vaccines vs. variants

Right now, the United States is a place of both hope and fear regarding COVID-19.

The hope comes from the increased pace and availability of vaccine distribution. The two-shot regimens from Pfizer and Moderna and the single-shot Johnson & Johnson have all been approved for emergency use and are being distributed as quickly as possible. There have been over three million shots given daily in recent days. It’s possible that a fourth vaccine, a two-shot course from AstraZeneca may also receive emergency use authorization in the coming weeks. Approximately 29% of adults in the US have received at least one vaccine dose. While most states concentrated first on the older demographic and health care workers, eligibility has expanded to include medically vulnerable adults and middle-aged adults. In some states, the eligibility age has or will soon drop to 16 where Pfizer vaccine is available or 18 with the other two vaccines. Trials are underway to determine the appropriate dosages for younger children. New data have shown that the Pfizer and Moderna vaccines are 90% effective at preventing infection in real-world application; this expands the information from the trials which looked for COVID symptoms and could have missed asymptomatic infections.

There are problems looming, though. A significant proportion of adults say that they will not be vaccinated at all. There is also a political divide in evidence. A recent survey showed that 49% of Republican men are refusing the vaccine. It will be very difficult to halt community spread if so many millions of people remain unvaccinated.

This vulnerability is in addition to the fact that too many places have relaxed their rules about wearing masks, the size of public gatherings, and capacity of indoor venues. Travel within the US has skyrocketed, including air travel. Many college students have gone on spring break trips to warmer states and gathered in large crowds without masks. The majority of states are seeing their COVID cases rise. Yesterday, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said that she felt a sense of “impending doom” because cases, hospitalizations, and deaths are rising as restrictions have been lifted. She and other health experts fear that the US is at risk for a fourth surge. The protection of the vaccines won’t be able to keep pace with the virus spread by people not observing public health guidance on precautions.

There is also the problem of more infectious variants. The B1.1.7 variant is spreading rapidly in some regions and there is a separate variant that has been identified in the New York City area. While the current vaccines seem to be doing a good job preventing these variants, it will still be harder to stop community spread with the more infectious variants in circulation.

I urge everyone to get vaccinated as doses become available for their age group in their localities. Because spouse B, daughter T, and I all participated in the Pfizer/BioNTech Phase III trials, we are fully vaccinated, B and T last August during the blinded phase of the study and myself in February when the placebo group was offered the vaccine to join the study group on long-term efficacy. (There are numerous posts about our experiences with the vaccine trial if you type Pfizer in my blog search box.)

I appreciate the things that are easier to do now that I am vaccinated. The most important thing is that I am much less worried when I visit my 96-year-old father, know here as Paco. Paco is also fully vaccinated and, while I still follow the protocols to mask and distance, I am now allowed to visit inside his apartment in assisted living.

I took an unmasked walk outdoors with a friend. I have been able to do some health care visits in person rather than virtually. I go to the grocery store with just one mask instead of two. I went to mass in person for the first time in a year and have reserved a place to attend Easter Vigil Saturday evening. My fully vaccinated sister stayed overnight at our house where we could safely be together maskless.

She and I even ate at an indoor restaurant for lunch, masked when we were not eating. The restaurant had good table spacing; our region currently allows 75% capacity at restaurants and our community transmission rate is low. In general, we usually still order carryout, but I think in a few months we may be more comfortable with dining in on a more regular basis. One of the good things about living in New York State is that we have generally been cautious about public health measures and the extent to which certain activities are allowed. Extensive testing is being done so that, if the number of cases begins to rise, they can react quickly to dial back on activities to keep the outbreak from getting worse. Having seen this measured, data-driven approach work in New York, I am that much more worried when I see other places abandon mask mandates and capacity restrictions precipitously. It not only hurts their own residents but also people in other locations because travelers can bring the virus home with them.

I don’t know yet when I will be comfortable resuming travel. If we can continue robust vaccine distribution and infection rates are low, maybe B and I will be able to take a short trip together for our anniversary in June. I had hoped to return to North Adams for another private writing retreat this spring, but I need to see what happens with vaccine distribution and transmission rates over the next few weeks to decide if that would be wise.

Of course, the big prize will be when we can go to the UK to visit daughter E, son-in-law L, and granddaughter ABC and finally get to meet granddaughter JG in person. We are hoping it will be on or before her first birthday in August, but it is impossible to plan. While the UK has also been on a vigorous push for vaccine distribution and re-opening, E and L haven’t been eligible for vaccination yet and what the rules will be for summer visitors from the US is a mystery.

Still, we are closer to being able to go than we have been before and we have also built up our own capacity for patience. Love, care, and concern for others are great motivators to remain cautious and vigilant until the pandemic is truly over.

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.

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.

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!

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.

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.