“Big” news from about 2 weeks ago that “virus is airborne” was not really anything new. We have known this since Spring. The virus is carried by both large and small particles.
- Large particles fall out of the air within 4 to 6 feet.
- Small particles can stay airborne, but diffusion and gravity decrease concentration in the air fairly rapidly. This is the basis of the 6’ for 15 min guidelines and this was not changed.
There was a large study announced this week from Australia addressing the survival of the virus on various surfaces. They found the virus could be recovered over a longer duration of time than previously thought, but also found that there was generally more rapid decay. In other words, it’s around longer, but less infectious.
- 3 weeks ago, Moderna poured cold water on the idea that their vaccine would be ready to go to approval before the end of the year, but yesterday, the CEO announced that it was looking like they would have adequate results to petition for a EUA in November which would mean distribution would begin in December and first vaccinations right around the New Year. He did hedge his bets, though.
- Pfizer and BioNTech also announced 2 weeks ago that they were looking at a EUA petition in mid to late November, which would put them on a similar December/January trajectory.
NOTE on both: These vaccines must be shipped and stored at -112 F. The shipping capacity to do that is very limited. Part of the Warp Speed Project has been to develop the logistics train required to do this shipping, but very little information has been released on how this would be accomplished
- AstraZeneca paused their trial over a month ago due to a single case of transverse myelitis, but then restarted trials everywhere except the US. The FDA has not explained why they will not allow a restart, although the FDA committee on vaccines is meeting this Thursday, so we may know more then. The UK had initially said that they expected approval and distribution of this vaccine by Christmas but have since said January is more likely.
- Johnson & Johnson paused their trial on October 10 and no information other than, it was due to an unexpected illness in a participant, has been released. The advantage of the J&J vaccine is that it is a single dose, whereas all the others appear that they will require a 2-shot series.
- More and more testing capability continues to be announced, but test demand continues to outstrip availability in many areas.
- The Yale-developed saliva test has reached commercialization and is generally available for less than $50-100 each (often subject to a minimum number of tests).
- For the Yale Test, or the Vault saliva test, due to the shipping involved, the turnaround time is still not adequate. For some situations where you predict you will need a test such as with international travel, or periodic testing for risk reduction, and you place your order in advance, the turnaround time can be as short as next afternoon, making this a very viable option.
- Increasingly looking like a potential game-changer.
- This is NOT entirely new technology. Many recent drugs for multiple disease processes utilize this approach, so this is not “experimental technology” as it is often referred to in the press.
- Ignore the headlines from last week that Ely Lilly had to stop their trial on the use of this technology in seriously ill patients. This was only one part of a 4-part trial, and it involved a massive dose of antibodies against an overwhelming infection and it just was not helping. That is not the sweet spot for antibodies: Antibodies are best used when an infection is still relatively early and the match of the number of antibodies to viral particles is reasonable.
- In fact, before Eli Lilly announced the pause on the high dose arm, they were announcing their petition for EUA on early treatment because the data was excellent.
- Regeneron similarly applied for EUA for its more well-known antibody treatment (a double as opposed to a single monoclonal antibody) for equally promising data.
- Both companies have said that once approved, they have adequate manufacturing capacity to meet demand.
- Similar to the news on antibodies not helping sicker patients later in their disease, The World Health Organization announced that their Solidarity Study found no benefit from Remdesivir.
- That study directly contradicts an NIH study that did show benefit. Many have questioned the design of the WHO study which, while large, was primarily observational.
- Additionally, the place where Remdesivir was failing was in the treatment of critically ill patients (since in much of the world, because of availability issues, it was being held for use in this population). Just like Tamiflu is best used early in the course of influenza, Remdesivir is best used early in the course of COVID-19.
- New cases of COVID-19 continue to surge in much of the world outside of Asia.
- Case counts in the UK are significantly higher now than they were in April and the European Region is seeing case counts more than double what they were in the initial wave in April. Especially hard-hit areas include central Spain, Austria, the north of England, Northern Ireland, and both far northern and southern France. There may be some evidence that this may be peaking, but still lots of steep epidemic curves in most of Europe. Importantly, death rates are not seeing these same increases with most countries being essentially flat on the numbers of deaths.
- In the US, current levels are at about 75% of the peak seen in mid-July, but they are still steadily rising. 38 states are seeing increases in cases and 12 states have seen a decrease or no change in cases. This is an improvement from last week, so we may be starting to see a peak.
- In many people’s minds, however, the bigger issue is fatalities. There are many difficulties in really determining what is a “covid-related death”, but the fatality rate is down or flat in half the states and up in half. The daily death rate is flat in the US and about 1/3 of what it was in mid-April.
- Better data will only be available in retrospect when we can look back to see the actual number of total excess deaths in 2020 versus 2019 adjusted for changes in population. It will also require also looking at deaths in 2021 to get a better idea of how many of these deaths would likely have occurred in the near future without COVID.