Pfizer vaccine approval

Today, August 23, 2021, the United States Food and Drug Administration has announced the full approval of the Pfizer/BioNTech vaccine against SARS-CoV2, the virus that causes COVID-19, for people aged 16 and up. People aged 12-15 are still being immunized under the emergency use authorization. It is also expected that, in the coming weeks, Pfizer will apply for emergency use authorization for children aged 5-11. Research is ongoing on children 6 months-4 years. Also, most adults will become eligible for a third dose to boost immunity, given from 8-12 months after the second dose.

Meanwhile, both Moderna and Johnson & Johnson, the other two vaccines available under emergency use authorization in the US, are continuing their research and applications to expand their age ranges and gain full approval, too.

It’s possible that, for some people who have been reluctant to be vaccinated, the full approval of the Pfizer vaccine might be enough to convince them to receive it. The US has seen many more shots being administered in recent weeks as the delta variant has surged and people realize that nearly all the people being hospitalized and dying are those who were unvaccinated. Unfortunately, it takes several weeks to build immunity from the vaccine so the delta surge will likely continue into the coming months.

The other expected impact of the full approval of the Pfizer vaccine is that more employers may mandate that their workers be immunized before returning to in-person work and more businesses may require immunization (or alternatively a recent negative test) for their patrons.

As regular readers may remember, my spouse B, daughter T, and I are all part of the Pfizer Phase III trial for the vaccine. B and T were lucky enough to receive the actual vaccine in August 2020 while I wound up being in the placebo group. When the vaccine received emergency use authorization, the study was unmasked so that people in the placebo group could receive the vaccine, which I did in February 2021. I will continue to be followed as part of the original study through August 2022. B and T, meanwhile, have entered into the third dose phase of the study. They will be providing data for the continued study of how much immunity boost occurs with the third dose and how long it lasts.

I continue to mourn for all those who are suffering as a result of the pandemic. Please, everyone, listen to the public health specialists in your area, receive the vaccine as soon as it is available to you, and mask, distance, and wash hands as directed. Please, do everything you can to protect the health of yourself, your loved ones, and your community.

good news, bad news, and uncertainty

Yesterday, I got my second dose of the Pfizer/BioNTech coronavirus vaccine as part of their ongoing Phase III trial. As I have written about previously, spouse B, daughter T, and I are all participants but they both received the vaccine last August, while I was in the placebo group. After the vaccine received emergency use authorization, Pfizer unmasked the study so that placebo group folks could receive the vaccine as well, which I gladly did.

B and T both had a day after their second vaccination that they didn’t feel very well, so I planned today as a down day for me. I do have a sore arm, headache, some body aches, fatigue, and a low-grade fever, but ibuprofen and rest are helping somewhat. Only a small minority of people have this level of side effects, but I am more than willing to not feel well for a day in order to have as much protection as I can from the severe form of COVID-19. While the science is not yet clear if the vaccine prevents asymptomatic or mild disease, the data show that moderate and severe cases that lead to hospitalization and/or death are rare.

I am grateful that Paco was among the first at the Health Center in his senior residential facility to receive the vaccine. Two weeks from now, when I will be considered to have peak immunity, it will ease my mind when I am allowed to meet with him indoors to know we are both fully vaccinated. We will still need to wear our masks and keep some distance, but it will feel safer than it has over this past year.

More good news on the vaccine front is that Pfizer and Moderna have been able to ship more doses of their vaccines than they had previously and that the Biden administration has improved distribution in conjunction with the states and local pharmacies and health centers. Pfizer has applied for permission to store its vaccine at regular, rather than ultra-cold, freezer temperatures for up to two weeks, which will make distribution easier. Another positive development is that the Johnson & Johnson vaccine candidate may receive emergency use authorization as early as this weekend. It is a one-dose vaccine that can be stored in the refrigerator, which will make distribution in rural areas and neighborhoods without good transportation options much more effective.

The worry, though, is that more variants of the virus are appearing. Some of them are more easily transmitted and may cause more severe disease. It’s not clear how well some of the vaccines work against some of these variants. It’s also not always apparent which variants will become widespread. For example, a new variant has been identified in New York City, but no one knows if it will become dominant, cause greater sickness, or be prevented by the vaccine.

To combat this, both Pfizer and Moderna are looking at changing their mRNA vaccines to account for new variants, as well as studying if a third dose – or even an annual booster – might be necessary to tame the coronavirus and keep it at bay. It’s part of the reason that it is so important for the Phase III trials to continue collecting data, so we can keep immunity levels in the populations as high as possible.

For now, I’m resting, cuddled under a black fleece throw that the clinical research center gave me, with their name embroidered on it, of course. While study participants do receive a stipend, they also occasionally receive little gifts and it’s nice to have this throw to keep me warm today. The best thing, though, is knowing that the vaccines are helping people and that, despite the uncertainties, we are gaining ground in the battle to end the pandemic.

There is still a long way to go and I beg people to continue to wear masks, keep appropriate distance, wash their hands, and avoid large gatherings. Get whatever vaccine is available to you when it is your turn. Check on vulnerable people in your community to see if they need help to stay safe. Support efforts to get the vaccine to vulnerable people around the world.

It takes all of us working together to end the pandemic and rebuild our communities.

Unmasked!

As my more frequent readers may recall, spouse B, daughter T, and I are all participants in the Pfizer/BioNTech coronavirus vaccine trial. The vaccine received emergency use authorization in the United States in December 2020. Pfizer is now unmasking people in the placebo group and offering to make them part of the vaccine group for further study as they plan to follow participants for two years to gather data on long-term efficacy.

Earlier this week, I received a call saying that I was in the placebo group, which B, T, and I had long suspected as they both had side effects after our injections but I did not. I will receive my first injection with the real vaccine in early February, timed to coincide with the end of the waiting period after the shingles vaccine I had this month. I am grateful for the opportunity to receive the vaccine and to contribute to the data which will help keep more people from suffering the worst consequences of COVID and eventually end the pandemic.

While we will still need to mask and distance, I’m hoping that, as I and others around me are vaccinated, I will be able to return to some places that I have not been able to visit. I may, at least occasionally, make a reservation to attend mass on the weekend, something that I always did pre-pandemic but have not done since March 2020. I may visit with friends indoors, which would be nice given that outdoor visits are tricky in the winter. Eventually, we may be able to travel again, although I’m afraid a trip to London will not be possible for some months.

The other piece of good vaccine news from our family is that my 95-year-old father, known here as Paco, has received his second shot of the Pfizer vaccine. In a couple of weeks, he should reach his maximum level of protection. This is particularly important because he is in an assisted living unit, which is considered a higher risk living situation. Presently, visiting is very restricted. T was able to visit him in person for half an hour today in a socially distanced visiting room; earlier this week, I was able to do a window visit, where we could see each other through a window while we spoke by phone. I am hoping that, as residents and staff all receive their vaccinations and as more members of families receive theirs, the state will relax visiting restrictions to allow masked visits into residents’ apartments. We haven’t been able to see Paco’s new place yet and would love to be able to help organize things for him.

In our little corner of upstate New York, we are chipping away at the pandemic, doing what we can to bring it under control. We know, though, that things in the country as a whole will be difficult throughout the winter. We have passed 414,000 deaths in the US with the expectation that we will reach half a million deaths in February. It’s staggering.

I’m hopeful that the Biden administration’s leadership and plans will help us get through this winter with the least amount of damage possible, although we have been warned that things will get worse before they get better. I hope each person will do what they can to help in the effort.

progress for Pfizer

Today is an important day for the Pfizer/BioNTech coronavirus vaccine.

In the United Kingdom, the first doses are being given, predominantly to those over the age of eighty. The recipients will need a second dose in three weeks.

In the United States, the Food and Drug Administration has published a 53-page review of the Pfizer/BioNTech data and confirmed the findings of safety and 95% efficacy. This clears the way for a public hearing on Thursday and possible emergency use authorization within days. Distribution will start within 24 hours of approval.

It is good that so much of the data is now public because you can see that the vaccine is safe and effective across different age, racial, and comorbidity groups. There is also evidence that some protection develops from the first of the two doses, although the highest level of protection begins about a week after the second dose.

As a Pfizer trial participant, I expect to hear back from the researchers shortly after the approval goes through. Pfizer plans to offer the vaccine to people in the placebo group in order to continue their long-term study on efficacy and safety. Among our family in the study, we expect that we have two who have already received two doses of the vaccine and one who is in the placebo group.

I can assure you that the suspected placebo person is anxious to join the vaccine group as soon as possible!

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.

the brains of dolphins

This article about dolphins from 2003 made me smile. Enjoy!
*****
Join us for Linda’s Just Jot It January! Find out how here:
https://lindaghill.com/2018/01/23/jusjojan-daily-prompt-january-23rd-2018/

 

a new wrinkle

Besides joining in with Linda’s One-Liner Wednesdays, my other Wednesday staple is facilitating a spirituality study group at my church. For the last decade at least, this group has been all women  – with me, at 54, the youngest in attendance.

Today, a young man joined us.

He is about the age of my daughters, in his twenties, which makes him the age of some of the grandchildren of the other women.

It’s going to be an adjustment.  Part of it is the gender difference. Part of it is the age difference. The biggest adjustment, though, is that most of the women in this class have been studying and pondering spiritual topics for decades and have a lot of background and experience with different authors’ perspective. Even for us, Richard Rohr, whose book Immortal Diamond we are currently studying, is sometimes difficult to grasp at first hearing, as the concepts are so deep and rich. It must be daunting to be thrown into the midst of the book with no preparation.

I will have to contemplate how best to offer background and explanations.

If the poor man is brave enough to return next week…