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)

Statins may slightly lower COVID-19 death risk; using a different vaccine as booster may offer more protection

By Nancy Lapid

(Reuters) – The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review.

Statins may protect slightly against COVID-19 death

Widely-used statin drugs for lowering cholesterol may be linked to a slightly lower risk of dying from COVID-19, new data suggest. Researchers at Karolinska Institute in Sweden reviewed the medical records of nearly 1 million residents of Stockholm over the age of 45 between March and November 2020, roughly 18% of whom had been prescribed a statin, such as Pfizer Inc’s Lipitor (atorvastatin) and Merck & Co’s Zocor (simvastatin). The people prescribed statins had more risk factors for poor COVID-19 outcomes: they were older, more often male, had more medical conditions, lower education levels and less disposable income. After taking all that into account, statin users were still 12% less likely to have died of COVID-19 during the study period, according to a report published on Thursday in PLOS Medicine. The researchers did not compare outcomes in people who actually got infected with the virus, however. And they only had data on prescriptions – not on whether patients took the medicine as prescribed. A formal clinical trial would be needed to confirm the findings. Still, they conclude, their data “suggest that statin treatment may have a modest preventive therapeutic effect on COVID-19 mortality.”

Boosting with a different vaccine is safe, may be better

People who got Johnson & Johnson’s COVID-19 vaccine as a first shot had a stronger immune response when boosted with vaccines from either Pfizer Inc/BioNTech SE or Moderna Inc, according to a study run by the National Institutes of Health. The trial, which included more than 450 adults who received initial shots from Pfizer/BioNTech, Moderna, or J&J, also showed that “mixing and matching” booster shots using different vaccine technology is safe in adults, the researchers reported in a paper posted on medRxiv on Wednesday ahead of peer review. Moderna’s and Pfizer’s vaccines are based on messenger RNA (mRNA) while J&J’s uses viral vector technology. The trial looked at a total of nine combinations of initial shots and boosters. Using different types of shots as boosters generally produced a comparable or higher antibody response than using the same type, the researchers reported. Mixing booster doses “may offer immunological advantages to optimize the breadth and longevity of protection achieved with currently available vaccines,” they said.

Old age alone does not predict COVID-19 mortality risk

Older patients are known to be at higher risk for poor outcomes after infection with the coronavirus, but among those hospitalized with COVID-19, other characteristics help predict who is likely to do poorly, new data suggest. In a review of data on 4,783 people age 65 and older who were hospitalized for COVID-19 early in the pandemic, researchers at Northwell Health hospitals in New York found that age itself did not independently predict whether a patient was more likely to die. Instead, they reported on Thursday in BMC Geriatrics, more important predictors of death for elderly patients were factors such as how independent they were before the infection, how sick they were when they arrived at the hospital, and their pre-existing medical conditions, such as high blood pressure, kidney disease, lung disease and dementia. The researchers noted that in facilities forced to ration care or facing resource shortages, some guidelines use advanced age as a reason to deny care. “Our findings support the American Geriatrics Society position statement indicating age alone should never be used to make decisions regarding resource allocation under conditions of resource scarcity,” the researchers said. “Although age is still an important factor in the overall risk of COVID-19 mortality… a comprehensive approach that accounts for the above factors is essential in preventing ageism.”

(Reporting by Nancy Lapid and Carl O’Donnell; Editing by Bill Berkrot)

New York must allow religious exemptions to COVID-19 vaccine mandate, judge rules

By Tom Hals and Nate Raymond

(Reuters) -A federal judge ruled on Tuesday that New York state cannot impose a COVID-19 vaccine mandate on healthcare workers without allowing their employers to consider religious exemption requests.

U.S. District Judge David Hurd in Albany, New York, ruled that the state’s workplace vaccination requirement conflicted with healthcare workers’ federally protected right to seek religious accommodations from their employers.

The ruling provides a test case as vaccine mandate opponents gear up to fight plans by President Joe Biden’s administration to extend COVID-19 inoculation requirements to tens of millions of unvaccinated Americans.

Vaccines have become highly politicized in the United States, where only 66% of Americans are vaccinated, well short of the initial goals of the Biden administration.

Seventeen healthcare workers opposed to the mandate sued, saying the requirement violated their rights under the U.S. Constitution and a federal civil rights law requiring employers to reasonably accommodate employees’ religious beliefs.

Hurd agreed, saying the state’s order “clearly” conflicted with their right to seek religious accommodations.

“The court rightly recognized that yesterday’s ‘front line heroes’ in dealing with COVID cannot suddenly be treated as disease-carrying villains and kicked to the curb by the command of a state health bureaucracy,” said Christopher Ferrara, a lawyer for the workers at the conservative Thomas More Society.

New York Governor Kathy Hochul, a Democrat, vowed in a statement to fight the decision, saying her “responsibility as governor is to protect the people of this state, and requiring health care workers to get vaccinated accomplishes that.”

At least 24 states have imposed vaccine requirements on workers, usually in healthcare.

New York’s Department of Health on Aug. 26 ordered healthcare professionals to be vaccinated by Sept. 27 and the order did not allow for the customary religious exemptions.

Hurd issued a temporary restraining order on Sept. 14 in favor of the workers while he considered whether to issue a preliminary injunction.

(Reporting by Tom Hals in Wilmington, Delaware and Nate Raymond in Boston; Editing by Noeleen Walder and Peter Cooney)

Pfizer study to vaccinate whole Brazilian town against COVID-19

BRASILIA (Reuters) -Pfizer Inc will study the effectiveness of its vaccine against COVID-19 by inoculating the whole population over the age of 12 in a town in southern Brazil, the company said on Wednesday.

The study will be conducted in Toledo, population 143,000, in the west of Parana state, together with Brazil’s National Vaccination Program, local health authorities, a hospital and a federal university.

Pfizer said the purpose was to study transmission of the coronavirus in a “real-life scenario” after the population has been vaccinated.

“The initiative is the first and only of its kind to be undertaken in collaboration with the pharmaceutical company in a developing country,” Pfizer said.

A similar study was conducted by the Butantan Institute, one of Brazil’s leading biomedical research centers, in the smaller town of Serrana, in Sao Paulo state, to test the CoronaVac shot developed by China’s Sinovac Biotech Ltd.

In May, Butantan said mass vaccination had reduced COVID-19 death by 95% in the town with a population of 45,644 people. The institute is considering extending the study for a third dose.

“Here we believe in science and we lament the almost 600,000 deaths from COVID-19 in Brazil,” Toledo Mayor Beto Lunitti said at a news conference announcing the Pfizer study.

Regis Goulart, a researcher at Toledo’s Moinhos de Vento Hospital, said its aim was to validate the real-world efficacy and safety of the vaccine seen in clinical trials.

The observational study will also be an opportunity to do long-term monitoring for up to one year of participants and to answer lingering questions such as the duration of vaccine protection against COVID-19 and new variants, Goulart said.

(Reporting by Anthony Boadle; Editing by Jason Neely and Mark Porter)

Genes may add to ethnic COVID-19 disparities; sickest patients unwell a year later

By Nancy Lapid

(Reuters) – Here is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review.

Genes may explain some ethnic differences in COVID-19 impact

The varying impacts of COVID-19 among ethnic groups might be partially due to genetic differences in the cell-surface protein the virus uses as a gateway, an international research team found. They analyzed genetic information from more than 85,000 volunteers, including 6,274 who were tested for the new coronavirus and 1,837 who tested positive. In the gene for ACE2 – the “receptor” protein through which the virus breaks into cells – they found rare variants that would alter the part of the protein to which the virus attaches itself. These variant genes “appear to vary in frequency between different ethnic groups,” said Jamal Nasir of the University of Northampton in the UK. Two were more common in Europeans than in East Asians, for example. Nasir and colleagues also found variants that appear to increase or decrease an individual’s ACE2 protein levels, which could affect vulnerability to infection, or severity. People who were not infected with the coronavirus were more likely to have a variant that decreases ACE2 levels, according to a report posted on Wednesday on medRxiv ahead of peer review. The next steps, Nasir said, are to confirm the findings by exposing human cells to the virus in lab experiments and to identify small molecules that can be used as drugs to block harmful genetic mutations’ effects.

Severe COVID-19 still affects patients a year later

Among 1,276 COVID-19 patients hospitalized in China early in the pandemic, 49% still had at least one symptom 12 months after first becoming ill, researchers reported on Friday in The Lancet. Most common were fatigue or muscle weakness. About a third still had shortness of breath or other lung problems, especially those who had been the most severely ill. In some patients, doctors saw a reduced flow of oxygen from the lungs to the bloodstream. Roughly one in four survivors reported depression. Among patients who had been employed before they were hospitalized, 88% had returned to work by 12 months – but overall, the survivors were not as healthy as people from the community who had not been infected with the coronavirus. The study only looked at patients from one hospital, and not many of them had been sick enough to require intensive care. Nevertheless, the fact that some patients still had symptoms “should be taken into account when planning delivery of healthcare services post-pandemic,” coauthor Bin Cao from the China-Japan Friendship Hospital said in a statement.

Pfizer vaccine safe in small study of very sick kids

In adolescents with serious neurological conditions, the side effects of the Pfizer/BioNTech vaccine are likely to be mild to moderate and clear up quickly, a small study suggests. The 27 children in the study, ages 12 to 15, had muscular dystrophy, cerebral palsy, or other neurological diseases, plus other conditions such as heart defects and immune deficiency – all of which put them at very high risk for severe COVID-19. They would not have been included in the main trials of the vaccine because they were too sick, the researchers said. Eleven children had averse events after the first or second dose, such as mild rash, fever, headache, gastrointestinal upset, difficulty sleeping, and low blood sugar. Most problems resolved within 72 hours, and the rest cleared up within a week, according to a report published on Thursday in Archives of Disease in Childhood. Although the study involved only a few children, “these data are especially important as they are representative of the children who are most likely to benefit from vaccination, and parents and clinicians may have concerns regarding an increased risk of unexpected events,” the authors said.

(Reporting by Nancy Lapid; Editing by Tiffany Wu)