Pfizer study exit

As you many recall, spouse B, daughter T, and I have all been participants in the Pfizer/BioNTech COVID-19 vaccine Phase III clinical trial since summer of 2020. B and T received the vaccine while I was in the placebo group, although I received the vaccine through the trial after the emergency use authorization came through. All three of us continued in the study of third doses.

I had hoped that Pfizer would extend our study to include fourth doses but they have decided not to do so. After researching and discussion with family and medical practitioners, I have chosen to end my participation in the trial early in order to receive a fourth shot, which I did on Saturday.

In the US at this point, government and public health officials are not making COVID policy as much as providing information for individual decision-making. I admit that this is frustrating as community behavior is so important with pandemics in general and the increasingly contagious omicron variants in particular. Emphasis has also shifted away from individual infection rates and toward making sure there aren’t enough serious infections to cause the health system to collapse.

My priority is still to try to avert infection. I don’t want to be sick if I can help it. While rates of hospitalization and death are low among those vaxxed and boosted, serious cases are still possible. While some are lucky to have no or mild symptoms, many still feel like they are suffering the worst flu/virus ever, being out of commission for at last a week. I am also concerned about the risk of long COVID, estimated to affect as much as thirty percent to over forty percent of total cases. Vaccination is estimated to halve the risk. (Please note that definitions of long COVID and the risk factors are currently in flux. As more data are collected and analyzed, these estimates will likely change.) Due to some factors in my family history, I may be at increased risk for developing long COVID. I also know that COVID infection can cause severe flares in people with interstitial cystitis, which I have.

I am very concerned about the possibility of inadvertently infecting others, including my family. I also have several immunocompromised friends who I want to protect.

Infection rates are high in my county now. I am continuing to mask in public and am back to avoiding crowds, including church services, concerts, and plays. Even with the high case counts here, most people are not taking precautions so I am being extra careful.

The boost to resistance to infection is likely to be short-lived, only a few weeks, but this is a critical time for me to have that extra protection. In mid-May, I am travelling to Northampton, Massachusetts to attend my 40th reunion at Smith College. The protocols there are strict, including mandatory vaccination and boosters, indoor masking, and many outdoor activities, so I feel relatively safe attending.

Ten days after my return, B, T, and I will travel to London, UK to visit daughter E and her family. Again, we will be very cautious with our behavior to avoid infection. We also want to protect our family, especially granddaughters ABC and JG who are too young to be vaccinated. JG is even too young to mask.

I’m happy to report that my side effects from my fourth shot have been mild, mostly a sore arm and a bit of tiredness.

I am grateful to Meridian Clinical Research who handled the trial locally and to Pfizer and BioNTech for developing the vaccine and getting it out to so many people so quickly. I am happy to have been of service by participating in the trial and stand ready to participate in additional clinical trials as they become available.

I will close with my accustomed plea for people to do all they can to end the pandemic with whatever means are available to them – vaccines, distancing, masking, avoiding crowds, increasing ventilation, etc. The pandemic is not over and our lack of attention only increases the possibility of new variants and extends the length of time before SARS-CoV-2 becomes endemic.

the pandemic – year 3

My first post about the pandemic was February 29, 2020, a Stream of Consciousness Saturday post, no less! COVID-19, the illness caused by the SARS-CoV-2 virus, was already killing people in China, other parts of Asia, and Europe but had just begun to sicken and kill people in the United States, where I live.

I’ve written dozens of posts since then about the impact of the pandemic on our lives and about spouse B, daughter T, and my participation in the Pfizer/BioNTech vaccine trial. Yesterday, B and T, who are being followed currently on the efficacy of the third dose, had an appointment for blood work to add to the data on the longevity of antibodies and other immune markers six months after their third dose. I am also boosted and remain part of the trial, although, as someone who was in the placebo group initially, I am now part of the group who received their third dose later, so I am not on the leading edge in terms of data. There is a possibility that, when Pfizer/BioNTech develop an Omicron-specific booster, we may be asked to participate in that phase of the trial as well. Meanwhile, we continue to do weekly check-ins via app and do testing if symptoms that could be COVID appear.

I am grateful that we are able to help advance the science on the vaccines which have averted millions of hospitalizations and deaths. Even though the Omicron variant causes more breakthrough cases among vaccinated and boosted individuals than earlier variants, the vast majority are still protected from serious complications and death. I’m just sad that so many people around the world, by personal choice or by lack of availability, remain unprotected.

While Omicron tends to cause less severe symptoms than some of the earlier variants, it can still be deadly. The case numbers in the US, almost all caused by Omicron at this point, are staggering, reaching record numbers. On January 11, the US reported 1.35 million new cases with 136,604 hospitalizations, both records. The case count is somewhat elevated by the fact that some states don’t report new cases over the weekend, making the Monday numbers higher, but the seven-day average is over 700,000, so there are extraordinary levels of infection in evidence. Some hospital systems are overwhelmed, especially because staffing is a challenge. Many health care workers are exhausted by the sheer volume of patients and length of the pandemic and some have left the field. Right now, there are also a lot of vaccinated and boosted staff who have developed breakthrough cases; even if they are asymptomatic, they could still be contagious, so they have to isolate until they test clear of the virus.

The difficult thing for me to accept is that so many people in the US have chosen not to be vaccinated, despite the risks to themselves, their families, and their communities. Because Omicron is so transmissible, the safest course of action is to be vaccinated and boosted, while continuing to mask in indoor public spaces, to distance from non-household members, to avoid crowds, to sanitize appropriately, and to test before (small) social gatherings. By combining all those measures, B, T, and I were able to travel to London, where Omicron was running rampant, and get home virus-free.

Yes, going into year three of this, we are all tired of having to think about COVID safety all the time, but the virus doesn’t get “tired” of mutating and infecting people. We need to do everything we can to promote public health and to protect those who because of age or health condition can’t develop vaccine protection. We have to continue to study the virus, including all variants, to assess their impacts, including how long and strong immunity is from vaccines and from infection. Unfortunately, many viruses don’t tend to confer long-lasting immunity. If they did, we wouldn’t continue to get common colds repeatedly. Current research on SARS-CoV-2 shows immunity extending to about eight months. Some suggest that immunity could stretch to five years but we can’t know that yet, as this virus hasn’t been around that long. It also looks like some of the variants, like Omicron, are better at evading immunity, whether from prior infection or vaccines. We also have to be prepared for further variants that could be even more transmissible and/or cause more severe disease.

We are still in the pandemic phase with COVID-19. The world is unlikely to be able to rid itself of the virus totally. At some point, we will reach an endemic phase, where the virus is in circulation but not causing widespread serious illness/deaths through some combination of vaccines, natural immunity, and treatments. Will year three be the final year of this pandemic? No one knows for sure, but I am trying to hang onto hope that it will be.
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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.

vaccine update

Here in the United States, we are continuing to roll out coronavirus vaccines as quickly as possible, although there are a few snags.

The biggest is that the one-shot Johnson & Johnson vaccine is on temporary pause, due to six cases of a rare blood clotting problem that have been reported among women aged 18-48 within two weeks after vaccination. Given that over six million doses have been administered, the percentage affected is tiny, but the two agencies in charge are being cautious, especially as a small number of similar cases have been reported in Europe in connection with the Oxford/AstraZeneca vaccine, which, like the J&J, is an adenovirus-based vaccine. The pause is allowing them to gather and assess data. Additional cases may surface because of the attention this is receiving in the media. It also lets physicians know to ask about vaccine status when a patient presents with blood clot symptoms. This is important because vaccine-related blood clots call for a different treatment regimen. The hope is that the J&J vaccine will again be cleared for distribution within the next two weeks.

The public reaction has been mixed. Some people say that this pause shows how closely public health officials are tracking the various vaccines and their effects, which raises their confidence level. Others are worried that this means the vaccines weren’t sufficiently tested. A few who have received the J&J vaccine are panicking.

As someone who has been involved in vaccine trials, currently the Pfizer/BioNTech coronavirus vaccine but previously trials for flu, adult RSV, and pneumonia vaccines, I can attest that researchers are very careful in how they conduct trials. However, when you have a side effect that seems to appear in such a small number of people, you are unlikely to find it in a trial of thirty thousand people. If it turns out that the blood clot complication does occur, a person is more likely to be struck by lightning than to develop a blood clot after J&J vaccination. I hope this would calm anyone who is panicking, although people often fear rare events while ignoring those that are much more likely to impact them.

I admit that it boggles my mind that, with over thirty-one million known COVID cases in the US and over 565,000 deaths, people would fear an extremely rare side effect more than the virus itself. There are still about 25% of adults who say they will not get vaccinated, which raises the prospect that we won’t be able to stop community spread and end the pandemic because the pool of susceptible people will remain too large. Also, remember that some people who have been vaccinated may still be infected, but their chances of being severely ill are greatly diminished. Still, the way to end the pandemic is to have 85-90% of people vaccinated so that cases of the virus can be contained rather than spreading throughout the community.

It will help when those younger than 16 can be vaccinated. Pfizer has currently asked for permission to add 12-15-year-olds to those eligible after conducting a trial with that age group. Pfizer, Moderna, and others are also conducting research on the best dosages for younger children.

Meanwhile, research is continuing into how long immunity from the vaccine will remain strong. Spouse B and daughter T who received the Pfizer vaccine last August as part of the phase III trial are part of the effort to answer that question. The six month figures showed that immunity remained strong but they will be followed for at least two years to see how that may change with time. The Pfizer CEO Albert Bourla has said that he thinks a yearly booster is a possibility; they have begun studying this with phase I trial participants. We’ll see when B and T have their one-year follow-up in August whether or not they will have extended the booster dose study to phase III participants.

It is my sincere hope that by then we will have been able to fly to the UK to visit our family there and to meet granddaughter JG in person. While we are doing all we can to make that safely possible, it is frustrating to still see so many people not willing to cooperate with public health measures to keep themselves, their loved ones, and their communities safe using masks, distancing, limits on gatherings, vaccines, etc. to end the pandemic.

Yesterday, there was a Congressional hearing at which Dr. Anthony Fauci, one of the leading health officials in the country, was testifying. Rep. Jim Jordan illustrates the dynamic that has resulted in the unfortunate and dangerous politicization of the pandemic. This is a public health issue, not a “freedom” issue. Living in a free society does not mean that everyone is free to do or say whatever they want; we each have a corresponding responsibility not to cause harm to others or damage their rights and human dignity.

This brings me to my last point. The pandemic affects the whole world. Under the prior administration, the United States suffered terrible losses and did not contain the spread of the virus. Under the Biden administration, the US is making progress and has taken some steps to help the rest of the world in the fight against COVID. The US is now part of the COVAX initiative to help distribute vaccines to lower-wealth countries, although this is just getting underway. It has also sent some of its stockpile of the AstraZeneca vaccine, which has not yet been approved for emergency use in the US, to Canada and Mexico where it has been. While I expect the US to retain doses of approved vaccines as boosters, I’m hoping that once everyone who will accept the vaccine in the US has been vaccinated that we will distribute all the other doses to countries that need them, along with whatever other logistical and medical help is needed.

We can never end the pandemic until the virus has nowhere on the globe where it can run rampant. To me, this is a moral imperative. Others may be motivated by economic self-interest. Whatever the reason, it needs to happen.

Valentine’s Day

The usual greeting for today would be “Happy Valentine’s Day!”

Not this year.

I’m having a difficult time using “happy” as an adjective after the last week.

My family has been struggling with caretaking issues for Paco, complicated by the pandemic. I’ve spent this weekend feeling as though I want to cry, but not quite being able to let myself do it.

It’s the opposite of “happy.”

The United States is also dealing with the first day after the second impeachment trial of our former president. The trial was sobering, as it drove home the extent of death, injury, and damage done during the insurrection and how very close the vice president and members of Congress came to being injured or killed. Somehow, even though more than 67 senators said that DT was responsible for inciting insurrection, only 57 voted to convict falling short of the two-thirds majority needed for conviction. There are likely to be legal repercussions for the former president coming through the judicial system, possibly both federal and state. Meanwhile, he is likely to seek revenge against those Republican members of Congress who voted for impeachment or conviction by advocating that their state parties censure them, by advertising against them, and by funding primary opponents.

Let me be clear that even if DT had been found guilty in the Senate trial, it would not have been an occasion of happiness. It is impossible to feel happy in the face of so much suffering, pain, and fear.

I am trying to find comfort in the message of Valentine’s Day that love is strong, enduring, and the most important aspect of our lives.

May it be so.

May it overcome our present situation.

first Pfizer vaccine dose!

Yesterday, I officially shed my membership in the placebo group of the Pfizer/BioNTech coronavirus vaccine Phase III trial and became part of the vaccine group.

Yay!

There was a blood draw first, so they can check to see if I already have antibodies, which is unlikely given my personal history, and can compare it to my bloodwork from earlier in the trial after my placebo shots. There was also a COVID test to see if I have an active infection, which is also unlikely because I have no symptoms and community spread is quite low in our area at the moment.

While I was waiting for thirty minutes for the vaccine to come up to room temperature and for thirty minutes after injection to make sure I didn’t have an adverse reaction, I was able to get some family business done. With spouse B and daughter T’s consent, I was able to pick up their vaccine cards, showing the dates back in August when they received their immunizations. Although we had long suspected that they had received the vaccine and I had received the placebo, we are happy to have the confirmation – and the documentation to prove it. As a higher proportion of the population gets vaccinated, we may need to be able to prove our vaccination status for accessing public transportation, employment, visiting privileges with Paco in his senior community, etc.

The Biden administration is working to get more Pfizer and Moderna vaccine doses out to the states for distribution and the United States may soon have a third vaccine receive emergency use authorization. If approved, the Johnson & Johnson vaccine would be a big help in getting more people vaccinated in more locations around the world more quickly. It is administered as a single dose and can be stored at regular refrigerator temperatures, making it much easier to distribute than the current mRNA vaccines which need very cold storage and two doses. The J&J vaccine will be much easier to get to rural folks and places that don’t have good access to public transportation and medical centers.

The more vaccine available and the more people vaccinated, the sooner we have hope to end the pandemic. This needs to happen everywhere around the world, though, for the pandemic to end. There have to be so few people that are susceptible to the virus that it can’t find enough hosts to continue spreading in the community. Until that point is reached, people will still need to be careful about masking, distancing, and hygiene.

We also need to be vigilant about virus variants and the length of time immunity lasts after infection or immunization. That’s why I’m proud to be able to play my small part in the fight by participating in the Pfizer trial. The data from this latest batch of former placebo group members will show if the vaccine remains effective against the new variants in circulation and add to the statistics of how long immunity lasts as we will be followed for at least another eighteen to twenty-four months.

Today, I have a sore arm and a bit of a headache, both expected side effects from a first dose. It’s a very small price to pay for the beginning of personal protection and the advance of science to help the world understand and defeat COVID-19.

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.

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