Pfizer booster

As part of my ongoing participation in the Pfizer/BioNTech COVID-19 vaccine phase III trial, yesterday I received a third vaccine injection, seven and a half months after my second. There was a blood draw to test levels of antibodies, T cells, etc. and the blood work will be repeated in a year. I will continue a weekly symptom check through a phone app and have a couple of phone appointments over the next year, too. The data collected will be used to inform on-going decisions about how often boosters may be needed in the future.

I’m fortunate that my side effects have been milder than they were with the second injection. I have a very sore arm, which is obviously from the shot. I’m tired and have a bit of a headache, which could be side effect and could be just life in general these days. Today is the one-month anniversary of Paco’s death, so how I am feeling could be attributable to that rather than to vaccine side effects. When spouse B and daughter T, who are also study participants, received their third doses, they both lost a day to fever, body aches, and fatigue; because I had had a similar reaction to my second dose, I was expecting a similar experience, but apparently have lucked out.

In the United States, a third dose of the Pfizer vaccine is approved for those aged 65 and up, people who have medical risk, and those in certain professions that have close contact with vulnerable populations. It’s possible that the third dose will be recommended more generally in the future as more data become available. It’s also likely that emergency use authorization for children aged 5-11 will come soon, with shots in arms starting in early November.

Recommendations on booster doses for Moderna and Johnson & Johnson are expected soon, as well as the possibility of mixing manufacturers, for example, someone who had the J&J vaccine having a booster from Pfizer. All the companies are continuing to study the vaccines for long-term efficacy and side effects, as well as safety, efficacy, and dosage for children six months through seventeen years. Currently, in the United States, only Pfizer is approved for ages 12-17.

Another helpful development is that Merck has applied for emergency use authorization of molnupiravir, an oral anti-viral to combat COVID. It would be given to patients in the early stages in hopes of keeping their illness from becoming severe. While it is already possible to give treatments by injection or infusion, such as monoclonal antibodies, this medication would be easy to prescribe and administer for home use. A decision by the FDA is expected within weeks.

Meanwhile, over the summer, COVID cases were devastating parts of the US, especially states with low vaccination rates. Total fatalities are over 700,000 with over 44 million cases recorded. In some areas, hospitals were so overwhelmed that they had to send patients out of state to receive care. This applied to COVID patients and also to patients suffering from other serious conditions. Two states, Idaho and Alaska, had to implement crisis standards of care, which means that whether or not an individual receives treatment beyond comfort care is determined by the likelihood of survival as there is not enough capacity to treat everyone that needs help. This resulted in non-COVID deaths from heart attack, stroke, etc. – patients who ordinarily would have been treated successfully but who died because there were not personnel, equipment, and space available to treat them due to intensive care units being filled with COVID patients.

The delta variant was the power behind the summer surge, but, at least, the fear of it encouraged more people to seek vaccination. The increase in vaccination rates is helping the case numbers to fall at this point. Still, the current rate of fully vaccinated people is only 57% with 66% receiving at least one dose. I am hopeful that the Pfizer vaccine being approved for elementary age children in the coming weeks will add significantly to our vaccination totals, at least in states where the vaccination rate among adults is higher.

There are still terrifying amounts of misinformation floating around about the vaccines that are keeping some people from taking them. Unfortunately, this is keeping the pandemic alive, resulting in illness, death, lack of access to medical care, and the possibility of even more dangerous new variants developing.

We are all in this together. Please, everyone, get vaccinated if you are eligible and follow reputable public health guidelines on masking, avoiding crowds, handwashing, etc. Your choices affect your family, friends, neighbors and community directly and your nation and the world, as well. We can’t truly end this pandemic until there’s no population anywhere still vulnerable to COVID-19.

If you won’t do it for yourself, do it for someone you love.

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.

SoCS: more on covid and vaccines

Here in the US, we are facing another wave of COVID. I think it is considered our fourth wave, but that has become pretty hard to define over the many months of the pandemic. What is different this time is that this wave is almost exclusively confined to the unvaccinated population, at least in terms of serious illness, hospitalizations, and mortality.

In New York State, where I live, the Northeast in general, and a few other states with high vaccination rates, you are seeing case numbers climb somewhat, largely because the delta variant is causing more breakthrough infections among the vaccinated, but you aren’t seeing extreme impacts on hospitals being overwhelmed and lots of serious illness and deaths.

In states like Missouri and Mississippi, with low vaccination rates, we are seeing conditions that look like the early days of the pandemic in New York, with hospitals overflowing with very sick patients, more than they have space, equipment, and personnel to handle. While in the first-wave, most of the very ill were elderly, now we are seeing that most of the very ill are younger adults. Even in these low-vaccination-rate states, the elderly are the ones most likely to have been vaccinated, so they are less impacted by this current wave, even with the delta variant making up a larger and larger share of infections.

As people who read Top of JC’s Mind from time to time may recall, I, spouse B, and daughter T are all part of the Phase III trial of the Pfizer/BioNTech vaccine. B and T both were in the original vaccine group and were vaccinated last August. They are now both enrolled in the follow-on study of booster shots and their efficacy. Like the original study, it is double-blind, so neither the participants nor the researchers know who received the actual booster and who received the placebo injection.

However, B and T are both having side effects similar to their other doses of the vaccine, so we are pretty sure that they got real booster shots, not placebos. For the record, last August, I got placebo shots. When the study was unmasked after the emergency use authorization was approved, I was offered the real vaccine, which I got in February. I remain in the study as part of the design to follow participants for at least two years. I don’t know if I might, in the future, wind up participating in a follow-on study for boosters as well. It will depend on how the results of the booster study that B and T are now in play out and whether more data is needed. It’s also possible that Pfizer may re-formulate in response to current and future variants and need a pool of test subjects for that. My family will continue to participate as long as we can be of use to help advance the science and protect public health.

It is so very sad to know how many people are suffering from COVID, especially now that we do have good vaccines available. I’m sad for people in countries or regions that don’t have access to the vaccine. I’m upset that there are so many who do have access but still remain unvaccinated, often because of misinformation about COVID and about the vaccines. Choosing to remain unvaccinated doesn’t just impact the individual’s health if they get infected. It also impacts public health, giving the virus more opportunities to mutate and create new variants. It also can spread the virus to others, which is especially dangerous if those people are also unvaccinated. Sadly, we are seeing an increase in hospitalizations of children, who aren’t yet eligible for vaccination, and teens, who are eligible but still have low vaccination rates in many states. Earlier this week, the state of Tennessee announced that it is ending all vaccine outreach to teens. It would be bad enough if this was just COVID vaccine but they are also ending outreach for other vaccines, like TDaP, HPV, hepatitis, and MMR boosters.

It’s appalling.

Please, everyone, remember that we are still in a pandemic – and will be until we can get COVID under control globally. If you have access to vaccines, please take them for your own good and for the good of others. Everyone needs to be vigilant to following public health and infection prevention measures recommended by public health professionals in your region.

COVID doesn’t care about your political views or whether or not you believe it exists. It is a virus that is just looking for a host to make it possible for it to replicate as many copies of itself as possible. If you are infected, you might be lucky and have mild symptoms, but you could pass it on to someone who might become seriously ill or even die. Or you might be unlucky and become seriously ill or die yourself.

The virus won’t care.

Your loved ones will.

*****
Linda’s prompt for Stream of Consciousness Saturday this week was to base your post on your least favorite word. I don’t often think of having a favorite or least favorite word, but I thought that COVID definitely qualified as being my least favorite entity at the moment. If you’d like to join in with SoCS, you can find out more here: https://lindaghill.com/2021/07/16/the-friday-reminder-and-prompt-for-socs-july-17-2021/

Another Pfizer vaccine advance

Yesterday, the Pfizer/BioNTech vaccine against COVID-19 was granted emergency use authorization for children aged 12-15, extending the prior age range of 16+. These younger teens can receive the same dosage as older teens with similar effect. This is good news because all high school and most middle school students should be able to be protected before schools open in August or September 2021.

Pfizer and other vaccine suppliers are currently studying the proper dosage for younger children. These eventual approvals will probably be split into several groups, 5-11-year-olds, 2-4, and 6-23 months. The research with these younger children takes longer because they have to start with lower doses and increase to find the lowest possible dose that will still mount a strong immune response. Until these children can be vaccine protected, they need for all the teens and adults to get vaccinated to reduce their chances of being exposed. While young children tend to be less sick than adults if they get infected, they can become very ill, even fatally, and suffer long-term symptoms. Even if they have mild or no symptoms, they also keep the community spread of the virus going, which means that the pandemic phase cannot end.

Canada gave authorization for 12-15 for the Pfizer vaccine last week. It’s expected that Moderna will be doing so soon. Pfizer has also applied for full authorization in the US, a process that will take several months to complete. I am especially pleased with the success of the Pfizer vaccine because data from spouse B and daughter T are part of the research findings that are showing how safe and effective the vaccine is. Monitoring for them continues to see how long immunity lasts and whether boosters are needed. I also continue to participate in the trial, but, because I was originally part of the placebo group, I didn’t receive the vaccine until February so my data are not useful for the longevity factor, although I could become part of a test group for boosters in the future if warranted.

Internationally, vaccine companies are continuing their research and manufacturing, but distribution is neither fast nor broad enough. India is particularly tragic, with widespread disease, scant treatment, and, despite being a major manufacturer of pharmaceuticals and vaccines, very little vaccine protection among its residents. President Biden has joined growing calls for vaccine companies to suspend their patent protections so that countries around the world can manufacture vaccines for their regions. This would also entail making available the raw materials, supplies, and expertise to manufacture the vaccines, some of which require new techniques such as mRNA.

I feel an odd mix of hope, dread, and sorrow. The COVID rate in New York State where I live is very low now. We are gradually relaxing some of our restrictions and I am planning to go on a writing retreat later this month. This summer, we think we are finally going to be able to travel to the UK to visit daughter E and her family and get to hold our granddaughter JG for the first time, although she is almost walking on her own and may not want to stop long enough to be held by the time we can get there.

At the same time, there are still people sick and dying in my state and exponentially more in other states and countries. It’s frustrating because we have treatment tools and vaccines now that we didn’t have a year ago but they aren’t reaching all the people that need them. What’s most frustrating is people who do have access but don’t take advantage of the opportunity, letting their fear, ideology, contrariness, or sense of invincibility stand in the way of personal and public health.

Please, everyone, continue to do all that is within your power to end the pandemic. This will look different depending on personal and community circumstances, but mask in indoor public spaces, distance when appropriate, be careful about the size of gatherings, stay home if you are sick, vaccinate when it’s available for you, keep up to date on the newest public health recommendations.

Show your respect for others and do your best to protect them. Pandemics are, by definition, phenomena that affect us all. It takes all of us working together to end one.

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.