BERLIN—Berlin’s state hospital groups Charite and Vivantes have stopped giving women under the age of 55 shots of AstraZeneca’s COVID-19 vaccine, spokeswomen for the hospitals said on Tuesday. The moves follow reports of rare but serious blood clots, bleeding, and in some cases death after vaccination, mainly in young women. “From the Charité’s point of view, this step is necessary because in the meantime further cerebral venous thromboses have become known in women in Germany,” a spokeswoman said in an emailed statement. Charite said the action was precautionary while they waited for final assessments. No complications have occurred in its hospitals following vaccinations with AstraZeneca. A spokeswoman for Vivantes clinics also said the move to pause the shot for younger women was a precautionary measure. Some 19,000 people work at the Charite hospitals and 17,000 at Vivantes, which operates clinics as well as care homes. Tagesspiegel, which first reported the …

Germany indefinitely suspended use of the Oxford-AstraZeneca COVID vaccine for  anyone under 60 following advice from STIKO, the country’s independent vaccine committee and external experts. The committee investigated reports of blood clots, some fatal, in people who received the vaccine

According to the Associated Press, Health Minister Jens Spahn and state officials unanimously agreed to give the vaccine only to people 60 or older unless they belong to a high-risk category where the benefits outweigh the risk of a serious side-effect.

“In sum, it’s about weighing the risk of a side effect that is statistically small, but needs to be taken seriously, and the risk of falling ill with corona,” Spahn told reporters in Berlin.

The European Medicines Agency (EMA) today said they’ve not yet identified any risk factors — such as age, sex or a previous history of blood clotting disorders — associated with the AstraZeneca vaccine.

The EMA issued a new statement reiterating their previous conclusion that the vaccine’s benefits outweigh the risks, but cautioned that people should be aware of the “remote possibility” of rare blood clots occurring, and must seek immediate medical attention in case of symptoms.

The EMA said it “continues to work with the national authorities in the EU Member States to ensure that suspected cases of unusual blood clots are reported” and analyzed.

As The Defender reported Tuesday, several regions of Germany, including Berlin and Munich, temporarily paused the vaccine for people under 60 after Germany’s vaccine regulator disclosed 31 cases of a rare brain blood clot, nine of which resulted in deaths. The decision was made as a precaution ahead of a meeting with national medical regulators scheduled for later in the day yesterday.

The outcome of the Tuesday meeting in Germany was the decision, announced today, to indefinitely suspend use of the AstraZeneca vaccine in people under 60.

The German regulators’ decision was “based on the currently available data on the occurrence of rare but very severe thromboembolic side effects. This side effect occurred four to 16 days after vaccination, predominantly in people [under] 60 years of age,” STIKO said.

STIKO is also looking into the possibility of administering a second shot with a different COVID vaccine, for those who have already received their first dose.

Chancellor Angela Merkel said the suspension of the vaccine’s use in the under-60s would help boost citizens’ trust in AstraZeneca’s COVID vaccine after a series of missteps, Reuters reported.

“Everything is based on one principle and that is trust,” Merkel said. “Confidence arises from the knowledge that every suspicion is counted in every individual case.”

In a statement ahead of the announcement, the vaccine maker said tens of millions of people had received the vaccine and that the EU regulator and World Health Organization concluded the benefits outweighed the risks.

AstraZeneca told CNBC it would continue to analyze its database to understand “whether these very rare cases of blood clots associated with thrombocytopenia occur any more commonly than would be expected naturally in a population of millions of people.”

“We will continue to work with German authorities to address any questions they may have,” it added.

Previously, Germany had not given the vaccine to people 65 and over, saying there was insufficient data on its efficacy in that age group. Earlier this month, more than 20 countries, including Germany, suspended use of the AstraZeneca vaccine after reports of rare blood clots in the brain, some resulting in death, in healthy people who received the vaccine.

Although authorized for use in the EU, AstraZeneca’s vaccine has been authorized for use in the EU, it has not yet received Emergency Use Authorization (EUA) in the U.S. The company plans to apply for EUA in the upcoming weeks. If approved, AstraZeneca would become the fourth available vaccine in the U.S., joining Moderna, Pfizer and Johnson & Johnson.

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Covid-19 vaccinations at Greater Emmanuel Institutional church in Detroit on Saturday. In Michigan’s largest city, local leaders are racing to vaccinate residents amid a rise in cases. Credit…Cydni Elledge for The New York Times

DETROIT — The country is a study in contrasts. New Jersey, New York, Connecticut, and other states in the Northeast continue to report high levels of cases, and troubling upticks have emerged in Illinois, Minnesota and some other Midwestern states. But in much of the South and West, case numbers remain relatively low…

Here’s Wednesday’s news on how COVID-19 is impacting Chicago and Illinois.

Latest

Chicago sees ‘quantum leap’ in COVID-19 cases — widening Lightfoot-Pritzker split over vaccine plans

Illinois’ COVID-19 uptick took another jump Wednesday as Chicago’s “quantum leap” in cases raised more concerns of a potential third surge of the virus, officials said.

Another 2,592 residents across the state were diagnosed with the virus among 77,727 tests, which lowered Illinois’ average positivity rate to 3.3%, according to the Illinois Department of Public Health.

But that key metric has shot up 57% overall in under three weeks, while COVID-19 hospitalizations have jumped 24% over the same time frame. More than 1,400 beds were occupied by coronavirus patients Tuesday night, the most the state’s hospitals have treated since Feb. 24.

Gov. J.B. Pritzker and Mayor Lori Lightfoot agree the uptick has halted any talk of further reopening — but they’re still far apart on when all adults should be eligible to receive a COVID-19 vaccine dose.

The governor voiced concern Wednesday over the city’s timetable for that move, saying “I think that they will want to do that sooner than they are currently planning to.”

Read the full story from Fran Spielman and Mitchell Armentrout here.

News

9:24 a.m. James Taylor kicking off rescheduled 2021 tour at the United Center

Live music may be returning to the United Center this summer.

James Taylor on Wednesday announced his postponed world tour with special guest Jackson Browne will kick off at the Chicago venue on July 29.

Tickets purchased for the original dates will be honored for the trek that wraps up Nov. 1 in San Diego. (The tour was originally slated for a stop June 9 the United Center; refunds are available at point of purchase for those unable to make the new date.)

Taylor postponed the tour last April due to the COVID-19 pandemic, which shut down all live music/theater venues across the country. Browne contracted coronavirus last March, revealing at the time he suffered only minor symptoms and recuperated while quarantining at home.

“(Jackson and I/James and I) want to thank all those who have graciously held onto their tickets; we appreciate your continued patience as we navigate these unchartered waters. We didn’t want to have to cancel this tour that we’ve been waiting so long to perform together, so we’ve been working to get these dates rescheduled to a time period when the U.S. is reopened and safe to gather for a concert,” the two legendary singer-songwriters said in a joint statement.”

Read the full story from Miriam Di Nunzio here.

New Cases & Vaccination Numbers

• Another 2,592 residents across the state were diagnosed with the virus among 77,727 tests.
• Nearly 500 Chicagoans are testing positive every day, an average figure that has jumped 37% over the past week.
• Illinois is vaccinating more people than ever as the state’s rolling average is up to a new high of 109,538 shots doled out per day.
• On Tuesday, 137,445 shots went into arms, the state’s third-highest daily total yet.

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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