Researchers look ahead to the potential uses and benefits of self-copying RNA vaccine

Jab-Vaccine-Administered

Important Takeaways:

  • Self-copying RNA vaccine wins first full approval: what’s next?
  • The endorsement last week by Japanese authorities of a jab against SARS-CoV-2 constructed using a form of RNA that can make copies of itself inside cells — the first ‘self-amplifying’ RNA (saRNA) granted full regulatory approval anywhere in the world — marks a pivotal advance.
  • Researchers have been trying to make saRNA vaccines a reality for more than 20 years.
  • “saRNA is a totally different beast.”
  • With approval for ARCT-154 secured in Japan, its developers are now seeking authorization in Europe; a regulatory decision is expected next year.

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Come and get your Booster shot: Biden admin urges all Americans to get the next round of vaccines

Biden Covid Shot

The American Heritage Dictionary “plagues”
1. A highly infectious, usually fatal, epidemic disease; a pestilence.
2. A virulent, infectious disease that is caused by the bacterium Yersinia pestis (syn. Pasteurella pestis) and is transmitted primarily by the bite of fleas from an infected rodent, especially a rat. In humans it occurs in bubonic form, marked by lymph node enlargement, and in pneumonic form, marked by infection of the lungs, and can progress to septicemia.
3. A widespread affliction or calamity seen as divine retribution.

Important Takeaways:

  • Biden Administration to Urge All Americans: Get a Coronavirus Booster Shot Now
  • All Americans will be urged by the Biden administration to get a coronavirus booster shot this autumn ahead of what it claims is a new wave of infections, a White House official said Sunday.
  • Reuters reports the official said while the Centers for Disease Control and Prevention reports an increase in infections and hospital admissions from the virus, overall levels remain low, however caution is urged.
  • Moderna and other coronavirus vaccine makers Novavax, Pfizer and German partner BioNTech SE have all reportedly created versions of their shots ready and aimed at the XBB.1.5 subvariant.

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Lest We Forget: The CDC bought cellphone data to track vaccination, lockdown compliance

CDC Building

Important Takeaways:

  • CDC bought cellphone data to track vaccination, lockdown compliance: report
  • The Centers for Disease Control and Prevention used location data from tens of millions of Americans’ phones to track compliance with lockdown orders and vaccination efforts, according to newly revealed documents.
  • The CDC specifically monitored Americans’ visits to churches and schools, as well as “detailed counts of visits to participating pharmacies for vaccine monitoring,” internal documents from the federal agency obtained by Vice show.
  • The CDC also reportedly tracked peoples’ movement during curfews and visits between neighbors.
  • A controversial “data broker” called SafeGraph initially provided the data to the CDC for free during the outbreak of the pandemic, the documents show. Then in 2021, the CDC reportedly hatched a deal to pay the company $420,000 for continued access.

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A new study called ‘Circulation’ examined young adults suffering from Post-vaccination myocarditis

COVID vaccine shot

Luke 21:11 “There will be great earthquakes, and in various places famines and pestilences. And there will be terrors and great signs from heaven.”

Important Takeaways:

  • American Heart Association Publishes Study Confirming mRNA Vaccines ‘May Contribute to Myocarditis’
  • A peer-reviewed study published in the journal called Circulation examined the cases of 16 adolescents and young adults hospitalized at Massachusetts General Hospital or Boston Children’s, suffering from post-vaccination myocarditis from January 2021-February 2022.
  • It concludes that those 16 young people had “markedly elevated levels of full-length spike protein” in their blood, “unbounded by antibodies.”
  • “Rarely, some individuals develop myocarditis after mRNA vaccination,” it reads. “The immune response driving post-vaccine myocarditis has not yet been elucidated. Understanding the immunophenotype associated with mRNA  vaccine–induced myocarditis is an essential  first step in preventing negative complications resulting from this novel vaccine technology.”
  • In other words, the researchers still aren’t sure why some people experience this dangerous type of heart inflammation while others don’t.
  • Overall, it seems to back research by the Florida Department of Health that found that the mRNA vaccines are associated with an 84% increase in cardiac-related adverse events among males 18-39 years old.

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America’s People’s Convoy Has Begun Making its Way to DC

Important Takeaways:

  • America’s People’s Convoy gets ready to roll! One thousand trucks begin 11-day drive from California to D.C. TODAY to protest COVID mask and vaccine mandates
  • The organizers also claim the convoy is ‘about freedom and unity,’ noting the truckers are ‘riding unified across party and state lines and with people of all colors and creeds’
  • Organizers and participants argue the ongoing COVID-19 restrictions and mandates are unconstitutional and claim the ‘government has forgotten its place’
  • The People’s Convoy has called on the federal government to end the National Emergency enacted at the start of the pandemic, which President Joe Biden extended on Friday despite calls from Congress to end it
  • The District of Columbia government – including Democrat Mayor Muriel Bowser – and the U.S. Capitol Police are requesting the National Guard assistance
  • DC leaders have also increased police presence in the city and plan to reinstall the fencing that surrounded the Capitol complex for much of 2021

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U.S. plans to invest billions in manufacturing COVID-19 vaccine

By Jeff Mason and Alexandra Alper

WASHINGTON (Reuters) -The United States plans to invest billions of dollars in expanding COVID-19 vaccine manufacturing capacity and make available an additional one billion doses per year, White House COVID-19 coordinator Jeff Zients said on Wednesday.

Activists have pressured President Joe Biden’s administration to increase vaccine supply to poorer countries.

Zients said the government was preparing to offer makers of the mRNA vaccines substantial help to expand infrastructure and capacity, including facilities, equipment, staff or training.

Pfizer/BioNTech and Moderna are the only makers of mRNA vaccines, though Zients said subcontractors of those companies would also be included.

Production will start in the second half of 2022, he said.

The investment in vaccine production is part of a private-public partnership to address vaccine needs at home and around the world and to prepare for future pandemics, he said. It will be paid for with funds from the American Rescue Plan Biden signed into law in March.

In the short term, the program would make a significant amount of COVID-19 vaccine doses available at cost for global use. In the long term, it would help establish sustained domestic manufacturing capacity to rapidly produce vaccines for future threats, Zients said.

Zients said 80% of Americans 12 and older have received at least one COVID-19 vaccine dose, highlighting a milestone in efforts to curb the spread of the deadly virus.

He also said 2.6 million kids aged 5-11 will have received their first shot of the COVID-19 vaccine by the end of Wednesday.

(Reporting by Jeff Mason and Alexandra Alper, Additional reporting by Doina Chiacu and Ahmed Aboulenein; Editing by Chizu Nomiyama, Bernadette Baum and David Gregorio)

Over 900,000 U.S. kids to get first COVID-19 shot by end of Wed -White House

WASHINGTON (Reuters) -Over 900,000 U.S. children aged 5-11 are expected to have received their first COVID-19 vaccine shot by the end of Wednesday, White House COVID-19 coordinator Jeff Zients said, as the government ramped up vaccinations of younger children.

The United States on Wednesday began administering Pfizer/BioNTech’s COVID-19 vaccine to children ages 5 to 11, the latest group to become eligible for the shots that provide protection against the illness to recipients and those around them.

“While our program is just fully up and running this week, by the end of the day today, we estimate that over 900,000 kids aged five through 11 will have already gotten their first shot,” Zients said during a briefing with reporters.

The figure comes from a White House analysis of available data from pharmaceutical partners, some states, and localities, Zients said, adding the CDC has not yet collected the full tally.

COVID-19 is the largest vaccine-preventable killer of children in that age group, with 66 children dying from it over the past year, U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said at the same briefing.

The seven-day average of total COVID-19 cases in the U.S. was flat at about 73,300 over the past week, she said, with the hospitalization rate also flat at 5,000 a day. The seven-day average of daily deaths fell 11% to around 1,000 per day.

(Reporting by Susan Heavey, Alexandra Alper, and Ahmed Aboulenein; Editing by Nick Zieminski and David Gregorio)

Factbox – Latest on the worldwide spread of the coronavirus

(Reuters) – New York City Mayor Bill de Blasio declared his coronavirus vaccination order for emergency responders a success, with no disruption to city services, despite a sickout by some firefighters who officials said were protesting the mandate.

DEATHS AND INFECTIONS

EUROPE

* Leaders of the world’s 20 biggest economies endorsed in Rome a global minimum tax aimed at stopping big business from hiding profits in tax havens, and also agreed to get more COVID vaccines to poorer nations.

* Britain will send 20 million vaccine doses to developing countries by the end of this year in what Prime Minister Boris Johnson will tell other world leaders is a much needed step to speed up the post-pandemic economic recovery.

* President Vladimir Putin said Russia may need the army’s help to build field hospitals for COVID-19 patients as the country battles a surge in infections that has led to a nationwide workplace shutdown.

* The Netherlands will impose new coronavirus restrictions this week in a bid to curb a recent surge in infections.

* Latvia has received shipments of emergency medical equipment from the Netherlands, Finland, Hungary and Sweden as it fights the worst surge in new COVID-19 cases in the European Union amid a low take-up of vaccinations.

AMERICAS

* The Biden administration said a planned rule requiring private-sector employers with 100 or more employees to mandate COVID-19 vaccines or regular testing will be published in the coming days.

* The United States is rolling out Pfizer/BioNTech COVID-19 vaccines for children aged 5 to 11 this week, but most of the 15 million shots being shipped initially are unlikely to be available before next week.

* U.S. states with the highest adult vaccination rates against COVID-19 are planning a big push to get children inoculated compared to states where hesitancy remains strong, potentially widening the gaps in protection nationwide, public health officials and experts said.

ASIA-PACIFIC

* Thailand, Australia and Israel eased international border restrictions significantly Monday for the first time in 18 months, offering a broad test of demand for travel worldwide amid the pandemic.

* New Zealand will extend coronavirus curbs for another week in its largest city of Auckland but ease some after that, with the country logging another day of record new infections.

* A declassified U.S. intelligence report saying it was plausible that the COVID-19 pandemic originated in a laboratory is unscientific and has no credibility, a Chinese foreign ministry spokesman said.

* Indonesia has approved the Sinovac Biotech vaccine for children aged 6-11, its food and drug agency said, following the U.S. Food and Drug Administration’s approval of the Pfizer/BioNTech vaccine for younger children.

MIDDLE EAST AND AFRICA

* The United Arab Emirates has approved for emergency use the Pfizer-BioNtech vaccine for children aged 5-11, the health ministry said in a statement carried by state media.

MEDICAL DEVELOPMENTS

* Novavax Inc expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within “weeks,” its chief executive told Reuters, after the shot received its first emergency use authorization from Indonesia.

ECONOMIC IMPACT

* Global equity markets rose at the start of a big week for central bank meetings, helped by bets of fiscal stimulus in Japan and undeterred by concerns of future interest rate hikes that have tempered bonds.

(Compiled by Aditya Soni and Federico Maccioni; Edited by Angus MacSwan and Arun Koyyur)

Cuba to welcome tourists as home-grown vaccine drive takes hold

By Marc Frank and Nelson Acosta

HAVANA (Reuters) – Cuba will open its borders and ease entry requirements next month after vaccinating most of its people with home-grown COVID-19 drugs, allowing it to welcome back overseas visitors and giving a shot in the arm to its ailing tourist industry.

Tough restrictions due to the pandemic, a drastic reduction in flights to Cuba, and a U.S. ban on most travel to the Communist-run island under former U.S. President Donald Trump have hobbled the business and left it trailing behind regional competitors such as the Dominican Republic, Puerto Rico, the Bahamas and Cancun.

But as Nov. 15, Cuba will only require visitors to carry proof of vaccination or a recent PCR to enter the country, replacing what were previously among the strictest protocols in the Caribbean, involving a quarantine period and multiple PCR tests.

A fully vaccinated population will prove a key selling point for an island already well-regarded for its safety, beaches and turquoise waters, said Francisco Camps, who supervises Spanish firm Sol Melia’s 32 hotels in Cuba.

“Cuba will be one of the safest sanitary destinations and we believe that we can reach visitations similar to 2019 by the end of next year,” he said.

Cuba’s home-grown vaccines are currently under review by the World Health Organization and most trial data has yet to be peer reviewed.

But among countries with more than 1 million people, Cuba is vaccinating faster than any other, according to a Reuters tally of official data.

The government says the pace is paying dividends, with COVID-19 cases and deaths falling off at least 80% since their peak mid-summer. At least 90% of the population has received at least one dose of one of the country’s three-dose homegrown vaccines.

“We are in a favorable moment as we begin to recover our customs, to be able to visit relatives and go on vacation, as well as improve economic activity,” Tourism Minister Juan Carlos Garcia said this month.

The pandemic closed schools, entertainment venues and restaurants as it reduced to near zero the all-important tourism industry – freezing foreign trips by Cubans and visits to the country from Cubans living overseas – exacerbating an economic crisis that has left residents short of food and medicine.

Cuba received more than four million tourists in 2019, contributing 10.6 percent to gross domestic product (GDP), and much more through supply chains and informal economic activity.

But this year just 200,000 guests have arrived and only another 100,000 are expected, Minister Garcia said.

Cuban economist Ricardo Torres said those numbers meant a “devastating” 92% drop in tourism this year, compared to 2019.

“So we are talking about next year for any real tourism recovery…which generates a knock-on effect and so is decisive to economic recovery,” said Torres, a visiting professor at American University in Washington.

The U.S. embargo sharply limits trade with Cuba, so the country depends heavily on flows of foreign currency and basic goods that travelers and the Cuban diaspora bring to the island.

Despite mounting optimism as tourism resumes, officials have cautioned economic recovery will be more gradual than initially thought following a sharp drop of 10.9% last year and another 2% through June.

The Varadero beach resort is already partially open, including for the domestic market, for which it is the favorite destination.

And life is slowly returning to the colonial district of Havana as it prepares to once more welcome visitors after a 19-month hiatus.

“Old Havana has been sad all this time because there have been no tourists,” said Ernesto Alejandro Labrada, owner of the Antojos restaurant, now packed with Cubans enjoying a meal before the visitors return.

(Reporting by Marc Frank; additional reporting by Nelson Acosta, editing by Dave Sherwood and Angus MacSwan)

U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children

By Manas Mishra and Michael Erman

(Reuters) -An expert panel will weigh authorization of Pfizer Inc and BioNTech’s COVID-19 vaccine for U.S. children aged 5 to 11 on Tuesday as it prepares to vote on a recommendation for the federal Food and Drug Administration.

An authorization is an important regulatory step toward reaching about 28 million children of these ages, most of them back in school for in-person learning.

The FDA need not follow the advice of its outside experts, but usually does.

While children rarely become seriously ill or die from COVID-19, some develop complications, and COVID-19 cases in unvaccinated children have risen due to the contagious Delta variant.

The age group is “far from being spared from the harm of COVID-19,” with the virus now one of the top 10 causes of deaths in American children, FDA official Peter Marks told the panel. He said there had been close to 100 deaths in that age group so far, and 1.9 million infections.

“In addition, infections have caused many school closures and disrupted the education and socialization of children,” he said.

FDA staff, in documents posted before the meeting, said the likely vaccine benefits in that age group clearly outweigh the potential harms, including the rare risk of heart inflammation.

Only a few other countries, including China, Cuba and the United Arab Emirates, have cleared COVID-19 vaccines for children in this age group and younger.

Since May, the World Health Organization has been urging rich countries to reconsider plans to vaccinate children and instead donate COVID-19 shots to the COVAX scheme for poorer countries.

The advisers are expected to pay close attention to the rate of the rare cases of heart inflammation called myocarditis that have been linked to both the Pfizer/BioNTech and Moderna vaccine, particularly in young men.

Pfizer and BioNTech are seeking clearance for a lower, 10-microgram dose version of the vaccine in children, versus 30 micrograms for everyone over the age of 12. The shot has been authorized for ages 12-15 since May and cleared for everyone over 16 since December.

The companies have said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.

After the FDA, a panel to the U.S. Centers for Disease Control and Prevention will make a recommendation on the administration of the vaccine. The director of the agency will make the final call.

Top U.S. infectious disease expert Anthony Fauci said on Sunday that it was likely the vaccine will be available to children in the first week or two of November.

If the number of myocarditis cases in the younger age group turns out to be similar to that in 12- to 15-year-olds, the hospitalizations prevented for COVID-19 would outnumber those prevented for myocarditis in most scenarios analyzed, FDA staff reviewers said.

“No matter what size of the safety database, there will always be uncertainties regarding benefits and risks, including for example, the risk of vaccine-associated myocarditis,” said Doran Fink, the FDA’s deputy director for vaccine development.

These uncertainties have to be addressed in surveillance data and studies following authorization, Fink told the panel.

Pediatric vaccinations are an important public health tool to prevent infectious diseases, even ones that do not cause high rates of mortality or hospitalization for children.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Editing by Caroline Humer, Richard Chang and Jonathan Oatis)