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FDA Approves Ebola Vaccine For USe And Distribution In United States – Forbes



On Thursday, the FDA announced the approval of the Ebola vaccine, Ervebo, for use in adults aged 18 and older. This follows the approval of the vaccine in Europe in November. Although Ebola is rare in the U.S., the vaccine’s approval will help in world-wide efforts to prevent future Ebola outbreaks and deaths. 

Ervebo’s U.S. approval is based on results from a study conducted between 2014-2016 during an Ebola outbreak in Guinea. These study results showed that the vaccine was nearly 100% effective in preventing patients from contracting Ebola with symptom onset greater than 10 days after vaccination. In addition, the vaccine was tested in Liberia, Sierra Leone, Canada, Spain and the U.S., with similar results. The approval was granted to Merck & Co., Inc.

The vaccine is administered as a single-dose injection that contains a protein from the virus. The most commonly reported side effects were pain, swelling and redness at the injection site, as well as headache, fever, joint and muscle aches and fatigue.

“Today’s approval is an important step in our continuing efforts to fight Ebola in close coordination with our partners across the U.S. Department of Health and Human Services, as well as our international partners, such as the World Health Organization,” said Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs, in an FDA statement. “These efforts, including today’s landmark approval, reflect the FDA’s unwavering dedication to leveraging our expertise to facilitate the development and availability of safe and effective medical products to address urgent public health needs and fight infectious diseases, as part of our vital public health mission.”

Ebola, formally known as Ebola virus disease (EVD) is caused by the Zaire ebolavirus. Although rare, the virus can cause serious and often deadly results. The first cases of the disease were noted in Africa in the 1970s, and since then several breakouts have caused thousands of deaths on the African continent. Since 2014 alone, there have been more than 28,000 cases and 11,000 deaths from Ebola, the FDA statement reported. According to the World Health Organization, up to 90 percent of those infected with Ebola can die from the virus. 

The virus causes fever, fatigue, muscle pain, headaches and sore throat. This soon escalates to vomiting, diarrhea, rash, impaired kidney and liver function. In more extreme cases, patients will develop internal bleeding and eventually death may occur. 

The virus is also highly contagious and is transmitted through direct contact with bodily fluids, blood and tissue of infected people, or in some cases infected wild animals. For example, some of the cases in Africa are believed to have been begun through the consumption of infected animal meat, most notably bats. In addition, health workers who treat infected patients are at extremely high risk for contracting the virus themselves. 

Due to the extreme need for the vaccine, the FDA granted the vaccine’s application a Priority Review and a Tropical Disease Priority Review Voucher, as well as a Breakthrough Therapy designation, in the hopes to expedite the drug’s development. 

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Manitoba officials to give COVID-19 update at 12:30 p.m. –



Health officials in Manitoba are set to give the latest news on COVID-19 in the province on Wednesday afternoon.

CBC News will live stream the update here at 12:30 p.m. Manitobans will hear from Dr. Jazz Atwal, acting deputy chief provincial public health officer, and Dr. Joss Reimer, a medical officer of health for Manitoba Health and a member of the province’s COVID-19 vaccine implementation task force.

The news conference comes one day after the province floated possible changes to public health orders that will expire on Friday.

Those possible tweaks, which are being considered for all regions but the hard-hit north, include allowing some small gatherings and scrapping restrictions on what can be sold in stores.

Manitoba also is reassessing how many vaccine appointments can be booked after the already reduced Pfizer-BioNTech shipments the province expected to get over the next few weeks were cut in half.

The slowdown comes after Pfizer temporarily paused some production lines as it aims to expand manufacturing capacity in the long term.

Help is on the way for Garden Hill First Nation in northern Manitoba, after federal Public Safety Minister Bill Blair approved a request for assistance from the Canadian Armed Forces for the community as it deals with an outbreak.

Cases in Manitoba’s Northern Health Region were down slightly on Tuesday; the area saw 500 new cases last week.

On Monday, the Manitoba Metis Federation opened a COVID-19 testing site for Métis people in and around Winnipeg.

The organization partnered with a local bioinformation services firm after it was unable to get information from the province on how many Métis people in Manitoba have tested positive for COVID-19, president David Chartrand said.

Meanwhile, federal Northern Affairs Minister Dan Vandal wrote to Premier Brian Pallister, asking that the federation to be included in the province’s vaccine task force and distribution plans. Vandal is also the member of Parliament for Winnipeg’s St. Boniface-St. Vital riding.

Manitoba has reported 229 confirmed cases of COVID-19 and 15 more coronavirus-linked deaths since Monday.

The province’s latest fatalities include a tally of 11 on Tuesday, the first time that number was in the double digits in nearly two weeks.

Those numbers are a marked improvement from two months ago, when daily case counts hovered around the low 400s and on one day peaked at 546 new cases.

Manitoba’s five-day test positivity rate, a rolling average of the COVID-19 tests that come back positive, has also been trending downward, though fewer people are being tested for the illness.

The decreasing numbers are why Manitoba is now in a position to consider loosening some of its pandemic rules, Chief Provincial Public Health Officer Dr. Brent Roussin said on Tuesday.

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New variants of novel coronavirus detected worldwide, worrying public health experts – CTV News



More variants of the novel coronavirus are being detected worldwide, ramping up fears in Canada around the increased transmission some of these variants could bring.

They’re known as “variants of concern” according to the World Health Organization, and since the first variant emerged in the U.K., it and other variants have spread to numerous countries. The U.K. variant alone has been detected in 60 countries. A new variant emerged this week in a German ski town in Bavaria, making up 35 newly-infected cases in the hospital, according to local media reports.

Officials said the variant was different than others making their way across the globe.

In virus-stricken California, where doctors are already dealing with overwhelmed hospitals as a result of the highly transmissible U.K. variant, another variant has also been ramping up.

It’s called “452R” and isn’t technically new — it was first detected in Denmark a year ago and in California since May. It’s not thought to be more deadly, but it could be more transmissible than the original virus, like most of the variants that have been discovered.

“Something that’s stickier like this new variant potentially is can cause us to have setbacks in all of the hard work that we’ve done so far,” said Dr. Peter Chin-Hong, a professor with the University of California San Fransisco School of Medicine.

Two of the variants causing a lot of concern are from Brazil and from South Africa.

Scientists from the lab that discovered the South Africa variant (known as the 501Y.V2 variant) explained that the variant is more efficient at targeting healthy cells because of key mutations in its structure.

“It has to get in and it has to get out before the cell dies, because the virus has no life of its own,” Alex Sigal, with the African Health Research Institute, explained to CNN.

Studying how these variants work will be a hugely important part of the COVID-19 response, WHO stressed in a recent press release. The organization held an emergency meeting last week to address the topic of the variants, affirming the importance of global collaboration on research.

In the meeting, WHO vowed to make the sequencing of different variants a priority by improving capacity for that type of research worldwide.

Scientists in Canada are also on the hunt to get answers about these variants and others like them.

Graham Tipples, medical scientific director of the provincial Public Health Lab in Alberta, told CTV News that variants outside of those scientists have already identified will certainly “continue to arise,” and that we’ll only know through research if they pose a unique threat or not.

“We need to understand whether any of them have significant altered characteristics that might affect immunization, that might affect diagnostics, that might affect causing more severe disease,” he said.

He added that scientists needed to keep an eye on the specific structure of the variants for testing as well.

“The targets that we have for our diagnostic test may be affected by a particular mutation, so we have to be aware of how the virus changes so that our tests don’t come up negative, because of a mutation.”

Some doctors are so concerned about the potential spread of these new variants in Canada that they’ve launched a petition asking governments to restrict travel to stop variants from arriving here.

The petition declares that “the #CanadianShield starts at the border” and notes that the B.1.1.7 variant – one of several terms for the U.K. variant – is estimated to be 30-60 per cent more transmissible than the current strain circulating in Canada.

The petition calls on the federal government to restrict international travel by more clearly defining essential travel and enforcing the criteria.

Scientists say we need to remain vigilant when it comes to these variants.

“There could be ones that may be more deadly down the road, and so we want to make sure we try to reduce the amount of virus spreading because the more we allow it to spread, the more chance of these variants to appear,” Jeff Kwong, a professor of public health and family medicine at the University of Toronto, told CTV News.

He pointed out that the U.K. variant has already led to huge outbreaks in the U.K. Only a few cases of this variant have been identified in Canada so far, but experts say if it is allowed to spread, it could become the dominant strain.

“We need to make sure we don’t allow for more cases to come into Canada, because once it catches fire here then we’re in big trouble,” Kwong said.

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What's different about the coronavirus 'variants of concern' flagged by WHO –



The seemingly more transmissible variants of the coronavirus first discovered in Britain, South Africa and Brazil are called “variants of concern” by the World Health Organization.

Viruses mutate or change all the time to gain a selective advantage over other variants or versions of the virus.

What sets the variants of concern apart from run-of-the-mill mutations is they could help the virus to infect human cells more easily or transmit person to person. If so, the variant gains a competitive advantage to wrestle aside other versions of the virus.

So far, there are no signs of the variants worsening severe outcomes from the disease directly. But the fear is they will lead to more hospitalizations and deaths by spreading much more easily to more people.

Here’s a look at what’s driving the concern and calls for more precautions in Canada.

Where are the variants found in Canada?

Canada’s national microbiology lab has to date reported 23 cases of the B117 virus variant first identified in the U.K. and two cases of the variant first reported in South Africa.

Most provinces aren’t testing all samples for the variants. Only Saskatchewan says all of its COVID-19 tests will detect the B117 variant.

Researchers at Aalborg University in Denmark screen and analyze all of the positive Danish COVID-19 samples for the variant that was first reported in Britain. Experts are calling on Canada to increase surveillance for variants. (Ritzau Scanpix/Henning Bagger/Reuters)

Health officials say when greater transmission results in more people testing positive, then more hospitalizations, intensive care admissions and eventually deaths will follow.

And the more that a virus circulates — either worldwide or in a particular community — the more opportunities it has to mutate.

How quickly and to what extent are the variants spreading?

Virus and infectious disease experts say that to get a handle on how quickly the variants are spreading in Canada requires more surveillance.

But genome sequencing is a research tool that is costly and time consuming to use clinically. That’s why labs across the country are working to develop faster assays for variants of SARS-CoV-2, the virus that causes COVID-19.

Dr. Barbara Yaffe, Ontario’s associate chief medical officer of health, noted Monday that some of the province’s cases of variants don’t have a travel history.

Travellers arrive on international flights at Vancouver International Airport last month. When coronavirus variants show community transmission, the source of an outbreak can no longer be traced back to travel abroad. (Ben Nelms/CBC)

“We do expect more cases to be identified in the weeks to follow, as there is evidence now of community transmission,” Yaffe said.

Last week, Yaffe called community transmission “a very serious concern that the vaccine will not be able to address quickly enough.”

Public health officials are on the lookout for variants showing community transmission because it means the source of an outbreak can no longer be traced back to travel abroad. At that point, an outbreak can quickly spiral, so time is of the essence.

If the B117 variant spreads in the community, the doubling time for cases could drop to 10 days in March from every 35 to 40 days now, Ontario health officials estimated.

What would experts like to see next?

Art Poon, an associate professor in the department of pathology and laboratory medicine at Western University in London, Ont., develops computer methods to study the evolution of viruses, such as an app called CoVizu that’s listed by the GISAID Initiative — an international non-profit project to share genome data on viruses.

Poon said that the variants of concern show more mutations than scientists would expect.

WATCH | New coronavirus variant emerges in Brazil:

Three COVID-19 variants are now worrying health officials. The ones first identified in Britain and South Africa are already here. The third is spreading fast in Brazil and beyond. It may be better at dodging the immune response, and even reinfecting survivors. 3:36

“I think, sadly, we’re going to see increasing frequency of this particular [B117] variant and disproportionate growth of this in other countries,” he said of what’s been seen so far in Britain.

Dr. Lynora Saxinger, an infectious disease specialist at the University of Alberta in Edmonton, is also looking for more surveillance of variants, as well as other precautions.

Saxinger said she would like to see tighter controls at Canada’s border with the United States, both by land and air. This includes checks to ensure international travellers obey requirements in the Quarantine Act and aren’t carrying the infection unknowingly and spreading it, as well as possibly an interprovincial travel ban, which has been proposed by B.C. Premier John Horgan.

“We don’t want there to be multiple importations of these difficult mutations before we have an opportunity to detect and control them,” Saxinger said. “We should probably try to keep a tight lid on things until we sort out what’s what, if this is a big deal, where it’s a big deal and how it might be controlled.”

Limiting importations of the variants means less fuel for the fire. “If you’re not having that many potential sparks hitting your tinder, you have a much better chance of being able to control it,” she said.

Saxinger is one of the signatories to a petition released Tuesday calling on the federal government to immediately act to reduce opportunities for variant entry by restricting international travel to essential travel, as well as other precautions.

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