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.

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.

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/

charting a pandemic path

Around the world, most of us are sharing in the battle to limit the damage from COVID-19 to the extent possible.

In some places, the path is proscribed by local or national government and there are not a lot of personal decisions to make.

Here in my county in upstate New York (USA), things are not laid out as clearly. I have been trying to prepare and make plans, but circumstances keep changing – and so must the plans. Our state and local governments and community organizations have been much more proactive than the federal government, but, as more and more cases are diagnosed closer and closer to where I live, additional measures continue to roll out.

Over a week ago, I started the general preparedness guidelines to have a couple of weeks of food and medications available in case we had to self-isolate. This was not a big deal for our house, but I have been much more concerned about preparing things for my dad, known here as Paco. He lives in a senior community in an independent living apartment, so he has a number of services available in-house, but I visit every day to check on him, make sure his medications are all organized and his schedule is laid out, etc. Early last week, a sign went up that people who were having any symptoms of illness should not visit. This is practical and a commonsense precaution that I would follow anyway, but, later in the week, the health care part of the center was closed to all visitors, except those whose loved one is in very grave condition. This meant that Paco could no longer go over to concerts and singalongs held in the health care facility. At the same time, they cancelled activities in independent living that involved outside performers or volunteers. For example, the Irish dancers would not be able to come for a scheduled pre-St. Patrick’s Day performance.

At this point, I had to face the probability that even healthy visitors might not be able to visit independent living at some point, so I started making contingency plans that could be carried out reasonably well without me. Sadly, we’ve had to cancel a planned visit from my sisters and their families to celebrate Paco’s 95th birthday later this month. They all live in areas where the virus is more prevalent and we didn’t want to risk them bringing it with them, given that they might not have obvious symptoms.

Thursday night into Friday, several large employers announced that they would be having most of their employees work from home starting on Monday. The universities had also announced that they were moving most of their instruction online for several weeks or the rest of the semester. Professional sports leagues announced they were suspending or delaying their seasons. Some combination of these functioned as a trigger that caused some people who hadn’t been taking the virus very seriously to spring into action – or, at least, into shopping. I went to my favorite grocery store to pick up a few things for Paco and for my household and was surprised to find that there was almost no peanut butter, canned legumes, frozen vegetables, etc. in the store. And I hadn’t even checked the cleaning supplies and paper goods aisles. The evidence of panic-buying took me by surprise. Given that I had been in concern and preparation mode for days, I had obviously underestimated the number of people who were suddenly paying attention and freaking out a bit.

On Saturday, the county executive announced that all primary and secondary schools will close through mid-April. Now, people are even more upset.

It appears that there are some people who still think that fears of the virus are overblown, given that we have no known cases in our county, even though our neighboring counties do have confirmed cases; they don’t want their personal and family routines disrupted. Others have been following the news and the advice of medical experts and realize that, while we can’t stop the virus completely, there will be fewer deaths and more treatment available to those with severe illness if we can spread out the number of cases over a longer period of time, so as not to overwhelm our medical system. The way to do that is to reduce the number of people who are in close contact and in large groups, also known as social distancing.

There are a number of different opinions about how much distance is required and how many is considered too many to be in a crowd. This leaves some situations to personal discretion. I admit that I had a difficult time figuring out what to do about church attendance this weekend. Our diocese has dispensed with our obligation to attend mass, but services are still being held. I am not especially concerned about my getting seriously ill, but I am concerned with the possibility of bringing the virus into Paco’s community, so I’ve decided to participate in a mass on television. At least for now, I plan to still shop. occasionally eat at restaurants, and attend small gatherings with friends. If we start seeing community spread in my town, though, I’d cut back further. If we get to that point, I’m sure I wouldn’t be able to visit Paco; it’s likely that only residents and staff would be allowed in the building.

I admit that it is disconcerting to know that, despite our best efforts, people are going to continue to get sick, some of them severely sick, and some of them will die. I hope that our communities will face up to this challenge and do as much as we can to protect people, especially the most vulnerable.

Be well. Be kind. Be thoughtful. Be considerate.

A timely poem from Anne Harding Woodworth

As we are all dealing with COVID-19 in some way, I wanted to share a topical poem with you.

Anne Harding Woodworth is an accomplished poet who I met through the Smith College Alumnae Chorus. We have sung together for several concerts, including three performances of Mozart Requiem on tour in Sicily. This poem brilliantly references the Requiem in the context of an audience-less performance held recently due to COVID-19 caution.

The site where it appears is New Verse News, which publishes poems on current topics of interest. I appreciate that they make it possible for poets to publish work about recent or ongoing situations without having to wait months for journal publications.

You can find “Mozart Requiem Streamed in a Time of COVID-19” here:  https://newversenews.blogspot.com/2020/03/mozart-requiem-streamed-in-time-of.html

SoCS: a disconcerting disconnect

There is a major disconnect between the president of the United States and public health regarding covid-19, the form of coronavirus that is causing illness and death around the world and which may soon cross the line to become a pandemic.

From its start in China, there are now major outbreaks in Japan, South Korea, Italy, and Iran, with cases in lots of countries in both hemispheres. Some of the countries have tested thousands of people, ramped up medical care, imposed quarantines, even closing schools for weeks as was just announced in Japan in the last few days.

Meanwhile, the United States has only tested a few hundred people. There are under a hundred confirmed cases, but most likely there are more cases that only had mild symptoms or no symptoms. This is dangerous because those people can spread the virus unknowingly.

Ordinary Americans have been watching the news of the spread of covid-19, first in China and then into other countries. Some doctors and public health specialists were speaking in the media about the epidemic – and preparedness and cases in the US. Earlier this week, some federal government officials who work in agencies like the Centers for Disease Control and Prevention had spoken publicly about the virus in the United States.

The stock market in the United States went down – a lot – this week, the steepest decline since the financial crisis of 2008. This finally got the president’s attention and there was an evening news conference about the virus in the US. Unfortunately, the president made mistakes in his remarks, including saying there were only 15 cases in the US when there were actually 60 confirmed cases. He also put the vice-president in charge of the US efforts against the virus, which is disconcerting because, as governor of Indiana, he botched an early intervention effort against HIV. It’s also disconcerting that all communication from the federal government has to be approved by him first, including public statements by Dr. Anthony Fauci, longtime director of the infectious disease department for the country.

Late this week, there was the announcement of the first covid-19 case that couldn’t be traced to someone who had contracted it abroad. This is an important development because it could mean that there would be community spread here in the US, which would also bring the world closer to declaring a pandemic. It’s scary because it brings to mind the flu pandemic of 1918, which infected millions worldwide and had a mortality rate of almost two percent. Early statistics from China show that covid-19 has a mortality rate of a little over two percent, which is beyond the ability of even large modern health systems to combat. There would be shortages of needed equipment like respirators and of appropriate hospital facilities that can isolate the patients so that no one catches the virus in the hospital.

Yesterday evening, I was watching a news station. Several times throughout the evening, the stories they were covering were interrupted by news of several new confirmed cases in different locations that appeared to be the result of community spread, instead of direct transmission from abroad or from being in the household of someone who contracted it abroad. This bring some communities in the US close to needing to impose states of emergency and doing things like prohibiting public gatherings, including school and work and church.

The most chilling thing for me was that, at the same time, the president was speaking to a rally in South Carolina, telling them that covid-19 in the US was a hoax perpetrated by Democrats.

This is disconcerting and irresponsible and shows how disconnected the president is from the reality that the country is facing.

To be clear, I am not a paranoid person regarding disease. I’m not running around in a mask and gloves in fear of covid-19. I am, however, vigilantly watching the public health news and, as recommended, making plans for possible cases and restrictions on travel and being out in public in my region.

While I hope and pray for safety and good health around the world, I want to be prepared to stay as safe as possible if this epidemic does become a pandemic. In the US, I hope that people will make sure that the information they get comes from a reliable source.

Sadly, our president is not a reliable source.
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Linda’s prompt for Stream of Consciousness Saturday this week is base the post on a word that contains “ect”. Join us! Find out how here:  https://lindaghill.com/2020/02/28/the-friday-reminder-and-prompt-for-socs-feb-29-2020/

2019-2020 SoCS Badge by Shelley!
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