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COVID-19 Update: Vaccines for Kids and an Upcoming Verdict on Boosters

External advisors to the U.S. Food and Drug Administration will meet on Sept. 17 to consider data from Pfizer and BioNTech in support of booster shots. Meanwhile, a timeline is being presented on the authorization of Covid-19 vaccines for children.

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COVID-19 Update: Vaccines for Kids and an Upcoming Verdict on Boosters

 

External advisors to the U.S. Food and Drug Administration (FDA) will meet this Friday to consider data from Pfizer and BioNTech in support of booster shots. Meanwhile, a timeline is being presented on the authorization of COVID-19 vaccines for children. Read on to find out more.

Pfizer Emphasizes Israel and U.S. Data in Support of Booster Shots

Pfizer plans to present to outside advisers to the FDA on Friday, September 17, on booster COVID-19 shots. It has indicated that data from the U.S. and Israel show the efficacy of the Pfizer-BioNTech vaccine drops over time. It also shows that a booster is safe and effective at preventing infections from SARS-CoV-2 and its variants.

“Real-world data from Israel and the United States suggest that rates of breakthrough infections are rising faster in individuals who were vaccinated earlier,” Pfizer said in the presentation, which has been published on the FDA website. The data also suggests that the decrease in effectiveness has less to do with the delta variant than waning vaccine immunity over time.

Pfizer Expects to Submit for Vaccine Authorization in Children in November

Pfizer and BioNTech are planning to apply for authorization to the FDA for their COVID-19 vaccine for children between the ages of six months and five years in November, Frank D’Amelio, Pfizer’s chief financial officer, said at a conference on September 14. Originally, they were expected to submit in early October, but Amelio told attendees at the Morgan Stanley Global Healthcare Conference it would be filed “in the weeks shortly thereafter the filing of the data for the five to 11-year-olds … assuming all of the data is positive.”

They are expecting the clinical trial data at the end of October.

FDA Seems Skeptical of Boosters Despite Pfizer’s Assertions

Although Pfizer has been asserting for some time that there will be a need for booster shots, several vaccine experts, including some with the FDA, appear skeptical. Last month, a committee with the Centers for Disease Control and Prevention (CDC) expressed preliminary support for boosters, particularly for people at high risk for severe disease and death. But FDA researchers wrote yesterday concerns about lower antibody levels and weaker protection against COVID-19, particularly with the delta variant. Still, they did not believe this decreased protection made the vaccines less effective. They wrote, “Overall, data indicate that currently, U.S.-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States.”

Moderna Also Suggests Vaccine Immunity Decreases Over Time

Most of the focus on booster shots has come out of Pfizer and BioNTech largely because much of the data derives from Israel, which exclusively uses the Pfizer-BioNTech vaccine. However, new data from Moderna also shows its vaccine wanes over time, hence the company’s argument in favor of booster doses.

Source: BioSpace

“This is only one estimate, but we do believe this means as you look toward the fall and winter, at minimum we expect the estimated impact of waning immunity would be 600,000 additional cases of COVID-19,” Stephen Hoge, M.D., president of Moderna, said in a conference call with investors.

The data contrasts with other studies suggesting that the Moderna vaccine holds its immunity longer, likely due to its higher dose of messenger RNA and a longer interval between shots.

Hoge noted, “We believe this (boosters) will reduce COVID-19 cases. We also believe that a third dose of mRNA-1273 has a chance of significantly extending immunity throughout much of next year as we attempt to end the pandemic.”

Parents Looking for Vaccine Trials for Children

The Wall Street Journal reported that some parents are trying to get their children into clinical trials of COVID-19 vaccines to protect them from the disease. For example, Rachael DiFransisco, from Cleveland, is trying to get her 14-month-old daughter Sybil into a trial. “This trial is our best shot at getting the vaccine as quickly as possible,” she said. “We want some semblance of normalcy for her.”

Children are at lower risk of severe disease and hospitalizations than adults, in general, but their numbers are increasing in hospitalizations because of the spread of the delta variant. This appears to be driving parents to seek vaccinations and trial participation.

As mentioned above, the Pfizer shot is likely to be authorized in November for children under 12. Moderna is expected to submit for emergency use authorization (EUA) for six- to 12-year-olds by the end of the year and early in 2022 for children six months to six years.

 

BioSpace source:

https://www.biospace.com/article/covid-19-timelines-for-booster-shots-and-immunization-for-children

 

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Huge Dock Worker Protests In Italy, Fears Of Disruption, As Covid ‘Green Pass’ Takes Effect

Huge Dock Worker Protests In Italy, Fears Of Disruption, As Covid ‘Green Pass’ Takes Effect

Following Israel across the Mediterranean being the first country in the world to implement an internal Covid passport allowing only vaccinated citize

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Huge Dock Worker Protests In Italy, Fears Of Disruption, As Covid 'Green Pass' Takes Effect

Following Israel across the Mediterranean being the first country in the world to implement an internal Covid passport allowing only vaccinated citizens to engage in all public activity, Italy on Friday implemented its own 'Green Pass' in the strictest and first such move for Europe

The fully mandatory for every Italian citizen health pass "allows" entry into work spaces or activities like going to restaurants and bars, based on one of the following three conditions that must be met: 

  • proof of at least one dose of Covid-19 vaccine

  • or proof of recent recovery from an infection

  • or a negative test within the past 48 hours

Via AFP

It's already being recognized in multiple media reports as among "the world's strictest anti-COVID measures" for workers. First approved by Italian Prime Minister Mario Draghi's cabinet a month ago, it has now become mandatory on Oct.15.

Protests have been quick to pop up across various parts of the country, particularly as workers who don't comply can be fined 1,500 euros ($1,760); and alternately workers can be forced to take unpaid leave for refusing the jab. CNN notes that it triggered "protests at key ports and fears of disruption" on Friday, detailing further:

The largest demonstrations were at the major northeastern port of Trieste, where labor groups had threatened to block operations and around 6,000 protesters, some chanting and carrying flares, gathered outside the gates.

    Around 40% of Trieste's port workers are not vaccinated, said Stefano Puzzer, a local trade union official, a far higher proportion than in the general Italian population.

    Workers at the large port of Trieste have effectively blocked access to the key transport hub...

    As The Hill notes, anyone wishing to travel to Italy anytime soon will have to obtain the green pass: "The pass is already required in Italy for both tourists and nationals to enter museums, theatres, gyms and indoor restaurants, as well as to board trains, buses and domestic flights."

    The prime minister had earlier promoted the pass as a way to ensure no more lockdowns in already hard hit Italy, which has had an estimated 130,000 Covid-related deaths since the start of the pandemic.

    Meanwhile, the requirement of what's essentially a domestic Covid passport is practically catching on in other parts of Europe as well, with it already being required to enter certain hospitality settings in German and Greece, for example. Some towns in Germany have reportedly begun requiring vaccination proof just to enter stores. So likely the Italy model will soon be enacted in Western Europe as well.

    Tyler Durden Sat, 10/16/2021 - 07:35

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    Tracking Global Hunger & Food Insecurity

    Tracking Global Hunger & Food Insecurity

    Hunger is still one the biggest – and most solvable – problems in the world.

    Every day, as Visual Capitalist’s Bruno Venditti notes, more than 700 million people (8.8% of the world’s population)..

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    Tracking Global Hunger & Food Insecurity

    Hunger is still one the biggest - and most solvable - problems in the world.

    Every day, as Visual Capitalist's Bruno Venditti notes, more than 700 million people (8.8% of the world’s population) go to bed on an empty stomach, according to the UN World Food Programme (WFP).

    The WFP’s HungerMap LIVE displayed here tracks core indicators of acute hunger like household food consumption, livelihoods, child nutritional status, mortality, and access to clean water in order to rank countries.

    After sitting closer to 600 million from 2014 to 2019, the number of people in the world affected by hunger increased during the COVID-19 pandemic.

    In 2020, 155 million people (2% of the world’s population) experienced acute hunger, requiring urgent assistance.

    The Fight to Feed the World

    The problem of global hunger isn’t new, and attempts to solve it have making headlines for decades.

    On July 13, 1985, at Wembley Stadium in London, Prince Charles and Princess Diana officially opened Live Aid, a worldwide rock concert organized to raise money for the relief of famine-stricken Africans.

    The event was followed by similar concerts at other arenas around the world, globally linked by satellite to more than a billion viewers in 110 nations, raising more than $125 million ($309 million in today’s dollars) in famine relief for Africa.

    But 35+ years later, the continent still struggles. According to the UN, from 12 countries with the highest prevalence of insufficient food consumption in the world, nine are in Africa.

     

    Approximately 30 million people in Africa face the effects of severe food insecurity, including malnutrition, starvation, and poverty.

     

    Wasted Leftovers

    Although many of the reasons for the food crisis around the globe involve conflicts or environmental challenges, one of the big contributors is food waste.

    According to the United Nations, one-third of food produced for human consumption is lost or wasted globally. This amounts to about 1.3 billion tons of wasted food per year, worth approximately $1 trillion.

    All the food produced but never eaten would be sufficient to feed two billion people. That’s more than twice the number of undernourished people across the globe. Consumers in rich countries waste almost as much food as the entire net food production of sub-Saharan Africa each year.

    Solving Global Hunger

    While many people may not be “hungry” in the sense that they are suffering physical discomfort, they may still be food insecure, lacking regular access to enough safe and nutritious food for normal growth and development.

    Estimates of how much money it would take to end world hunger range from $7 billion to $265 billion per year.

    But to tackle the problem, investments must be utilized in the right places. Specialists say that governments and organizations need to provide food and humanitarian relief to the most at-risk regions, increase agricultural productivity, and invest in more efficient supply chains.

    Tyler Durden Fri, 10/15/2021 - 23:30

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    Economics

    China Coal Prices Soar To Record As Winter Freeze Spreads Cross The Country

    China Coal Prices Soar To Record As Winter Freeze Spreads Cross The Country

    One week ago we discussed why the "worst case" scenario for China’s property crisis is gradually emerging; to this we can now add that China’s worst case energy crisi

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    China Coal Prices Soar To Record As Winter Freeze Spreads Cross The Country

    One week ago we discussed why the "worst case" scenario for China's property crisis is gradually emerging; to this we can now add that China's worst case energy crisis scenario is also about to be unleashed as cold weather swept into much of the country and power plants scrambled to stock up on coal, sending prices of the fuel to record highs.

    Electricity demand to heat homes and offices is expected to soar this week as strong cold winds move down from northern China, according to Reuters with forecasters predicting average temperatures in some central and eastern regions could fall by as much as 16 degrees Celsius in the next 2-3 days.

    Shortages of coal, high fuel prices and booming post-pandemic industrial demand have sparked widespread power shortages in the world's second-largest economy. Rationing has already been in place in at least 17 of mainland China's more than 30 regions since September, forcing some factories to suspend production and further disrupting already broken supply chains.

    On Friday, the most-active January Zhengzhou thermal coal futures closed at a record high of 2,226 per tonne early. The contract has risen almost 200% year to date.

    China's three northeastern provinces of Jilin, Heilongjiang and Liaoning - also among the worst hit by the power shortages last month - as well as several regions in northern China including Inner Mongolia and Gansu have started winter heating, which is mainly fuelled by coal, to cope with the colder-than-normal weather.

    Meanwhile, even though Beijing has taken a slew of measures to contain coal price rises including raising domestic coal output and cutting power to power-hungry industries and some factories during periods of peak demand, so far all measures have failed with coal surging by 40% in just the past three days. Beijing has also repeatedly assured users that energy supplies will be secured for the winter heating season, and went so far as to order energy firms to "secure supplies at all costs." Well, the energy firms heard it, because on that day, thermal coal closed at 1,436 yuan. Two weeks later it is some 800 yuan higher.

    Unfortunately for Beijing, the power shortages are expected to continue into early next year, with analysts and traders forecasting a 12% drop in industrial power consumption in the fourth quarter as coal supplies fall short and local governments give priority to residential users.

    Earlier this week, we reported that China undertook its boldest step in a decades-long power sector reform when it allowed coal-fired power prices to fluctuate by up to 20% from base levels from Oct. 15, enabling power plants to pass on more of the high costs of generation to commercial and industrial end-users. read more

    Steel, aluminium, cement and chemical producers are expected to face higher and more volatile power costs under the new policy, pressuring profit margins.

    Meanwhile, the latest Chinese "data" on Thursday showed factory-gate inflation in September hit a record high; but since thermal coal is the one commodity that correlates the closest to PPI, absent a sharp drop in coal prices in the next few weeks, expect the next PPI print to be far higher. Meanwhile as the power crisis leads to further shutdowns in domestic production, some banks - such as Nomura - have gone so far to predict that China's GDP is set to shrink in coming quarters.

    China, which laughably aims to be "carbon neutral" by 2060 even as its president announced he will skip the COP26 UN Climate Change Conference in Glasgow, has been "trying" to reduce its reliance on polluting coal power in favor of cleaner wind, solar and hydro. But coal remains the source for some 70% of China's electricity needs.

    Of course, China is not the only nation struggling with power supplies, which has led to fuel shortages and blackouts in many European countries. and threatens to send US heating bills up as much as 50% this winter. he crisis has highlighted the difficulty in cutting the global economy's dependency on fossil fuels as world leaders seek to revive efforts to tackle climate change at talks next month in Glasgow.

    China will strive to achieve carbon peaks by 2030, Vice Premier Han Zheng said in a video message at the Russian Energy Week International Forum, according to state-run news agency Xinhua late on Thursday. He also said that China and Russia are important forces leading the energy transition and they should cooperate and ensure smooth progress of major oil and gas pipeline and nuclear power projects.

    Translation: Russia better save that nat gas and not ship it to Europe as China will soon be needed even BCF Russia an provide. As for China

     

    Tyler Durden Fri, 10/15/2021 - 22:50

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