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.

Pfizer vaccine update

My spouse B, daughter T, and I are participating in the Pfizer/BioNTech coronavirus vaccine trial. My most recent update on our personal experience is here, but I wanted to share an open letter from Pfizer which you can find here.

President Trump has been intimating that a vaccine would be available under emergency authorization by election day November third, which has led to fears that the companies might compromise the science in order to meet that deadline. The companies, though, have been trying to reassure the public that they will adhere to sound scientific and public health principles.

The letter from Pfizer’s chairman and CEO Albert Bourla explains that there are three necessary components for vaccine approval: effectiveness, for which they expect data by the end of October; safety, for which they will have data in the third week of November; and manufacturing data to ensure consistent quality. If there are good results confirmed by outside experts, Bourla believes that Pfizer will be able to apply for emergency use authorization from the United States Food and Drug Administration shortly after the safety data are available in the third week of November.

Even if the emergency and final authorization is approved, Pfizer will continue its study for two years in order to monitor safety and longevity of effectiveness.

I appreciate Pfizer’s transparency of their process and truly hope that their vaccine will be shown to be safe and effective so that we can begin to protect first our most vulnerable and eventually everyone from COVID-19. I also hope that lots of other companies in the US and around the world will also produce safe and effective vaccines so we can end the pandemic as soon as possible.

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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