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.

post-election

I was relieved when Joe Biden and Kamala Harris were projected winners in the US election, becoming president and vice-president elect. Some say that those terms should not be used until the vote is certified in each state or until the electoral college meets in December but it has been common in past election cycles to do so and I’m observing the norm.

While there are still ballots being counted, it is clear that Joe Biden has comfortable margins of victory in enough states to have earned the presidency. Election officials and volunteers of all political persuasions are continuing to work hard to complete the final tallies of the record number of ballots cast. Despite the pandemic, attempts by both foreign and domestic actors to suppress the vote, postal service slowdowns, and unfounded accusations of malfeasance, this election saw the highest percentage of voter turnout in more than a century.

When Biden was reported as the projected winner on Saturday morning, spontaneous celebrations broke out around the country and around the world. Although there were some demonstrations with upset Trump supporters, there was not an outbreak of violence as many had feared. Congratulations poured in from around the nation and the world. On Saturday evening, Harris and Biden gave moving victory speeches, recognizing the historic achievement of the first woman and first person of color to become vice-president and calling for national unity to combat the pandemic and rebuild our economy and society. There has been particularly moving coverage of the impact of Kamala Harris’s election among girls, particularly those of African or Asian descent, who are excited to see someone who looks like them about to become vice-president.

Unfortunately, President Trump refuses to accept the reality that he has lost the election. Even more unfortunately, many of his supporters believe his baseless claims of widespread voter fraud. Perhaps most distressingly of all, many other Republican leaders, including Senate Majority Leader Mitch McConnell, are refusing to acknowledge that Biden has won the election.

This has delayed the official mechanisms that facilitate a smooth transition between administrations. While the Biden/Harris team is moving forward with their governing plans for after the inauguration on January 20th, most notably the convening of a coronavirus task force comprised of physicians and pubic health experts, they do not have access to all the current government personnel and assets that they need because the Trump-appointed head of the General Services Administration refuses to ascertain that Biden has won the election. With so many pressing issues, it is vital that these resources are available to the Biden-Harris transition team as soon as possible.

On Saturday morning, I wrote a simple message of congratulations to Joe Biden and Kamala Harris on Facebook. I did get one angry face as a reaction among the thumbs up and hearts, which I understand. There was also a negative comment that I wound up deleting because I don’t allow unchallenged falsehoods, conspiracy theories, or profanity on my social media. I remain committed to thoughtful dialogue and hope to be able to engage in some as the opportunity arises in the coming months.

I started writing this post early this morning and it is now late afternoon, so I will close, but, someday, I’ll write a post about my background that might prove elucidating about how my mind works.

Stay tuned.

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.

Calling on Republican Senators

As I write this, the US presidential race has not yet been called, although it is likely to be called later this weekend for Joe Biden. This would mean that Kamala Harris, as vice president, would preside over the Senate, with the power to break tied votes.

We also don’t know what the final make-up of the Senate will be and we won’t know until January as the state of Georgia, in a highly unusual circumstance, will have run-off elections for both of their Senate seats in January.

Regardless of the final composition of the Senate in 2021, I am making a plea to those Republican senators who actually want to help craft legislation and govern the country rather than engage in obstruction under the leadership of Sen. Mitch McConnell.

I think that those senators should form their own caucus. Their first act would be to vote for Sen. Chuck Schumer as majority leader, so that House-passed legislation would actually be considered in the Senate rather than gathering dust on McConnell’s desk as it has been.

They would then meet with the Democratic caucus on a regular basis to offer their ideas for advancing bipartisan solutions to the nation’s problems, which could then be enacted and signed into law. I’m sure that the Democrats would gladly agree to this solution to the Senate gridlock that has prevailed for years.

In my mind, some senators who might consider such an initiative are Sen. Romney of Utah, Sen. Collins of Maine, Sen. Murkowski of Alaska, and Sen. Toomey of Pennsylvania. Perhaps Sen. Sasse of Nebraska. They would not necessarily have to leave the Republican party to become independents, although some with strong support in their home states might be able to do that, thus obviating the threat of a primary challenger.

A lot would depend on what becomes of the Republican party without Trump as president. Will it attempt to revert to being a traditional conservative party or continue in the rather haphazard counter-factual populism it has exhibited in recent years? Would even the willingness to engage in bipartisanship be enough for the Republican leadership to kick out any senators who dared to attempt it?

In the House, the Democrats will still hold a small majority, but there might be some Republicans willing to form a similar caucus to help craft and advance bipartisan legislation.

Joe Biden has a long history of bipartisan cooperation as a senator and as vice president and has been speaking for months about restoring unity to our deeply fractured country.

Republican members of Congress, how do you respond to this call? You swear an oath to the Constitution which proclaims that our government is to “form a more perfect union” and to “promote the general welfare”.

Are you willing to act for the good of all people or only that segment that voted for you?

Update: A few minutes after I posted this, Joe Biden was projected the winner and is now President-elect. This will mean Vice-President Kamala Harris will preside over the Senate and have the power to break tie votes.

SoCS: journalists

Journalists in the United States have been working overtime to keep us all apprised of the latest facts in the election. I’m very grateful for their hard work and their expertise.

So, this post will be short so I can get back to watching. Another group of votes from Pennsylvania is due to be announced any minute.

Confession: I’m watching as I write.

Yay, journalists!

*****
Linda’s prompt for Stream of Consciousness Saturday this week is a word containing jour. Join us! Learn how here: https://lindaghill.com/2020/11/06/the-friday-reminder-and-prompt-for-socs-nov-7-2020/

2019-2020 SoCS Badge by Shelley!

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.

early vote

This is the first presidential election year that New York State has had extensive in-person early voting. Because B, T, and I were planning to be out of the country on election day, we decided we would avail ourselves of that opportunity rather than voting absentee by mail, an option that was expanded this year to include fear of illness to protect people from exposure to coronavirus.

Across the country, there were long lines for early voting but no one knew how New York voters would respond. There was also no historic basis from which to plan. The first day of early voting was Saturday, October 24. We reasoned rightly the first weekend would be busy, so we planned to vote on Monday afternoon.

It was still very busy. It took us two and a half hours to vote, most of which was spent standing in a social distanced and masked outdoor line. Just as we were near the door into the library polling place, the line stalled. It turned out that one of the two ballot printing machines had stopped working, so the final check-in took longer, but all the election workers, volunteers, and people in line were very patient and respectful.

Because the lines were long, the county board of elections added more early voting hours so that wait times would be shorter.

I was glad to see so many here and across the country making themselves heard through their votes. The US has historically had low voter turnout and I’m hoping that the energy around voting this year will mark a new era of greater civic participation.

Our votes and voices are important. We all need to vote and make sure that our votes are counted. We also need to be patient while the counts are completed and certified.

It’s been a looooooong election season but it’s almost over. Stay strong, everyone!

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.