Pfizer booster

As part of my ongoing participation in the Pfizer/BioNTech COVID-19 vaccine phase III trial, yesterday I received a third vaccine injection, seven and a half months after my second. There was a blood draw to test levels of antibodies, T cells, etc. and the blood work will be repeated in a year. I will continue a weekly symptom check through a phone app and have a couple of phone appointments over the next year, too. The data collected will be used to inform on-going decisions about how often boosters may be needed in the future.

I’m fortunate that my side effects have been milder than they were with the second injection. I have a very sore arm, which is obviously from the shot. I’m tired and have a bit of a headache, which could be side effect and could be just life in general these days. Today is the one-month anniversary of Paco’s death, so how I am feeling could be attributable to that rather than to vaccine side effects. When spouse B and daughter T, who are also study participants, received their third doses, they both lost a day to fever, body aches, and fatigue; because I had had a similar reaction to my second dose, I was expecting a similar experience, but apparently have lucked out.

In the United States, a third dose of the Pfizer vaccine is approved for those aged 65 and up, people who have medical risk, and those in certain professions that have close contact with vulnerable populations. It’s possible that the third dose will be recommended more generally in the future as more data become available. It’s also likely that emergency use authorization for children aged 5-11 will come soon, with shots in arms starting in early November.

Recommendations on booster doses for Moderna and Johnson & Johnson are expected soon, as well as the possibility of mixing manufacturers, for example, someone who had the J&J vaccine having a booster from Pfizer. All the companies are continuing to study the vaccines for long-term efficacy and side effects, as well as safety, efficacy, and dosage for children six months through seventeen years. Currently, in the United States, only Pfizer is approved for ages 12-17.

Another helpful development is that Merck has applied for emergency use authorization of molnupiravir, an oral anti-viral to combat COVID. It would be given to patients in the early stages in hopes of keeping their illness from becoming severe. While it is already possible to give treatments by injection or infusion, such as monoclonal antibodies, this medication would be easy to prescribe and administer for home use. A decision by the FDA is expected within weeks.

Meanwhile, over the summer, COVID cases were devastating parts of the US, especially states with low vaccination rates. Total fatalities are over 700,000 with over 44 million cases recorded. In some areas, hospitals were so overwhelmed that they had to send patients out of state to receive care. This applied to COVID patients and also to patients suffering from other serious conditions. Two states, Idaho and Alaska, had to implement crisis standards of care, which means that whether or not an individual receives treatment beyond comfort care is determined by the likelihood of survival as there is not enough capacity to treat everyone that needs help. This resulted in non-COVID deaths from heart attack, stroke, etc. – patients who ordinarily would have been treated successfully but who died because there were not personnel, equipment, and space available to treat them due to intensive care units being filled with COVID patients.

The delta variant was the power behind the summer surge, but, at least, the fear of it encouraged more people to seek vaccination. The increase in vaccination rates is helping the case numbers to fall at this point. Still, the current rate of fully vaccinated people is only 57% with 66% receiving at least one dose. I am hopeful that the Pfizer vaccine being approved for elementary age children in the coming weeks will add significantly to our vaccination totals, at least in states where the vaccination rate among adults is higher.

There are still terrifying amounts of misinformation floating around about the vaccines that are keeping some people from taking them. Unfortunately, this is keeping the pandemic alive, resulting in illness, death, lack of access to medical care, and the possibility of even more dangerous new variants developing.

We are all in this together. Please, everyone, get vaccinated if you are eligible and follow reputable public health guidelines on masking, avoiding crowds, handwashing, etc. Your choices affect your family, friends, neighbors and community directly and your nation and the world, as well. We can’t truly end this pandemic until there’s no population anywhere still vulnerable to COVID-19.

If you won’t do it for yourself, do it for someone you love.

SoCS: more on covid and vaccines

Here in the US, we are facing another wave of COVID. I think it is considered our fourth wave, but that has become pretty hard to define over the many months of the pandemic. What is different this time is that this wave is almost exclusively confined to the unvaccinated population, at least in terms of serious illness, hospitalizations, and mortality.

In New York State, where I live, the Northeast in general, and a few other states with high vaccination rates, you are seeing case numbers climb somewhat, largely because the delta variant is causing more breakthrough infections among the vaccinated, but you aren’t seeing extreme impacts on hospitals being overwhelmed and lots of serious illness and deaths.

In states like Missouri and Mississippi, with low vaccination rates, we are seeing conditions that look like the early days of the pandemic in New York, with hospitals overflowing with very sick patients, more than they have space, equipment, and personnel to handle. While in the first-wave, most of the very ill were elderly, now we are seeing that most of the very ill are younger adults. Even in these low-vaccination-rate states, the elderly are the ones most likely to have been vaccinated, so they are less impacted by this current wave, even with the delta variant making up a larger and larger share of infections.

As people who read Top of JC’s Mind from time to time may recall, I, spouse B, and daughter T are all part of the Phase III trial of the Pfizer/BioNTech vaccine. B and T both were in the original vaccine group and were vaccinated last August. They are now both enrolled in the follow-on study of booster shots and their efficacy. Like the original study, it is double-blind, so neither the participants nor the researchers know who received the actual booster and who received the placebo injection.

However, B and T are both having side effects similar to their other doses of the vaccine, so we are pretty sure that they got real booster shots, not placebos. For the record, last August, I got placebo shots. When the study was unmasked after the emergency use authorization was approved, I was offered the real vaccine, which I got in February. I remain in the study as part of the design to follow participants for at least two years. I don’t know if I might, in the future, wind up participating in a follow-on study for boosters as well. It will depend on how the results of the booster study that B and T are now in play out and whether more data is needed. It’s also possible that Pfizer may re-formulate in response to current and future variants and need a pool of test subjects for that. My family will continue to participate as long as we can be of use to help advance the science and protect public health.

It is so very sad to know how many people are suffering from COVID, especially now that we do have good vaccines available. I’m sad for people in countries or regions that don’t have access to the vaccine. I’m upset that there are so many who do have access but still remain unvaccinated, often because of misinformation about COVID and about the vaccines. Choosing to remain unvaccinated doesn’t just impact the individual’s health if they get infected. It also impacts public health, giving the virus more opportunities to mutate and create new variants. It also can spread the virus to others, which is especially dangerous if those people are also unvaccinated. Sadly, we are seeing an increase in hospitalizations of children, who aren’t yet eligible for vaccination, and teens, who are eligible but still have low vaccination rates in many states. Earlier this week, the state of Tennessee announced that it is ending all vaccine outreach to teens. It would be bad enough if this was just COVID vaccine but they are also ending outreach for other vaccines, like TDaP, HPV, hepatitis, and MMR boosters.

It’s appalling.

Please, everyone, remember that we are still in a pandemic – and will be until we can get COVID under control globally. If you have access to vaccines, please take them for your own good and for the good of others. Everyone needs to be vigilant to following public health and infection prevention measures recommended by public health professionals in your region.

COVID doesn’t care about your political views or whether or not you believe it exists. It is a virus that is just looking for a host to make it possible for it to replicate as many copies of itself as possible. If you are infected, you might be lucky and have mild symptoms, but you could pass it on to someone who might become seriously ill or even die. Or you might be unlucky and become seriously ill or die yourself.

The virus won’t care.

Your loved ones will.

*****
Linda’s prompt for Stream of Consciousness Saturday this week was to base your post on your least favorite word. I don’t often think of having a favorite or least favorite word, but I thought that COVID definitely qualified as being my least favorite entity at the moment. If you’d like to join in with SoCS, you can find out more here: https://lindaghill.com/2021/07/16/the-friday-reminder-and-prompt-for-socs-july-17-2021/

Vaccinated and (mostly) unmasked

Shortly after I wrote this post, the US Centers for Disease Control and Prevention published new guidance regarding mask wearing/distancing among fully vaccinated people in response to newly published research findings.

The good news is that fully vaccinated people can stop wearing masks indoors with extremely low risk of contracting or spreading coronavirus. Mask wearing is still recommended in medical settings such as hospitals. Requirements to mask on public transport remain in effect, as do any mandates or policies put in place by state/local governments and businesses.

The bad news is that people who are not fully vaccinated might also stop wearing masks – and wouldn’t stand out because others would just assume if they weren’t wearing a mask that they were vaccinated – and so could be exposing themselves and their contacts to coronavirus, which would drive up infection rates. This is not helped by states that have already dropped their mask mandates or never had them in the first place.

Some governors immediately dropped their mask mandates while others, such as Governor Cuomo of New York where I live, are reviewing the situation before making any changes.

Personally, I expect that I, though vaccinated, will not be making many changes in my mask behavior immediately. The few stores that I frequent are likely to keep their mask policies in place for now. Visiting my father in the health care building of his senior community will probably still require masking because, although they are vaccinated, the residents are still vulnerable due to their age and underlying health problems. If the state does drop the mask mandate, small businesses, such as hair salons and restaurants, may decide to let vaccinated customers unmask and could easily ask for proof of vaccination to give peace of mind to their employees and customers.

I am frustrated by the media commentary surrounding this CDC announcement. For weeks, commentators have been complaining that the CDC was too slow in changing its recommendations for vaccinated people and that it was a disincentive to get vaccinated. The CDC was waiting for additional scientific findings to be published before making changes, but, now that they have, the commentators are complaining that it happened too fast.

They are also complaining that the CDC guidance is confusing. It’s not. It is meant for use on an individual level and it’s very clear about what activities fully vaccinated individuals can do without masking/distancing and what activities unvaccinated people can do without masking/distancing. The CDC and the federal government are not the ones with authority to require masks in stores, churches, etc. State and local governments and businesses do that.

So, please, everyone, stop whining, learn about the recommendations from the CDC and the policies in place in your local area, and behave accordingly for the safety of yourself and others.

If you are eligible for vaccination but haven’t done it yet, make arrangements to do so as soon as possible so you don’t become seriously ill or pass the virus on to someone else.

Remember to be kind and respectful to others. Some vaccinated people will choose to continue wearing masks because they are immunocompromised and more susceptible. I know people with allergies who are continuing to mask outdoors to protect themselves from high pollen counts. Some parents of children who are too young to be vaccinated wear their masks to be a good example for their children. It is not your business to criticize someone else’s decision and masking is never a wrong choice when it comes to public health. In some countries, masks have been common for years, especially during flu season or when there are air quality problems.

The CDC recommendations rely on public trust. Unvaccinated people need to demonstrate that they are worthy of trust by following the public health guidance. Overall infection and death rates are down, but they will spike again if people don’t continue to vaccinate and mask/distance until they complete the vaccine process. A spike might not happen until colder weather drives more people indoors, but it won’t happen at all if we can get the vast majority of teens and adults vaccinated by fall.

The prospect of the epidemic phase of COVID-19 being over by fall is within reach, but only if people follow this guidance and get vaccinated.

Let’s do it!

post-vaccine life

With my immediate family in the US vaccinated against COVID-19, we are inching our way back to a more interactive life while still following the national and New York State guidelines.

The most important thing that has happened for us personally is a greater ability to see my dad, known here as Paco, who lives nearby in the assisted living unit of his long-time senior community. After months of not being able to visit, we can now go to his apartment, albeit in pre-arranged thirty minute slots. I can also sign him out to go for a car ride; previously, he was only allowed away from the unit for medical care.

This has meant that I can see him more times per week and that I can take him out for treats. Last week, we went to an ice cream stand in the afternoon. This morning, I was able to bring him to get a doughnut and coffee. We are still being cautious about indoor spaces, so I don’t bring him into buildings. We enjoy our treats in the car or at outdoor tables.

The best thing, though, was that my older sister and her spouse were able to come visit for a couple of days last week. They hadn’t been able to visit since last summer. They live in Maryland and couldn’t enter New York until recently due to our travel/quarantine restrictions. Because of the vaccines, those have been relaxed. With all of us vaccinated, we were able to have everyone to our house for dinner. B made lasagna from Nana’s recipe, homemade Italian bread, sautéed asparagus, and apple pie. It was all delicious – and extra heartwarming to be together after so many months apart.

We are also starting to work our way back to activities like dining indoors. I’ve had one lunch and one dinner inside restaurants. We wore masks when not eating or drinking and the tables were spaced so that we weren’t very close to other diners. We are likely to continue doing carryout more often than dining in for a while, especially because dining in most likely involves having to make reservations while carryout is easier to do spur-of-the-moment.

There was just a national policy announcement clarifying mask use recommendations for outdoor events in light of vaccinations. Vaccinated people can exercise, socialize in small groups, and eat outdoors without needing to wear a mask. They should, though, continue to mask if they are in a large group setting, such as a sporting event or concert where the crowd would be close together for extended periods. It is good to have this clarification, but it won’t make much difference for our family. New York has had a mask mandate in place for over a year, but it was adapted in order to deal with the circumstances. Given that we don’t live in a congested area, we were already accustomed to taking maskless walks in our neighborhood. If we stopped to talk to someone, we would just keep six feet of distance between us. Still, it was good to see that there are now different recommendations in place for vaccinated and unvaccinated people. Perhaps it will serve as motivation for people who haven’t yet been vaccinated to arrange to do that. In many locations, you don’t even need to make an appointment in advance.

If people need more motivation to get vaccinated, they can switch on a news report from India to see the horrific toll that the virus takes when it sweeps through an unvaccinated population. The infection and hospitalization rates are staggering. A new variant has emerged and there are so many deaths that the system to handle them is overwhelmed.

This virus remains very dangerous, capable of inflicting serious illness and death. The vaccines are safe and very effective. Everyone aged sixteen and over in the United States has access to vaccine and should be immunized unless there is a personal medical issue that precludes it. If you don’t feel personally vulnerable, remember that, even if you yourself don’t get severe symptoms, you could pass the virus on to someone else who could become very ill or die.

The only way to end the pandemic is for there to be large-scale immunity everywhere. Every effort we make, whether it is our individual vaccination and precautions or our large-scale efforts such as sending vaccines, treatments, and supplies wherever they are needed around the world, is part of what is needed to end this.

And remember: People taking vaccines approved for emergency use are not “guinea pigs.” The “guinea pigs” are the hundreds of thousands of people like me and my family who volunteered to be in clinical trials. (B, T, and I are all part of the Pfizer/BioNTech phase III trial. I’ve posted about it a number of times over the past months.) Government agencies and the pharmaceutical companies are continuing to collect data and have affirmed that the dangers of contracting COVID are much, much greater than any side effects of the vaccine.

Please, everyone do your part to keep yourself and others safe. Vaccinate, mask, distance, and practice good hygiene. Pay attention to credible medical and public health sources. The rewards of being able to safely gather, to give a hug to a loved one, to see a friend’s smile are simple, yet profound.

We just need to work together to make it possible for everyone, everywhere.

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.

A quiet Fourth

Yesterday was celebrated as Independence Day in the United States. We usually just call it the Fourth of July, which it is, of course, everywhere in the world.

Celebrations this year were muted by the ongoing COVID catastrophe. While we still have the virus pretty well controlled where I live in the Northeast US, much of the rest of the country is experiencing a rapid spread which is threatening to overwhelm the health care system. Many states in the South and West are breaking their records for new cases daily and some are belatedly issuing mandatory use of masks in public and closing bars, indoor restaurants, and beaches, in hopes of reducing their infection rates.

It breaks my heart to see the level of suffering, knowing that much of it could have been avoided if leaders and the public understood and respected what the public health experts have been telling us. Wear a mask. Wash your hands. Stay six feet away from people who don’t live in your household. Avoid gatherings. Stay at home except for essential work and errands.

The advice works! We proved it in New York State and other states in the Northeast. This is also how most of the other countries that have gotten their transmission rate to low levels did it.

On Independence Day, the United States commemorates the signing of the Declaration of Independence, which declares that all are equal and have the right to life, liberty, and the pursuit of happiness. Some of the people who won’t wear masks say doing so is an affront to their liberty, but liberty is not a license to abandon responsibility. I recently saw a political cartoon by Dave Whamond where a man was declaring his right to drive his car in the opposite direction on the highway. (It didn’t end well.) No person’s “liberty” should be allowed to interfere with someone else’s rights.

The Declaration of Independence ends, “we mutually pledge to each other our Lives, our Fortunes and our sacred Honor.” It was clear that the document was not about something so small as personal desire or preference or grievance.

We each bear a responsibility to others.

Don’t drive the wrong way down the highway.

Wear a mask.

New York’s reopening plan

I’ve posted several times about how my state is handling the pandemic. Unlike many other states, New York State has taken a methodical, metric-based approach.

The whole state has been under a program called PAUSE, which is a stay-at-home order for all but essential workers and shopping for necessities. Starting on May 15th, certain regions of the state that have met the criteria will be moving into phase one of four for re-opening certain businesses.

My region, the Southern Tier, is qualified to re-open companies with worker and customer safety plans in place in construction, manufacturing, delivery/curbside pick-up retail, wholesale, agriculture, forestry, fishing, and hunting. The region needs to continue to meet the criteria each week, including testing and having contact tracers available. If criteria continue to be met, other businesses will open in phases. If the statistics show an outbreak is developing, the phased-in businesses will close until all the criteria are again met.

The state has a website called New York Forward, which has up-to-date information about the plan and the current status of each region. There is more information about the phase-in of businesses here. For those who would like more detail, there are many different pages and sections available on different aspects of the plan from the New York Forward main page link above, as well as a 50 page book, which includes some history, the basics of the plan itself, and future goals.

While there are no certainties in dealing with the pandemic, I am reassured that there is a detailed plan with metrics based on science and the experiences of other places dealing with the virus. It’s also good to know that there is continuous monitoring of the situation so that we can adapt the implementation as needed.

For the good of our state and the health and well-being of our residents, I hope the plan works well. If it does, I hope other governments will be able to use it as a template for their own plans.

We are better off if we make thoughtful, science-based decisions. This pandemic has shown how connected the world is. We all need to cooperate if we are ever going to end this diesase.

election aftermath

I have been giving myself some processing time before writing about the outcome of the US presidential election. I also delayed writing because I have been busy with family/household issues, but I am awake at an obscure hour so I may as well start in on this post.

I had written before about by afraid of Trump’s rhetoric during the campaign; I also had written about being a supporter of Bernie Sanders, whose policy ideas most resemble mine, who went on to support Hillary Clinton when she won the nomination and supported most of those policies.

I had also expressed hopes that the country would come together after the election.

Things don’t seem to be going that way.

I admit to be being puzzled by Speaker Ryan thinking the Republicans have a mandate to privatize Social Security, block grant funding to the states, cut business taxes, and other long-time Republican establishment goals when a) Trump campaigned against the Republican establishment b) Trump lost the popular vote c) the Republicans lost seats in both houses of Congress d) 47% of registered voters didn’t vote in the election and e) he thinks that somehow President Obama, who did win a majority of the votes in his two elections did not have a mandate.

I had hoped that Trump would gather a team around him who had experience and background in various aspects of government which, as a businessperson who has never held elective office, he lacks, but, so far, many of his picks have been problematic, especially in regards to preserving civil liberties.

I am still afraid.

I am most afraid for the American people.

I’m afraid for those who believed Trump’s promises to bring back their jobs in manufacturing, mining, and the oil and gas industries. A president does not have the power to do this because these businesses are part of global markets. The price of oil is influenced by supply and demand worldwide. Appalachian coal can’t compete with Wyoming coal because it has different properties. Most manufacturing is highly robotized and doesn’t employ as many workers as assembly lines used to.

I grew up in an area that lost a lot of jobs and population when mills closed down and have lived for the past 34 years in an area that lost a lot of population and jobs in tech and manufacturing. I know what it is like to have the younger generation need to move out of the area to find work and to find different kinds of work than their parents and grandparents had. I’m sorry, but no president can restore towns and cities to what they were ten or twenty or thirty or forty years ago. Our country was built on change and ingenuity. We have to adapt to present realities and educate and innovate and create new opportunities for the future. I’m afraid for those people who have been left behind and afraid that they are going to be disappointed again.

I’m afraid for all those who belong to groups that have been blamed, vilified, or characterized as suspect during the campaign by someone or other. Muslims, Jews, Christians. Latinos. Immigrants. Syrian refugees. LGBTQ folks. Women. Black voters. Those who are in the lower socioeconomic strata. Reporters. The less educated. Experts. (I admit that I have a lot of trouble understanding how people can vilify those who have devoted years of education, research, and experience to become experts in their fields, yet this happened frequently during the campaign. Not that I understand other parts of the blame game any better.)

I’m afraid for anyone who has ever suffered bullying or abuse and who has experienced renewed pain due to words and behavior brought out in the campaign.

I’m afraid for the US-born children and spouses of undocumented people who fear the deportation of their loved ones, and even their own deportation if the administration tries to overturn birthright citizenship.

I’m afraid for those in the military who might be deployed in unwise ways.

I’m afraid for public health if the ACA is repealed rather than being amended.

I’m afraid for public health and the environment if industry is allowed to increase pollutants and if greenhouse gas emissions go up. Many areas of the country and the world are already being impacted by climate change and the US cannot afford to pull back from our participation in international agreements. I think that most states and companies will continue to pursue greenhouse gas decreases and renewable energy increases no matter what the federal government says, but it would be much better to have the federal government leading the way instead of fighting it.

The last time I was afraid about the qualifications of the incoming president and administration was the election of George W. Bush, another candidate who was elected despite having lost the popular vote. I thought at the time “How bad could it be?” and it wound up being ten times worse than I had feared.

I am much more apprehensive about the upcoming Trump presidency. Given his volatility and lack of experience, I am very, very afraid of what may happen over the next four years.

I’m not alone.