November 22, 2020

An illustration picture shows vials with Covid-19 Vaccine stickers attached and syringes with the logo of US pharmaceutical company Pfizer and German partner BioNTech, on November 17, 2020. (Photo by JUSTIN TALLIS / AFP) (Photo by JUSTIN TALLIS/AFP via Getty Images)

And the first weekend of my time away from work draws to a close. I really can’t consider it much of a vacation as doing interesting things outside of my usual patterns is somewhat unwise at the moment. I can’t really think of it as a staycation either as that tends to imply a certain amount of business with life and a need to retreat to the comforts of home and I’ve been spending far too much time there over the last nine months. We’ll just have to think of it as time off work and time to get some of those projects that always fall to the bottom of my ‘to do’ list ticked off. The first one was entitled ‘Haul Out the Holly’ and I accomplished it today together with my friend Holly (how seasonal) and her daughter Naomi. We got all the bins of Christmas out of storage and half the decor is up. I seem to have guessed about right in terms of what I kept and what I let go in the downsizing although half a Christmas tree has gone missing and had to be replaced with a quick run to Home Depot. The trees and all should be finished in the next couple of days. I know it’s a bit early but I decided that if there was ever a year to be early with the holiday decorations, 2020 was it. And I may keep them up through Valentines.

An old high school friend with whom I have recently been in communication (the positive joys of social media) asked me my thoughts on the Covid-19 vaccines that have been in the news recently and what may come of them. I am not an immunologist or a virologist, just a poor geriatrician trying to make sense of this brave new world along with the rest of you but I have been seeking out information where I can. So, this evening’s entry in the Accidental Plague Diaries can be called something like ‘When Can I Get My Shot’. The basic answer is ‘I don’t know’. There are something like 100 vaccine candidates out there being worked on world wide. There are a couple of motivations. The first is the beneficence of being able to protect us form the virus. The second is the potential of enormous sums of money to be made by successful products. Given the politics and sociology of this moment, I don’t think we’re going to see the kind of gestures made in the past such as the discoverers of insulin refusing to patent or take recompense or, more recently, Jonas Salk’s not wanting to profit off the polio vaccine.

For a vaccine or any other pharmaceutical to come to market, there’s basically a three step process. First, you have to show that the drug or vaccine does what you think it does in a test tube or cell culture. Second, you have to show that in an animal model and provide data that it’s safe for humans. Third, you have to present data on human trials showing efficacy and safety and then you can get approval. The incredible need for a vaccine in this particular case has allowed a certain fast tracking over this system and a very rapid development of phase three human trials. Two different vaccines have completed a phase three trial and showed roughly 90-95% efficacy in preventing Covid-19 with minimal side effects.The first is a vaccine from Pfizer in association with a small German biotech company BioNTech. Despite certain politicians touting it as an American solution, it was developed in Germany with German money. The vaccine works by using mRNA (synthetic messenger RNA) targeted to encode a piece of the RNA the virus uses to manufacture its proteins. This idea is relatively new and has only been in use in the lab for about fifteen years so these vaccines are not the same as older virus vaccines like flu or measles which actually use the viral proteins themselves to confer immunity. The mRNA is injected into your muscle tissue where it is taken up by muscle cells and the muscle cells use this mRNA to make the viral proteins. Your immune system recognizes these as foreign and gears up antibodies to them. Therefore, if you run into the actual virus later, your immune system is primed to take it out before it can ever establish itself in your body. It’s a nifty little idea and, as you’re not actually shooting foreign proteins into someone, you’re less likely to have negative reactions.

The hitch is that mRNA is not a very stable molecule. In order for it not to degrade or transform into something that would cause your cells to start making the wrong protein, it has to be kept very, very cold (-70 degrees C). This is a good deal colder than your average freezer. Therefore, in order to be able to distribute the vaccine, you have to have a cold chain in place that can ensure the vaccine stays at a super low temperature from the time and place of manufacture to its end destination where it is defrosted just in time to be used. This can be done. The Shingrix shingles vaccine requires similar cold temperatures and has been safely distributed for some years. (There were shortages early on due to manufacturing capabilities but they have been worked out and it’s now easy to receive at most major pharmacies).

The Moderna vaccine, which is an American product, Moderna being based in Massachusetts, is also an mRNA vaccine which works in essentially the same way as the Pfizer/BioNTech does. Moderna’s big selling point is that their formulation is more shelf stable and does not require quite as cold a temperature and will last longer at room temperature than the other product. Mind you, neither product has yet obtained FDA approval. Pfizer has filed for an Emergency Use Authorization that will allow them to circumvent much of the usual red tape. Moderna is expected to follow suit within the next couple of weeks. Once the EUA is granted, it will be legal for them to manufacture, distribute and administer the products. When will that be? I’m going to trust that there are still scientists at the FDA who will know how to interpret the data and will make decisions based on that rather than on drug company press releases (the source of the vast majority of the news coverage on these products.) I have a healthy skepticism of drug company press releases. Go back a century or so and you’ll find lovely ads for ‘Heroin – the new sedative for cough’. I’m sure the makers of thalidomide had great things to say about their product when it was released. In more recent years, you can ask me about my experiences with the Merck Corporation and Vioxx next time you see me. The chances are good that there will be something available in the next few months but we’ll have to see what happens when it’s released to a general, rather than a study population. And then there’s all the issues as to who should get it and how quickly.

In the meantime, the numbers don’t look good. Those of you who have been reading these little essays of mine for a while may remember I wrote up a table of how many days it took for a million cases to occur in the US. We passed 12 million yesterday. Just six days after we passed 11 million. Which was only seven days after we passed 10 million. For those who run around saying things like ‘I’m not worried, It’s only a 1% mortality rate’ think about what that means. There are roughly 200,000 cases diagnosed daily at the moment. That means 2,000 people have been told they are going to die. The problem is we don’t know which 2,000. So we’re having between four and five 9/11s a week in terms of mortality alone, and that doesn’t even begin to touch what the morbidity both short and long term might be. Those of us who work in health care are tired. We know that the numbers today means the hospitalizations will be skyrocketing in four to six weeks, just in time for Christmas. What’s going to make a difference in terms of life and death for many is going to be the number of functional acute care nurses and other staff that are going to be available. If they’re sick or burned out, we gots nuttin’.

If you’re going to have Thanksgiving with the family, set up card tables on the lawn. (or in the carport if it’s raining…) And wash your hands. And wear your mask. And check on your health care worker friends and neighbors.

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