I last discussed COVID-19 back in March when the original shelter-in-place orders were issued for the San Francisco Bay Area. As these restrictions are being ramped up again, and promising vaccine trial results are released, it seems like a good time for a COVID-19 Update.
By now, we all know what COVID-19 looks like. Above is the depiction of the coronavirus from the CDC website. No changes since March.
No Cure Yet
Until we have a vaccine, there is no cure for COVID-19. Despite claims that social distancing has saved millions of lives, it has not. The truth is that until we have a cure, we have at best only postponed the inevitable. Since March we have learned that:
- Physically distancing is the most important means of slowing the spread of COVID-19.
- Masks help both the wearer and those around them.
- All mass gatherings without masks are potential super-spreader events. The virus does not care about your reasons for the gathering.
- Shutdowns should be used only to keep our healthcare systems from being overwhelmed.
- Halting elective surgery does not increase the number of available ICU beds for COVID-19 patients, and causes more harm than good.
- The increases in depression, anxiety, drug abuse, overdoses, child abuse, spousal abuse and suicides are significant and need to be measured.
- We need to measure and report accurately the negative health effects associated with the shutdowns, so we can weigh both the actual risks and the potential benefits.
Hope On the Horizon
Your tax dollars are doing something useful. Operation Warp Speed has significantly sped up a traditionally slow process. Pfizer announced that their vaccine is 90% effective in clinical trials. This is substantially better than the 50-60% expected. On the other hand, the “n” for this determination is 94 cases. “N” is the number of people in the phase 3 study. The first interim efficacy analysis conducted on November 8, 2020, revealed the vaccine was over 90% effective. If this small sample is an accurate representation of the world population, then 90% of humans will become immune with the two doses of vaccine, and the pandemic will end.
Moderna announced early results from its trial today. The Moderna COVID-19 vaccine shows nearly 95% protection. The “N” for this study is 95. Only five of the COVID-19 cases were in people given the vaccine, 90 were in those given the placebo. This calculates to the vaccine protecting 94.5% of people exposed. The company hopes to have up to one billion doses available for use around the world next year. Availability depends on your country. Moderna is approved in the US, but not in the UK where is not expected to be available until after the spring of 2021. Moderna received $2.5 billion US dollars for research and development of their vaccine.
Actual results for these vaccines may vary. Even assuming the best, logistically, it will take a Herculean effort to get the vaccine distributed, two doses are required and the storage and shelf life of the vaccine pose some challenges.
Vaccine Distribution
Once we have a working vaccine, currently our only cure for COVID-19, we need to distribute it. It needs to be made in large volumes, stored and shipped to doctors offices, so that it can be administered. If any of these steps falter, COVID-19 will run its natural course and millions more will die, unnecessarily. Current projections by Pfizer are to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
Vaccine Dosage Schedule
This vaccine requires two doses to reach the 90% effective mark reached in the trial. The doses are given 3 weeks apart and 90% achieved immunity 7 days after the second dose. This means it takes 28 days from the first vaccination until you have a 9 out of 10 chance of developing immunity to COVID-19. To date, no serious safety concerns have been reported. This is important because this is a new type of vaccine and may have new risks. It is also unclear how long the immunity will last.
Vaccine Storage
I received a seeming unrelated email this morning from my alma mater, UC Davis, announcing the 2021 Freezer Challenge. The Challenge runs from December 2020 through August 2021, and is a competition to improve the efficiency of use of refrigerators. What does this have to do with the COVID-19 vaccine?
The new Pfizer vaccine requires storage at -70°C. This requires specialized ultra-low temperature freezers. It is important to note in our power insecure state one ultra-low temperature freezer uses as much electricity as a typical single family home. If the freezer fails, the vaccine has only a five day shelf life. The Freezer Challenge is an International competition started at UC Davis to save energy through good management practices, temperature tuning, freezer retirements and upgrades and cutting-edge techniques. This vaccine is going to increase the demand for ultra-low temperature freezers and the energy needed to store it. Pfizer is working on a vaccine that can be stored and shipped at higher temperatures.
The Moderna vaccine can be stored in a regular refrigerator for up to 30 days, and for six months at -20°C. This greatly simplifies shipping ans storage. No wonder Pfizer’s CEO unloaded $5.6 million in stock on the day he made the vaccine announcement.
Vaccine Shelf Life
Once defrosted, the vaccine needs to be given within 5 days.
Politics Make For Poor Medical Care
I wanted to keep this post optimistic, but if I am being objective, there is good and bad in everything. Pfizer CEO, Dr. Albert Bourla, caused some controversy by saying he did not accept US taxpayer’s Operation Warp Speed money, he neglected to mention he took half a billion dollars from German taxpayers for R&D, and some of his anti-US (Trump) spin was lost after Pfizer later admitted it is participating in Operation Warp Speed. Additionally, your US taxpayer dollars are contractually obligated to buy 2 billion dollars worth of vaccine from Pfizer. We are all in this together, for better or worse.
Even the anti-Trump CNN reports:
- “Pfizer’s vaccine progress is certainly not solely attributable to the Trump administration’s Operation Warp Speed public-private partnership program. But it was not accurate for Pfizer to suggest that it is operating entirely apart from Operation Warp Speed; the company has a major agreement to sell at least 100 million doses of its vaccine to the federal government, and Pfizer acknowledged in a Monday statement to CNN that it is in fact “participating” in Operation Warp Speed through this deal. Also, at least some independent experts say the Trump administration deserves partial credit for Pfizer’s progress.“
Now, if you are a Trumper feeling angry or an anti-Trumper feeling defensive about the above. Stop. Realize this emotion is politically driven and not medical and certainly not scientific. The truth is, this type of division is less than useful. The virus does not consider your political views as it enters your airway, corrupts your clotting systems and kills you, your family, your friends or your neighbors. All the worlds citizens are at risk, regardless of the depth of their political convictions.
Objectively, participating in government programs comes with strings, which may or may not be helpful in the larger view. Pfizer has access to billions of dollars and could, and I would say in this case should, do it’s research as independently from politics as possible. Pfizer’s entire reputation depends on making good products. Governments have competing agendas.
There is also friction between Trump and Pharma. Trump thinks we in the US pay too much for pharmaceuticals compared to other countries, and he was about to propose sweeping reforms. The pharmaceutical industry was not a fan of these plans. Politics make for poor medical care as the focus, saving lives, can be put in the backseat, while greed and power do the driving, even during a world-wide pandemic.
Big Picture
We need a cure. It’s that simple. As a doctor, I don’t care who brings it, as long as it is safe and effective. This may seem amoral, but science is amoral. Cures may begin with intuition, but cures also require investments in time and money. Cures may originate from thought experiments, but they must stand up to the rigors of the scientific method – trial and error. The answers are never perfect, and sometimes we learn more for the errors than the successes. This is why we still call it the practice of medicine.
History has shown us time and again that just something that sounds reasonable may still be false. Doctors don’t cure for recognition. Doctors treat for results. We work hard so that our patients can find something other than their illness to worry about. Hopefully, this is the path we are on, politics be tolerated.
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