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.

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.

vaccine trial – injection 2

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

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

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

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

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

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

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

COVID vaccine trial update

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

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

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

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

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

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

SoCS: check-up

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

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

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

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

2019-2020 SoCS Badge by Shelley

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

a vaccine trial

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

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

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

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

What a week!

I started the year by posting for 33 days in a row, thanks largely to Linda’s Just Jot It January.

Then, I fell off the wagon.

Today, though, I am taking advantage of being kept inside by a snowstorm to try to process what has been a surreal week into a post.

On the personal side, my spouse B has been involved in a major workshop week with co-workers from the US and Germany, so he has been working loooong days, sometimes capped off by group dinners that run late into the evening. Between his schedule and working around the weather, things were already feeling unsettled here.

This just added to what has been a very unsettling week here in the United States. T and I had watched giant swaths of the impeachment trial of Donald Trump. The House managers who served as prosecutors were very methodical in laying out their case. The president’s defense team was much harder to follow and tended to be in conflict with both some of the evidence and some of what other members of the team had presented. Their arguments were often circular.

For example, one of the arguments that the president’s team was making against the second article of impeachment for obstruction of Congress was that the House should have gone to court to enforce their subpoenas. Meanwhile, a court case that the House had brought trying to enforce subpoenas in the ongoing investigation of Russian election interference saw the Justice Department lawyers arguing that the courts weren’t the proper remedy, that impeachment was! As Rep. Adam Schiff, who was leading the House managers, said, “You can’t make this stuff up.”

Because the Senate had voted not to call witnesses or request documents, the first part of the week was about senators being able to speak for ten minutes about their reasoning behind their upcoming trial vote on Wednesday. However, on Tuesday night, President Trump gave his State of the Union address before a joint session of Congress.

The State of the Union is usually a very formal and solemn opportunity for the president to lay out their agenda for the coming year, including what legislation they would like to see taken up by Congress and passed. It was obvious from the start that this address was not going to follow that norm, when the Congressional Republicans started chanting “four more years” before the president even began speaking.

Much of the president’s message mirrored his campaign speeches. As a reasonably well-informed citizen, I knew immediately that some of the things the president was claiming were not true. He tried to take credit for things that actually happened during the Obama administration. He said he would always protect health insurance for those with pre-existing conditions at the same time the Justice Department is in court trying to have those protections under the Affordable Care Act thrown out.

It was surreal.

The State of the Union often features special guests of the president who sit in the gallery near his family. Their stories are inspiring and heart-warming. President Trump added a twist, though, in that most of the people received a surprise reward.  This seemed to harken back to Donald Trump’s experience as a “reality show” celebrity. A couple of these surprises made me cringe. There was a girl, attending with her mom, who received a scholarship to attend a private school. Education is a wonderful thing and I am happy for this girl, but the president framed it as her leaving “a failing government school.” In the United States, we don’t call them “government schools”; we call them public schools. One of the responsibilities of our government is to provide free public education through primary and secondary school. If a public school is doing poorly, it is up to our government at all levels, working on behalf of the taxpayers, to ensure that the school is brought up to a high standard – for the good of those students and the general public. To see the president totally abrogate responsibility for our public schools, which serve the vast majority of US students, was disheartening.

The shocking part of the evening was the “surprise” awarding of the Presidential Medal of Freedom to talk radio personality Rush Limbaugh. This is the highest civilian honor in the United States and is usually given to individuals who have brought people together in a positive way. By contrast, Rush Limbaugh has been sowing division for decades. He regularly belittles people who don’t follow his particular brand of conservatism. [Fun fact: He once railed against a women’s prayer group of which I was a member. We were a small, local group getting lambasted on nationally syndicated radio. It was ironic, because his actions gave us more power and visibility and led to a 60 Minutes interview.] Limbaugh has recently revealed a stage 4 lung cancer diagnosis; it is appropriate to ask for prayers and well wishes on his behalf, but the Medal of Freedom is not an appropriate honor for so divisive a figure.

Speaking of prayer, yesterday was the National Prayer Breakfast, which is sort of an unusual occasion in and of itself, but I can’t give its history here as this post is already shaping up to be long. First, though, there needs to be a wrap-up of the impeachment trial.

As expected, Trump was not removed from office. All the Democratic and independent senators voted for removal on both counts. There had been hope that some of the more moderate Republicans would join them, especially on the abuse of power article. Several Republican senators, in opposition to the president’s assertion that his behavior was “perfect”, issued statements saying that what the president did was inappropriate but didn’t warrant removal from office so they were voting for acquittal.

In the end, one Republican, Utah senator and former presidential nominee Mitt Romney, did vote to remove the president on the abuse of power charge. In his ten-minute floor speech, he spoke about how difficult this decision was. He is a devout member of the Church of Jesus Christ of Latter Day Saints (Mormons) and because he had sworn an oath to God to deliver “fair and impartial justice” and because the House managers had put forward convincing evidence of the president’s abuse of power, he decided that he must follow his conscience and vote to convict. He did not let political expediency deter him from his obligation to follow the dictates of his faith and the Constitution. He has faced immediate backlash from the president and other members of the Trump family, as well as from some of the conservative media. I appreciate Romney’s integrity. It took a lot of courage to vote against a president of one’s own party in an impeachment trial. Indeed, this is the first time that that has happened in the United States.

Which brings me back to the prayer breakfast…

The keynote had been on the subject of love and, in particular, the Christian call to love one’s enemies. When President Trump, who is ostensibly Christian, spoke, he proceeded to attack the faith of those he considers his enemies. After speaking about the impeachment, he said, ” I don’t like people who use their faith as justification for doing what they know is wrong.  Nor do I like people who say, ‘I pray for you,’ when they know that that’s not so.” This was a thinly veiled attack on Sen. Romney for his impeachment vote and House Speaker Nancy Pelosi, who, in answering questions from reporters has revealed that she prays every day for the president. Speaker Pelosi was sitting at the head table, only a few feet away from the president as he spoke. As a fellow Catholic, I admire Nancy Pelosi’s prayer life and don’t doubt for a minute that she sincerely prays for the president and for our country every day. That the president dismisses people of faith, equating his own viewpoint as being right and theirs as being “wrong”, compounds the damage that he has done to our country.

After President Clinton’s impeachment and trial, he apologized again to the country and made a plea for reconciliation and moving forward as a nation. (He was impeached for lying under oath about an affair.) By contrast, when President Trump spoke later in the day after the prayer breakfast, he did not admit any wrongdoing and blamed everything on Democrats and anyone else he considers an opponent.

At this point, without a unifying leader, I don’t know how Americans can fully come together as a nation to meet our challenges. I do want to point out, however, that, under Speaker Pelosi’s leadership, the House of Representatives has passed over 300 bills, the vast majority of which are bipartisan, that Majority Leader McConnell has refused to take up in the Senate. I am a member of NETWORK lobby for Catholic Social Justice. Every Congressional session, NETWORK scores the votes on ten bills that deal with social justice issues, such as fair pay, access to medical care, and equal justice. For the first time ever, this year they were unable to score the Senate because they hadn’t held votes on the bills that were companions to the House-passed bills. I and millions of other Americans expect and deserve more.

I swear that I did not spend the whole week on nothing but politics. I wrote a new poem in response to a challenge on The Ekphrastic Review. If it gets accepted, you can be sure there will be a link here at Top of JC’s Mind – and a mini-celebration that I managed to get a poem published in 2020.

Now, I think there is a snow shovel that is calling my name…

 

 

finished and unfinished

The opening statements are finished.

The presentations from the House managers (the prosecutors) and the President’s counsel (the defense) are finished.

The two days of questions from the senators and answers from the teams are almost finished.

Tomorrow, there will be votes to consider hearing from witnesses and obtaining documents from the executive branch. The vast majority of US voters want there to be witnesses and documents as part of the trial. Many of us have been called to jury duty and know that fair trials always have witnesses and documentary evidence. Unlike presidential impeachments of the twentieth century, this one was not preceded by a special or independent counsel investigation, so there were not tens of thousands of pages of documents, depositions, and testimony already assembled. In the current impeachment, this was compounded by the blanket assertion of the president that he did not have to turn over any documents or allow any testimony from anyone in his administration. This is totally unprecedented. During the impeachment investigation of Richard Nixon, he directed all of his staff and Cabinet to testify before the Congressional committee and turned over documents. Some of the staff went to prison because of their wrongdoing. When the Oval Office tapes were revealed and Nixon tried to not turn them over as evidence, the Supreme Court quickly ruled that they must be turned over to the Congress. Hiding evidence of a corrupt act is also a corrupt act.

Still it appears that the Republicans want the trial finished this week before the Super Bowl, the Iowa caucuses, and the President’s State of the Union address.

If the Republicans vote to not have witnesses called and vote to acquit, the trial will still feel unfinished. More evidence will come out in the days and weeks ahead and people will rightly ask why the evidence was not presented at the trial. They will also rightly ask if the senators upheld their oath to do “impartial justice.”

When things are left unfinished, there is a sense of unease.

I think uneasiness lies ahead for the US.
*****
Join us for Linda’s Just Jot It January! Following prompts is not required, but I chose today to use the prompt “finished.” Find out more about Just Jot It January here:  https://lindaghill.com/2020/01/30/daily-prompt-jusjojan-the-30th-2020/

the other side

Because I want to be informed, even when it is scary, I listened to the first day of Trump’s defense in the impeachment trial.

It was puzzling.

A lot of what the president’s team spoke about wasn’t related to the case. It seemed that they were bringing up a lot of different issues in order to distract from the evidence that the House managers had presented over the three days of their presentation.

There were also a number of instances in which the defense would quote a certain person’s testimony and say, because that person didn’t know a certain piece of information, then it must not be true, failing to note that another witness or piece of evidence did provide that information. They also complained about there not being proof of such-and-such, which would be either proven or disproven if the administration hadn’t blocked all document requests and subpoenas for testimony.

It’s also confusing when the president’s lawyers try to draw parallels between this impeachment investigation and prior ones that had had a justice department investigation prior to Congressional proceedings. Other things are just strange, such as the defense saying that Congressional committees need a vote in the House before issuing subpoenas and/or document requests. Congressional committees routinely issue document and testimony requests in their oversight investigations.

If I, a citizen with no legal training, can notice these things, how can the senators, many of whom are lawyers or who have staff with legal expertise, fail to notice these problems?

I don’t know if the president’s team will make more sense in the next two days of the trial or not, but their first day is not at all convincing.
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There are still a few days to join in with Linda’s Just Jot It January! Find out more here:  https://lindaghill.com/2020/01/26/daily-prompt-jusjojan-the-26th-2020/

 

awesome

I have been watching major chunks of the impeachment proceedings against Donald John Trump, as he is officially referred to in the impeachment and trial.

The House managers, members of the House of Representatives who act a prosecutors, have been impressive in presenting their case, as well as pointing out which documents and testimony they have subpoenaed, but not received, which relates to the second article of impeachment, obstruction of Congress. (The first article is abuse of power, which, in this trial, is related to solicitation of Ukraine for help in the president’s election bid.)

The House managers take turns presenting evidence in a very methodical way, using video clips, emails, phone records, etc. to make their case. They are all well-prepared and well-spoken, but one is especially awesome – Representative Adam Schiff of California.

Rep. Schiff was a federal prosecutor and has comprehensive knowledge of the law. He chairs the Senate Intelligence committee, which did most of the fact-finding in the case, and was named lead House manager. As such, he has acted as the “closer” for the presentations, speaking with conviction and, at times, passion about the United States, our laws, and our futures. I found the closing of the second day of testimony to be especially powerful.

There was some talk, although not from him, that Adam Schiff might run for the Democratic nomination for president in 2020. I’m glad that he didn’t, because he is exactly where our country needs him the most right now, speaking up for the Constitution and laws and against corruption.

The case that he and the other House managers have made is so compelling that I am frightened when I hear that some Republican members of Congress are dismissing them totally and that the president will engage in even more corrupt behavior, knowing he will not have to suffer the consequences for his actions.

I am terrified for both the short-term and the long-term consequences for our democracy if a president is allowed to be so openly corrupt and is not removed from office. With Rep. Schiff, I believe, “Right matters and the truth matters.”
*****
Usually when I post on Saturdays, I follow Linda’s Stream of Consciousness prompt. This week’s involved writing about the last unsolicited business call we received, but, between caller id, do not call registry, and new spam blocking, I don’t receive those kinds of calls anymore. Instead, you are subjected to more non-stream-of-consciousness posting on the ongoing impeachment trial of Donald John Trump. I’m sure that is more painful than unsolicited business calls.

But, please visit Linda here, and join the fun for Stream of Consciousness Saturday and/or Just Jot It January.