PARIS—President Emmanuel Macron on Wednesday ordered France into its third national lockdown and said schools would close for three weeks as he sought to push back a third wave of COVID-19 infections that threatens to overwhelm hospitals. With the death toll nearing 100,000, intensive care units in the hardest-hit regions at breaking point, and a slower-than-planned vaccine rollout, Macron was forced to abandon his goal of keeping the country open to protect the economy. “We will lose control if we do not move now,” the president said in a televised address to the nation. His announcement means that movement restrictions already in place for more than a week in Paris, and some northern and southern regions, will now apply to the whole country for at least a month, from Saturday. Departing from his pledge to safeguard education from the pandemic, Macron said schools will close for three weeks after this …

Over 100 people have tested positive in Washington state for COVID-19 even after getting fully vaccinated, authorities said Tuesday. Epidemiologists found evidence of 102 so-called breakthrough cases since Feb. 1. That number represents 0.1 percent of people in the state who have been fully vaccinated against the CCP (Chinese Communist Party) virus, which causes COVID-19. The […]

The post Over 100 Fully Vaccinated People in Washington State Test Positive for COVID-19 appeared first on NTD.

A big question among parents and teachers as more schools reopen is when their kids will be vaccinated against COVID-19. Some have wondered whether the vaccine is even necessary for children. There is news on that front. In a press release on March 31, 2021, vaccine maker Pfizer suggested its vaccine is as effective in children ages 12-15 as it is in young adults. However the results of Pfizer’s vaccine trials in adolescents have not been fully released or reviewed by the Food and Drug Administration, and that will take several weeks.

Dr. James Wood, a pediatrician and assistant professor of pediatric infectious diseases, explains what doctors know today about the risk children face of getting and spreading the coronavirus and when vaccines might be available.

Do kids really need to get the COVID-19 vaccine?

The short answer is yes. A lot of studies have shown that COVID-19 isn’t as severe in children, particularly younger kids – but that doesn’t mean kids aren’t at risk of getting infected and potentially spreading the virus.

Children under 12 who get COVID-19 do tend to have mild illnesses or no symptoms, while teenagers seem to have responses somewhere between what adults and younger kids have experienced. The Centers for Disease Control and Prevention found that teens were about twice as likely to be diagnosed with COVID-19 as children ages 5-11.

Researchers are still trying to understand why we’re seeing these differences between older and younger kids. Behavior probably plays a part. Teenagers are more likely to engage in social or group activities, and they may or may not be wearing masks. Immune differences and biologic factors may also play a role. Non-SARS-CoV-2 coronaviruses are common in children, often resulting in upper respiratory infection. Is their frequent exposure to other coronaviruses helping protect them from severe COVID-19? That is one hypothesis. We know younger kids’ immune responses in general are different from adults, and likely play a role in protection.

It’s important to remember that while most children get only mild symptoms, they still face risks. At least 226 U.S. children with COVID-19 have died, and thousands have been hospitalized.

The key to minimizing the risk is to make sure kids eventually get vaccinated, follow social distancing recommendations and wear masks.

Are kids spreading the virus?

In a setting like a school where mask-wearing and social distancing are enforced, young kids seem to not spread the virus very much when the rules and guidelines are being followed. One CDC review found little difference in community cases in counties with elementary schools open and those with remote learning.

If precautions aren’t being taken, children infected with the coronavirus very well could spread it to adults. What isn’t clear yet is how great that risk is.

To keep schools as safe as possible, continuing schoolwide mask and social distancing policies will be important. With teenagers in particular, mask rules can’t hinge on whether the person has been vaccinated or not. Until herd immunity within the whole community is at a good level, social distancing and masking is still going to be the recommendation.

So, when can kids get vaccinated?

Right now, the Pfizer vaccine is the only one in the U.S. authorized for teenagers as young as 16. Before kids under 16 can be vaccinated, clinical trials need to be completed in thousands of young volunteers to assess the vaccines’ safety and efficacy, and the results must be fully reviewed by the Food and Drug Administration.

Pfizer said it expects to submit results from its adolescent trials for review soon. Vaccine manufacturer Moderna also has trials underway with adolescents. If their vaccines are shown to be safe and effective and regulators authorize them, kids 12 and up could be vaccinated before school starts in the fall.

Realistically, young children probably won’t be eligible for the vaccine until late fall or winter at the earliest. Moderna announced in mid-March that it had started testing its vaccine in children ages 6 months to 11 years. Pfizer said it is also starting testing in young children, but these trials take time.

What’s different about the vaccines kids will get?

The composition of the COVID-19 vaccines for children is the same as used in adults – the difference is that children may require a different dose.

The first step in vaccine trials is to figure out the right dose. The companies want to find the lowest possible dose that is both safe and produces a target level of antibodies. For example, Moderna uses a 100-microgram dose in adults. It is testing three different doses for children under age 2 – 25, 50 and 100 micrograms – and two doses for children over age 2, at 50 and 100 micrograms.

Once the company determines the optimal dose, it will launch a placebo-controlled trial to test its effectiveness, in which some children will get a placebo and some will get the vaccine.

A rigorous system for pediatric vaccine trials is well established in the U.S. These trials are key to assessing the safety and efficacy of vaccines in children, which can differ from adults.

I am optimistic that a safe and effective vaccine will be available for children. Thus far, there have not been any safety signals from either the adult or adolescent studies that have been worrying to me as a pediatrician, but the studies still need to be done in children.

How can parents create safe playdates for kids?

When I talk to parents, I explain that it’s a risk-versus-benefit question. Each family has a different tolerance.

From a medical standpoint, the mental health of kids and having them play with other kids is an important part of childhood.

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I would say that unvaccinated kids playing indoors without masks on is still not a great idea. The risk is just too high at this point. As weather warms up, I would encourage kids to play outside. Ride bikes, play and socialize – just do it in a safe manner.

We all have pandemic fatigue, including medical professionals. As the weather gets warmer, I think everyone just wants to get back to normal. The worst thing we can do, right as we start to see a light at the end, is fall backward again – because that would just make it that much longer for everyone.

This story was updated with Pfizer’s announcement on March 31.

The Conversation is an independent and nonprofit source of news, analysis and commentary from academic experts.

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This article is republished from The Conversation under a Creative Commons license. Read the original article here: https://theconversation.com/when-can-kids-get-the-covid-19-vaccine-a-pediatrician-answers-5-questions-parents-are-asking-157512

Fifteen million doses of Johnson & Johnson (J&J’s) vaccine failed quality control after workers at a Baltimore manufacturing plant negligently combined ingredients from AstraZeneca and J&J’s COVID vaccine.

The mix-up forced regulators to delay authorization of the plant’s production lines and prompted an investigation by the U.S. Food and Drug Administration (FDA).

According to The New York Times, the plant is run by Emergent BioSolutions, a manufacturing partner with J&J and AstraZeneca, whose vaccine has yet to be authorized for use in the U.S.

Emergent has been cited repeatedly by the FDA for problems such as poorly trained employees, cracked vials and mold around one of its facilities, according to records obtained by the Associated Press through the Freedom of Information Act.

AstraZeneca and J&J’s COVID vaccines employ the same technology which uses a version of a virus — known as a vector — that is transmitted into cells to make a protein that then stimulates the immune system to produce antibodies.

However, J&J’s and AstraZeneca’s vectors are biologically different and not interchangeable.

Federal officials said Emergent’s mistake was human error that went undiscovered for days until J&J’s quality control checks uncovered it, according to people familiar with the situation. By then, up to 15 million doses had been contaminated, reported The Indian Express.

The error does not affect any J&J doses currently being distributed and administered in the U.S., as those were produced in the Netherlands where operations have been fully approved by federal regulators.

“As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards,” J&J said in a statement Wednesday. “This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality.”

Details of the issue were identified and addressed with Emergent and the FDA, J&J said.

An FDA spokesperson told news outlets: “FDA is aware of the situation, but we are unable to comment further. Questions about a firm’s manufacturing facilities should be directed to that firm.”

As reported by The Defender, J&J has never made a vaccine, but since entering the pharmaceutical market in 1959, the company has made a lot of headlines and has been fined billions of dollars for bad, including some illegal, behavior.

Developing a vaccine requires many years and necessitates the establishment of an R&D infrastructure vastly different than the structure required for conventional drug development. Yet the company was able to rush to market its first vaccine for a viral strain identified just 14 months ago.

J&J has a relationship with the Bill & Melinda Gates Foundation and the Global Alliance for Vaccines and Immunizations and has a $1 billion deal with the U.S. government to provide 100 million doses of its Emergency Use Authorization experimental vaccine.

According to the FDA, J&J’s vaccine consists of a “replication-incompetent recombinant adenovirus type 26, a SARS-CoV-2 spike protein, and contains the following inactive ingredients: citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate 80, sodium chloride, sodium hydroxide and hydrochloric acid. The adenovirus is also grown in the PER.C6® aborted fetal cell line.

Polysorbate 80, an ingredient in J&J’s vaccine, is a suspected underlying cause of anaphylactic COVID vaccine adverse reactions. Studies show that polysorbate 80 disrupts the normally protective blood-brain barrier.

As The Defender Reported, the FDA authorized J&J’s single-dose COVID vaccine in late February with a reported overall efficacy rating of 66% for preventing “moderate to severe COVID-19.” The vaccine was only 42.3% effective about a month after getting the shot in people 60 or older who had comorbidities.

Although the FDA identified no safety concerns with J&J’s COVID vaccine, suspected vaccine injuries associated with the vaccine have been reported to the Vaccine Adverse Events Reporting System since March 2 — the primary mechanism for reporting adverse vaccine reactions in the U.S.

The post 15 million J&J COVID Vaccines Thrown Away After Ingredient Mix-Up With AstraZeneca appeared first on Children’s Health Defense.

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AstraZeneca will ask FDA to greenlight its coronavirus vaccine in the first half of April after US trial found it is ‘100% effective’ against severe Covid and does NOT cause blood clots

• Latest trial of the AstraZeneca jab was done on 32,000 people in US, Chile and Peru and adds to success
• Nobody who received the real vaccine developed severe Covd-19 or died of it, making it 100% protective
• No severe side effects nor increased risk of blood clots in people in the study
• Research was carried out because US wanted US-based trial before approving it for use on its own citizens

Molecular biologist Dr. Richard Elbright insisted that World Health Organization COVID-19 investigators – especially Peter Daszak – were “participants in disinformation” on their recent mission to China to uncover the…

The post Award-Winning Biologist Slams Peter Daszak And WHO COVID Colleagues For Peddling Chinese Communist Party ‘Disinformation.’ appeared first on The National Pulse.

(JustTheNews.com) Theme parks in California, set to reopen next month, are telling visitors not to scream or shout – or even to breathe heavily – while on rides, including roller coasters.

“The California Attractions and Parks Association advises in the new guidelines for its “Responsible Reopening Plan” that theme park visitors should avoid activities that increase the spread of COVID-19, such as singing, shouting, heavy breathing and raising one’s voice,” reports People.

“This rule applies when visitors are on the parks’ rides, meaning guests are recommended to stay silent on roller coasters that usually encourage people to do anything but,” the magazine said.

Colorado’s health department moved 26 counties to the lowest level on the state’s color-coded COVID-19 dial Wednesday, eliminating most public health restrictions in those less-populated areas now at Level Green — including all caps on dining capacity at restaurants.

The “Dial 3.0” changes that took effect Wednesday, March 24, 2021, also remove all limits statewide on the size of personal gatherings. And they allow bars to reopen, at limited capacity, for the first time since last summer in counties at Level Blue, which, in the metro area, include Jefferson and Arapahoe. Last call for alcohol in those counties returns to 2 a.m., as well.

Furthermore, restaurants and gyms in Level Blue counties can operate at 100% capacity as long as they maintain 6 feet of distance between parties, though state officials concede that distancing requirement “will be a limiting factor for most indoor spaces.”

Restaurants and gyms with 5 Star state certification in counties at Level Yellow — those include Denver, Douglas, Boulder and Adams — also can resume operating at 100% capacity, provided they can meet that 6-foot distancing requirement.

Changes have not yet been made to the statewide mask mandate, which expires April 3, because officials still are reviewing public input on the plan released last week to lift nearly all requirements for facial coverings in counties at Level Green, according to the health department.

The easing of restrictions was expected as the Colorado Department of Public Health and Environment announced Friday evening that it would make it easier for counties to move to Level Green on the dial, which has been used by the agency to set COVID-19 restrictions in communities based on local transmission of the coronavirus.

The revised dial is expected to remain in place until mid-April, after which the state will retire it and issue a new public health order handing most control over COVID-related restrictions to local public health agencies.

“Coloradans have made great sacrifices to protect ourselves and our communities from COVID-19 over the past year,” said Jill Hunsaker Ryan, executive director of the health department in a statement. “While this is still a time for caution, these changes to the dial better reflect where we are in the pandemic today, and the balance we are trying to strike between disease suppression and economic hardship.”

Going green

The counties that moved to Level Green are: Moffat, Rio Blanco, Jackson, Delta, Gunnison, Ouray, Dolores, San Juan, Hinsdale, Saguache, Rio Grande, Conejos, Costilla, Huerfano, Custer, Clear Creek, Gilpin, Lincoln, Kit Carson, Cheyenne, Kiowa, Bent, Prowers, Baca, Phillips and Sedgwick.

Two counties — Crowley and Otero — already were at Level Green, which now places no state restrictions on restaurant, office, gym, retail, personal services or outdoor event capacity.

For counties at Level Green, the only remaining restrictions are on bars, indoor group sports and camps, and indoor seated or unseated events, all of which are capped at 50% of capacity or 500 people, whichever is fewer.

Under the proposal introduced by the state last week, the dial changes were to be followed by a modified mask order from the governor on April 4 that, in counties at Level Green, would only require masks be worn at schools by children ages 11 to 18 because they do not yet have access to vaccines.

For counties at Levels Blue, Yellow, Orange and Red, the proposal said masks would be required for that same group of students and in any indoor public places with 10 or more people present. The existing statewide mask mandate would remain in effect in any counties reaching Level Purple, the highest phase.

State officials, in announcing Wednesday’s changes, said feedback received about the proposed mask changes will be considered before the current order expires and any decision is made on a subsequent modified order.

“COVID-19 still presents risks to healthy Coloradans, so everyone should continue to take precautions until the vaccine becomes widely available and used,” the health agency said in a news release.

Increased vaccinations

The Department of Public Health and Environment previously said it was making the changes to the dial because of the progress the state has made in vaccinating Coloradans against the coronavirus. To date, 894,526 people are fully immunized in the state.

But Colorado also has seen its months-long decline in COVID-19 hospitalizations stall and an increase in the number of cases involving the more contagious variants of the coronavirus.

On Tuesday, Dr. Anthony Fauci encouraged Americans to keep public health measures in place or else risk seeing another rise in infections as is occurring in Europe, according to PBS NewsHour. Those measures include wearing masks, physically distancing and avoiding large gatherings.

Under Wednesday’s dial changes, there are no longer limits by the state on personal gathering sizes, although the Department of Public Health and Environment said it will follow guidelines from the U.S. Centers for Disease Control and Prevention. The federal agency still recommends avoiding larger gatherings and crowds.

Currently, there are 22 counties at Level Blue on the dial. In those counties, bars can now open at 25% capacity or 75 people, whichever is fewer. Retail and business offices also can open at 75% capacity in Level Blue counties.

Seated and unseated indoor events at locations with 5 Star certification in Level Blue counties can now operate at 50% capacity with a 500-person cap, while similar events at 5 Star-certified locations in Level Yellow counties can operate at 50% capacity with a 175-person limit.

There are no state restrictions on capacity at outdoor events in Level Green or Blue counties.

Thirteen counties, including Denver, are at Level Yellow. And only Pitkin County is at Level Orange, having just been moved up to the third-highest level on the dial.

The move comes as Mayor Lightfoot defended her administration and its “very robust oversight” of vaccines distributed by the city.

Anosh Ahmed, the Loretto Hospital executive at the center of a series of COVID-19 vaccination controversies, has resigned, the hospital’s board announced Wednesday night.

The board said it is continuing its investigation into actions taken by Dr. Ahmed, Loretto’s chief operating officer, after a series of stories that hospital executives had used city-supplied vaccine for the Austin community Loretto serves at vaccination events at the Trump Tower downtown and at other locations — in some cases giving shots to those who were not eligible.

“If our review should uncover anything further that indicates our processes were compromised, there will be additional consequences imposed on those responsible for these actions,” Chairman Edward Hogan said in a statement.

Before his resignation, Ahmed had been reprimanded by the hospital and given a 60-day suspension, a source told the Sun-Times Wednesday.

Lightfoot defends city oversight

The announcement came just hours after Mayor Lori Lightfoot defended her administration’s job overseeing scarce COVID-19 vaccine supplies even though Loretto and at least one other city partner were exposed in just over a week for misallocating shots, including to ineligible people.

“We have very robust oversight,” Lightfoot said at a news conference Wednesday. “We have a right to expect — and per our contract — that people abide by the rules and they give us accurate reporting. And what we’ve seen in at least two instances, that hasn’t been the case.”

Lightfoot responded to questions about the city’s protocols for making sure the COVID shots are going to where they’re intended — especially to vulnerable communities — after two problematic cases became public in just over a week.

The Loretto Hospital was caught last week after giving vaccine doses to people at Trump Tower and reportedly to at least two high-end businesses even though those shots are intended for the West Side Austin community, which has been badly affected by the virus. On Tuesday, the city said the clinic Innovative Express Care misallocated 6,000 doses of vaccine intended for Chicago Public Schools employees. The city now is withholding vaccine distributions to both the hospital and the clinic.

Clinic officials said in a statement that the issue was a miscommunication, a characterization that Lightfoot ripped into Wednesday.

“I know that’s what they’re saying but it’s absolutely false,” a visibly angry Lightfoot said.

“They’re going to say a lot of things I suspect yesterday, today, tomorrow,” Lightfoot added, “but the fact of the matter is we gave them every opportunity to get right with what the rules and responsibilities are for every provider who has the privilege of getting access to the vaccine and they repeatedly failed to hold up their end of the bargain. And so now they’re dealing with the consequences of those actions.”

She promised “very swift action” for any health care providers that don’t follow the rules of distributing vaccines to those who are the most needy and eligible under current guidelines.

The trouble at Loretto was first reported by Block Club Chicago. The online site reported Wednesday that there was another questionable vaccination event tied to Ahmed, this time at Maple & Ash, a Gold Coast steakhouse at 8 W. Maple St. The hospital vaccinated Trump Tower employees, where Ahmed has a condo, and held another event at a high-end Gold Coast watch store he frequented, Geneva Seal Fine Jewelry & Timepieces, 112 E. Oak St., Block Club has reported.

In a statement, Maple & Ash corporate parent What If Syndicate didn’t deny that employees were provided shots through Loretto and only said “there have been no sanctioned vaccination events within our company.”

Geneva Seal has not responded to requests for comment.

The hospital also has been questioned about vaccinations at Chief Executive George Miller’s south suburban church and a WBEZ-reported story detailing an invitation to Cook County judges and their spouses to jump the line and get vaccinations at Loretto.

Loretto’s board has said it is disciplining Ahmed and Chief Executive George Miller, though it has not publicly disclosed the punishment.

Gov. J.B. Pritzker weighed in on the Loretto controversy Wednesday, saying “if you’re violating those guidelines, you shouldn’t be getting vaccine to give out.”

“People who are the administrators of the vaccines need to be responsible, need to follow the rules that have been set out — the guidelines that have been set out by the state, and, in that case, by the city,” Pritzker said.

Contributing: Mary Mitchell, Mitchell Armentrout, Madeline Kenney

Brett Chase’s reporting on the environment and public health is made possible by a grant from The Chicago Community Trust.

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After two weeks of lifting its mask mandate and allowing businesses to open at full capacity, Texas is not seeing a surge of new COVID-19 cases. Gov. Greg Abbott, a Republican, issued an executive order (pdf) that went into effect on March 10 to loosen COVID-19 restrictions. Although the government’s statewide mask mandate was lifted, individual businesses were still able to “limit capacity” or impose mask mandates at their own choosing. But in Austin and Travis County, residents 10 years or older still have to wear a mask outside their home after a district judge refused to grant Attorney General Ken Paxton a restraining order that would have ended a mask mandate enforced by Travis County and City of Austin officials. The trial is set to take place on Mar. 26. Texas had been witnessing a downward trend in COVID-19 cases and hospitalizations prior to Abbott’s announcement ending the restrictions. …