GOOD
Moderna reported the first early clinical trials with their novel vaccine. The results were extremely encouraging, with patients developing levels of antibodies comparable to patients who had recovered from COVID-19, and the antibodies were, indeed neutralizing (i.e., presumptively protective against infection).
SORTA
- The trial only contained four patients and was designed to test initial levels of safety.
- It took 43 days for the antibody levels to rise to those levels. Remember this time frame when you think about how we will implement vaccines once they are available. There is a significant time lag between immunization and protection. Just because you get a vaccination today, it does not mean that you are safe tomorrow. The lag will be at least 15 days and could be quite longer particularly if the vaccine eventually requires more than one dose.
- Moderna hopes to be able to enter Phase II trials in mid-July. These studies, involving several hundred people are to determine dosing levels and efficacy and will, as you see from above, will take at least another few months before the data can be analyzed. After the completion of these trials, there will be a Phase III trial. This needs to involve at least 3,000 people and is critical to look at potential side effects and safety in various population groups, age, sex, clinical presentation, etc. These trials also require several more months, so Moderna has said, if all goes perfectly, this vaccine may be available in mid 2021 at the earliest.
And these trials are critical. They cannot be reduced in size or time frame by a desire to “do away with unnecessary regulations”. They are critical because on top of everything else, we will have to convince 50% of the population in this country, and around the world to get vaccinated, or the virus will continue to infect and kill. Herd immunity in this country alone is insufficient. It must also be done worldwide, or it will come back here. There is already tremendous resistance to vaccines. The effort to convince the population to get vaccinated will be Herculean and, G-d forbid if, after insufficient Phase III trials, rushed through for expediency, if production methods are not sufficiently vetted, if after that we identify adverse health problems associated with a released vaccine, that effort will fail and we will be in a far, far worse hole than we are now.
Now, here are some problems.
There are currently around 100 different vaccines in stages of development. Each will need to go through the same Clinical Trials, Phase I, II and III before they can be distributed. The government is apparently, and hopefully, gearing up now for the production, storage, distribution and delivery of a vaccine even prior to one being proven and approved. Of course, each vaccine may have very, very different methods for production, so preparing for all is almost impossible.
More importantly, look at the numbers. A phase III clinical trial requires thousands of patients. Where do you get those patients? They need to be within a well-described group of people, with equal potential exposure to the virus, because you want to be able to test if the group that you are immunizing is less likely to become infected than a comparable, preferably identical group that is not immunized. Where will you find this group? It will most likely be in some area in the world where the virus is expanding, where immunization is socially, politically and financially possible; where the patients are accessible for monitoring, blood testing and observation. Since this won’t be happening until the latter part of this year and into the next, where will these groups be? Also, with 100 potential vaccine candidates, where will we find 100 different groups of 3,000 people to test these different vaccines? Will we be able to find even more than 1?
What if those potential test patient groups are in foreign countries? How will we convince those countries to allow US to preempt THEM for these groups of patients? What if those countries themselves are in the process of developing their own vaccines? Or if the new vaccines were developed within the WHO world collaboration program into which the US has chosen not to participate?
THE BAD
13 sailors aboard the USS Theodore Roosevelt, who had previously tested positive for COVID-19, who had recovered and who had tested negatively at least twice for the presence of virus, have now tested positive again and many have shown new “influenza-like” symptoms and are being treated in hospital.
This is particularly disturbing as it suggests that even after you have recovered from the disease, you may still be able to be re-infected.
SORTA
Every observation needs to be taken at the most basic non-prejudiced level. There are several caveats here.
- With the low accuracy in general of these tests, were these individuals actually negative in their previous tests? It is possible that there were still low levels of virus that were undetectable by the tests used.
- There are now 30 variants of the virus that have been identified in China, so it is possible that the new infections were from variant strains.
- Even if they got re-infected, if that re-infection resulted in a less severe illness, particularly if it did not become lethal, then the results are at least a little bit less disturbing.
- We have spoken before about the fact that not all antibody responses will include “neutralizing” antibodies, i.e., antibodies that can block infection. I would not be surprised at all if a fraction of infected individuals, who survive the disease (perhaps because they had mild symptoms or even were asymptomatic) developed an immune response to the virus that could be observed, but which was insufficient to provide even short-term protection from infection.
So, the bottom line is, although this information is, indeed troubling, it should not induce panic. I have been as realistic as possible at the problems, existent and emerging. I have never put on rose-colored glasses or let my wishes take over my reason. With regards to this new information, I would suggest that this result is actually to be expected. As I said in a previous essay, the Theodore Roosevelt was a perfect opportunity to do a controlled study of the infection statistics of this virus. Unfortunately, this was not done. Had it been done however, I would have predicted that there would have been a fraction of the previously infected population who would still be vulnerable to a new infection.
THE UGLY
The politics remain disturbingly irrational, biased and delivered based on projections rather than science. Some politicians seem to believe that the purpose of scientists is to provide them with information that will support their political position, rather than allow the science to dictate the politics.
Blame the Chinese, the WHO, the CDC, the Obama Administration, the Trump Administration, Mitch McConnell, Uber or Ibuprofen. The US, with 4.5% of the world’s population, the largest economy in history, infrastructure, research, academic excellence, freedom, democracy and military supremacy, now has almost one third of all deaths from COVID-19. We aren’t learning.
Last week Peter Navarro and Mike Pompeo both accused China of trying to steal our viral vaccine research data. What? Why aren’t we GIVING it to everyone, including the Chinese? Why isn’t the whole world working together to get a vaccine as soon as possible? Will we ask for other countries to share their data with us if they get ahead? No? The virus is not red nor blue, not neither. It respects no borders, no rules, no laws. If you stop it here, it will pop up there. If you ignore it there, it will spread here.