Friday, December 11, 2020

COVID vaccines 101


COVID vaccines 101:

AKA: Why YOU should get a COVID vaccine

As everyone has heard by now, Rhode Island is beginning to distribute COVID vaccinations to first responders, emergency department staff and home healthcare workers in the next few weeks. Many people have questions and concerns about the vaccinations, particularly regarding the safety and effectiveness of the vaccines. This blog series is intended to answer common questions and give general information about the vaccines. 

First: why get a vaccine at all? 

The short answer: this is a big part of getting the country back to normal. The vaccine will boost your immune system and allow it to recognize COVID. This will help protect us and our brothers and sisters on the front lines and help to generate herd immunity . It will help prevent severe illness and likely help prevent transmission. Until they are used in the “real world” the actual effectiveness will not be known. What IS known is the overall safety of the vaccines and the ability of the vaccines to generate antibodies. 

Let’s get started:

What exactly does a vaccine do?

A vaccine introduces something to your body to prepare it to recognize illness-causing virus or toxin in the future. In some cases, that “something” is a live virus that has been altered to be inactive. In others, it is a protein that is found in the virus or toxin. Usually this is done by directly injecting the protein, toxin or virus into your body. By introducing this substance to your body, your immune system can “learn” to recognize it and rapidly make antibodies if you are exposed to it in the future.

The two COVID vaccines receiving the most attention (Pfizer and Moderna) introduce a protein unique to COVID in a relatively new way. The way the COVID vaccines work is by giving your body a set of “instructions” for making a harmless COVID protein called a “spike” protein. Your cells will use the mRNA (which acts as a set of instructions) to make this harmless spike protein. Your immune system then recognizes the spike protein as “foreign” and produces antibodies to it. The cell then destroys the mRNA.

COVID has this protein on its surface and it uses it to get into our cells. If COVID can’t get into our cells, it can’t replicate… So the spike protein is a great choice for vaccine target. Once your body produces antibodies to the spike protein, those antibodies will “stick” to the spike protein, making it easy for your immune system to recognize and destroy the virus particles and inactivating the spike protein so it can’t get into your cells.

Fun fact: The mRNA used in the vaccines does NOT enter the cell nucleus, where our DNA is kept. It's very complicated why… but things can't just “go into” the cell nucleus. The mRNA does not "become part of our DNA." The cell destroys it once it reads the instructions to produce the spike protein. So, no superpowers yet!

Are the vaccines safe? Do they work? How do we know?

First, let’s get one thing out there: NO drug or vaccine is 100% safe. All drugs and vaccines have side effects. The goal is to determine what the risks are, compare those risks to the risks of the disease, and show there is a clear benefit. Some drugs have common, severe side effects and even fatal complications (think chemotherapy agents), but since the disease carries a high degree of risk (cancer), they still might be approved for use. To contrast that, some drug have known, rare complications (such as a risk of bleeding or ulcers with ibuprofen or aspirin) but those complications are so rare that those drugs are used widely.

Vaccines are given to HEALTHY people so the bar for safety is set much higher than a drug to cure sick people.

Prior to authorization for use, companies are required to release ALL data and information from vaccine trials, including animal studies and all 3 phases of trial, much more than is available to the general  public.  It’s thousands of pages of information. It is all reviewed prior to FDA approval for use.

So far there is data from about 20,000 people immunized  (and 20,000 who received a fake "placebo" shot) in the Pfizer trial and more than 15,000 (and 15,000 + who received a placebo) from the Moderna trial. With so many people vaccination, most if not all of the common side effects will be known. There is a chance a VERY rare side effect (like, for instance the 1 in a million chance of a condition called Guillain Barre syndrome that we see with seasonal flu vaccine) will not be seen until mass vaccinations occur. But it’s important to remember that those very rare side effects are just that- very, very rare and are present in vaccinations we use today. There is nothing in all of medicine that doesn’t have some amount of side effects.

It is important to remember, not all things that happen after a vaccination are due to the vaccine. Think about a nursing home. A number of people in a nursing home die every month. Once nursing homes are vaccinated, a number of residents will still die every month. Some people will get a COVID vaccine and then die in an MVC, or have a heart attack. Don’t be fooled into thinking that every sensational news report of post-vaccination events is directly related to the vaccine. they WORK?!

It's very clear from the data that the vaccine is safe... What about effectiveness? This is probably the trickiest thing to figure out in a trial... It's hard to predict how well the vaccine will really perform in real life, especially when and if people stop wearing masks/etc. Still, the data in terms of effectiveness is pretty amazing. It seems to hugely decrease the likelihood of severe infection and probably prevents a lot of primary infection as well. If that effectiveness data holds up you will be less likely to get COVID and MUCH less likely to die/end up really sick if you do get it.

This image shows the incidence of COVID infections
with vaccination (flat line) and with placebo- see the difference??

How did they develop the vaccines so fast? Doesn’t that mean they cut corners and the vaccine has not been proven to be safe?

There's a lot of misconceptions, particularly regarding the "rushed" development of this vaccine. As opposed to reassuring people, the unfortunately named “Operation Warp Speed” seems to have given the general public the impression that the vaccines were “rushed” and are therefore unsafe.

Typically, a vaccine takes 10-15 years from start to widespread manufacturing and development. You generally have to finish each stage, process data, prove efficacy and safety and THEN you can try to get funding to move to the next stage. There are several reasons vaccine development happened so fast with COVID. 

First, there was already significant progress on vaccines for coronaviruses, including the mRNA technology, particularly after the SARS and MERS outbreaks occurred. A major reason these vaccines did not make it all the way to production involves simple economics. Even though those diseases were severe, the outbreaks associated with them were brief and contained. Once those outbreaks ended, the funding also dried up to further develop the vaccines. Normal coronaviruses such as those that cause the common cold are widespread and common but aren't generally severe enough to make a vaccine worthwhile. COVID is a perfect storm of a severe, extremely widespread coronavirus with a huge need (and eventually a huge market, because obviously these companies need to be profitable).

Second, the government paved the way by 1) financing with over $10 billion 2) accelerating the approval process/paperwork/etc and  3) giving the go-ahead and funding to START vaccine production DURING the phase 1 trial. So these vaccines were in production before the data was back- a HUGE risk that no company would ever accept under normal circumstances. There was a big chance one if the vaccines would have failed trials and all that work and money would have been lost. The "operation warp speed" really just cut red tape, provided funding and accelerated production.

Fun fact: COVID is NOT the first vaccine to be developed quickly. The mumps vaccine took only 4 years to develop, using science developed during WWII. The 2009 H1N1 (the original “swine” flu) took only just over 5 months.

What about all these side effects I keep hearing about?

When a vaccine or drug is developed, it is required to keep careful track of any and all side effects and events that happen after administration of the drug. ALL events are recorded, whether related or not. If you’ve ever actually read the inserts that come with medications, you know that just about any side effect can be found in the list. Common side effects are just that- the most commonly seen events after vaccination. The Pfizer study found the most common side effects were reactions at the site of the injection, fatigue, headaches, muscle pain, chills joint pain and fever. These side effects were more common after the second dose. Side effects like these are expected when your immune system mounts a response- just like when you really get sick. There were no overall safety concerns raised during the trials.

“Serious reported events” are more closely investigated, and sometimes a trial is even halted until it can be determined whether the event was related to the vaccine. About 1% of people in the Pfizer trial reported “serious adverse events” such as heart attacks; this rate is what was expected in the general population. What that means is, these events most likely had nothing at all to do with the vaccine- they were simply the usual ailments that are expected to happen in a population of humans. 

Fun fact: Among the “reported adverse events” were a shoulder injury in the injection group and a stroke and a heart attack that occurred in the placebo group. 

How long will the vaccine work for?

It's too early to tell how long it will work. It will take large scale distribution of the vaccine to really test how much and how long it will prevent COVID transmission. That's how all vaccines work, really. The trails prove safety and efficacy (how well it works) but they aren't truly "real life." In mice the Pfizer vaccine gave protection for 13 weeks, which could translate to years in humans. The good news is, even some protection over a limited amount of time will likely make a huge impact because so many people are at risk and it spreads so easily.

Fun fact: Many vaccines require a repeat dose or a “booster”, both for waning immunity and for changes in the pathogens over time. Influenza is a great example with the whole “yearly flu shot” thing, but even diseases such as tetanus and whooping cough do require a periodic “booster.”

To wrap this up: if you want further convincing, talk to your peers and colleagues who are going to get the vaccine. I am getting one as soon as possible, and I’ll be giving them to my daughters, 92 y/o grandmother and dad as soon as they are available. 

Thank you! 

Hang in there and be safe!

-The EMS Division

Disclaimer: The above is intended to answer commonly encountered questions in layperson terms, using the most up to date information at time of writing. Do your homework, look for reputable information and ask questions. We will periodically update this as more information becomes available. 


Links for further reading:

FDA “vaccine development 101” 

CNBC video on the basics of vaccine development, clinical trials and the approval process

Operation Warp Speed Info Sheet:

Full FDA briefing on Pfizer trial data:

Washington Post "What you need to know about COVID vaccines:"

Sunday, August 2, 2020

Killer Complacency

The dog days of summer are upon us. 

Drink On Beach Free Stock Photo - Public Domain Pictures

Long, hot days. Beaches. Poolside afternoons. The return of restaurants and bars. 

It's easy to think that COVID is gone, faded off into the sunset like the star of a B grade Western movie. It isn't. 

COVID is alive and well... And spreading. 

In the beginning, when COVID was new and scary, we were worried. We were vigilant. We worried about having enough PPE. We worried about going home to our families. We stripped down and changed clothes outside. We slept in separate beds. Some of us quarantined from our families. We demanded action. We wanted the maximum PPE and looked with envy on the new stories from China featuring hospital workers in full body protective gear. 

We have been lucky to be in a state that took extreme measures and was able to get the epidemic under control. We endured isolation, school closings, shortages of everything and in the end achieved stabilization of cases. We got to open back up. Gyms, restaurants and stores are back in business. We go to the beaches and parks. We have enjoyed a feeling of semi-normalcy. 

But COVID is still here. 

As of 7/31/2020 Rhode Island has seen 18,950 confirmed COVID cases and over 1000 people have died with COVID infection. Across the country fire fighters have contracted COVID. Over 5000 of them. 50 have died. In many states cases are increasing dramatically. 

                                                                             COVID cases in U.S.: Map of 50,000 coronavirus cases state-by ...      

We are seeing a huge decline in the use of PPE by EMS and fire crews.  This has led to multiple recent incidents where entire crews have had to quarantine after exposure to COVID+ patients without PPE. Masking and social distancing are nearly non-existent in the station. Personnel are forgetting to wear maximum PPE on codes and needlessly exposing themselves, their families, their stations. 

It is unfortunately just a matter of time before an agency loses an entire station for 14 days from exposure to an asymptomatic or mildly symptomatic on-duty crew member. 

COVID is everywhere. Ask any of your friendly neighborhood ER docs- since this started we have seen ALL types of patients come to the hospital that are COVID+. Healthy motorcycle accident? Stroke? Chest pain? Intoxicated? Psych? Yup....we see all of these come back COVID+. The dispatch screening tool does not catch any of these. 

WEAR YOUR MASKS, BE VIGILANT. Please. So we don't have to support your family through your extended illness. Watch you be put on a ventilator. Watch you lose your mother/father/husband/wife and have to wonder if it was you that exposed them. PPE works. I have personally cared for dozens, perhaps hundreds of COVID patients. Thanks to my PPE I have not gotten ill (and I now have the negative antibody test to prove I haven't been infected). Please, just do it. 

For EMS leadership: Do not underestimate your role in this. Model and mandate masking when social distancing is not possible. Encourage staff to remain vigilant. We are in this together and need to hold each other accountable. 

This video was produced by the Dallas Fire Department. Please watch and share. COVID is real. Masks work. N95, goggles, gloves and gowns are mandated on all cardiac and respiratory arrests. Be safe. Do not become a victim of complacency. 

You would never go into a fire without your safety equipment. COVID is an invisible fire. ANY patient you see may have it. Young, old, sick or not. Protect yourself, your families, your brothers and sisters. Wear your masks. Wear your eye pro. WEAR YOUR MASKS. 

Fighting fire with collaboration | Kentucky Guard

**Special thanks to our friends in Dallas for producing and allowing this powerful video to be widely shared. **

Tuesday, May 19, 2020

It's Safety Tuesday! EMS Week 2020

Welcome to EMS week.
It's Safety Tuesday!

This week marks the 46th annual EMS week. Authorized by President Ford in 1974, we carry on the tradition to celebrate our EMS providers and the important work you do in our nation's communities. We are saddened that EMS week cannot look like normal but are determined to celebrate you nonetheless.  

Generally, "Safety" and "EMS" triggers specific ideas; safe driving, MVCs, roadside traffic, agitated patients and family members, electrical wires and the infamous "BSI scene safety" blurted out at the beginning of every EMS practical exam. We all know and (mostly) respect these tangible, visible safety hazards. We are well trained to look for certain "invisible" hazards as well- CO, HS, asphyxiants and conducted current.

Some invisible hazards are harder to recognize.

Safety has a whole new meaning these days. Mental health and fatigue, burnout and complacency are perhaps the most dangerous things facing out providers these days. Close to home we have our own epidemic of our own- suicide and substance abuse amongst EMS providers. 

The COVID pandemic has stressed and stretched our already taxed personnel to  the limit. We face an unseen, menacing hazard on every call, in every station and even in the grocery store. A pervasive threat that has forced us to change routines and forgo much of what we use to relieve stress and decompress. Now, more than ever, mental health must be at the forefront of our agendas. 

In many ways, this part of the pandemic is even tougher than the beginning, We have settled begrudgingly into new routines with no real end in sight. Even the much awaited "reopening"has been painfully, albeit rightfully, slow. We are about to mark the much-awaited beginning of summer, Memorial Day Weekend, with few beaches, few vacations and none of the large gatherings and details that mark the summer months. Life has become a grind, with no real end in sight. 

We acknowledge this is REALLY hard.
We take comfort that we are all in this together
We look forward to the other side

One thing we DO have is each other, our families and friends. For many, the silver lining of this pandemic has been more, and perhaps more meaningful, time as home. Time to think about goals, plans and projects. As much as we mourn the loss of "now" we can and should look forward to later, when things DO return to normal with cookouts and beach days, when bars and gyms are open. This epidemic has been hard at home and hard at work. Some of us are barely treading water at home and look in disbelief at Instagram posts of new patios and baked bread. Some of us are enjoying time to work on projects and hobbies. Everyone has a different COVID-normal, and that is perfectly OK. We need to acknowledge and celebrate both things- putting in new gardens AND simply making it through a tough day of homeschooling. 

Your overall response to all of this has been remarkable. Despite the threat, you have showed up to work, day in and out, and done the job you always do- serving the community and protecting public safety. 

In the middle of the true, gritty, meat of this pandemic it is SO important not to become complacent. Be vigilant with PPE and hand hygiene. Wear your masks. Social distance. Keep a broad differential when evaluating patients- not all chest pain and SOB is COVID. 

Most importantly, keep an eye out for your partners and colleagues. Please reach out, every day, to at least a few of your co-workers. If you are struggling, don't go it alone. 
There is ALWAYS someone ready to talk. 

Thank you for all you do!

Please see below for some excellent resources from NAEMSP

An oldie but a goodie EMS week post on sleep and fatigue:

Strategies for EMS of address sleep health/fatigue during the COVID-19 Pandemic:
The University of Pittsburgh Department of Emergency Medicine EMS Shift Work Project highlights a few evidence-based strategies for improving sleep health and intended for EMS clinicians and other first responders who must work extended shifts, extra shifts or overtime during the COVID-19 Pandemic.

Emotional Coping Toolkit for Healthcare Workers:
The Toolkit for Emotional Coping for Healthcare Staff (TECHS) is a set of concrete tools healthcare staff can use during these challenging times. It provides guidance and practical tips for supporting colleagues, as well as a stand-alone presentation of the toolkit that can be viewed by groups or individuals.

EMS System for Metro Oklahoma City & Tulsa provider update on the mental health impact of COVID on EMS providers:

Wednesday, April 29, 2020

In Defense of Masking

Photo credit: Me, with only partial PPE
If you're anything like me, your head is spinning with all of these mask recommendations. In the past few months everything we do has changed so drastically it's hard to know what's true or correct anymore. In an effort to cut through some of that, I put together quick summary of what masks we use, when, and why. Hopefully this will give you a better understand if why most of us are only visible from the eyes up these days.

The “It’s not me, it's you” Masks

Photo Credit: 3M

This makes us safe by filtering out droplet and aerosolized particles. It’s called an N95 because it halts 95% of the particles that are larger than 0.3 microns (and because the mask is Not to be used in environments that contain oil1). Basically this is the most common “high level” protection mask used in healthcare, and for most healthcare workers in most settings this is sufficient. It’s not 100% effective against all aerosols (which is why intubation teams in the hospital will use PAPRs or CAPRs that have higher levels of air filtration and provide more face protection2), but it does a very good job in most situations.

The facts that an N95 is only a half face covering and is only rated to filter out 95% of particles are why a face shield is recommended to be used at the same time, and why even though most EMS providers have N95 on for most patient encounters, we are still being selective in who we use aerosol generating procedures on (like BiPAP, oxygen above 6L via nasal cannula, or intubation). Hence this look in the hospitals:

Credit: USA Today, Chris Young AP

PAPR (Powered Air Purifying Respirator):
Photo Credit: 3M

CAPR (Controlled Air Purifying Respirator):
Photo Credit: MaxAir

The “It’s not you, it’s me" masks

Surgical masks

Photo Credit: 3M

This keeps others safe from us. It is designed to trap the secretions of a surgeon and prevent her or him from contaminating a sterile field. This is what we are wearing in the hospital all the time.

Cloth masks

Photo Credit: 3M

This mask is used with a similar purpose to the surgical mask, but it is better used in public. This mask will catch some secretions but (probably) less than a surgical mask.

Which is better? Cloth or Surgical:

In general, surgical masks are going to be safer for those around us. There are regulations and standards that dictate what the mask should be made of and how it is constructed, so overall it will be safer2. That said, not all cloth masks are less protective than surgical masks3.

What should we be wearing on a call?

When you're around patients, the best mask to keep you safe is a N95. This is what the CDC recommends when supplies are ample, and is more than what the WHO recommends. Having this mask on during general patient care enables you to feel protected when the patient's condition changes in an emergency and you need to switch to an aerosol generating procedure during care.

The caveat here is that this is what is recommended when supplies are ample. That is not the case right now, so that is why this is not recommended in all places for all patient encounters. Following your local protocols and policies is important here because they will take into account this balance of what protection is needed by who and (hopefully) based upon the best available evidence and expert opinion, along with supply levels, PPE use rate, and reliability of getting replacement supplies (not all agencies can just ask the Pats to go pick up PPE for them…).

What should we be doing in the station?

A surgical mask or cloth mask is best in these situations. The biggest reason is that we don’t actually know who has COVID and who doesn’t, and we don’t know who can spread it and who can’t. Studies show that between 30 and 60% of people are asymptomatic when the virus is detected in a nasal swab, and a portion of those will never become symptomatic. This not only means you could be spreading it to people before you know you put them at risk, but that you and those around you may never even know they have been exposed. This is another reason why we mask in the hospital even though we are all asymptomatic, and why we are asked to mask in public.

Yes, we could try to increase testing to see who is an asymptomatic carrier and who is not, but everything has limitations. So it is very likely that an unknown percentage of people will test negative, never have symptoms, and still be able to pass the virus around. No, a mask will not protect all people in all circumstances, but it is the cheapest, simplest, and best thing we can do to keep our workforce healthy right now.

What about reusing masks?

There is some evolving evidence that reusing masks may be ok. Again, this is not ideal because once you put it on it’s safe to assume it's contaminated. In a situation with ample supplies we should not be reusing any of these masks, but that’s not the world we live in right now, so don’t touch the outside of the mask once you put it on (unless you’re doing a seal check with gloves and then immediately disposing of those gloves) and make sure you clean your hands before and after putting the mask on or adjusting it.

Points to remember (TL;DR):

Wear a surgical mask or cloth mask when outside your house.

Wear a surgical mask or N95 (N95 is better but not always available) when treating patients.

Wear an N95 when doing something that is aerosol generating on someone who does or might have COVID.

Clean your hands often.

Masking is the cheapest, simplest, and best thing we can do to keep our workforce healthy right now. Please do it!


Tuesday, April 21, 2020

Patient Refusals in the Age of COVID-19 - PART I

The people you do not bring to the hospital scare the S%*# out of me.  There, it feels good to say that out loud…

If we want to pull on that thread a little more, any EM or EMS doc can tell you a litany of stories/anecdotes about patients who presented to us with benign sounding stories and ended up having something deadly/scary.  Although we tend perseverate on the patients we almost sent home, the ones that really keep us up at night (and our psychiatrist/therapists employed), are the ones we sent home, then realize on our drive back from work that we could have missed something bad.  Sometimes we follow-up with the patient the next day with an innocuous phone call (this is my preferred method to avoid multiple sleepless nights), sometimes we just lose a little sleep and keep that experience for our next shift so you don’t make the same mistake again.  And we always DREAD the words of our colleagues:  “Remember that patient you saw last week…” which usually ends in painful self-reflection and learning for next time.

Those of us who have been in EMS for a while have probably had these moments ourselves.  Picture this:  It is late and you are roused from bed to go to an address you know by heart, for a complaint that sounds like nonsense.  You get there and the patient looks the same as every other time you have been there and does not want to be transported.  You obtain your refusal, entering the patient information by memory and return to the station for some much-needed rest before shift change and heading home. You wake up from your post-shift nap to a text string from your shift relief:  They just cleared the hospital after intubating/stabilizing/coding your refusal from the night before.  After you get over your nausea and period of reflection, you can see already see the QA email coming your way, the root cause analysis meeting with your medical director, and most importantly, a bad outcome for your patient.

So how do we sort this all out? Do we just bring them all to the hospital?  Are we really just playing roulette every time we take a refusal?

Kind of.  Here is the thing:  These patients trust you.  You represent the healthcare system to them and they do not know the limitations of your evaluation.  When you take their vitals and say they “look ok” they hear “you are fine.”  When you look at the EKG and say it “looks good” they weigh this the same as having serial troponins, a cardiology evaluation and stress test in the hospital.  Combine this with an exaggerated fear of the hospital right now and you have a recipe for disaster (and poor patient outcomes). 

So does COVID really change this?

You bet it does!  First of all patients are TERRIFIED to come to the hospital right now, which should make you think about how worried they were about their complaint to make them call 911 in the first place.  Some anecdotal data from our system has somewhere around 1/3rdof the patients who are refusing citing COVID as their main reason. The key is not to anchor on the fact that they are refusing now as proxy for their not being sick.  Additionally, we need to realize there is a lot of potential badness out there in the world that we need to sort through in our assessment and presentation of the risks of refusal to the patient.

Thanks for scaring the S*&# out of me doc, will I ever be able to sleep again?

 Yes!  The key is to obtain a good history and exam on your patients.  Think about what could be causing their symptoms and encourage ED evaluation for patients who call for help.  If the patient insists on refusing, think of all the bad stuff that could happen to them if they were not evaluated and explain that to them.  Do not be overly reassured by vital signs and “normal” EKGs, as you know, these are meant to identify the critically ill, not to screen the population for moderate illness.  Most importantly, the more worried you are about them, the more you play dirty:  Scare the heck out of them, use the words “up to an including death” as part of your refusal spiel, CALL their family members and put the patient on the phone, promise delicious turkey sandwiches, ginger ale and backrubs in the ED.  Finally, seek assistance from online medical control as there is evidence (1) that just speaking to a physician on the phone can encourage 50% of patients refusing transport to come to the hospital!

Stay Tuned for Part II:  The "shelter in place" protocol in RI...