping that, as I and others around me are vaccinated, I will be able to return to some places that I have not been able to visit. I may, at least occasionally, make a reservation to attend mass on the weekend, something that I always did pre-pandemic but have not done since March 2020. I may visit with friends indoors, which would be nice given that outdoor visits are tricky in the winter. Eventually, we may be able to travel again, although I’m afraid a trip to London will not be possible for some months.

The other piece of good vaccine news from our family is that my 95-year-old father, known here as Paco, has received his second shot of the Pfizer vaccine. In a couple of weeks, he should reach his maximum level of protection. This is particularly important because he is in an assisted living unit, which is considered a higher risk living situation. Presently, visiting is very restricted. T was able to visit him in person for half an hour today in a socially distanced visiting room; earlier this week, I was able to do a window visit, where we could see each other through a window while we spoke by phone. I am hoping that, as residents and staff all receive their vaccinations and as more members of families receive theirs, the state will relax visiting restrictions to allow masked visits into residents’ apartments. We haven’t been able to see Paco’s new place yet and would love to be able to help organize things for him.

In our little corner of upstate New York, we are chipping away at the pandemic, doing what we can to bring it under control. We know, though, that things in the country as a whole will be difficult throughout the winter. We have passed 414,000 deaths in the US with the expectation that we will reach half a million deaths in February. It’s staggering.

I’m hopeful that the Biden administration’s leadership and plans will help us get through this winter with the least amount of damage possible, although we have been warned that things will get worse before they get better. I hope each person will do what they can to help in the effort.

what hasn’t changed

The last few years have been challenging for me and my family. As I have written in (many) posts, these personal challenges have been compounded by what is happening in the United States.

As I begin a busy week in caring for my family, the back drop is the horrifying news that United States has passed 20 million confirmed COVID cases with over 352,000 known deaths with COVID. It is immeasurably sad – and infuriating because we could have prevented a large share of these with good public health measures and accessible, timely medical care. There is hope for the coming months with vaccines becoming available and the incoming administration has a good team to improve the national pandemic response.

Unfortunately, the current president and many Congressional Republicans are still trying to prevent the duly elected Joe Biden and Kamala Harris from taking office as president and vice-president on January 20th. Over the weekend, an hour-long recording of a telephone call from the president to the secretary of state of Georgia and his legal counsel was released, in which the president repeatedly pressures and threatens them to change the certified election win of Joe Biden to a win for Trump. On Wednesday, both houses of Congress will meet to count the electoral college votes, which will be 306 for Biden and 232 for Trump. Nevertheless, over a hundred Republican members of the House of Representatives and a dozen Republican senators plan to challenge or vote against acceptance of the count from six states Biden won, including Georgia, Pennsylvania, and Arizona. Given that dozens of court cases alleging fraud or procedural problems with the voting system have already been dismissed and the proper certifications by the states have been done, there are no real grounds for the objections and they will be defeated after hours of debate. That so many members of Congress are willing to violate their oath to uphold the Constitution and US law is frightening and disconcerting and does not bode well for passing needed legislation through Congress.

Yes, the change from 2020 to 2021 did not erase any existing problems, but we need to work toward rectifying them and making life better for people, not devolving into lies and blaming others.

*****
Join us for Linda’s Just Jot It January. Find out more here: https://lindaghill.com/2021/01/04/jusjojan-prompt-the-1st-fingertips/

another day

So, as I write this, it is December 25th which we celebrate as Christmas, but 2020 is very different.

I haven’t been able to post much this month, in large part because we have been dealing with some health difficulties with my father, known here as Paco. He spent five days in the hospital and, earlier this week, was admitted to the skilled nursing and rehabilitation unit in the senior community where he lives.

Because of COVID restrictions, no visitors are allowed but we have been in touch by phone. Before he went to rehab, we did have a family early-Christmas celebration, but we sent a couple of small gifts to his room so he would have something to open today.

We hope to videochat with daughter E and family in London UK this afternoon, which will be evening there. They have already posted photos of granddaughters ABC and JG in their holiday attire. Last night, we were able to watch the Christmas Eve mass from their church. While it is sad that we were not able to see them at all in 2020, technology does help.

Spouse B, daughter T, and I are spending the day at home with scaled-back gift exchange and lots of our family favorite foods, fresh-baked date nut and cranberry breads for breakfast and lasagna from Nana’s recipe with homemade braided herb bread for dinner and apple-blackberry and an outrageously good brown-sugar and maple pecan pie for dessert. B enjoys cooking and baking special meals, so he is taking the lead with all this while I act assitant. It’s nice to have familiar things in such a topsy-turvy year.

Unfortunately, the huge snowstorm we had last week that dropped forty inches (one meter) of snow on us has set us up for flood warnings today. We got about three inches (8 cm) of rain yesterday and overnight, which, coupled with at least another couple of inches from snowmelt, has led to flooding. The Susquehanna is expected to crest tonight at major flood stage level in our town. While our home should be okay, we are concerned for our neighbors who live closer to the river.

I know for many Christians around the world, this Christmas is very different than the usual celebrations, but the underlying message of peace and good will to all is still there to bring comfort to us in these troubled times. I share wishes for peace and good will, for good health and love with all of you; whatever your personal faith or philosophy might be, these gifts are universal.

progress for Pfizer

Today is an important day for the Pfizer/BioNTech coronavirus vaccine.

In the United Kingdom, the first doses are being given, predominantly to those over the age of eighty. The recipients will need a second dose in three weeks.

In the United States, the Food and Drug Administration has published a 53-page review of the Pfizer/BioNTech data and confirmed the findings of safety and 95% efficacy. This clears the way for a public hearing on Thursday and possible emergency use authorization within days. Distribution will start within 24 hours of approval.

It is good that so much of the data is now public because you can see that the vaccine is safe and effective across different age, racial, and comorbidity groups. There is also evidence that some protection develops from the first of the two doses, although the highest level of protection begins about a week after the second dose.

As a Pfizer trial participant, I expect to hear back from the researchers shortly after the approval goes through. Pfizer plans to offer the vaccine to people in the placebo group in order to continue their long-term study on efficacy and safety. Among our family in the study, we expect that we have two who have already received two doses of the vaccine and one who is in the placebo group.

I can assure you that the suspected placebo person is anxious to join the vaccine group as soon as possible!

today

This wasn’t the plan.

I expected right now I would be in a plane somewhere over the Atlantic after a month in the UK visiting daughter E and her family, meeting granddaughter JG, walking granddaughter ABC home from nursery school, celebrating US Thanksgiving in London on what is there just the fourth Thursday of November.

I thought I would get to attend mass for the first time since March as we celebrated JG’s baptism, wearing the white dress that I, E, and ABC wore before her, as well her Aunt T and great-aunts.

Of course, there would have been two weeks in quarantine before any of the visiting, but still…

It was a blessing in disguise that the news of the UK lockdown leaked early, before we flew out, so that there was time to cancel. It took most of the month, but I finally got all the charges refunded.

I had planned to get a lot of writing done while we were in quarantine and to do a long-delayed, self-guided retreat, neither of which happened this month as the usual things that needed doing were before us here and the inevitable bumps in the road appeared that needed attention. I was also impossible to ignore/escape the maelstrom of news on the election and its aftermath and of the horrifying, continuing escalation of the coronavirus pandemic.

Enter the first Sunday of Advent, with its message of watching in hope.

I’m struggling with that.

By nature, I’m neither an optimist nor a pessimist. I try to be more of a realist. I know that with over 13 million confirmed cases so far and a seven-day average of new confirmed cases of about 160,000, compounded by Thanksgiving travel, the United States is going to have further acceleration in COVID cases in December and most likely into January, as well. There are also going to be spikes in hospitalizations and deaths flowing from that. Although there will likely be some vaccine administration starting in December, there won’t be enough to make much of a dent in transmission. The exception is that, if health care workers are vaccinated first as expected, we may be able to keep our hospitals staffed well enough to meet the surge in cases this winter.

I do have hope that the incoming Biden administration will have staff and appointees who are capable of improving the lives of people here and beginning to repair our international relationships. However, I am disheartened by the efforts of the current administration to undermine the chances that Biden’s team can implement changes quickly and easily. There are a number of last-minute rule changes, treaty withdrawals, troop withdrawals, and other measures that will make the transition even more difficult than anticipated in this time of public health emergency, economic downturn, civil rights protests, and general distrust in government.

Sigh.

So, one foot in front of the other. Doing the best I can manage under the circumstances.

Stay tuned.

the Moderna vaccine

Today, Moderna announced that their early data indicate their coronavirus vaccine is 94.5% effective. This follows the announcement last week from Pfizer/BioNTech that their vaccine, with which I and two members of my family are participating in the phase III clinical trial, is over 90% effective in the immediate time period after the second immunization.

Like the Pfizer vaccine, Moderna’s is a messenger RNA vaccine. The caveats that I wrote about here apply, but there is now hope that there will be two effective vaccines approved for emergency use in the United States before the end of the year. I’m sure the companies are also pursuing approval in other countries, as well.

Unlike Pfizer, Moderna accepted US government funds for the development of their vaccine. Like Pfizer, the US government also pre-ordered 100 million doses from Moderna. Initially, priority will be given to health care workers and other front-line occupations, expanding to highest risk people. Availability, pending full approval, for the general public will not be until spring 2021.

The Moderna vaccine will be easier to distribute than the Pfizer one because it can be kept for up to a month in a refrigerator. The Pfizer vaccine currently needs a super-cold freezer or dry ice for transport and storage.

Having two good candidates that might be available for the most vulnerable this winter is great news. I’m hoping that more of the vaccines currently in Phase III trials will also be shown safe and effective in the coming weeks. The more vaccines we can make available, in the US and around the world, the better, so we can get the pandemic under control globally.

Meanwhile, Pfizer, Moderna, and other companies need to continue their trials, following everyone who received the vaccine for the coming months to watch for how effective the vaccine is over time, if it protects some people better than others, e.g. seniors or children, and how much it might reduce symptoms in vaccinated people who do become sick with COVID versus unvaccinated. It’s possible that the placebo group may be released early from the studies when the vaccine is fully approved for ethical reasons. The companies may very well ask those participants if they would like to join the study as a second set of vaccinated subjects, doubling the amount of data on vaccine efficacy over time.

So, more good news today, but we have to keep in mind that masks, distancing, restrictions on gathering, etc. will need to stay in effect for months still. Until we have a large majority of the population fully vaccinated – and both the Moderna and Pfizer vaccines need two doses several weeks apart – we need to stay on guard. Sadly, the United States passed 11 million cases recently and is approaching a quarter of a million deaths. We need to do better now, not let more people suffer while we wait for the vaccines to be generally available.

in the middle of a nightmare

The pandemic has been more severe in the United States than globally for months – and now things are getting worse very, very quickly.

Yesterday, there were over 159,000 new cases diagnosed, which broke a record set the day before. There are entire states that are out of intensive care beds – or hospital beds in general. In some states, hospitals have to triage patients and turn some away who would benefit from care in favor of other patients who are sicker but have a higher chance of recovery.

Some places are so short-staffed that COVID-positive staff are continuing to work if their symptoms allow.

The hospitalization rate is also a lagging indicator. If the hospitals are this stressed now, what will the situation be in two weeks, given the huge numbers of new diagnoses this week?

I’ve reached a new level of dread.

New York State, where I live, still has one of the lowest infection rates in the country. Governor Cuomo is tightening restrictions on gyms, indoor dining and gatherings, as well as further ramping up testing and contact tracing in hot spots. Unfortunately, after all these months, there is an outbreak among residents in the skilled nursing unit of my father’s senior living community, as well as a number of staff members. The health center is in a separate building from where Paco lives in an apartment, so we are hoping the virus won’t spread, but it is very worrying for all of us.

And what, you may ask, is the Trump administration doing to address the explosion of cases, hospitalizations, and deaths?

Nothing.

Vice-president Pence, who chairs the coronavirus task force, finally held a meeting this week after several weeks without doing so during the campaign. There were no new actions or recommendations after the meeting.

Meanwhile, President-elect Biden has named a first-rate committee of physicians and public health experts to set up the plan against COVID for his administration, which will begin January 20th. Unfortunately, because the Trump administration refuses to acknowledge that Biden will be taking office, the Biden task force does not have access to the current plans in development for vaccine deployment, distribution of supplies, etc., which is an appalling and dangerous state of affairs.

What is even more appalling and dangerous is that, with the situation becoming more and more dire daily, the Trump administration is making no attempt at all to save people for illness, disability, and death.

I’m finding the level of stress and dismay crushing.

People desperately need help now.

January 20th is still a long way off.

over 90%

Today, Pfizer/BioNTech announced analysis that showed over 90% effectiveness of their coronavirus vaccine, currently in Phase III clinical trials. There are over 43,000 people around the world enrolled in this study, including spouse B, daughter T, and me. My most recent post on the trial is here.

That is an extraordinarily high percentage for a vaccine; for comparison, most years, the seasonal flu vaccine is about 50% effective. Lest you think that Pfizer or BioNTech are exaggerating the data, neither company did the analysis. That was accomplished by an independent science review board.

While this is welcome news, there are some cautions involved. The number of cases of COVID among the large study group is still small; as time goes on, it’s possible that the efficacy rate might drop. Because the virus and the vaccine are so new, there is no way to know how long immunity might last. This is part of the reason that the study is set to last for two years, so more data can be collected about the long-term efficacy, longevity, and safety of the vaccine.

Besides the speed with which this vaccine was developed, the remarkable thing is that this is among the first messenger RNA vaccines to be tested in a large trial. If it is shown to be safe and effective, there are hopes that the Moderna vaccine, also currently in Phase III trials and an mRNA vaccine, may be effective as well. Additionally, there are vaccines that were developed in more traditional ways in Phase III trials. The more vaccines that are shown to be safe and effective, the more people can be vaccinated in a shorter timeframe, so that we can bring the global pandemic to an end, perhaps as early as late 2021 or early 2022.

It’s possible that Pfizer will be able to apply for emergency use authorization in the United States later in November, after there is two months of safety data from half the study participants after their second dose. This, along with manufacturing safety data and the efficacy numbers, will be considered by the Food and Drug Administration to determine if the vaccine can begin to be distributed, with full approval coming after more data is collected.

It’s worth noting that Pfizer/BioNTech have a contract to provide 100 million doses to the United States government if the vaccine is approved. Unlike some other companies, though, Pfizer and BioNTech did not take money from the US for their research and trial expenses. The contract is for $1.95 billion but the US government will distribute it free of charge.

My hope is that this and several other vaccines will be approved over the next few months so that as many people as possible can be protected as quickly as possible, starting with frontline health workers, first responders, and those most vulnerable due to age, underlying conditions, living facilities, and occupation.

We got the sad news today that there are several people in the skilled nursing unit of Paco’s senior community who have tested positive for the virus. Access to the unit had already been restricted, so there is hope that it will not spread any further, but we are all worried about those impacted.

The sooner we have vaccines – and better treatments – the better.

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.