Week 36 coronavirus update – New developments

To summarize where we are now

Since my last post four months ago there have been no major clinical break throughs until this week. The virus is spreading as was predicted, yet we are still very far from the “herd immunity” state.

We understand the virus and the illness. Treating with steroids and antibiotics within the first five days of the illness reduces your risk of needing hospitalization by about 50%. Current hospital-based treatment protocols now reduce your risk of dying by about 60% compared to April of this year.

There is a lot of basic science research ongoing, but its clinical relevance will be slow in coming. Remember the internet contains a plethora of information and a dearth of perspective and wisdom. Reading one article written by an expert does not make one an expert, and for every expert, there are always other experts in that field who have somewhat different opinions.

Testing is more readily available, but lab turn-around time seems to be more variable than ever. Some of the hospitals are doing their own testing and can get results within 2-3 days. Commercial labs are taking 3-10 days to get results back to us.

The nasal swab PCR tests are now very accurate. Rapid Coronavirus testing is still not as accurate as we would like.

The serum antibody test is still problematic. It is still not as accurate as we would like and does not tell how much antibody you have.

IF you had an illness consistent with COVID-19 this year, then the antibody test will reasonably accurately tell you if you had COVID. IF you did not have an illness consistent with COVID-19 this year AND the test comes back positive, then you most likely have a false positive test.

To solve the problem of the insensitivity of the antibody test I require TWO positive antibody tests to confirm that you indeed had the illness. Most of the respiratory illness going around is still not COVID-19.

There is some line of thought out there that antibodies against the SARS-CoV2 virus only last a few months. This is not a broadly accepted position in the medical and epidemiologic world. To date there have been only very rare cases where someone has contracted COVID-19 again after recovering from it the first time. 99.9+% of people do not get COVID-19 a second time.

Now to the vaccine developments

Yesterday Pfizer announced that their vaccine was showing over 90% protection from COVID-19. Almost immediately after the first announcement they announced that vaccine availability would likely not be until the summer 2021.

I take this announcement as supporting information that vaccines will be able to be developed with a high degree of protection. That’s all we can say at this time.

There are still unfortunately major problems to overcome.

1. There are 130 vaccine trials around the world with many different kinds of vaccines being studied. Results are still pending for all of them. We like to see success rates over 90%. However the FDA has stated that it would consider a vaccine trial “successful” if it prevented the illness 50% of the time. That low level is hard to accept medically, and I could not support a vaccine where half the people who received it would not get a benefit.
2. A Lilly study of antibody therapy does not look like it will be effective (see section below about strange times), so I guess we’re down to only 129 ongoing studies.
3. None of these studies are at a point of being able to be independently reviewed or submitted to the FDA for approval.
4. The Pfizer vaccine needs to be stored at -90 degrees Fahrenheit and is purported to be useful for 24-48 hours at room temperature. Although Pfizer says they have figured out a way around this limitation, others are skeptical that this vaccine can be widely distributed with these low temperature requirements. This is also the critique of the Moderna vaccine, although it does not require as low temperatures for storage and transport. Again Moderna downplays that possible limitation.
5. How will “the vaccine” be distributed? and to whom? My sense is that there will likely be designated vaccine centers. This would possibly mean hospitals, large clinics, or public health department facilities capable of storing and administering large quantities of vaccine. I would hope my practice would be able to get vaccine, but at present I am not optimistic that I am large enough to be one of the early ones that receives some of the 200+ million vaccines that need to be distributed in the US.
6. What are the criteria for prioritizing who will get the vaccine first, second, third, etc.? I think this will be more easily addressed based what we already know.
7. I am concerned that the need to get something out hastily to the public may take precedent over solid independent scientific and medical review prior to release.

As of last evening the Denver Post reported that Gov. Polis is saying Colorado could receive 200,000 vaccines by the end of the year. This is presuming the Pfizer vaccine gets EUA (Emergency Use Approval) from the FDA. I still believe this is a time to be cautious about accepting the first available vaccine. Pfizer has not released information about side effects or other untoward events.

What we likely won’t know about the vaccines in the next year

1. We likely won’t know how long immunity from the vaccine will last. That would impact the possible need and frequency of booster vaccinations.
2. We won’t know about any potential long term complications from the vaccine.

This is a time of great strangeness…

As mentioned earlier, Eli Lilly had an antibody study for COVID-19 discontinued because of lack of effectiveness. This was one of the many therapies Pres. Trump received. Yet despite its lack of evidence in a clinical trial, the FDA approved its use yesterday for non-hospitalized individuals with COVID-19. This seems to fall in the same category of usefulness as hydroxychloroquine.

Speaking of hydroxychloroquine, it has once again been found not to be helpful in hospitalized patients with COVID-19. There are still those on the internet touting its usefulness despite overwhelming information to the contrary.

So for now remember!

Stay safe, social distance, wear masks when in public, avoid large crowds, and quarantine yourself immediately if you become ill until you know what you have.

I do not see anything of our current way of life changing until next summer when there may be an available vaccine or two. Perhaps the Pfizer vaccine will show great safety and effectiveness and be released for use tomorrow. As the old saying goes, “I will wait to see the whites of its eyes…” (Sorry, I may be dating myself on that one.)

Lastly vaccinating 200 million or more in the US, as well as the whole rest of the world, will not happen overnight.