Vol.16 (2020/11/30) Results of antibody tests at our clinic / Trends in the third wave in Japan and around the world / Vaccine development status / Masks and face shields / etc.

[1] About antibody-positive patients at our clinic

At our clinic, we are conducting tests on people who have no symptoms such as fever or cough (and have not had any within the past two weeks), and from October 2th to November 10th, 15 people took the initial test, and 11 people tested positive for antibodies (positive rate: 14%). This is double the previous average of 383%. The number is clearly increasing.

We have summarized the positive cases so far (35 people were positive on the first test, and 3 people were observed for the second time three months later).

(Figure 1) Age distribution of antibody test positive individuals

Since the tests are conducted as part of health checkups and outpatient clinics, there are few people in their 20s, who are more likely to cause clusters, and most of the tests are in their 30s to 50s.

(Figure 2) Gender of antibody-positive individuals

74% were men and 26% were women.

(Figure 3) Presence or absence of symptoms in antibody-positive individuals

When checking the past symptoms of antibody-positive people, only 20% had fever symptoms.
The majority (69%) were asymptomatic people suspected of being infected (through close contact) at home or at the gym, and the route of infection was unknown.

(Figure 4) Antibody titers by symptoms

Many asymptomatic people had low antibody titers, but there were also a few with high titers, and it was found that this does not necessarily coincide with the symptoms.

(Figure 5) Change in antibody titer (initial dose → 3 months later)

These are the changes in the five people whose antibody titers were measured again three months later. Four of them had decreased antibody titers.
However, the number has increased by only one, and the possibility of asymptomatic reinfection during the period cannot be ruled out.

[2] Trends in Japan and the world

●Japan: The third wave has arrived. The number of cases is still increasing.

(Figure 6) Trends in Japan

Source: Ministry of Health, Labor and Welfare website
https://www.mhlw.go.jp/stf/covid-19/kokunainohasseijoukyou.html#h2_1
*Data as of November 11th

Global situation

The United States is by far the most affected, but the death toll is higher in Europe than it was in the first wave.

(Figure 7) Trends in the number of infected people by country

Source: Ministry of Foreign Affairs of Japan Overseas Safety Website COVID-19 Infection Status in Each Country and Region
https://www.anzen.mofa.go.jp/covid19/country_count.html

(Figure 8) Changes in the number of daily deaths

The number of deaths in Japan is lower than in the United States and the United Kingdom, but higher than in China and South Korea.
(The vertical axis is a logarithmic graph)

(Figure 9) Comparison of the number of deaths (USA, UK, Japan)

(Figure 10) Comparison of the number of deaths (Japan, South Korea, China)

Source: Financial Times Coronavirus tracker: the latest figures as countries fight Covid-19 resurgence
https://www.ft.com/content/a2901ce8-5eb7-4633-b89c-cbdf5b386938
*Data as of November 11th

[3] Vaccine situation

Pfizer, Moderna, and AstraZeneca are also promising. They have artificially altered the spike structure to increase the efficiency of immune induction. As a result, they have achieved a very high efficacy rate of over 90%.

Vaccines around the world

According to data presented at a meeting of the US CDC (Centers for Disease Control and Prevention),
The Pfizer vaccine can be stored for up to six months at temperatures between minus 60 and 80 degrees, and for five days at temperatures between 2 and 8 degrees.
The Moderna vaccine can be stored at -20°C for up to six months, and at 2°C to 8°C for 30 days.

(Figure 11) Status of the two vaccine development companies

Source: NHK NEWS WEB What are the characteristics of the COVID-19 "Pfizer" and "Moderna" vaccines?
https://www3.nhk.or.jp/news/html/20201117/k10012716811000.html

Slaoui, chief advisor to Operation Warp Speed, the government's initiative in vaccine development, predicted that vaccinations could begin as early as the 11th of next month. The vaccine was applied for emergency use authorization by the pharmaceutical giant Pfizer on the 20th. Final-stage clinical trials have shown it to be 95% effective, and the Japanese government has agreed to supply 1 million doses. "If around 2000% of the population is vaccinated, herd immunity will be achieved around May next year," he said.
It has been reported that the Pfizer vaccine may be approved in the UK this week, and the Minister of Health in Germany has said that vaccinations may begin as early as next month. What is of concern is safety. Pfizer has said that "no serious safety concerns have been reported." However, vaccine development usually takes years.
Slaoui, Chief Advisor to Operation Warp Speed: "We don't know the long-term safety, but 1000 to 2000 people are dying every day. We can't afford to spend a long time observing the progress. Hundreds of thousands of vaccine trial participants over 40 years have shown that 90 to 95 percent of serious side effects occur within 40 days of vaccination."
"Safety has not been sacrificed for speed. Scientific integrity has not been compromised. The incredible scientific advances in this type of vaccine have condensed what would have taken years of work into months," said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases.

Source: livedoorNEWS Pfizer "vaccine" vaccinations to begin in the US on the 11th of next month
https://news.livedoor.com/article/detail/19268690/

● Japanese vaccines

COVID-2 DNA Vaccine: Phase 3/XNUMX Clinical Trials
We are currently developing a novel coronavirus DNA vaccine, and once it has been reviewed and approved by the Institutional Review Board (IRB) at the clinical trial site, we will begin a Phase 2/3 clinical trial. In this trial, we will increase the number of cases to evaluate the safety and immunogenicity of the dosage used in the Phase 1/2 trial. In addition, after the dosage is finalized in this trial, we plan to conduct a large-scale placebo-controlled Phase 19 comparative trial to verify the efficacy of the vaccine in preventing the onset of novel coronavirus disease (COVID-3).

[Summary of Phase 2/3 clinical trials of the new coronavirus DNA vaccine]

• Target number of cases: 500 cases (2.0mg dose: ① 250 cases, 2 doses at 2-week intervals, ② 250 cases, 4 doses at 2-week intervals, ① and ② each include 50 placebo cases)
• Number of participating facilities: 8 facilities in the Kansai and Kanto areas
• Study period: November 2020 to March 11 (Vaccination is scheduled to be completed around March 2022. The study period includes a 3-week follow-up period after vaccination.)

Source: Anges Inc. press release
"COVID-2 DNA Vaccine: Phase 3/XNUMX Clinical Trials"
https://www.anges.co.jp/pdf_news/public/hYbPKBHSdQMD9pG3d0LJCmgd1U0OAXPD.pdf

[4] Effectiveness of masks and face shields: Fugaku simulation

The RIKEN Institute has announced the results of a simulation conducted on the effectiveness of different types of masks and face shields as part of research and development into novel coronavirus countermeasures using the supercomputer Fugaku.
Looking at this, it is clear that masks other than nonwoven fabrics will leak a lot, and face shields are virtually ineffective.

In Figures 12 to 14 below, yellow indicates leakage from gaps, blue indicates transmission, and red indicates adhesion.

(Figure 12) Effect of masks (non-woven masks, handmade cloth masks (polyester equivalent), handmade cloth masks (cotton equivalent))

When comparing particle size, even nonwoven masks allow 30% of small particles to escape.

(Figure 13) Effect of masks (comparison by particle size)

Compared to non-woven masks, face shields allow almost 100% of small to medium-sized particles to leak through.

(Figure 14) Comparison of masks and face shields

Source: RIKEN uses supercomputer Fugaku to analyze the difference in droplets from non-woven and handmade masks
https://pc.watch.impress.co.jp/docs/news/1272611.html

Summary: The following figure shows the amount of exhaled and inhaled droplets, with no mask considered as 100%. If you wear a mask, droplets are suppressed even when you cough, and they do not fly far. Even if there are gaps in the mask around the cheeks and nose, droplets are suppressed by about 8%. This shows once again that wearing a mask is essential for protecting yourself, as it can suppress droplets by about 7%.

(Figure 15) Summary

Source: Toyohashi University of Technology press release (October 2020, 10)
https://www.tut.ac.jp/docs/201015kisyakaiken.pdf