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Clear link between AstraZeneca and rare blood clots in brain, EMA vaccine chief says – National Post

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‘In my opinion, we can now say it,’ said Marco Cavaleri, chair of the vaccine evaluation team at the European Medicines Agency

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There is a link between AstraZeneca’s COVID-19 vaccine and very rare blood clots in the brain but the possible causes are still unknown, a senior official for the European Medicines Agency (EMA) said in an interview published on Tuesday.

“In my opinion we can now say it, it is clear that there is an association with the vaccine. However, we still do not know what causes this reaction,” Marco Cavaleri, chair of the vaccine evaluation team at the EMA, told Italian daily Il Messaggero when asked about the possible relation between the AstraZeneca shot and cases of brain blood clots.

Cavaleri added that the EMA would say there is a link although the regulator would not likely be in a position this week to give an indication regarding the age of individuals to whom the AstraZeneca shot should be given.

He did not provide evidence to support his comments.

AstraZeneca was not immediately available for comment. It has said previously its studies have found no higher risk of clots because of the vaccine.

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The regulator has consistently said the benefits outweigh the risks as it investigates 44 reports of an extremely rare brain clotting ailment known as cerebral venous sinus thrombosis (CVST) out of 9.2 million people in the European Economic Area who have received the AstraZeneca vaccine.

The World Health Organization has also backed the vaccine.

The EMA said last week that its review had at present not identified any specific risk factors, such as age, gender or a previous medical history of clotting disorders, for these very rare events. A causal link with the vaccine is not proven, but is possible and further analysis is continuing, the agency said.

A high proportion among the reported cases affected young and middle-aged women but that did not lead EMA to conclude this cohort was particularly at risk from AstraZeneca’s shot.

The EMA is expected to give an update of its investigation on Wednesday.

Some countries, including France, Germany and the Netherlands, have suspending the use of the vaccine in younger people while the investigations continue.

Scientists are exploring several possibilities that might explain the extremely rare brain blood clots that occurred in individuals in the days and weeks after receiving the AstraZeneca vaccine.

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European investigators have put forward one theory that the vaccine triggers an unusual antibody in some rare cases; others are trying to understand whether the cases are linked with birth control pills.

But many scientists say there is no definitive evidence and it is not clear whether or why AstraZeneca’s vaccine would cause an issue not shared by other vaccines that target a similar part of the coronavirus.

In a separate interview, Armando Genazzani, a member of the EMA’s Committee for Medicinal Products for Human Use (CHMP), told La Stampa daily that it was “plausible” that the blood clots were correlated to the AstraZeneca vaccine.

Some countries limit AstraZeneca vaccine use amid concern over blood clots

Some countries are restricting use of the AstraZeneca vaccine against COVID-19 while others have resumed inoculations, as investigations into reports of rare, and sometimes severe, blood clots continue.

The European Medicines Agency and the World Health Organization have said the benefits outweigh the risks, but are monitoring the situation.

AstraZeneca said in March its vaccine was 76% effective in preventing symptomatic infections in a U.S. trial, and that studies did not indicate higher risks of clotting.

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VACCINE BEING USED, WITH OR WITHOUT RESTRICTIONS

AUSTRALIA:

Will continue its inoculation program with the shot despite a blood clotting case reported on April 2, health officials said on April 3.

AUSTRIA:

Resumed use.

BULGARIA:

Resumed inoculations from March 19.

CYPRUS:

Cyprus resumed inoculations on March 19.

CANADA:

To pause offering vaccine to people aged under 55 and require a new analysis of the shot’s benefits and risks based on age and gender.

FRANCE:

Approved resumed use of the vaccine on March 19, but said it should only be given to people aged 55 and over.

FINLAND:

Resumed using the AstraZeneca vaccine from March 29, but will only give it to people aged 65 and over.

GEORGIA:

Has limited the use of the vaccine after a nurse died of anaphylactic shock, and vaccinations will continue only in full-fledged medical centres, news agency TASS reported on March 19.

GERMANY:

From March 31, Germany limited use of the shot to people over 60 and high-priority groups, following further reports of a rare brain blood disorder. On April 1, Germany’s vaccine commission recommended that people under 60 who have had a first shot of AstraZeneca’s vaccine should receive a different product for their second dose.

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ICELAND:

Resumed use on March 25 after suspending it on March 11.

INDONESIA:

Resumed using the vaccine on March 22 but warned against the use of the vaccine in people with a low blood platelet count.

IRELAND:

Resumed use after EMA recommendation.

ITALY:

Resumed use on March 19, and Italians who decline to be inoculated with it will be given an alternative later.

LATVIA:

Said would restart administering the shots from March 19.

LITHUANIA:

Restarted use on March 19.

NETHERLANDS:

Currently using the vaccine only for over 60s, either at a doctors’ surgery or by a doctor at nursing homes.

NORTH MACEDONIA:

Health Minister Venko Filipce said on March 31 that AstraZeneca shots would be limited to people aged over 60 as a precautionary measure.

ROMANIA:

Resumed use after the EMA assessment after temporarily stopping vaccinating people with one batch of the vaccine on March 11.

SOUTH KOREA:

President Moon Jae-in received the vaccine on March 23 ahead of an overseas trip, as the country inoculates senior citizens and health workers.

SPAIN:

Spain said on March 30 it would use the vaccine for people aged 55-65, and a day later said it would extend the vaccination to essential workers aged over 65.

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SWEDEN:

Resumed use of the vaccine on March 25 for people aged 65 and older, but restrictions are in place for Swedes under 65.

THAILAND:

Began use on March 15, with Prime Minister Prayuth Chan-ocha the first to be inoculated, after delaying rollout the week before.

USE SUSPENDED

CAMEROON:

Suspended administration of the vaccine it was scheduled to receive on March 20 as part of the global vaccines sharing scheme COVAX, the health ministry said.

DENMARK:

Will prolong its suspension of the shot by three weeks pending further investigations after its two-week pause ended on March 25. A local survey indicated that one in three Danes would decline to get the shot.

NORWAY:

Norway will delay a decision over the use of the vaccine, authorities said on March 26, with a decision expected by April 15.

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As COVID-19 vaccines for kids get closer, experts weigh up how to reassure parents – CBC.ca

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As Pfizer Inc. and BioNTech say they’ve moved a step closer to providing their COVID-19 vaccine for younger children, one mother says she’s keen to have her eldest vaccinated, but hears some hesitation among other parents.

“As parents, you’re nervous and you’re apprehensive, obviously, about any risks,” said Fallon Jones, who lives in Halifax with a five-year-old daughter and two-year-old son.

“But we have to weigh the pros and the cons here, and I think that this is a good opportunity to protect them against a potentially deadly virus,” she told The Current’s Matt Galloway.

Pfizer-BioNTech said Monday that a clinical trial of its COVID-19 vaccine recorded a robust immune response in five- to 11-year-olds, and the company plans to seek regulatory approval as soon as possible. Children received two shots, each one-third the dose size given to adults. The findings have not been peer-reviewed, nor published.

Pfizer-BioNTech COVID-19 vaccine appears safe, effective in younger kids, expert says

3 days ago

Although he cautions Pfizer-BioNTech has yet to release the raw data supporting the claim that its COVID-19 vaccine is safe and effective in kids aged 5-11, it’s ‘reasonable’ to assume that’s accurate, says Dr. Christopher Labos, a cardiologist with a degree in epidemiology. 2:35

For any vaccine to be approved by Health Canada, the manufacturers supply the necessary clinical trial data for review. If the regulator grants approval, the National Advisory Committee on Immunization (NACI) will make a recommendation on their use, but the final decision to deploy the vaccines rests with provincial authorities.

In a statement to The Current, Health Canada said the makers of all COVID-19 vaccines approved in Canada are conducting or planning studies in adolescents and younger children, but it has so far not received any submission for the approval of any COVID-19 vaccine for children under 12.

In her work at a vaccine hesitancy clinic in Calgary, Dr. Cora Constantinescu meets parents who are experiencing “a lot of fear and anxiety” around their children potentially getting the vaccine.

“We often have parents who are fully vaccinated themselves, who may be hesitant about their kids,” said Constantinescu, a pediatrician and infectious disease doctor at Alberta Children’s Hospital.

She said that parents talk to her about things they’ve seen online, including “anti-vaccine rhetoric and a lot of misconstrued science.”

In Halifax, Jones said she often hears other parents say they don’t know what’s in the vaccine, so they won’t give it to their kids. When she asks if they knew what was in the vaccines their kids received as babies, the response is usually no, she said.

“I completely respect and understand how there would be some fear associated with it,” she said. 

But ultimately, “we trusted our doctors then and we trusted the science then, and we need to do the same with this vaccine.” 

Dr. Cora Constantinescu said that as parents approach the decision, they should consider the negative impacts of COVID-19 on children. (Submitted by Dr. Cora Constantinescu)

How should parents approach vaccine question?

Constantinescu said many parents have seen misinformation on social media, where there is a “huge polarization of the pro-vaccine and the anti-vaccine crowd.”

“The parents are caught in the middle, scared and worried about their kids, trying to make the best decision they can,” she said.

As parents approach the decision, they should consider the dual impact of COVID-19 on children, she said.

“We’re seeing the direct effects of COVID on children, and we know that that can range from mild disease, to respiratory illness, to being hospitalized, having a multi-system inflammation, to ending up in ICU,” she said.

There is also an indirect cost, including mental health issues and issues around socialization, she said.

How a doctor discusses vaccine hesitancy with patients

10 months ago

Dr. Cora Constantinescu, an infectious disease specialist from the Vaccine Hesitancy Clinic in Calgary, discusses how she approaches conversations around vaccine hesitancy, the impact of those conversations and what’s needed in messaging around the COVID-19 vaccine. 3:44

The news from Pfizer-BioNTech gives her hope that those impacts can soon be addressed, but she warned that the data has not yet been made public, or reviewed by Health Canada.

If it is approved, she said parents should approach the vaccine as an issue of “personal protection first.”

“It’s about protecting their kids directly, looking out for them, and wanting to return them to a normal life,” she said.

‘Pull out all the stops’ to protect kids

Dr. Kashif Pirzada, an emergency physician in Toronto, wants to see a safe vaccine for kids approved and available as quickly as possible.

“I’m calling for all of these processes to be speeded up and done very transparently,” said Pirzada, who is also a co-founder of Masks4Canada, a group that advocates for public health measures to slow the spread of the virus.

Dr. Kashif Pirzada said that when a vaccine is approved for younger children, ‘we should pull out all the stops and get these shots into little arms as quickly as possible.’ (Dr. Kashif Pirzada)

He added that more work should be done to reassure parents that the vaccines are safe. He warned that COVID-19 is not harmless to children, and the longer they remain unprotected, the more infections there will be.

In the meantime, vaccination sites and health-care workers could be prepared to ramp the vaccination campaign back up, he said.

“Once that approval comes, we should pull out all the stops and get these shots into little arms as quickly as possible.”


Written by Padraig Moran. Produced by Rachel Levy-McLaughlin, Arianne Robinson and Joana Draghici.

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Gold price drops as Powell talks 'gradual' tapering, downplays Evergrande contagion concerns – Kitco NEWS

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(Kitco News) The gold market saw its earlier gains reversed as Federal Reserve Chair Jerome Powell talked about “gradual” tapering while downplaying China’s Evergrande contagion effect on the U.S. market.

On Wednesday, the Fed said it may soon start tapering its $120 billion in monthly asset purchases, with central bank officials showing growing support for raising interest rates in 2022. 

“If progress continues broadly as expected, the Committee judges that a moderation in the pace of asset purchases may soon be warranted. These asset purchases help foster smooth market functioning and accommodative financial conditions, thereby supporting the flow of credit to households and businesses,” the Fed said in a statement.

When clarifying the Fed’s stance at a press conference following the Fed statement, Powell indicated that it would be a “very gradual taper,” which could conclude in the middle of next year.

Powell also pointed out that the central bank has the freedom to speed up or slow down the tapering process as it sees fit. He added that markets should not expect a rate hike while the Fed is still tapering.

Tapering does depend on substantial further progress made by the U.S. economy. And if the economy continues to advance in line with expectations, the Fed could move ahead with tapering at the next meeting.

“For me, it wouldn’t take a knockout [August] employment report. It would take a reasonably good employment report for me to feel like that test is met,” Powell said. “I would say that in my own thinking, the test is all but met. I don’t personally need to see a very strong employment report. Again it’s not to be confused with the test for [rate] liftoff, which is so much higher.”

The Fed Chair was also asked about China’s Evergrande debt issue, which sparked a rout in the markets earlier this week.

“The Evergrande situation seems very particular to China, which has very high debt for an emerging economy,” Powell told reporters. “Corporate defaults in the U.S. are very low right now … You would worry that it would affect global financial conditions through confidence channels.”

When asked about the stock-trading policies for Fed officials, Powell replied that they are “not adequate” and the Fed “could do better.”

Powell noted that it is reasonable for Fed officials not to own the same assets as Fed buys. “We are going to be looking at all those things,” he said.

On the debt ceiling issue, Powell also urged Congress to raise the debt limit in a timely fashion. “It is critically important. Failure to do that is something that could result in severe damage to the economy and financial markets.”

He added that no one should assume Fed can protect the economy if the debt ceiling is not raised.

In response to Powell’s comments, gold saw some losses as markets interpreted Powell’s comments as upbeat when it came to the U.S. economy. At the time of writing, December Comex gold futures were trading at $1,767.20, down 0.62% on the day.

Live 24 hours gold chart [Kitco Inc.]

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China asks local governments to prep for Evergrande downfall: Report – CNBC Television

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