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.

SoCS: what became of my engagement ring

When B and I became engaged, he gifted me with a diamond ring. We shopped for it together several months after our engagement began, choosing a simple solitaire setting which we had lowered so that it wouldn’t hit the keyboard if it turned diamond down while I was playing the organ. The following spring, it was joined by a simple gold wedding band.

I wore my rings that way for years, but some problems developed. My pinkie finger developed a callus where the diamond would rub against it. It would sometimes crack open, which was very uncomfortable. Over time, I gained a bit of weight, which made the once loose fit a bit too tight. I took to just wearing my wedding band most days.

Ten-ish years ago, I decided to make a change. I brought my rings to a local jeweler with an idea. They removed the diamond from its setting and used some of the gold to re-size my wedding band while preserving the original engraving inside. The diamond was re-set into what I call a family ring. The diamond represents the April birthday of daughter E. There is a November topaz for B, a pink zircon for me (October), and alexandrite for daughter T’s June birthday. The alexandrite is especially interesting because it looks purple when I’m indoors but a blue-green in sunlight.

I don’t wear my family ring all the time but I love it when I do. Even when I’m not wearing it, I love knowing that it exists, the four of us safely connected even when we are physically far away from each other.

*****
Linda’s prompt for Stream of Consciousness Saturday this week is “ring.” Join us! Find out more here: https://lindaghill.com/2020/11/13/the-friday-reminder-and-prompt-for-socs-nov-14-2020/

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.

Election Day

B and I baked an election day pie early this morning with an important message: VOTE! We did early voting last week and will be watching television coverage as the returns begin to come in this evening, by which time our tummies will be full of our fruits-of-the-forest pie. Today’s rendition is made with apples, raspberries, blueberries, and rhubarb.

some assembly required

As I wrote about Saturday, I’m not doing what I expected I would be today, arriving in London, UK for a month, with two weeks in quarantine and two visiting family, including meeting our newest grandchild JG.

I had spent weeks making arrangements for the trip, letting lots of other things, such as writing blog posts, slide. Instead, I spent a lot of time on the phone and online covering personal and family obligations for the four weeks of the trip plus the two weeks of quarantine required by New York State when we returned. I, along with B and T, also spent hours and hours organizing and cleaning the house to be ready for my sisters to stay here to be on hand for our dad, known here as Paco, while we were away. I had planned time to work on my poetry collection while we were in quarantine. I also had some reading and blogging work lined up.

And now, I need to figure out how to organize myself for the next six weeks.

And in general.

Again.

Still.

In my experience, the thought that I can organize my life and have things go according to plan is an act of hubris or, perhaps, folly. Over these last decades, my life plans have seldom unfolded as envisioned. Things happen. Priorities change. Plans get abandoned or put on hold. This is not a complaint, but an observation.

I know I have limited control, yet I somehow feel the need to make a plan when I sense there is a turning point, or, at least, a juncture when circumstances have changed.

A consequence of the household re-organizing we did to get ready for my sisters to come house-sit is that, for the first time in almost four years, B and I have moved back into the master bedroom, which we had given over to daughter E when she moved back home for almost three years while waiting for her spousal visa to be approved in the UK. The nearby room that had served as ABC’s nursery has now become B’s at-home office; his office building closed in March due to the pandemic and no one knows if or when it will re-open. My desktop computer is now in a guest room upstairs, opposite where T’s room is and has been throughout all the rest of the configuration changes. The living room, dining room, and kitchen are more organized than they have been in years.

I suppose the first part of my plan should be to keep things clean and organized, which would be an ongoing chore as I don’t enjoy cleaning and organizing. One of the things that made the task of getting ready to leave so daunting was the psychic strain of dealing with sorting and packing cards and other memorabilia from the last few years which included my mother’s final illness and death and E and ABC living with us. In truth, I will most likely never have a minimalist house, especially as we are storing things from both my and B’s parents’ homes and our adult daughters’. Some of it may migrate to E and T eventually…

But I digress. There is some hope that I can use our new configuration to my advantage, such as getting used to writing sequestered with my desktop rather than my laptop in the midst of the household.

The larger issue may be to de-clutter my mind. Over these last few years, when intergenerational care responsibilities have been my primary focus, I have gradually been shedding more and more of the things that used to occupy my time, such as extensive research and commentary on environmental/social justice issues and on women’s equality in the Catholic Church. I still care about those things and keep up on them to an extent, but I have let my membership in a lot of the related organizations lapse as I attended to in-person responsibilities. Admittedly, my email inbox is still overflowing with news – and requests for money – from too many entities, but I’m hoping to whittle down further after the election to free up more time and brainpower for other things.

It’s not that I don’t still care about these issues. I am heartened by the convergence of social and environmental justice issues that has happened this year and I will continue to lend support, but I will do it through a few select organizations with which I have a special connection, such as NETWORK, the Catholic social justice lobby that I joined in observance of the Jubilee in 2000. I am also heartened by the witness and energy of the Millenials and Gen Z in this convergence of social, racial, gender, economic, and environmental justice and will gratefully support their leadership with what experience and wisdom I can offer.

I’m hoping that 2021 will bring a new administration and Congress to Washington that will restore functionality and care for the common good to our national government. The last four years have been disturbing and exhausting and keeping up with the news has become an obsession and a time sink. I’m hoping to get back to a place where it doesn’t take so much energy to keep up with the news so that I can concentrate on writing and other mental work.

One of the very immediate conundrums is that I have to wrap my head around being at home on election day this Tuesday. We voted early last Monday and I had myself mentally prepared to be in London, five hours ahead as the election results began to come in. Instead, I think I will be staying up late Tuesday night into the wee hours of Wednesday, as results begin to be reported. We all know that the vote count will take several days, but the early numbers may allow some states to be called on election night. I’m hoping that everyone – the politicians, pundits, and public – will stay calm and that there will be an orderly transfer to a new administration and Congress.

Personally, I’m hoping that I will be able to spend more time writing. I promise that will include some blog posts, although I’m sure I will never be the on-topic, on-schedule blogger-type. I most want to write more poems and do revisions to produce a new version of my collection that centers on the North Adams MA area where I grew up and to which I have returned as a member of the Boiler House Poets Collective. Optimally, I’d like to have it together by spring so that I can do a manuscript review with my poet-friends. I also need to do some more submissions for my chapbook. Rejections have been coming in and two contests that I had planned to enter this fall have been pushed back, so I will need to hunt out more opportunities. I should also send out some individual poems to journals; I’ve been ignoring this for the most part over the last several years but need to get back to it.

I suppose I’d better plan some time for writing holiday cards and letters…

I also need to factor in time for essential shopping and errands for our household and for Paco. The pandemic and the supply chain problems it has caused have made shopping a major undertaking. It has also changed the way I help Paco, as I try to minimize time indoors his senior community’s building. Eventually, when there is widespread vaccine use, I’ll be able to resume regular in-person visits, but for now I am trying to deal with most things by phone and quick drop-offs.

I don’t know whether or not I can make some semblance of a schedule for myself or a plan to better work toward these goals. I had some hope as I started to write this post yesterday, but now I have all the uncertainties of the election, the pandemic, and personal life swirling about in my head.

But, hey, here is a long blog post about to be published, which is in line with my goals, so….

Progress?

Stay tuned.

And send good vibes.

SoCS: unwelcome news

It’s Halloween, which is traditionally a day for “trick or treat.” This has usually been mostly treats with very few tricks, but my family is suffering from a trick this year.

My spouse B, daughter T, and I have been planning for weeks to spend the month of November in London, UK, visiting daughter E, son-in-law L, granddaughter ABC and meeting new granddaughter JG in person for the first time. We were going to need to quarantine our first two weeks there, followed by two weeks for visiting, and returning to two weeks of quarantine back here in New York State. We had re-arranged appointments, stocked freezers and refrigerators for our housesitter and for my father, made a bunch of care arrangements for him, etc. etc. etc.

And now, everything is cancelled.

The UK, which, like much of Europe, is suffering a COVID spike, is instituting a raft of new restrictions which make travelling for leisure there impossible.

We are sad not to be able to see our family. We had planned to have JG’s baptism while we were there. Not only is our trip cancelled but the baptism will also need to be postponed.

When we planned the trip months ago, the spike wasn’t expected until winter, so we had hoped to sneak in before things got bad. The reality was that summer holidays started more cases and, when people went back to school and work, the case numbers went up quickly.

Of course, here in the US, the country has never had the pandemic tamped down across the country. We are lucky to be in New York State which has been able to keep its rate pretty low compared to most of the rest of the country, but the country as a whole is suffering record numbers of illness and death.

The prospect of winter making things even worse is horrifying.

I wish I could say that we would know when in 2021 we could safely travel to London, but it is unknowable. I guess I’ll just say sometime in 2021, we’ll get there.

Will JG be crawling by then?

Or walking?

*****
Linda’s prompt for Stream of Consciousness Saturday this week is “trick.” Join us! Learn more here: https://lindaghill.com/2020/10/30/the-friday-reminder-and-prompt-for-socs-oct-31-2020/

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.

SoCS: JG+toys

two-month-old granddaughter JG whom we plan to meet in person next month

*****
Join us for Linda’s One-Liner Wednesdays! Find out more here: https://lindaghill.com/2020/10/14/one-liner-wednesday-the-thing-nobody-talks-about/

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.