Tag: clinical questions

Johnson & Johnson and the EUA application

Posted on by Dr. Nykki
a schedule board with 11a-5p COVID Vaccine and 2:30 Ice Cream, among other things
This is the best daily schedule Ever.

It’s all alphabet soup in the end

So Johnson & Johnson have submitted their data to the FDA for emergency use authorization (that’s EUA for those of you who speak alphabet soup). The data on this one are super interesting, so I’m going to talk about some new things we know! 

What is an EUA, anyway?

An Emergency Use Authorization means that (1) an emergency exists involving some kind of serious or life-threatening health condition (it is all alphabet soup here) (2) there are no traditionally-approved treatments for this condition (3) the FDA have reviewed the existing data on an intervention (could be a procedure, a medication, a device, etc) and it looks like it might have a benefit even though the full criteria for FDA approval have not been met. 

 

Sometimes, later information comes out that makes it clear that the intervention is not, in fact, helpful, and the EUA gets revoked. We have seen that several times with this pandemic – with certain COVID tests, with certain medications, and even with certain kinds of personal protective equipment. The FDA continuously evaluates the information that’s available to them. 

 

What manufacturers are hoping for, of course, is that the long-term data will support full FDA approval in the end. An EUA is not a shortcut to approval – it’s a tool that we have to use when lives are at stake and we can’t afford to wait for the usual (potentially years-long) process to grind along. 

 

What about the Johnson and Johnson vaccine? 

J&J applied for EUA for their vaccine on Friday. It’s a single-dose adenovirus vector vaccine (they are still running trials on a 2-dose version), so this vaccine works a little differently than the two vaccines currently on the market. Basically, J&J are using an adenovirus – a particular type of virus that’s really good at getting the body’s attention, thanks to the fact that they infect pretty much everybody (this is another common cold-causing virus) – and have modified it so that it’s not so good at actually copying itself any more. What it does do is present a set of instructions to the cells (just like the mRNA vaccines) to make viral spike proteins.

 

This vaccine uses DNA — so it depends on the body to translate the instructions for making spike proteins into mRNA and take them to the factories. It can’t actually affect the DNA that’s inside your cells already (and neither can the mRNA vaccines); it simply doesn’t have the enzymes to unzip your cells’ DNA and break it apart. 

 

J&J enrolled a little over 43,000 people in their global trial, and saw 468 symptomatic cases of COVID-19 in that trial. They designed the study to look for moderate to severe COVID-19 at 14 and 28 days after vaccination, as well as for all symptomatic infections. They also did genetic tracking on the types of COVID-19 infections they saw. 

 

So what did they find? A couple of interesting things. 

 

The vaccine was 66% effective in preventing moderate to severe COVID-19 at 28 days after vaccination — and there was enough data to say that in the US, it’s more like 72%. That’s not as good as the 94-96% prevention that Pfizer and Moderna have reported, but it’s still pretty substantial; about as effective as the adult pneumonia shot (Pneumovax23 in the US). There’s a bit of more important information in the report, though: J&J reports no cases of COVID-related hospitalization or death after day 28 in the vaccinated group. 

 

This is a vaccine that protects people. It’s a good vaccine! 

 

It may not be quite as amazingly amazing as Moderna and Pfizer’s prevention numbers (although preventing hospitalization and death is a BIG deal), but it has pretty solid safety information: there were no cases of anaphylaxis reported during the trials, and the placebo arm reported higher rates of serious adverse effects than the active vaccine arm. J&J notes that this is actually not the first vaccine candidate using this technology (their Ebola vaccine was actually approved in Europe in 2020), and that they’ve seen similar safety profiles in those long-term trials. This is a vaccine whose driving technology has a longer-term track record.

 

This vaccine also has some ability to see through a false nose and sunglasses! It’s not perfect; it did show decreased efficacy against the South African variant B.1.351 (remember: this variant coronavirus is super friendly AND doesn’t quite look like its wanted poster), but still protected people about half the time. That’s not bad! It’s about as good as the old shingles shot was for shingles prevention (the new one is almost 90%).

 

We have some pre-print data that suggests Moderna and Pfizer’s vaccines work to neutralize the mutant viruses in test tubes — but humans are not test tubes, pre-print data still needs outside eyes to look at it, and so we don’t know what the real-world effects will be. 

 

And this is where I remind you that variant B.1.351 has been seen in the United States, and this is why — even when you’re vaccinated — it’s still important to wear your mask, keep your respectful social distance, and avoid spending time with groups of people indoors, especially if there is eating and drinking involved.

 

 

 

Reasons to delay vaccination until you can talk with your doctor

Posted on by Dr. Nykki

a vaccine certification

Who should not get vaccinated (right now)?

Vaccine eligibility in Indiana (this is where I live, so it’s the state whose health department notifications I receive) was updated this morning to include people ages 65 and up. If you (or your loved one) need to sign up then it can be done through ourshot.in.gov or by calling the 211 line. Your local Area Agency on Aging (wow, say that three times fast) can also assist you. If you or your loved one are a long-term care resident then several pharmacy groups have been working to vaccinate people where they live. If you are a health care worker or you come into regular contact with infectious material then you can also be vaccinated (ourshot.in.gov or 211). 

 

I’m told that your public library may be another place where you can get help signing up for your vaccine (I cannot say enough good things about public libraries)!

 

My Facebook feed is full of people I love getting vaccinated on a regular basis, and I’m so excited about that! I do want to cover a question I promised I would come back to in more detail, though: 

Do you have any info on not getting a vaccine if you have allergies?

Things I know should make you talk to your doctor or delay signing up: 

  • If you have a known allergy to PEG (polyethylene glycol), polysorbate, or any other of the (very short) list of vaccine components, talk to your doctor before you sign up because you may be at increased risk of an allergic reaction
  • If you have a history of severe reactions or anaphylaxis to another vaccine or infused (IV) medication, talk to your doctor to make a decision based on your particular case. 
  • If you had your first shot and had anaphylaxis (or any serious reaction) to that shot, talk to your doctor before you commit to another. 
  • If you have dermal fillers (a type of injectable treatment for wrinkles and aging skin) then your response to the vaccine may include a (treatable, mild) reaction at those sites and you should talk to your doctor to know what to expect.
  • If you are actively under quarantine for COVID-19 exposure please don’t come in to get vaccinated while you are under quarantine. We don’t think your immune response will be fast enough to prevent development of COVID-19 and you’ll expose everyone at the vaccination site.
  • If you are positive for COVID-19 please wait until your isolation period is over and your symptoms are resolved. You may consider delaying a little longer (up to 60-90 days), depending on your personal risks of exposure and the vaccine supplies where you are located. 
  • If you’ve had another vaccine (flu, shingles, pneumonia shot, etc) you should wait 14 days before your coronavirus vaccine (and wait 14 days after it before you get any other vaccines) because we don’t know if there are any interactions that would affect your immune system’s response. 
  • If you received a monoclonal antibody infusion for COVID-19 specifically, we are recommending you wait 90 days after the infusion, because we don’t know exactly how those synthetic antibodies will interact with the vaccine.
  • If you have HIV or are immunocompromised, we have some data on how the vaccines work, but not as much as for people with more robust immune systems. These vaccines CANNOT give you COVID-19 (remember that post on how they work?) but you should talk to your doctor about the latest information.  
  • If you are in super fragile health and a day or two of feeling awful might actually kill you, talk to your doctor before you get your shot. 

 

And one more: If you are pregnant. 

 

The World Health Organization has released a statement about pregnant people and the Moderna coronavirus vaccine, and it’s just about as long as anything I could have written. I’ll try to summarise: 

 

“We don’t have enough data about this vaccine in pregnant people to make a definite statement about its safety (or about how well it works). The science behind the vaccine suggests that it should be safe, and animal studies have not shown any harm, but until we have a meaningful amount of data from actual pregnant people, you should talk with your doctor about your personal risk of contracting COVID-19 and severe disease, then make a decision based on the benefits to you and the fact that we don’t know for sure whether there are risks.”

 

That’s still a lot. The CDC’s recommendations at this point take a couple of pages and are roughly the same (“people who are pregnant and part of a group recommended to receive a COVID-19 vaccine may choose to be vaccinated”) 

 

What this amounts to is: We think this is probably safe, but we don’t have the data to back it up yet, and as responsible scientists we feel that we need to tell you we are making an educated guess about the safety of these vaccines in pregnant people. 

 

That’s a pretty long and relatively specific list of reasons not to get vaccinated. 

A couple of things that are not on the list:

  • Medications: I am not currently aware of any medications (other than the vaccines and monoclonal antibodies I mentioned above) that are a concern with the COVID-19 vaccines. The trials were performed on people with a variety of common diseases, and people were instructed to keep taking their regular medications. There’s no noted concern in the published data for any medication interactions. 
  • There’s been a little chatter about whether it’s okay to use acetaminophen, ibuprofen, and aspirin type medications to treat your post-vaccine symptoms. A review paper published in 2016 looked at the available data on whether these medications affected your immune response. It turns out that they might decrease your response a little bit! However, that effect is small, and because vaccines are designed to create a robust (strong) immune response, it may not make a real-world difference. We don’t know for sure.
  • Asthma: We are good to go, asthmatics! If you have particularly severe asthma, then check with your doctor. 

 

Happy vaccinating! 

 

 

 

Vaccine Schedules

Posted on by Dr. Nykki

 

Dr. Nykki's mom and granddad
Two people who are excited about this vaccine – my mom and her dad – from my 2017 archives

Introducing Mom…

Today, my mom called me to let me know that she had received her first shot of Pfizer’s vaccine. She’s a pretty healthy not-too-much-over-70 woman who assured me that the biggest symptom she has had so far was a feeling of amazement and dawning relief. 

 

We are all carrying around a lot of stress and anxiety — for so many reasons — and I think it’s important that we continue to acknowledge that. It’s okay to feel anxious! It’s also okay to be tired of living under a burden of constant vigilance, because that is emotionally and physically exhausting, and we have been living under COVID vigilance since roughly March of last year to varying degrees. 

 

Take care of yourself, if you can, this coming weekend. Go outside if that’s feasible for you, and take some time to breathe fresh air (if you are quarantining or isolating, then take appropriate precautions to avoid others breathing your freshly-exhaled air, but get some fresh of your own). Write a letter to yourself or so  meone you care about (It’s okay! Wash or sanitize your hands after handling your mail because that’s good practice any time you handle something a zillion people and machines have been touching, but the risk of getting COVID from your friend’s letter is minimal, if any). Make some tea, if you enjoy tea. Take a long bath. Get dressed in nice clothing if you have been living in sweats. Exercise if you have not been (exercise outside if you can): exercise triggers your body’s natural antidepressants. 

 

None of this is going to make it okay that we’re living lives of vigilance and separation. But the really amazing thing about human beings is how good we are – when we let ourselves – at finding creative ways to solve our problems. Give yourself permission – because I am giving you permission – to be your most amazing self this weekend. I’m interested to know what that looks like, if you decide you want to share.

Mom had a vaccine question for today’s diary: 

 

What happens if I don’t get my second dose right at 21 days (or 28 days)? What if my second shot is late?  

 

Short answer: 

 

You’re still considered to be fully vaccinated, even if your second shot is waaaay after your first, although we don’t have data to give you a definite answer beyond 6 weeks yet. That’s consistent with our recommendations for all the routine vaccinations you’re likely to get — we don’t generally restart shot series. 

 

Long answer: 

 

Most vaccines – regardless of the trick they use to do it – work by invoking your immune system’s short-term defenses and long-term memory cells. For vaccines that are given in a series (like your childhood shots are), each shot builds on the memories of the one before it, reinforcing the protective responses of your immune system to create long-lasting defenses. 

 

Let’s look at tetanus as a great example. The idea behind tetanus vaccination is to protect you from Clostridium tetani infection, which causes tetanus (cheerfully known as lockjaw to some folks). C. tetani lives in dirt and makes a toxin that causes serious muscle spasms, and getting tetanus naturally does not protect you from future infection (yikes!). Fortunately, we have an extremely effective set of vaccines to help your body protect itself against tetanus. We measure that protection by checking levels of tetanus antitoxin. 

 

The first dose of a tetanus vaccine creates almost no protection — but it primes your immune syste for the next; after the third dose nearly every vaccine recipient has high enough levels of tetanus antitoxin to safely step on a dirty nail without getting lockjaw (I don’t recommend stepping on nails regardless). That protection lasts for about 3-5 years, so we give a booster shot to kids who are entering kindergarten, and another one in the early teenage years. At that point you may be protected to some degree for 20-30 years because your immune system remembers – but we still currently recommend a booster every 10 years to keep the memories fresh, and if you happen to encounter a dirty nail we’re going to give you a booster dose to make extra sure you stay safe.

 

If you happen to miss out on one of those childhood doses, we don’t make you restart the series – because we’re counting on the long-term memory cells (remember the memory B and memory T cells? We talked about those a couple of weeks ago) to pick up where they left off with the next vaccine in the series. For almost every vaccine on the market (exceptions: certain cholera and typhoid vaccines), that remains true; we recommend a minimum time to wait between vaccine injections in order to let your body finish round one of recognizing and remembering so it can launch its best response to round two, but there is no maximum time. 

 

The data we have at this point is only good for a delay of about six weeks between vaccines, and only on the Pfizer vaccine. Because Moderna’s vaccine is so similar, we are making an educated choice to treat it similarly, and as we continue to vaccinate more people – and make difficult decisions about how to distribute a limited vaccine supply – we may learn more (scientists love data! Even if it’s not in a controlled experiment) and be able to expand that information. 

 

For now, if you have gotten two doses of the Pfizer or Moderna vaccines – spaced at least 21 (Pfizer) or 28 (Moderna) days apart (the CDC says you can have a grace period of up to 4 days early), then you are considered to be fully vaccinated. 

 

And thanks for asking the question, Mom!

 

A little bit of hope

Posted on by Dr. Nykki

kid in a mask

These numbers really are good ones

The last few diaries have been pretty intense. It’s time for something a little lighter, I think. 

 

My office staff have been getting pretty good at fielding inquiries about the vaccine lately. I hear them on the phone sometimes: “Yes, you can call 211 or I can help you get registered.” “Well, I got my shot and I’m feeling just fine.” “Let me send a message to your doc so we can get the best advice for you.” 

 

My news feed is full of a mélange of articles about coronavirus outbreaks, Disney World (I cried when I cancelled my February plans), Dungeons and Dragons, and vaccine news. I keep an eclectic mix of sources flowing; sometimes I click on articles I know I’m going to disagree with just so that I don’t lose perspective, and sometimes I send myself articles that I think I could probably use for later.

 

I learn something every time I write one of these diaries, so that makes it worth all the effort. If you’re itching to see where I get my information (I keep a very casual bibliography!) I’ve compiled all of my entries at d20doc.com with source links.

So let’s talk about the vaccine news, shall we? 

Some sobering statistics, first, to get your math brains warmed up: The first death from coronavirus in the United States was on February 6, 2020. On May 28, 2020 the United States passed 100,000 deaths from coronavirus. On September 22nd we crossed the 200,000 mark; on December 14th, 300,000. Yesterday – January 19th – we passed 400,000 deaths from COVID-19. Over the last one year we have seen the time it takes for 100,000 people to die from COVID-19 shorten from four months (May to September) to four weeks. 

 

A third of those deaths were in people over the age of 85. Two-thirds of them were in people over the age of 75. Four-fifths of them were in people over the age of 65. And 95% were in people over the age of 50. 

 

If you are young, and relatively healthy, your chances of surviving a coronavirus infection are really quite good. I’ve talked a little bit in another vaccine diary about some of the things that might linger without killing you, and on another day I’ll cover the data regarding what’s called morbidity from COVID-19, because the death statistics (the mortality) of this virus are really only the first few paragraphs of the story. 

 

But today I want to talk about hope — hope that you can measure in numbers. 

 

New England Journal of Medicine, December 10th, 2020: Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine (the Pfizer data) is published. Four days later, the United States will have lost the entire population of Pittsburgh to COVID-19. The Background of the article’s abstract  closes with the sentence “Safe and effective vaccines are needed urgently.”

 

If you can’t sleep tonight, read the Pfizer article. It’s full of words like “lipid nanoparticle–formulated” and “modified intention-to-treat (mITT) efficacy population” which make the right people very excited, and sometimes make everyone else go cross-eyed. That’s how scientific journal articles are written – full of very specific and highly technical terms – and it’s part of why everyone who hasn’t been studying Doctor as a second language has trouble understanding what it all means. 

 

Here’s what Pfizer’s data says, in plain English: “We saw protection beginning about 12 days after the first dose and improving dramatically at 7 days after the 2nd dose. We observed 170 cases of symptomatic COVID-19 that were diagnosed at least 7 days after the 2nd dose, and only 8 happened in our vaccine group. We observed 10 cases of severe COVID-19 out of 170 cases. Only one of those happened in our vaccine group.”

 

New England Journal of Medicine, December 30th, 2020: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine (the Moderna data) is published. The United States has lost another 40,000 people. Safe and effective vaccines are still needed urgently, and Moderna starts throwing around the “lipid nanoparticle-formulated” terminology from the get-go. 

 

Moderna says: “We had symptomatic COVID-19 confirmed in 196 people in our trial; only 11 of those cases were in the vaccinated group. We had 30 cases of severe COVID-19 and one death in our trial. All of those cases were in the unvaccinated group.”

 

Let’s talk about that for a moment. 

 

These trials were not designed or powered to test whether or not the vaccines will prevent severe COVID-19 (remember those terms? It means that we don’t have the numbers to make statements about severe COVID-19 with certainty, no matter how much my brain is screaming “THAT CANNOT BE RANDOM” at me). But they were designed and powered to test whether or not the vaccines will prevent symptomatic COVID-19. And they showed that they can do that just about 95% of the time. 

 

We have a long way to go yet before we are ready to abandon masks and social distancing. There were 49.2 million adults in the United States over the age of 65 in 2016. That’s a lot of people at increased risk! I know a few of those folks, and they are pretty cool people who make the world a better place. They also desperately want to see their grandchildren, and it is cold outside in Indiana in January.

 

If you are fully vaccinated (not the day after your second Pfizer or Moderna jab, but 7 to 14 days after it) then your risk of contracting coronavirus from your grandkids is significantly less than it was before you got your shot. It’s not zero! This isn’t a perfect protection! But if your family has been careful all the way around (that means wearing masks all the time outside your immediate family group, avoiding indoor gatherings especially if people are unmasked or eating and drinking, socially distancing in public, and staying clear of spaces that make those precautions difficult) then you should have a conversation – with your doctor, with your loved ones, and with yourself – about the benefits and risks of getting to see the people you have been isolated from for so long. 

 

Because the more people we vaccinate, the more people we protect – and when my careful precautions meet your 95% protection, we can create a safer space for both of us.

And you can’t put a number on that kind of hope. 

 

 

 

 

Norway’s Death Reports in Frail Elderly; reading a medical news article

Posted on by Dr. Nykki

a negative BINAXNow Covid test

My brain is wired for panic

At one week out from my vaccine, I’ve had no new concerns. I have friends and family members reporting fever, fatigue, malaise, nausea, and vomiting – sometimes after the first dose – so I’m grateful to my immune system for all the favors it’s doing for me. Keep it up, immune system!

 

I’ve had a news article come up on several of my feeds lately, and so today’s diary is going to be about the Norway data and reading breaking medical news articles.

 

The article in question, depending on your news source of choice, begins with the headline “Norway Raises Concern Over Vaccine…” or “23 Die After Pfizer Vaccine…”; and that’s certainly a headline that will raise concern. I’m concerned! But we’ve been talking a lot about science lately, and the way that our brains tell us things that may or may not be strictly true, so I’m going to take you through a deep dive into the publicly available information and what it means from a scientific standpoint.

 

The article I’m using is from the British Medical Journal (a peer-reviewed publication with reasonable standing in the medical community, so a source I trust), but it reflects most of the same information you’ll find from any news source that is doing its research: Norwegian physicians had reported 23 deaths in patients who had recently received the Pfizer coronavirus vaccine. Those deaths were in care home patients (nursing home patients), many of whom were “very frail”. Some of those patients underwent autopsies and Norwegian health authorities felt that the side effects of the vaccine may have contributed to the deaths of the patients. 

 

I’m going to walk you through the way I responded to this information, and let’s see where it takes us, shall we? 

 

Brain (FULL PANIC MODE ON): That’s a lot of deaths! What’s going on?!! Why are all these people dying  in Norway?! I need to call my nursing homes and make sure nobody is dead!! What if I have been telling people bad information?! What if I’m a bad scientist and a worse doctor?! 

 

My brain is very excitable. It is also basically programmed for threat avoidance, because our brains are supposed to keep us alive, so it’s better in general if they’re a little paranoid (especially if you’re living in a world full of unpredictable things actively trying to kill you, as humans have done for much of our history). But that means that sometimes we have to take a moment, let the initial shock and awe wear off, and take another look at what we’re seeing. 

 

So let’s take a look, now that my brain has stopped running in panicked circles and screaming, shall we? 

 

Step 1: How reliable is the source of my information? 

 

I had the same general headline from multiple news sources, which is usually (but not always) a positive sign of reliability, and so I walked it back to a medical journal that I trust for confirmation. 

 

The data itself comes from Norway – which has a centralized government-funded health care system, in which enrollment is automatic. Citizens have the option to purchase private insurance, but only about 10% of the population has done so. The relationship between the Norwegian government and the citizens of Norway is generally good. This means that they have ready access to certain health data through national registries, and the information we are being given is likely to be reliable. 

 

Step 2: What are the actual facts being reported? 

 

BMJ reports upwards of 20,000 doses of Pfizer’s vaccine were administered in Norway in the last few weeks and 23 deaths were reported in frail elderly patients “shortly after” receiving the vaccine. 13 of those deaths have been investigated — and it was felt in those cases that vaccination responses may have contributed to the deaths. The article also notes that around 400 deaths a week occur in care homes in Norway on a normal basis.

 

We are not given a clear definition of “frail” or “elderly”, although both of those terms are kind of a “we know it when we see it” thing for doctors. We also are not given any information about whether the reported deaths are more than the usual number expected. Remember — Norway is monitoring its citizens’ health just as closely as the US is (maybe more closely) and so it’s expected that medical personnel should report EVERYTHING so that the data scientists can sort it out. 

 

Step 3: What is the relationship between the facts? 

 

There is a potential correlation between administration of the vaccine and death in frail elderly patients. That means that it’s possible that these two numbers are going to move together:  if more frail elderly patients are vaccinated, then more of them will die shortly after the vaccination at a rate of about 10 deaths per 10,000 doses administered. It’s also possible that these two numbers have nothing in common, and as more frail elderly patients are vaccinated, more of them do very well. 

 

There is also concern for causation: in the patients whose deaths have been investigated thus far, it’s possible that vaccine responses may have been a factor in their deaths. That’s certainly a point of concern, and one that I’m going to be following for more information on.. 

 

Step 4: What other information do I already have that is important to consider? 

 

Pfizer did present data on safety in patients who were age 80 and up — but as widespread vaccination programs take place, we have rapidly exceeded the number of people enrolled in clinical trials. That means that instead of 73,000 data points (Pfizer enrolled 43,000 people and Moderna enrolled 30,000 people in Phase 3) we have over 12 million in the US alone. 

 

The more data we have, the smaller our p value gets, and that means that we can be more confident when we say that a particular reaction is (or is not) likely to be related to vaccination.

 

I take care of frail elderly patients in care homes on a regular basis. I worry about things like fevers, not eating well, vomiting, and diarrhea in those patients. They don’t have a lot of extra reserve — so when they get dehydrated, low on electrolytes, or hypoglycemic (low on blood sugar), that can be a really serious event that they may not be able to recover from. So I can certainly understand from a medical standpoint where enthusiastic vaccine responses (the kind that sent my otherwise-healthy colleagues home from work for a day) might have a devastating effect on someone without that reserve. 

 

Step 5: What am I going to do with all this information?

 

I’m not going to let my brain tell me to panic. Panicking does not help me be a better doctor, and it does not help me provide better information to my patients. 

 

I AM going to flag this topic in my mind as something that I want to continue to learn more about — I expect more data to come out as scientists and doctors across the world continue to observe and report what they are seeing, and I want to know what the data says. Because this is important. 

 

I AM going to use the information I have to inform my discussions with frail elderly patients and their families. It’s going to be important to talk about the possibility of an enthusiastic vaccine response and what that means, as well as to talk about what their risk of catching COVID-19 is and what that means. I can’t make a decision about vaccination for my patients and their families; my job is to be the best resource that I can be for them, and to help them make the best decision they can for themselves — and that decision may be different from one patient to another. 

 

Step 6: Keep learning. 

 

Never stop learning. Never stop asking questions. 

And don’t be afraid to say “I don’t know, but I’ll find out.”

 

 

 

 

Breastfeeding, Pregnancy, and coronavirus vaccines

Posted on by Dr. Nykki

 

Babies are some of my favorite patients

My arm only hurts if I push right where I got my jab (what a delightful term). I made it through a topsy-turvy clinic schedule without excessive fatigue, and I currently have nothing to complain about to the nice folks at V-safe who sent me my daily reminder text to find out how I was doing. 

 

I also do not have any new super powers, unless you count filling the dishwasher without being asked to (I am a terrible housemate).

Can I (should I) get the coronavirus vaccine while pregnant or breastfeeding?

 

Short answer: It depends. 

 

Long answer: 

Let’s talk a little bit about how mRNA vaccines work so that we’re all on the same page with regard the science of vaccines, because I think that helps answer the question. There are, after all, some vaccines that you are NOT currently recommended to get while pregnant (MMR, Varicella, Live influenza, Zostavax; HPV, Meningococcal B) so the question with a new vaccine is certainly relevant.

 

Vaccines work by introducing your body to an antigen (A recognizable part of the thing we are protecting against) in some sort of low threat way. Bodies are excellent at recognizing things that do not belong — and not only do they seek and destroy, but they create specific antigen binding molecules called antibodies, as well as engaging your T and B the memory cells to remember, locate, and inactivate that particular antigen should ever be encountered again. There are no three strikes rules in your immune system.

 

One of the first widespread vaccines in the Western world was the smallpox vaccine. The process of smallpox vaccination (ask anyone who was a vaccinated child prior to 1972 about their scar) involves scratching a hole in the skin and introducing a close cousin to smallpox called cowpox into the hole. Cowpox is much less deadly than smallpox, and vaccinating with cowpox dramatically reduced the attack rate of smallpox, which is a disease that now has the dubious distinction of existing only in the laboratory. 

 

We still use live virus in some vaccines today. The MMR, Varicella, live inactivated influenza, and Zostavax (old shingles) vaccines use a live inactivated virus – real viruses that have been in some way altered to make them slow and sluggish; easy prey for a nimble immune system. However, as any pregnant person can tell you, pregnancy makes everything in the body go haywire – including the immune system. So we don’t give live virus vaccines to pregnant people (or people with heavily suppressed immune systems) because of the risk that the virus could pose to parent or baby if it proved to be too quick on its feet. 

 

The majority of vaccines today don’t use whole live virus, inactivated or not, because we’ve learned a lot of more predictable ways to present antigens to our cells. I’ll save the lecture on vaccine subtypes, but mRNA vaccines are a whole new way of presenting antigens from a public health standpoint. 

 

And that’s a big part of the anxiety around these vaccines, right? This is all new technology, after all. 

Except that it isn’t. In the oncology research labs, where some really amazing scientists keep trying to find better ways to treat cancer, mRNA vaccine technology has been under development for more than a decade. It’s not, actually, all that new. It’s just never been used for -this- type of vaccine before.

 

Your cells contain vast lengths of DNA – the instructions for making the proteins that make you –  folded up into those infamous double helices and stashed in the nucleus in tightly knotted chromosomes. In order to make a protein, a lot of complicated biology happens to make a copy of the relevant section of DNA, using a strip of bases known as mRNA. That’s short for messenger RNA, which is exactly what it does: mRNA takes the instructions from the DNA and carries them into the ribosomes, where it’s used as the blueprint for assembling amino acids into a protein. 

 

Enter the mRNA vaccine. When you are injected with an mRNA coronavirus vaccine, your body is handed a whole bunch of little instruction manuals for making an easily recognizable part of the coronavirus spike protein. Because RNA looks like RNA no matter where it came from, your cells pick it up and hand it over to the ribosomes. The ribosomes do their thing, and voila! Your cells have made a viral antigen. It’s recognizable by your body as Definitely Not Me, and so your immune system gets to work recognizing, remembering, and neutralizing. There’s no actual coronavirus involved in the administration, and nobody has to get scratched with a stick and rubbed with cowpox. 

 

Still with me? That was a lot of immunology. 

 

Back to our pregnant-and-nursing people who are still waiting for me to explain what all of this has to do with them, then, and I’ll explain. 

 

There are two types of vaccines that we don’t recommend giving during pregnancy: live inactivated ones (because your immune system is being deliberately suppressed by your body in order to avoid letting it notice that you’re growing a person who is about half Definitely Not You, and so we don’t trust it to catch the live virus in a safe and efficient manner), and vaccines for which we don’t have enough safety data to make a call yet, but where delaying vaccination for nine to ten months is unlikely to pose a significant risk to the pregnant person. 

 

And that’s where it depends. 

 

You see, yellow fever is a highly contagious infectious disease in some parts of the world — and the only vaccine we have is a live inactivated one. But because the risk of dying from yellow fever is so high, the yellow fever vaccine is still recommended in pregnancy if you can’t avoid going to an area where you are at high risk of catching it. 

 

We don’t have enough data on either of the coronavirus vaccines in pregnancy (see yesterday’s post on the power of numbers) to make a clear statement about safety. The science says that there is nothing in the way the coronavirus vaccine works that would pose a threat to a developing infant (it’s just a set of instructions, after all) — but I don’t have an absolute answer to give you here. 

 

If you are pregnant and you get COVID-19, you are more likely than a nonpregnant person who’s otherwise just like you to have severe COVID-19 disease (including ICU admission and death). You are also at increased risk of preterm labor and delivery, and of having a cesarean section at that delivery. Those are notable concerns!

 

Being vaccinated in late pregnancy may allow your body to pass antibodies across the placenta to protect your baby, as well. That’s why we give pregnant people a Tdap vaccine at 28 weeks – to help protect babies from whooping cough through what we call passive immunity. The body is designed to pass antibodies through the placenta to a growing baby, in order to help protect that baby against things that its immune system is likely to encounter. Developing passive immunity through vaccinating pregnant people has not been tested with coronavirus vaccines, but it’s likely that it will happen to some degree. 

 

If you are pregnant and eligible for the vaccine, you should talk to your doctor about being vaccinated so that you can make the best decision based on the data available. If your risk of exposure to COVID-19 is high, then you and your doctor may decide that getting vaccinated is the safest course. If your risk of exposure is low, then maybe you will make a different decision. 

 

What if I want to get pregnant soon?

 

There’s no reason that we know of to avoid being vaccinated if you’re planning to get pregnant. We aren’t aware of any effects on fertility related to the vaccine — and the spike protein is pretty unique. Remember, we are teaching your body to recognize a single part of the coronavirus itself – so if there were concerns about fertility related to coronavirus immunity, we would be quite likely to see them in people who had recovered from COVID-19. 

 

What about breastfeeding babies?

 

mRNA is very fragile. It’s designed to run a set of instructions from one part of a cell to another and then be recycled. Remember all those amazing ultra-cold freezers that the Pfizer vaccine required? That’s because mRNA breaks down very quickly at room temperatures. The vaccine itself is unlikely to make it to your baby through breast milk — but if some of it did survive that long, then being doused in hydrochloric acid in the baby’s stomach will finish it off. 

 

What we know is that antibodies are expressed in breast milk and are another source of protection from infection for a growing baby. Being vaccinated while breastfeeding is likely to provide some passive immunity for your baby, and is unlikely to cause any harm to them. However, some people are very sensitive to illness, and because they may feel poorly for a day or so (I hope everyone’s vaccine experience is as flawless as mine!), that may affect their ability to breastfeed (it’s still safe, but nursing a baby when you feel like dirt is No Fun) or to maintain milk supply (stay hydrated!!!) through those days. It may take extra effort to make sure breastfeeding the baby continues without interruption.

 

There are trials being started now (in animals) looking at reproductive safety specifically, so if more data emerges, I will try to update!

 

 

 

Vaccine Protection Questions

Posted on by Dr. Nykki

a portion of the EUA consent for Pfizer vaccine

24 hour vaccine report

I was contacted yesterday early afternoon by our incident command asking if I had really meant that I was willing to participate in rollout testing for our COVID vaccine program, because if so they’d love to have me between 4:30 and 5 to get my shot. 

 

I am prone to enthusiastic responses to vaccines, and am somewhat notorious for developing a 6 to 8 in welt on my upper arm after getting my flu shot. I did not have that response this year to the flu shot, and it was such an anomaly that half the office had come by to look, so I did give the idea some careful consideration. 

 

I had actually planned on doing my initial vaccine next week on the 23rd of December because nothing says Christmas presents like monitoring yourself closely for vaccine reactions.  I am also on-call this week, and part of the risk of getting vaccine is having a reaction, but after review of the literature available to me I felt like probably the 2nd dose is more likely to cause an issue that would actually get in the way of me doing my job (we’ll see in three weeks),  and I am quite frankly a sucker for being helpful if it means making history happen.

 

So I got my 1st coronavirus vaccine around 5:00 yesterday afternoon.

 

For complete transparency, I went to the gym on Wednesday the 16th of December and did upper body reps until failure in multiple supersets. When I went in to get my vaccine last night, I was already having some low-grade muscle aches throughout my upper body.

 

By bedtime I had essentially no response. I had no increase in pain in my upper arm, no erythema, nope welt, nothing at all. There was in fact so much nothing that I made my husband take a picture of it so that I could really see, and – in his words – “one of the two spots in this picture is a freckle, and one of them is where the shot went in, I can’t tell which one is which.”

 

I woke up this morning with two sore arms. My right is the usual discomfort I expected from the gym on Wednesday (foam roll, people, it’s real) but my left arm is definitely a little more painful than the right. My deltoid has a dull ache in it every time I lift my arm. It’s not enough to stop me but it’s a reminder. I took some naproxen, because that is my analgesic of choice. 

 

That ache has continued through most of the day so far; this morning it was a gentle reminder every time I use that arm, but this afternoon (without any more naproxen), my arms feel pretty much the same. I still have no significant redness, no swelling, and no actual tenderness at the site.   Currently, rating this somewhere between the flu vaccine and the Tdap (which hurts).

Questions I don’t have answers for about this vaccine: 

Does this protect me from giving COVID to others?

I don’t know for sure. When scientists design an experiment, they determine what they are testing and how they are testing it in advance. Sometimes it is possible to use the data from an experiment to draw other conclusions, but we always have to be careful when using an experiment to answer questions it wasn’t designed to ask. 

We know from the remarkable data gathered by the  Fairbanks School of Public Health and the Indiana Department of Health early in the pandemic that something like 40% of people who were positive for coronavirus DNA were asymptomatic or pre-symptomatic.   These patients can only be detected through surveillance testing ( either testing everyone in a certain set of people or testing known contacts of ill persons) or by testing them when they develop symptoms later, and are known to be transmitters of the virus.

The vaccine trials that were done and are still ongoing were not designed to test for asymptomatic coronavirus infections.  Testing for COVID-19 through the trial protocols was only done on symptomatic individuals – people who were sick in some way. Because Pfizer didn’t test everyone on a regular basis regardless of symptoms, we don’t actually know what the prevalence of asymptomatic infections was in this study.

That means I’m still wearing my mask to protect you — and perhaps now it’s even more important for me to do so. 

How long does the vaccine protect me for?

I don’t know. We just don’t have the long term data on efficacy yet. We can hope that immunity will be measured in years (although a seasonal vaccine, like the flu shot, is still very much a possibility).  We can also hope that enough people get the vaccine and have enough immunity to mitigate the seriousness of infections, reducing the health care system overload and giving us time to develop effective treatments for this disease.