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Vol.11　When can children get COVID-19 vaccine? Do we need it?

アンカー 11

Last Updated 1 April 2021. Cellspect Co., Ltd.

So far, the global COVID-19 vaccination has hit 345 million doses, but clinical trials for children are still in progress to determine the safety and effectiveness of the vaccine. Here is what the experts want you to know about COVID-19 vaccination for children.

 

• Why kids need their own COVID-19 vaccine trials?

Children’s immune systems are very different from adults’, and their immune responses can be different at different ages, from infancy through the teenage years.  Children’s immune systems are still maturing and are unpredictable, so they might react to the coronavirus differently or have side effects that don’t occur in adults. Therefore, the U.S. Food and Drug Administration requires all new vaccines need to be independently studied in children.

 

• Why children's vaccination is important? Do they even need them?

Children under age of 18 are more than 20 percent of population. Although children have fared better than adults in the coronavirus pandemic, if these 20 percent of people remain unvaccinated, that means they have the potential to continue transmitting the coronavirus. What's more important is that experts note that it’s difficult to reach herd immunity without vaccinating children. Herd immunity is a long-promised goal at which the pandemic slows to a halt because the virus runs out of people to infect. Scientists have estimated that 70 to 90 percent of the population might need to be immunized against the coronavirus to reach herd immunity, especially with more contagious variants expected to circulate widely in the country. Undoubtedly, the COVID-19 vaccination has to include children if we’re going to get to herd immunity.

 

• When can kids get vaccinated? What’s the current progress?

The Pfizer vaccine already is cleared for use starting at age 16 while Moderna is for use starting at age 18. That means some high schoolers could get in line for those shots whenever they become eligible in their area.

　So far, Pfizer and Moderna both have completed enrollment for studies of children ages 12 and older, and expect to release the data over the summer. Experts said the adolescent and pediatric trials won’t take nearly as long as the adult trials because they don’t require as many participants as the Phase 3 trials in adults. Pfizer and Moderna took months to recruit 55,000 adult volunteers for Phase 3 trials. For adolescent trials, the companies recruited about 3,000 and 2,600 respectively.

Researchers don’t want to wait for trial participants to come in contact with someone infected with COVID-19 to determine the vaccine’s efficacy, unlike the adult trials. Instead, they’ll measure children’s immune response and compare it with the adults'. If children get the same immune response, then the extrapolation is that they have the same protection.   

Moderna has just announced that clinical trials in children as young as 6 months old and up to 11 years old has begun on March 18 and Pfizer-BioNTech trial of children ages five to 11 is likely to begin as early as March.

 

In order to allow schools to operate as normally as possible, various vaccine companies are also speeding up the trials. “For children 12 years of age and up, there will be a vaccine available before the next school year in autumn,” said a principal investigator for the Pfizer trial. “It’s probably more likely the end of 2021 to early 2022 for younger kids, but maybe it’ll go a little faster than that.”

 References:​

  1. U.S. Food and Drug Administration: FDA https://www.fda.gov/ 

  2. Respective vaccine companies

  3. Clinical trial data: https://www.clinicaltrials.gov/ 

アンカー 12

Vol.12　COVID-19 Might Lead to A “Mental Disorder Pandemic”

Last Updated 9 April 2021. Cellspect Co., Ltd.

The COVID-19 has affected people from all walks of life and has significantly changed people’s lives. Physically, it greatly affected older generations and mentally, it will likely greatly affect younger generations. Fear, worry, and stress are normal responses to perceived or real threats, and at times when we are faced with uncertainty or the unknown. Added to the fear of contracting the virus in a pandemic such as COVID-19 are the significant changes to our daily lives as people's movements are restricted in support of efforts to contain and slow down the spread of the virus. As the pandemic wears on, ongoing and necessary public health measures expose many people to experiencing situations linked to poor mental health outcomes, such as isolation and job loss.     

 

In March, the Ministry of Health, Labor and Welfare of Japan has released the final figures for those who committed suicide in 2020. The total number of suicides last year was 21,081 nationwide, an increase of 912 (4.5%) from 2019. In addition to an increase of 15% in women, the number of children and students up to high school is the highest ever. It is believed that the growing social unrest caused by the novel coronavirus is having a critical effect.

 

The younger generation was particularly noticeable, with 311 under the age of 20 increasing by 44% and 837 in their 20s increasing by 32%. By occupation, the number of people employed increased by 1534 (34%), the number of housewives increased by 1168 (14%), and the number of students increased by 387 (44%). It can be seen that the number of women who are having troubles is increasing. In addition, child suicide is also conspicuous. There were 14 elementary school students (+6), 146 junior high school students (+34), and 339 high school students (+60), for a total of 499. It is 25% higher than the previous year, and has been the highest since we started collecting statistics in 1978.

 

A study by Michiko Ueda, an associate professor at Waseda University, showed that the number of suicides in Japan increased significantly in the two months after Japan ended the state of emergency. In terms of quantity, it is an increase of 7.72% over the same month average of the past three years. Women under 40 have the highest growth rate of all age groups (63.1%). "Even if the state of emergency is lifted, the impact on the economy will continue, so we have to be very careful. It is important to create a society where people in need can easily ask for help, and employment support. In addition to expanding the consultation system, it is necessary to prepare a system to support society as a whole by taking care of each person if there are people in need,” said Prof. Ueda.     

 

This phenomenon is not only happening in Japan. Actually, “mental disorder pandemic” is ongoing all over the world. According to US CDC survey, throughout the pandemic, anxiety, depression, sleep disruptions, and thoughts of suicide have increased for many young adults in the US. They have also experienced a number of pandemic-related consequences – such as closures of universities, transitioning to remote work, and loss of income or employment – that may contribute to poor mental health. An earlier survey in US from June 2020 showed similar findings for young adults relative to all adults. The survey also found that substance use and suicidal ideation are particularly pronounced for young adults, with 25% reporting they started or increased substance use during the pandemic (compared to 13% of all adults), and 26% reporting serious thoughts of suicide (compared to 11% of all adults). Prior to the coronavirus outbreak, young adults were already at high risk of poor mental health and substance use disorder, yet many did not receive treatment.

 

According to WHO, while many countries (70%) have adopted telemedicine or teletherapy to overcome disruptions to in-person services, there are significant disparities in the uptake of these interventions. WHO has issued guidance to countries on how to maintain essential services ̶ including mental health services ̶ during COVID-19 and recommends that countries allocate resources to mental health as an integral component of their response and recovery plans. WHO also urges countries to monitor changes and disruptions in services so that they can address them as required.

 

Taken together, obviously, Covid-19 has caused both physically and psychologically pandemic. The impact of mental illness may be more far-reaching and broader. People should consider, for example, increasing the use of resources for the diagnosis and treatment of mental health conditions and expanding the use of telemedicine to address the consequences of this epidemic on mental health.

 References:​​

  1. U.S. CDC: CDC https://www.cdc.gov/

  2. 厚生労働省: https://www.mhlw.go.jp/index.html

  3. Michiko Ueda. “Japan’s suicide rate highlights the other health challenges stemming from the pandemic” Washington Post, Dec. 30, 2020

  4. WHO: https://www.who.int/ 

アンカー 13

Vol.13　The link between COVID-19 and Air Pollution

Last Updated 16 April 2021. Cellspect Co., Ltd.

Recently, due to the air pollution caused by PM2.5, it is worried that the air pollution in Japan may affect the health or even worsen the ongoing COVID-19 pandemic. Truly, new emerging research is shedding light on the links between air pollution and severe illness from COVID-19 -- underscoring the critical need to ensure healthy air for all. It has been reported that air pollution represented by particulate matter (PM) such as PM2.5 increases the number of people infected with the novel coronavirus infection (COVID-19) and the number of severely ill people all over the world.


In a U.S.-based study released in September 2020, researchers at the SUNY College of Environmental Science and Forestry found that an increase in exposure to hazardous air pollutants is associated with a 9% increase in death among patients with COVID-19. They confirmed that this increase was really caused by the hazardous air pollutants, not by differences in wealth or other health reasons. The higher the air pollution index, the more it correlated to poor health outcomes due to COVID-19. The likely reason: these pollutants cause respiratory stress, thereby increasing vulnerability to severe illness from COVID-19.

 

In December 2020, in another study, utilizing a mix of epidemiological data, satellite data and other monitoring information from around the world, the researchers estimated that, on average, 15% of worldwide deaths from COVID-19 may be linked to chronic exposure to air pollution. This study breaks down results by region and by country. For example, the study’s estimates show that air pollution contributed to 27% of COVID-19 deaths in China, 18% in the United States, 15% in Mexico, 14% in the United Kingdom, 6% in Israel, and just 1% in New Zealand. The researchers also distinguished between fossil-fuel related air pollution and other sources of human-caused air pollution. In the U.S., 15% of COVID-19 mortality is specifically attributable to fossil fuel-related air pollution.

 

Moreover, researchers from the Harvard School of Public Health also looked at the impact of long-term exposure to PM pollution on COVID-19 death rates. They examined 3,089 counties, accounting for 98% of the United States’ population. The researchers found that just a small increase (1 microgram per cubic meter) in long-term average exposure to fine particle pollution is associated with an 11% increase in the COVID-19 death rate for that county.  

 

Recently, a research group led by Hiroshisa Takano, a professor at the Graduate School of Global Environmental Studies, Kyoto University found that PM2.5 will expand the cell entry port of the novel coronavirus. The results were published in the "Environmental Research".

 

According to Prof. Takano et al., when the novel coronavirus invades the body, two molecules, ACE2 and TMPRSS2, in the cells of the infected target (host: human or animal) are critical. The more these two molecules, the more likely it is to cause infection. Their research group investigated the subsequent changes in the lungs of mice that inhaled PM collected from the atmosphere by the cyclone method. As a result, ACE2 and TMPRSS2 are increased especially in type 2 alveolar epithelial cells, which are very important cells for maintaining lung extension. That is clear that PM is expanding the entry point for the novel coronavirus.

 

PM2.5 is a very small particle with a diameter of 2.5 μm (1 μm = 1/1000 of 1 mm) or less floating in the atmosphere. PM is a cause of air pollution containing such as soot, dust, and sulfur oxides (SOx) emitted from factories, automobiles, ships, and aircraft. PM2.5 concentration fluctuates depending on the season, and the concentration tends to increase from March to May every year. There are also differences depending on the region. You can check the PM2.5 concentration in your area at the following site: Atmospheric Environmental Regional Observation System: AEROS (http://soramame.taiki.go.jp/)

 References:​​

  1. Tomoya Sagawa et al. “Exposure to particulate matter upregulates ACE2 and TMPRSS2 expression in the murine lung” Environmental Research Volume 195, April 2021, 110722.

  2. Editorial Staff, January 4, 2021. “Understanding the link between COVID-19 Mortality and Air Pollution” American Lung Association

  3.  Atmospheric Environmental Regional Observation System: AEROS (http://soramame.taiki.go.jp/)

アンカー 14

Vol.14　Increasing population growth and density are major drivers in the emergence of zoonotic diseases

Last Updated 23 April 2021. Cellspect Co., Ltd.

Humans are creating or exacerbating the environmental conditions that could lead to further pandemics, new University of Sydney research finds. New modeling from the Sydney School of Veterinary Science suggests pressure on ecosystems, climate change and economic development are key factors associated with the diversification of pathogens (disease-causing agents, like viruses and bacteria). This has potential to lead to disease outbreaks. The research is recently published in the international journal, Transboundary and Emerging Diseases.
 

As the human population increases, so does the demand for housing. To meet this demand, humans are encroaching on wild habitats. This increases interactions between wildlife, domestic animals and human beings which increases the potential for bugs to jump from animals to humans. “To date, such disease models have been limited, and we continue to be frustrated in understanding why diseases continue to emerge,” said Professor Ward, an infectious diseases expert in this study. “This information can help inform disease mitigation and may prevent the next COVID-19.”

 

In this study, the authors used 13,892 unique pathogen combinations and 49 socioeconomic and environmental variables to develop this model. Information from 190 countries was analyzed using statistical models to identify drivers for emerging and zoonotic (diseases transmitted between animals and humans) diseases. They found a greater diversity of zoonotic diseases in higher income countries with larger land areas, more dense human populations, and greater forest coverage. The study also confirms increasing population growth and density are major drivers in the emergence of zoonotic diseases. The global human population has increased from about 1.6 billion in 1900 to about 7.8 billion today, putting pressure on ecosystems.

 

Countries within a longitude of -50 to -100 like Brazil, developed countries like United States and dense countries such as India were predicted to have a greater diversity of emerging diseases. The researchers also noted weather variables, such as temperature and rainfall, could influence the diversity of human diseases. At warmer temperatures, there tend to be more emerging pathogens. Their analyses demonstrate that weather variables (temperature and rainfall) have the potential to influence pathogen diversity. These factors combined confirm human development – including human-influenced climate change – not only damages our environment but is responsible for the emergence of infectious diseases, such as COVID-19. In recent years, the zoonotic diseases that have brought great impacts also include SARS, avian (H5N1) and swine (H1N1) flu, Ebola and Nipah.
 

“Our analysis suggests sustainable development is not only critical to maintaining ecosystems and slowing climate change; it can inform disease control, mitigation, or prevention,” Professor Ward said. “Due to our use of national-level data, all countries could use these models to inform their public health policies and planning for future potential pandemics.”

 References:​​

  1. Balbir B Singh et al. 2021 Mar 16 “Geodemography, environment and societal characteristics drive the global diversity of emerging, zoonotic and human pathogens” Transbound Emerg Dis.

  2. Emily Henderson. 2021 Mar 30 "Research finds key factors that could lead to further pandemics” News Medical Life Sciences.

  3. 2021 Mar 30 "Factors that may predict next pandemic” The University of Sydney news release.

アンカー 15

Vol.15　Comparison of COVID-19 vaccination coverages between Japan and the world 

Last Updated 14 May 2021. Cellspect Co., Ltd.

From Apr 12, the Japan government started vaccinating people aged 65 or older, a group of roughly 36 million people, nearly two months after the country began vaccinating healthcare workers.

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Public survey shows that there was no major difference between Japan and other countries in coronavirus vaccine acceptance. As Japan prepares to expand the scope of its coronavirus vaccine rollout to the entire population, 62.1% of people have expressed a willingness to receive a shot, a recent online survey by Tokyo Medical University has shown on mid-March. The results were broadly in line with a Kyodo News survey conducted in February, which showed 63.1% of respondents in Japan expressing a willingness to get a shot, with women in their 40s and 50s the wariest.

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However, the share of the total population that received at least one vaccine dose (vaccination rate) in Japan currently lags far behind Britain, United States and many other countries. It is also lower than the global average of 6 percent and Asian average of 3 percent. Currently, just over 1.1 million people in Japan have received at least one dose of the Pfizer vaccine, less than 1 percent of its population of about 126 million. The rollout has been held back due to production delays and the European Union's export controls, which require individual shipments to be authorized, as well as Japan's requirement for clinical trials to be held domestically in order for vaccines to be approved. Moreover, domestic drugmakers have been slow to develop their own vaccines. Although Anges Inc, Daiichi Sankyo Co, Shionogi & Co and KM Biologics Co have begun clinical trials, it all still have some way to go before going to market.

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As of mid-April, the highest vaccination rates in the world are Israel (61%), the United Kingdom (48%) and the United States (37%). Among Asia, the countries with the highest vaccination rates are Singapore (19%), Hong Kong (8%), India (7.5%) and China (6%). The countries with the least vaccination progress in Asia are Vietnam (0.06%) and Taiwan (0.1%), which have also experienced few COVID-19 cases.

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Israel was first to show that vaccinations were having a nationwide effect. The country has led the world in vaccinations, and by February more than 84% of people ages 70 and older had received two doses. Severe covid cases and deaths declined rapidly. A separate analysis in the U.K. showed similar results.

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It’s now a life-and-death contest between vaccine and virus. New strains threaten renewed outbreaks. In the early stages of a campaign, the effect of vaccinations are often outweighed by other factors of transmissibility: virus mutations, seasonality, effectiveness of mask use and social distancing. In time, higher vaccination rates should limit the Covid-19 burden around the world. But with an increasing strain on the medical system amid a resurgence of infections, there is concern that doctors and nurses may not be able to keep up with the vaccination schedule. The torch relay for the Olympics, meanwhile, began in Japan in late March, which means the Olympics is very close. Clearly, the government should speed up the arrangements and promotion of vaccines.

En_コロナ学術情報コラムVol15.png

 References:​​

  1. .Balbir B Singh et al. 2021 Apr12 “Japan trails world in COVID vaccine rollout 2 months after its start” JapanToday News.

  2. 2.Our World in Data (Oxford): https://ourworldindata.org/team

  3. 3.Covid-19 Vaccination Tracker: https://www.pharmaceutical-technology.com/covid-19-vaccination-tracker/

アンカー 16

Vol.16　Why is vaccine patent waivers on COVID-19 vaccines so contentious?

Last Updated 21 May 2021. Cellspect Co., Ltd.

last October, 58 developing countries including India and South Africa proposed to the World Trade Organization (WTO) that they should be exempted from patents for the COVID-19 vaccine. This proposal was supported by many developing countries but opposed by many high-income countries. The United States, the United Kingdom, Canada, Japan, and EU member states have rejected this proposal, believing that intellectual property protection plays an important role in promoting scientific innovation, and that patent waivers may hinder scientific innovation, and there is already a “COVAX” to promote equitable global access to the COVID-19 vaccine.

 

However, on May 5 this year, the U.S. government reversed its previous attitude and announced that it would support the COVID-19 vaccine patent waivers. On the same day, U.S. Trade representative Katherine Tai stated that the government's move is to popularize safe and effective vaccines as soon as possible and end the COVID-19. Why does the United States change its attitude, and will this move really help the spread of the COVID-19 vaccine?

 

The main reason for supporting the COVID-19 vaccine patent waivers stems from the reality of unfair vaccine distribution. According to the New York Times, 1.27 billion doses have been vaccinated globally, which is equivalent to 16 doses for every 100 people. 83% of vaccinations were completed in high-income and upper-middle-income countries, and only 0.3% in low-income countries. It is believed that the US attitude towards vaccine patent waivers changed because the US government has faced tremendous pressure in recent weeks, and the outside world has asked for measures to alleviate the global vaccine shortage. It may also be the negotiation strategy of the United States. Perhaps what the United States really wants to achieve is for vaccine manufacturers to voluntarily share vaccine patents or reduce vaccine prices.

 

However, simply abandoning patents cannot solve the problem of insufficient vaccine supply. Opponents say that this is like sharing a recipe without raw materials or instructions. What we really need to do is to eliminate trade barriers and solve supply chain bottlenecks and shortages of raw materials. The development of mRNA vaccines involves 80 to 100 patents. Even if all these patents are obtained, it is impossible to fully understand the precise details of how to produce vaccines. In addition, the patent waiver may cause the supply of vaccine raw materials to flow to production sites with low production efficiency and doubtful quality, and there is a risk of counterfeit and inferior vaccines entering the world's vaccine supply chain. Patent waiver will also deprive pharmaceutical companies of the motivation to continue to study mutant viruses, new vaccines, and new treatment methods, which will have a negative impact on future scientific research and innovation in response to the epidemic. Pharmaceutical companies also believe that patent waivers will trigger competition from already scarce raw materials.

 

Apart from patent waivers, what else can promote the equitable distribution of vaccines worldwide? "Financial Times" said that under pressure, the United States is ready to share its large reserves of AstraZeneca vaccines that have not yet been approved by its regulators. Other countries can also provide surplus vaccines to less developed countries. Another goal that can be achieved in the short term is the relaxation of export controls on vaccines and raw materials produced by relevant countries. Pharmaceutical companies issue licenses to manufacture vaccines to companies in developing countries. This is what some companies are doing now.

 

WHO advocates that it coordinate technology transfer, encourage pharmaceutical companies and patent holders to authorize other companies to produce vaccines through WHO, and at the same time assist in training employees of authorized companies. This is a good long-term solution because in the future It is very likely that another virus that is more terrible than the COVID-19 will emerge. It is urgent to establish a future-oriented international health and medical cooperation system that can respond to the global pandemic.

 References:​​

  1. Ashutosh Pandey. 2021 May “Explainer: Why patents on COVID-19 vaccines are so contentious” Deutsche Welle News Release.

  2. 2021 May “US support for waiving COVID-19 vaccine patent rights puts pressure on drugmakers – but what would a waiver actually look like?” The Conversation News Release.

アンカー 17

Vol.17　Measles, Polio and BCG Vaccines Can Boost Immunity to Coronavirus

Last Updated 26 May 2021. Cellspect Co., Ltd.

As the world waits for a COVID-19 vaccine, some scientists are testing whether shots already in use for other diseases might provide some protection from the worst impacts of the disease caused by the coronavirus. On May 18, the Global Virus Network (GVN) proposed that live attenuated vaccines (LAVs), such as those for tuberculosis (BCG), measles, and polio, may induce protective innate immunity that mitigate other infectious diseases, triggering the human body's natural emergency response to infections including COVID-19 as well as future pandemic threats. 

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The Global Virus Network (GVN) is a coalition comprised of human and animal virologists from 63 Centers of Excellence and 11 Affiliates in 35 countries, and colleagues. The scientists of GVN suggest that LAVs prospectively might offer a vital tool to bend the pandemic curve, averting the exhaustion of public health resources and preventing needless deaths, and merit being studied. The perspective was published in the famous journal, Proceedings of the National Academy of Sciences of the United States of America (PNAS).

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Human's innate immune response is the first line of defense against invading, new pathogens. The outcome of any infection depends on the race between the pathogen and the host defense systems. So far, a review of epidemiological, clinical and biological evidence suggests that induction of innate immunity by existing LAVs, that is, the broadly effective vaccines, can protect against unrelated infections such as coronavirus, and could be used to control epidemics caused by emerging pathogens. This is especially valuable because LAVs can fill the gap until specific vaccines are available and in particular when COVID vaccine have not reached certain countries globally.

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"Even in the case of a microorganism such as SARS-CoV-2, for which we have been able to develop vaccines fairly quickly, it is still a minimum of one and a half to two years until a safe and effective vaccine can be produced, tested, distributed, and delivered globally," said Dr. Dean Jamison, a leading global health economist of the Institute for Global Health Sciences, University of California, and the GVN. "In this period, countless lives have been lost and economic havoc has been unleashed in the world economy. This could be even more tragic in the case of a future pandemic for which the development of a vaccine is more challenging, transmission is more rapid, or herd immunity more difficult to achieve. LAVs that stimulate innate immunity could serve as a stop-gap until an effective vaccine is widely available."

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"Besides protecting against infection, innate immunity stimulation also has the potential to be used therapeutically in the early stages of disease, as well as to boost the effectiveness of vaccines that promote a specific adaptive immune response. This potential, while theoretical, is also worthy of further study," said Dr. Konstantin Chumakov, Associate Director for Research for the U.S. Food and Drug Administration's (FDA) Office of Vaccines Research and Review, and a GVN Center Director.  "As we wrote last year in a perspective published in Science, studies with the oral poliovirus vaccine (OPV) from the 1960s and 1970s demonstrated nonspecific immune protection and found that OPV reduced the incidence of seasonal influenza and acute respiratory disease."

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In 2014, a World Health Organization (WHO)-commissioned review at the recommendation of the Strategic Advisory Group of Experts on vaccines (SAGE) concluded that LAVs reduced child mortality by more than expected. The same patterns were observed in high-income settings, including in the U.S., as having a live vaccine as the most recent vaccine being associated with a halving of the risk of hospitalization for non-targeted infections.

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GVN said that LAVs against tuberculosis and smallpox have been associated with better long-term survival. For example, OPV campaigns in West Africa have been associated with a 25% reduction in all-cause mortality, with each additional dose reducing mortality by a further 14%. Several basic science observations make clear the central importance of innate immunity in controlling coronaviruses including SARS-1, SARS-CoV-2, and MERS. Further, control of coronaviruses by bats is largely associated with an appropriate balancing of innate immune responses between resistance and tolerance. It is critically important from both scientific and public health perspectives that we complete rigorous trials evaluating the effectiveness of LAVs in preventing COVID-19 or mitigating its severity. The findings from these trials will inform if, and how, we could incorporate LAVs into our toolkit against future pandemics.

 References:​​

  1. Ashutosh Pandey. 2021 May “Explainer: Why patents on COVID-19 vaccines are so contentious” Deutsche Welle News Release.

  2. 2021 May “US support for waiving COVID-19 vaccine patent rights puts pressure on drugmakers – but what would a waiver actually look like?” The Conversation News Release.

アンカー 18

Vol.18　Good news: The Covid-19 vaccine seems to work well according to worlds data

Last Updated 4 June 2021. Cellspect Co., Ltd.

　After actively administering vaccines in many countries, data from May show that in the countries with a full vaccination rate of more than 20%, the number of newly diagnosed cases has almost fallen sharply after people are vaccinated. Although the virus variants are still worrying, the epidemic prevention and control have made great progress. Here are a few examples as representative.

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　In terms of vaccination, Israel can be regarded as a model of global vaccination. The Israeli Journal of Health Policy Research pointed out that Israel was able to achieve rapid results in the early stages of vaccine delivery because the government immediately used special funds to purchase and distribute vaccines, clearly set the priority of vaccine delivery, and carefully designed vaccine promotion activities to encourage people to vaccinate. With the majority of the population having received the Pfizer-BioNTech vaccine, and about 92% of those 50 and older inoculated or recovered, Israel has been gradually reopening its economy after three lockdowns. The country's Health Ministry of Israel announced on May 24 that local COVID-19 restrictions will be removed following a successful vaccine rollout that has nearly stamped out new infections. The country reported just 12 new cases on May 24, down from a daily peak of more than 10,000 in January.

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　At the end of 2020, the United Kingdom is facing a record number of single-day diagnoses and the discovery of a faster-spreading mutant virus strain. British Prime Minister Johnson & Johnson announced that it has entered the third nationwide lockdown. It was also from this time that the United Kingdom took the lead in launching a large-scale campaign. As of May 27, 56% of the British people had received at least one dose of the vaccine, and 35% of the population had been fully vaccinated. The number of confirmed cases has dropped from about 80,000 people a day at the peak to more than 3,000 people now. As the epidemic improves, relevant social restrictions in the UK are gradually relaxed, including allowing indoor gatherings of less than 6 people and outdoor gatherings of less than 30 people. Bars, cinemas, museums and other places have also been opened.

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　The epidemic trend in the United States is very similar to that in the United Kingdom. The US has reached a "landmark day" in the Covid-19 pandemic as 60% of American adults have gotten at least one dose of a coronavirus vaccine, the director of the US Centers for Disease Control and Prevention said On May 17. The United States reported 392 deaths from the epidemic that day, and the average daily death toll in 7 days fell below 550, the first time it fell below 600 since March last year.

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　According to the statistics so far, when the vaccination rate reaches a certain level (about 20% or more), with appropriate epidemic prevention policies and good hygiene practices, the number of new diagnoses in a single day is indeed much more stable than before vaccination. However, it is important to note that it takes time to obtain immunity through the vaccine. The vaccine will have a good protective effect about 14 days after the second dose of the vaccine. Therefore, the control of the epidemic will delay the vaccination rate by several weeks.

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　However, there are also few countries where the epidemic situation has not dropped significantly after vaccination. Seychelles, an African island country located in the Indian Ocean, has the highest coverage rate in the world, with 60% of the fully vaccinated population, but there are still large-scale infections so far. According to the "New York Times" report, of the 60% of the population fully vaccinated in Seychelles, 57% were vaccinated with the China Sinopharm vaccine and 43% were vaccinated with the Oxford AZ vaccine. The World Health Organization said it is working hard to investigate the reason.

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　Vaccination is so far the best way to achieve herd immunity. To reach the threshold of herd immunity for COVID19, it is generally estimated that 60% to 70% of the entire population will be vaccinated. However, as the number of cases increases and the infectivity of the COVID-19 variant virus increases, the threshold for herd immunity also increases. Experts estimate that the threshold for herd immunity must be raised to 80%. However, this is not a simple goal because religious factors, suspicion of the government, or doubts about the safety of vaccination are involved. In most countries, more than 30% of the people are usually unwilling to be vaccinated. Experts can only appeal as much as possible, since this virus is unlikely to disappear, but people can do everything to make this virus into a mild infection, and vaccines are the only way now.

 References:​​

  1. Reuters: http://reuters.com/

  2. CNN: https://edition.cnn.com/

  3. The Israeli Journal of Health Policy Research

  4. Our World in Data: Coronavirus (COVID-19) Cases

アンカー 19

Vol.19　An updated summary of emerging SARS-CoV-2 variants

Last Updated 11 June 2021. Cellspect Co., Ltd.

Genetic variants of SARS-CoV-2 have been emerging and circulating around the world throughout the COVID-19 pandemic. WHO proposed labels for global SARS-CoV-2 variants of concern (VOC) and variants of interest (VOI) to be used alongside the scientific nomenclature in communications about variants to the public. VOC are variants that clear evidence is available indicating a significant impact on transmissibility, severity and/or immunity that is likely to have an impact on the epidemiological situation. VOI are variants that may have impact but not so worrying or lack of clear evidence. 

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In mid-May, WHO just announced India variant (SARS-CoV-2 B.1.617.2) as the fourth variants of concern (VOC). This variant was first detected in India, having rapidly displaced the B.1.1.7 strain that emerged in the UK in late 2020and is now dominant in the UK and India.  As of 31st May 2021, there are four VOC and six VOI in WHO's list.

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Emerging research suggests the variant may be more transmissible than previously evolved ones. Surveillance data from the Indian government's Integrated Disease Surveillance Programme (IDSP) shows that around 32% of patients, both hospitalized and outside hospitals, were aged below 30 in the second wave compared to 31% during the first wave, among people aged 30–40 the infection rate stayed at 21%. Hospitalization in the 20-39 bracket increased to 25.5% from 23.7% while the 0-19 range increased to 5.8% from 4.2%. The data also showed a higher proportion of asymptomatic patients were admitted during the second wave, with more complaints of breathlessness.

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The WHO said there may be some evidence of reduced neutralization for the current vaccines. In another laboratory study, a group of scientists led by Olivier Schwartz, at the Pasteur Institute reported a slightly diminished efficacy by Pfizer vaccine and low levels of antibodies induction by AstraZeneca vaccine against sub-variant B.1.617.2. A group of researchers from the Francis Crick Institute, published in The Lancet shows that humans fully vaccinated with the Pfizer-BioNTech vaccine are likely to have more than five times lower levels of neutralizing antibodies against the Delta variant.

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Research on the Indian variant strain is still in progress. A recent British study on May 28 pointed out that the Indian mutant may be caused by mutations in Spike protein S1 and S2 cleavage sites P681R, which enhances the ability of Furin converting enzyme to cut it, thus leading to virus increased replication, transmission, and pathogenicity. 

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Previously, scientists have cracked the two key proteins required for the new coronavirus to invade the human host. One is the ACE2 protein that binds to the ACE2 receptor of the host cell, and the other is the serine protease TMPRSS2 that activates the virus S protein to enter the host cell. Scientists now believe that Furin converting enzyme may also play an important role, because in the India variant, at the S1/S2 connection site on the spike protein, there is a small segment containing a unique sequence of Furin protease cleavage site, which is 681PRRAR/S686, which is not found in other subvariants of coronaviruses, and this cutting site may be a key site for virus replication, increased transmission and pathogenicity. Studies believe that the mutation of P681R site greatly enhances the cleavage ability of Furin protein, which also proves that arginine (R) replaces the original site mutation to enhance the cleavage ability. However, this study was published on "bioRxiv" and has not yet been peer reviewed, so further confirmation is needed.

 

The following is an updated table presenting possibly elevated risk information for variants.

En_コロナ学術情報コラムVol19.png

 References:​​

  1. WHO: Tracking SARS-CoV-2 variants: https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/

  2. CDC: SARS-CoV-2 Variant Classifications and Definitions: https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html#Consequence

  3. European Centre for Disease Prevention and Control: https://www.ecdc.europa.eu/en/covid-19/variants-concern

  4. Thomas P. Peacock et al. 2021 May 28 “The SARS-CoV-2 variants associated with infections in India, B.1.617, show enhanced spike cleavage by furin” bioRxiv.

  5. Emma C Wall et al. 2021 June 3 “Neutralising antibody activity against SARS-CoV-2 VOCs B.1.617.2 and B.1.351 by BNT162b2 vaccination” The Lancet.

アンカー 20

Vol.20　BIO 2021: Future development of the novel coronavirus antibody drug and diagnostic industry

Last Updated 25 June 2021. Cellspect Co., Ltd.

The world’s largest biotech event, BIO Digital 2021, was launched on June 14th. From 14th to 18th, scientists from all over the world were invited to discuss about how COVID-19 has reset our scientific expectations and transformed the way the public sees science and how biotechnology surpassed expectations and delivered the tools to end COVID-19. Here are some important conclusions from biotech R&D sections, pharmaceutical companies and government health departments on future development of the novel coronavirus antibody drug and diagnostic industry.

 

Experts proposed 4 countermeasures for variant viruses: 

•  Global real-time genomic surveillance of virus

The Office of the Assistant Secretary for Prevention and Response (ASPR) of the US Department of Health emphasized the importance of "surveillance" for controlling the current epidemic. Because of the large number of people infected, the epidemic area and genotype of the virus are changing rapidly over time. Therefore, in addition to the importance of case-based surveillance, there is still a need to strengthen the global surveillance of virus gene. In the past year, the United States has improved a lot in its overall epidemic surveillance, including the hospital notification system and the supply chain of related materials. However, it is hoped that the whole genome sequencing surveillance of the virus can be used globally. Establishing the most immediate and nimble system as soon as possible is the way to effectively suppress the epidemic.

 

•  Broad-spectrum drugs that directly attack viral RNA are more effective

Many vaccines have been developed around the world, but it is still difficult to completely contain the epidemic due to the mutation of the virus. Arpa Garay, president of MSD Global Pharmaceuticals, said that the future direction of drug development should not target only the viral spike protein like the current monoclonal antibody therapeutics or vaccines. It should have broad antiviral effects, such as "inserts" into viral RNA and destroys viral functions. It is more effective for variants that have constantly mutations on the surface.

 

•  "Intramuscular injection" of antibody drugs is a trend

The latest research and development trend for coronavirus antibody indicates that current antibody therapies of emergency use authorization (EUA) are all intravenous (IV) injection forms. In order to improve the convenience of treatment, many companies like Regeneron and AstraZeneca are actively developing an intramuscular (IM) injection version. The key to changing the IV to the IM injection form is to greatly reduce the injection volume and dosage while ensuring the efficacy. A cocktail strategy including the use of a mixture of multiple antibodies to increase the coverage of the antibody against the virus is also one of the methods to overcome this challenge. In order to deal with emerging diseases in the future, it is also an urgent task to develop broad-spectrum antibodies or small molecule therapies against influenza viruses, coronaviruses, etc., so as to be as high as possible. Reduce the occurrence of the next pandemic.

 

•  Improve clinical trial infrastructure of low-income countries 

For countries with scarce medical resources, testing alone is quite difficult, let alone being included in the clinical trial? Therefore, it is hoped that in the future, low-cost testing and improved clinical trial infrastructure can help these countries to obtain resources more equitably; at the same time, this is also one of the ways to prevent the spread of the epidemic worldwide and the continuous mutation of the virus. 

 

Future trends in COVID-19 testing

Paul Sheives, Roche's Director of Federal Health Policy, believes that testing has real power in a pandemic and is more than simply diagnosing pathogens. To find the infected person as soon as possible, in addition to high-throughput testing, there is also a need for rapid transmission of test results. Therefore, these tests need to be connected to digital health platforms. This will also change the medical behavior of users and move toward the remote development of diagnosis. 

However, even though testing is relatively important, it is often listed in the final investment list. Experts said that the government should provide guidance on regulatory supervision, clinical verification, and marketing to accelerate the development of home and laboratory testing to obtain emergency authorization. At the same time, it is also necessary to take the lead in joining the international market and create more orders for these cooperatively supported companies. Moreover, in order for innovative testing to continue to be developed, the speed of review should also be accelerated, and the R&D and production of these companies should be supported through incentives, cooperation, investment, and procurement. 

Experts believe that "why test, how to process test results, and how to interact the results with health care" will be prior questions to be established in the new diagnosis era. These will ensure that a country has better detection equipment and capabilities in the future to face possible emerging public health threats.

 References:​​

  1. Bio Digital 2021: https://www.bio.org/events/bio-digital​

  2. Bio Digital section: Diagnosing the Future: The Impact of the COVID-19 Pandemic on Diagnostics

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