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.

a package!

Like many other places during this pandemic, our stores have been out of yeast for weeks.

I usually keep a jar of bread machine yeast in the refrigerator. Besides using it in the machine, B sometimes uses it to make treats like Chelsea buns. As my jar was running low, every time I went to a store, I would check to see if I happened to catch a new shipment coming in, but either my timing was never right or there wasn’t any in the warehouses to send to the stores.

I decided to look online. I couldn’t find any jars or packets, but finally found a one-pound bag of Fleischmann’s instant yeast. I wasn’t used to the term “instant yeast” but apparently it is the same as rapid-rise or bread machine yeast. The yeast is sourced from Canada, so perhaps instant yeast is the term most often used there.

It took over a week to arrive, but now we should be supplied for a long time, given that this bag is equivalent to four of the jars I usually buy.

The pandemic has changed my perspective of time so much. I admit to thinking maybe this yeast will last until we have a vaccine available to the public so that the pandemic will be well and truly over.

Of course, this won’t be a miracle like the story of Elijah and the widow in 1Kings 17, where the flour and oil did not run out until the drought was over, but it does symbolize to me that same sense of perseverance, that call to not be afraid while we wait, watch, and work for better times.

triple threat

My mom, known as Nana here at Top of JC’s Mind, has been having some cardiac issues and has been going to rehab twice a week. Last week, she had to miss because of the giant snowstorm and because she seemed to be suffering from a cold.

She had already been to the walk-in medical clinic once for her cough, but on Friday, her condition worsened, so she went back. They were concerned that she might have developed pneumonia so they ordered a chest X-ray from the hospital. The plan had been for her to stay at the hospital until the X-ray was read, but they were so busy, we had to take her home to wait for the results the next morning.

When the X-ray came back positive, we went back to the hospital. We spent the day in the emergency room, while they ran more tests. We were shocked that Nana’s “cold” had actually been type A influenza. The extra-strength flu vaccine that she had received last fall had kept down the usual fever and body aches that one expects from flu.

The other factor involved was some continuing problems with congestive heart failure symptoms. We are hoping to get a better understanding of the cardiac factors involved so we can chart the best possible course going forward.

Nana has been improving steadily with intravenous antibiotics and diuretics. We are hopeful that she will be able to come home in a few days, in time for Paco’s 92nd birthday this weekend.

We would all appreciate any healing thoughts and/or prayers that you might send out on Nana’s behalf.