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Volunteers still needed to test variety of COVID-19 vaccines – CP24 Toronto's Breaking News

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Lauran Neergaard, The Associated Press


Published Tuesday, November 17, 2020 8:12PM EST

Two COVID-19 vaccines might be nearing the finish line, but scientists caution it’s critical that enough people volunteer to help finish studying other candidates in the U.S. and around the world.

Moderna Inc. and competitor Pfizer Inc. recently announced preliminary results showing their vaccines appear more than 90% effective, at least for short-term protection against COVID-19.

If those early results hold up and U.S. regulators agree the shots are safe, emergency use of small, rationed supplies could start in late December. Other countries with contracts for early doses would undertake their own reviews.

But multiple vaccines will be needed to meet global demand and help end the pandemic, raising concern that studies that still need to sign up thousands of volunteers could run short if people wait for an already OK’d option instead.

“We don’t want to see that happen,” said Dr. James Cutrell, an infectious disease expert at UT Southwestern Medical Center in Dallas.

Supplies aside, other COVID-19 vaccines under development may work differently in different populations and “we likely will benefit from having a menu of vaccine options,” Cutrell said.

“We still need volunteers,” stressed National Institutes of Health Director Francis Collins, urging Americans to sign up.

Additionally, participants in the Moderna and Pfizer studies who originally got dummy shots would almost certainly be offered the real vaccine if the U.S. Food and Drug Administration allows emergency use. But no one knows how long protection would last, meaning those studies also must continue to track recipients somehow.

“It’s one thing to be effective two months after your last vaccination and another thing to be effective a year” later, said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s vaccine division. “It’s going to be really important to complete these clinical trials and the trials of the other vaccines so we can make comparisons.”

The promising Moderna and Pfizer news bodes well for some of their competitors, said Dr. Anthony Fauci, the U.S. government’s top infectious disease expert whose team at NIH helped develop the Moderna candidate.

Those shots target the “spike” protein that studs the surface of the coronavirus, and the early results prove that’s enough to generate “a protective response,” Fauci said. “Conceptually this looks good” for other spike-focused vaccines made in different ways.

Here’s a scorecard of the frontrunners in the global vaccine race:

GENETIC CODE VACCINES

The Moderna-NIH vaccine and the candidate developed by Pfizer and its German partner BioNTech aren’t made with the coronavirus itself, meaning there’s no chance anyone could catch it from the shots.

Instead, the vaccines are made with a brand-new technology that injects a piece of genetic code for the spike protein. That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, enough to prime the immune system to react if it later encounters the real virus.

There are no licensed mRNA vaccines for people, so scientists had no idea if or how well the COVID-19 candidates might work.

Both manufacturers are working to scale up production in factories in the U.S. and Europe. They can’t simply partner with other vaccine companies to take on some of the work because the technology is so different than the way most of today’s shots are made.

“It is not a very easy or quick swap,” said Moderna CEO Stephane Bancel.

TROJAN HORSE VACCINES

A different way to target the spike protein: Use another, harmless virus to carry the spike gene into the body. Once again, the body produces some spike protein and primes the immune system.

Britain’s Oxford University and AstraZeneca are making their version of this “viral vector” vaccine with a cold virus, or adenovirus, that normally infects chimpanzees. Studies of tens of thousands of people are underway in the U.K., U.S. and several other countries.

Johnson & Johnson is using a human adenovirus for its version, and is the only option in advanced U.S. testing aiming to show if a single dose rather than two would be enough.

China’s government authorized emergency use of CanSino Biologics’ adenovirus shots in the military ahead of any final testing. Russia likewise began offering an adenovirus vaccine ahead of late-stage tests.

PROTEIN VACCINES

Novavax makes its vaccine candidate by growing harmless copies of the coronavirus spike protein in the laboratory and packaging them into virus-sized nanoparticles.

There are protein-based vaccines against other diseases, so it’s not as novel a technology as some of its competitors. Novavax has begun a large final-stage study in Britain, and is set soon to begin another in the U.S.

“KILLED” VACCINES

Spike-focused vaccines aren’t the only option. Making vaccines by growing a disease-causing virus and then killing it is a tried-and-true approach – it’s the way Jonas Salk’s famed polio shots were made.

China has three so-called “inactivated” COVID-19 vaccine candidates in final testing in several countries, and has allowed emergency use in some people ahead of the results. An Indian company is testing its own inactivated candidate.

Safely brewing and then killing the virus takes longer than newer technologies. But inactivated vaccines give the body a sneak peek at the germ itself rather than just that single spike protein.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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Families of 737 Max crash victims say plane is still unsafe, demand public inquiry – Canada News – Castanet.net

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Families of Canadians killed in the Boeing 737 Max crash say the plane remains unsafe and should stay grounded, despite being cleared for takeoff by regulators in the United States.

Paul Njoroge, whose wife, three children and died in the March 2019 crash of Ethiopian Airlines Flight 302, told the House of Commons transport committee Tuesday the aircraft is still “unstable.”

He and Chris Moore, whose daughter was among the 18 Canadian citizens who lost their lives, are calling for an independent inquiry into Transport Canada’s validation of Boeing’s best-selling airplane.

Moore says Canadians deserve to know why Transport Canada did not take action even after issuing a letter of concern before the crash about the Max plane’s anti-stall system, which safety regulators have said U.S. authorities failed to properly review.

Transport Canada said last week its recertification standards for the Max 8 diverge from those of U.S. regulators, including added procedures on the flight deck and differences in pilot training.

The Max planes have been grounded since March 2019 after the deadly crashes of a Lion Air flight near Jakarta in October 2018 and the Ethiopian Airlines flight less than five months later.

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Victims' families tell MPs Boeing 737 Max should stay grounded for now – CBC.ca

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Canadians who lost loved ones in a deadly crash on a Boeing 737 Max plane in 2019 told MPs today that the aircraft should remain grounded in Canada, even though the U.S. has cleared it to fly again.

Family members of people killed in 737 Max crashes told the House of Commons’ transport committee this afternoon they want Canada to launch an independent inquiry into the crashes before clearing the planes for service.

“I believe the plane is still unsafe to fly,” said Paul Njoroge, who lost his entire family last year on Ethiopian Airlines Flight 302.

“I still have nightmares about how my wife must have felt helpless, seeing the fear in our children’s eyes, knowing they were about to die.

“We want Transport Canada to go back to the drawing board … I think that’s the only way Canadians can feel safe stepping onto a 737 Max.”

Canada’s 737 Max fleet has been grounded for 20 months in response to two deadly crashes. In March 2019, an Ethiopian Airlines flight plunged from the air southeast of the capital Addis Ababa minutes after takeoff, killing everyone onboard — including 18 Canadians and a family of permanent residents to Canada. Five months earlier, another 737 Max owned by Lion Air plunged into the Java Sea shortly after takeoff, killing all 189 passengers.

Ethiopia’s investigation report pointed the finger at Boeing, saying flaws in the aircraft’s design caused the crash. Inaccurate sensor readings activated the MCAS anti-stall system, which pointed the plane’s nose down as pilots struggled to right it, the report said.

Transport Canada has been working with the United States’ Federal Aviation Administration and received a directive listing changes to the aircraft. The department’s safety experts have been doing their own independent review of those proposed changes to determine if the 737 Max is safe to fly again. 

Transport Minister Marc Garneau’s office said today the experts’ work is expected to conclude “very soon.”

‘Desolation and pain’

The families said today they want Transport Canada to explain why it approved the planes to fly in the first place, and why the fleet wasn’t grounded immediately after the crash in 2018.

Njoroge’s wife Carolyne Karanja, their three children (Ryan Njuguna, Kellie Pauls and Rubi Pauls) and mother-in-law Anne Karanja all died on board Ethiopian Airlines Flight 302. He reminded MPs the 737 Max they were on blasted a nine-meter-deep crater in the ground when it hit.

“The tragic death of my family left me in a chasm of solitude, desolation and pain,” he said. “I am here today because I believe that the crash that killed my family was preventable.”

Paul Njoroge with his wife Carolyne, daughter Kellie and son Ryan, who were killed along with his youngest daughter, Rubi, and his mother-in-law when Ethiopian Airlines Flight 302 crashed after takeoff from Addis Ababa on March 10. (Njoroge family)

Njoroge said aviation regulators around the country were not “diligent enough” when they decided to allow the 737 Max to fly. 

“Certainly, Canada would not have lost its 18 citizens and an unknown number of Canadian permanent residents had Transport Canada made prudent decisions after the crash of Lion Air Flight 610,” he said. 

Garneau has been criticized by victims’ families for not grounding Canada’s 737 Max fleet of 41 planes after the first crash, and for Canada being one of the last countries to do so after the second crash. 

Families want to know what data Canada had after the first crash when it issued a directive to pilots to memorize a 5-step process to deal with a potential problem with the plane.

Garneau said in March 2019 it would have been “premature” to ground the fleet before investigators could pinpoint the cause of the second crash.

Garneau told the transport committee in March 2020 that Canada was “scrambling for information” and “had no clear picture of what happened” until data showed similarities to the Lion Air crash. Garneau said he notified the U.S. on March 13, 2019, and it followed suit two hours after Canada grounded the plane.

Too many unanswered questions, said Chris Moore

Chris Moore’s 24-year-old daughter Danielle died in the Ethiopian crash. He reminded the committee that Transport Canada had questions about the 737 Max as early as 2016 — but Canada didn’t get answers from Boeing and the U.S. Federal Aviation Administration before it approved the plane as safe to fly, according to government documents. 

The documents show Transport Canada’s test pilots asked for more information about the plane’s automated anti-stall system before the 737 Max was certified, but didn’t get an explanation in time. 

“Our government didn’t fully understand what they were validating,” said Moore. “Transport Canada was essentially rubber-stamping a doomed MAX plane. Eighteen Canadians perished and our government shrugged.”

Chris and Clariss Moore’s daughter Danielle died on March 10, 2019 when Ethiopian Airlines Flight 302 crashed. (Tina Mackenzie/CBC)

David Turnbull, Transport Canada’s director of national aircraft certification, told the committee in March 2020 that the questions pilots asked about the aircraft’s anti-stall system form a regular part of the certification process. He insisted Canada would never allow the planes to fly if it was aware of any safety issues. 

In a statement, Garneau’s office said today that Transport Canada wanted to know if a “stall warning system, versus a stall protection system” was being used that would have required that a “higher degree of design integrity be met.”

“In the end, Transport Canada was satisfied that the systems in question represent a stall identification system.”

Moore said today there are still too many unanswered questions.

“Did any engineer recommend grounding the plane?” he asked. “Did Canadian and American authorities feel superior in their knowledge and downplay the Lion Air crash because it occurred in a developing country? Would Canada have grounded the Max if the crash happened in Canada?”

The U.S. House Transportation Committee’s investigation released damning details about how Boeing “jeopardized the safety of the flying public” to keep up with production pressures, and cited a “culture of concealment” at Boeing that involved hiding flaws with the new MCAS system from 737 MAX pilots.

Garneau’s office said if Canada approves the aircraft to fly again, there will be conditions.

“These differences will include additional procedures on the flight deck and pre-flight, as well as differences in training,” said Garneau’s director of communications Amy Butcher in a statement to CBC News.

The office insisted Canada will not allow the plane to fly again until Transport Canada “is fully satisfied that all its safety concerns have been addressed, and that enhanced flight crew procedures and training are in place in Canada.”

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Josh Brown: I expect to see the Dow hit 100000 in my lifetime – CNBC Television

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  1. Josh Brown: I expect to see the Dow hit 100000 in my lifetime  CNBC Television
  2. Stocks surge as Biden transition begins  News 1130
  3. WATCH: Trump crashes press conference to celebrate DOW going over 30,000  The Post Millennial
  4. Dow targets 30000 on Biden transition, stimulus odds  BNN
  5. Trump brags about Dow 30,000 at surprise news conference, leaves after a minute  CNBC
  6. View Full coverage on Google News



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