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

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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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Canada signs deal with Pfizer for millions of pediatric COVID-19 vaccine doses- PM Trudeau

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Canada has signed a deal with  Pfizer Inc to receive 2.9 million doses of their pediatric COVID-19 vaccine shortly after it is approved for use by Health Canada, Prime Minister Justin Trudeau said on Thursday.

“We will be receiving enough doses in Canada to ensure that all children in Canada, aged five to 11, can receive the vaccine,” said Trudeau. The vaccine is currently being reviewed by Health Canada.

 

(Reporting by Julie Gordon in Ottawa, Editing by Franklin Paul)

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Canada government, provinces agree COVID-19 vaccine travel passport – officials

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Canada’s federal government and the 10 provinces have agreed on a standard COVID-19 electronic vaccination passport allowing domestic and foreign travel, government officials told reporters on Thursday.

The deal prevents possible confusion that could be caused if each of the provinces – which have primary responsibility for health care – issued their own unique certificates. The officials spoke on the condition they not be identified.

The document will have a federal Canadian identifying mark and meets major international smart health card standards.

“Many (countries) have said they want to see a digital … verifiable proof of vaccination, which is what we’re delivering,” said one official.

In addition, federal officials are talking to nations that are popular with Canadian travelers to brief them about the document.

The Liberal government of Prime Minister Justin Trudeau announced earlier this month that from Oct 30, people wishing to travel domestically by plane, train or ship would have to show proof of full vaccination.

 

(Reporting by David Ljunggren; Editing by Alistair Bell)

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The Ottawa area's weekly COVID-19 vaccination checkup: Oct. 21 – CBC.ca

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Highlights:

  • Updates to Ontario and Quebec’s proof-of-vaccination systems.
  • More details on the reopening of the U.S. land border.
  • Another step toward approval of a vaccine for children age five to 11.
  • Ottawa hits some major vaccination milestones.

Every Thursday, CBC Ottawa brings you this roundup of COVID-19 vaccination developments throughout the region. You can find more information through links at the bottom of the page.

There have been more than 3.5 million doses administered in the wider Ottawa-Gatineau region, which has about 2.3 million residents.

That’s about 25,000 doses in the last week, slightly fewer than the previous weekly count.

Provincial picture

Ontario’s proof-of-vaccination QR codes can be used starting Friday. People can still give paper or PDF proof, but the QR codes and provincial app used to check them are meant to be more efficient.

Quebec has a new vaccination record specifically designed for use out of the province.

Proof of vaccination is now required for visitors to many health-care facilities in Quebec. While its unvaccinated health-care workers aren’t yet suspended without pay, they are losing their pandemic bonuses.

Most members of Parliament — and anyone else entering the House of Commons — will have to be fully vaccinated when Parliament returns on Nov. 22.

Ninety per cent of eligible Quebec residents have had at least one dose and 86 per cent are fully vaccinated.

Eighty-eight per cent of Ontario residents age 12 and up have at least one vaccine dose, while about 83 per cent are fully vaccinated.

Quebec is allowing bars and restaurants to reach full capacity under its vaccine passport and halving the two-metre distance rule as of Nov. 1.

One week later, the United States land border with Canada reopens to non-essential travel for the fully vaccinated, including those with mixed doses.

WATCH | The upcoming U.S. border rules: 

Travellers with mixed vaccine doses to be accepted in U.S.

5 days ago

CBC News explains the United States’ new stance on travellers with mixed vaccine doses. The country will now accept Canadians with mixed vaccines, including AstraZeneca, when the new rules begin on Nov. 8. 3:15

After submitting its trial data, Pfizer has officially asked Health Canada to approve its vaccine for children age five to 11.

Ontario’s health minister says the province will be ready to go when the first such vaccine is available.

WATCH | What expanded eligibility may look like: 

COVID-19 vaccines for kids could face hurdles after approval

Health Canada is reviewing data for the first COVID-19 vaccine for younger children, but even if it’s approved, the hurdles could include vaccine supply, distribution and getting some parents on board. 3:38

Ottawa

The capital still has regular and pop-up clinics for anyone eligible to get a first, second or third dose, has neighbourhood vaccine hubs, and is bringing mobile vaccine clinics to those who request it.

There are pop-ups Friday afternoon at the Banff-Ledbury Pavilion and Saturday at Communauté Catholique Congolaise Bondeko d’Ottawa-Gatineau in Vanier.

More than 1.6 million doses have now been given to Ottawa residents.

Of the city’s total population of just over one million, 78 per cent of residents have had at least one dose, including 90 per cent of residents born in 2009 or earlier.

Seventy-five per cent of the total population is fully vaccinated, as are 86 per cent of eligible residents.

This combined bar and line graph shows vaccination numbers for Ottawa residents born in 2009 or earlier. Every age demographic is above 85 per cent fully vaccinated except for two: 18 to 29 and 30 to 39. Both moved slightly closer to that mark in the last week. (Ottawa Public Health)

An infectious disease specialist said this high level of vaccination will begin to reflect in a declining number of new cases — even among people who don’t have the vaccine.

Western Quebec

CISSSO continues to list recurring, mobile and pop-up clinics online.

The Outaouais has distributed more than 596,000 doses — combined first, second and third — among a population of about 386,000.

All in a Day8:57How to talk about COVID-19 breakthrough cases

Cardiologist and epidemiologist Dr. Christopher Labos talks to us about how to talk about COVID-19 breakthrough cases and possible side effects from taking the COVID-19 vaccines in a way that doesn’t contribute to vaccine hesitancy. 8:57

Kingston, Frontenac and Lennox & Addington

It’s managing smaller clinics and mobile clinics to better reach areas with lower vaccination rates, with options shared regularly online and on its social feeds.

A mobile clinic is coming to the Addington Highlands Community Centre in Denbigh Thursday afternoon.

The region, with a population of about 213,000, has had more than 328,000 vaccine doses — combined first, second and third — given to residents.

The health unit has now given a first dose to about 89 per cent of its population 12 and older, and about 85 per cent of eligible people have been fully vaccinated.

WATCH | What it means when a health unit is around 90% vaccinated: 

Ottawa reaches 90 per cent of residents with first dose, offering hope for herd immunity

2 days ago

Dr. Gerald Evans, an infectious disease specialist at Queen’s University, said Ottawa’s high rate of vaccination means case numbers should decline, even among those who aren’t vaccinated. 1:01

Eastern Ontario Health Unit

About 324,000 vaccine doses have been administered among a population of about 209,000. About 90 per cent of residents 12 and older are partially vaccinated, and about 86 per cent are fully vaccinated.

Details for its regular and pop-up vaccine clinics are regularly shared on its website and social media. There are clinics Thursday at Cornwall’s Benson Centre and Friday at Rockland’s Jean-Marc Lalonde Arena.

Leeds, Grenville and Lanark.

The health unit has given nearly 296,000 doses to residents, seeing 97 per cent of its eligible population with at least one dose and about 94 per cent of those residents have at least two doses.

The unit is posting walk-up vaccine locations on Twitter and online. Upcoming options include Prescott’s Leo Boivin Arena Thursday and the Christian Reformed Church in Athens Friday.

It’s making sure people saw the updated guidance they don’t have to space out flu and COVID-19 shots.

WATCH | Hospital workers in Ottawa area mostly vaccinated against COVID-19

Majority of Ottawa-area hospital staff fully vaccinated as deadline arrives

6 days ago

Dr. Alan Drummond, an emergency room physician at the Perth and Smiths Falls District Hospital, says health care providers have an obligation to get vaccinated in order to keep patients safe — and those unwilling to do so should find other careers. 0:55 

Hastings Prince Edward 

There are regular clinics in Bancroft, Belleville and Picton. It lists community clinics on its website.

About 256,000 doses have been administered to this area’s residents. Another 5,200 or so doses have been given at CFB Trenton.

Eighty-nine per cent of the local population 12 and older has now had a first dose. Eighty-two per cent are fully vaccinated.

When ready, the Mohawks of the Bay of Quinte say their clinic for kids age five to 11 will operate out of the Mohawk Community Centre.

Renfrew County

The health unit regularly shares pop-up and walk-in clinic information online. There are clinics in Arnprior and Deep River Thursday.

With a population of about 109,000, Renfrew County has distributed about 154,000 doses as of its last update Oct. 12.

About 87 per cent of its eligible population, including military at Garrison Petawawa, have at least a first dose and about 83 per cent are fully vaccinated.

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