This post will attempt to answer the following questions:
What is an emergency use authorization (EUA)?
What are the official efficacy results for the Pfizer vaccine?
What’s the difference between efficacy and effectiveness? Does it matter?
Were there any safety issues?
What were the major side effects of the vaccine and how should we treat them?
I typically try to make these posts more personal for people by describing my own experience with COVID-19. I know many people feel distant from the pandemic and many have told me it really helps them to get a frontline point of view. Today I was just too excited. The reason for my elation is that I read the briefing document from the EUA analysis of the Pfizer vaccine put out by the FDA. I figured I’d summarize the report in laymen’s terms. It is a 58 page document (and that’s just the summary) and may be too much for people on the go.
There was a sense of foreboding outside room 527 that night at shift change. The unfortunate soul in that room had been in the hospital over a week with COVID-19 and had followed the pattern we had seen countless times. She had a severe case and was on a lot of oxygen but was holding her own without a lot of symptoms as long as she kept her oxygen on. Then, without warning, her blood work showed signs of rapidly increasing markers of inflammation and she started to look worse. She had escalating requirements for oxygen and was put on CPAP. The thing that was so scary to me as I started the shift that night was how she looked. She just looked so tired. She could not open her eyes or say even a few words. Her breathing was rapid and shallow and it didn’t appear she could last much longer. I adjusted her CPAP but over the next couple of hours, her oxygen levels started to drop. I had no choice but to put her on a ventilator.
The unspoken foreboding was palpable in the room. We all knew that when patients go on the ventilator things usually don’t turn out well. Most will not survive, many will have prolonged hospital courses with severe disabilities, few walk out of the hospital, and nobody is ever the same.
Up until two weeks ago we had just a few COVID patients in total in my hospital and none in the ICU. For a few months we had quietly slipped back to our usual routine. We were caring for those sick with heart attacks, severe infections, drug overdoses, and other sundry calamities that can befall the human body and land someone in the ICU.
He was a lonely older man without any living family. He came into the hospital with severe COVID but, after several days, stabilized. He wasn’t getting better and he wasn’t getting worse. We had given him all the standard treatments and were hopeful that he would improve. Then, as is often the case with COVID-19, he rapidly deteriorated over the course of a day and ended up on life support.
She was only in her 30s. She only had mild diabetes. She developed a cough, aches and fever about a week prior to when I saw her. Many of her coworkers had recently tested positive for COVID-19 and she tested positive as well. Gradually she noticed difficulty breathing prompting her to come to the hospital where she had low oxygen levels and was promptly admitted. She was not in long when she worsened further and was transferred to the ICU. When I saw here she was requiring a lot of oxygen and her lab work did not look good. We gave her all the standard treatments – decadron, remdesevir, convalescent plasma, and lovenox – and she stabilized for several days. She was still requiring high levels of oxygen and using CPAP at night but she was not getting worse. In fact there were some signs of improvement.
I have a clear memory of kneeling down next to her as she sat in the chair in her room. She was calm but I could see the fear behind her eyes. She was struggling to maintain control in the face of her situation. I had to nearly scream to be heard over the buzz of the negative pressure generator and my PAPR, “You’re stable and you’ll start getting better soon,” I told her. The minute I said it I could see the tension ease on her face and feel it ease in myself as well.
That was the last thing I said to her.
That night she stood up to use the commode and her oxygen dropped precipitously. This had happened before but she had always recovered in a few moments. This time she didn’t. She lost consciousness, her pulse slowed, and then her heart stopped beating. CPR was started and fortunately the team was able to resuscitate her quickly and placed her on a ventilator. Things got much more difficult from there. We induced a medical coma and paralyzed her to reduce her oxygen usage. We put her in a special bed that rotates her to keep her face down and improve blood flow in the lungs. We did everything possible with the ventilator to keep her oxygen up. She stabilized somewhat but if she was manipulated or turned on her back her oxygen would quickly drop to life threatening levels. We had nothing more we can do for her. Our only option was to transport her to a special center to hook her up to a heart lung bypass machine called ECMO.
What would you say is strongest single predictor of behavior and attitudes towards COVID-19? What factor makes it most likely that someone will follow masking and social distancing guideline?
You would be considered reasonable if you answered that those with the greatest risk of dying would be the most cautious. You would be wrong. You would be considered a rational thinker if you answered that healthcare workers that are confronted with the sick and dying from COVID-19 would have the strongest emotional response motivating them to extra caution. You’d be wrong. You would not be thought crazy if you answered that those with more education would be more careful because they have more of an understanding of the complicated factors at play. Again, you’d be wrong.
When I was growing up watching sports there used to be a segment on Monday Night Football entitled “You Make the Call”. The audience would be shown a specific play that required referee intervention. We would then be asked to play pretend referee and decide if it was a touchdown, a penalty, or some other point of rules contention concluding with the phrase “You make the call”. The game would cut to commercial and a lively debate would usually ensue. When the commercials were over they would show the play in slow motion and give you the correct call. I thought it would be a good idea to do a COVID-19 version of “You Make the Call”. I’ll give you the scenario and you can decide how you would respond if you were the doctor.
He woke up in the morning with a bit of a headache. It was not that bad and he hadn’t slept much so he attributed the headache to sleep deprivation. His throat was a bit scratchy but he had allergies every fall and this was typical for him. He decided to get tested to be safe. His rapid antigen test was positive and he is calling to ask you what he should do. What would you tell him to do?
“My friend told me that masks only work half the time and that there’s no difference between wearing them and not wearing them.”
This was an unsolicited outburst from my 10-year-old daughter the other day. She was quoting a girl in her class. I was not entirely concerned with the opinion of the preadolescent but was concerned about where this gross misinformation was coming from. While I didn’t investigate, I assume that this child did not do an exhaustive search of the latest literature on the effectiveness of face coverings in preventing COVID-19. This would mean that she was parroting something she heard from an adult. While I again did not investigate, I assume that this adult did not do an exhaustive search of the latest literature on the effectiveness of face coverings in preventing COVID-19 either. As is the case for many things these days, lack of knowledge is not an obstacle to the vehement expression of opinion. You only need to read an online article to form a strong and unwavering opinion of anything.
But since the question is floating around out there I thought I would give an updated answer to the question that just doesn’t seem to want to die: Do masks work or not?
“We have had multiple family members with vague symptoms all of whom tested negative but the father is COVID positive. He then had a follow up test that was negative. Is this sufficient to clear him to go back to school?”
How about this one:
A person had congestion and achiness Monday. The next day she tested negative. She felt a bit better over the next few days but not back to normal (she was also running on very little sleep). A week later her symptoms started up again and were more severe. She is now recovering over the past few days. She has no known exposure. Do you think the negative test on day two clears her and her husband? Technically, she would be 10 days since the start of the second round of symptoms by next weekend but, if this is a second illness and is covid, her husband would not be. Should she be tested today? Does that then put her and her husband into the questionable awaiting result group?
How would you answer? At best, if you’re wrong and say everyone is clear you could expose an entire school or community and lead to schools shutting down, more people stuck in quarantine, and great financial hardship. At worst, you could be the cause of serious illness or perhaps people dying.
“We are informing you that one student in 7th grade tested positive for Covid and a second 7th grade student is symptomatic and waiting for test results. All students in 7th grade are considered “exposed” due to the student testing positive and they will need to remain quarantined at home through Friday, September 18th.” And thus it starts.
It took just over a week of schooling before the above message came by email. My 7th grader is now in quarantine. Fortunately she is not sick and wasn’t in close proximity to the infected kids (as far as she knows) so she didn’t likely get infected. Since there were a few kids who tested positive they sent the entire grade home. Unfortunately the news has put our house is in a minor state of turmoil. I know every other 7th grade family has had their lives unsettled as much or more than ours. For many it is much more than an inconvenience.