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Oxford-Astra Covid vaccine review to start in Europe – Hindustan Times

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European regulators are set to start an accelerated review of a Covid-19 vaccine front-runner from the University of Oxford and AstraZeneca Plc, according to a person with knowledge of the situation, in a sign the shot could be the first to seek approval in the region.

The European Medicines Agency is expected to announce the “rolling review” as soon as this week, according to the person, who didn’t want to be identified because the decision is still private. Such assessments are used in emergencies to allow regulators to see trial data while the development is ongoing to speed up approvals of drugs and vaccines that are urgently needed.

The move would be a key step forward for the Oxford-AstraZeneca shot after trials were halted earlier this month due to concerns about a participant in the U.K. study who became ill. The partners, along with companies such as Pfizer Inc. and Moderna Inc., are sprinting ahead with experimental shots as governments look for a way out of the global crisis.

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The death toll from the disease exceeded 1 million this week, while the infection rate has rapidly picked up again in Europe.

While the British regulator cleared the Oxford-Astra trial to restart less than a week after it was paused and studies in South Africa, Brazil and India have resumed, U.S. authorities have yet to give the go-ahead.

Late Wednesday, Reuters reported that the U.S. Food and Drug Administration had widened its investigation of the incident that led to the trial halt, citing people familiar with the matter.

The EMA’s head of vaccines, Marco Cavaleri, said in July the agency would start rolling reviews of potential candidates after the summer. The approach means that a final approval could be granted a matter of days after the review period ends. Cavaleri said at the time the first approval of a vaccine could come by the end of the year.

In a normal environment, drugmakers submit trial data to the regulator for a review that can take many months. Once that’s complete, an opinion is given on whether the product should be authorized for use, which must be signed off by the European Commission.

In emergencies like a pandemic, a rolling review avoids delays so that an EMA recommendation and approval from the European Commission can be sought as quickly as possible. The agency started such an evaluation of remdesivir to treat Covid-19 in April, while trials were ongoing, and the drug was given conditional approval three months later.

AstraZeneca declined to comment. A spokesperson for the EMA declined to comment on the review.

“EMA has always stated that it will communicate the start of a rolling review for Covid-19 treatments or vaccines,” it said in a statement. “We have not made such an announcement for a vaccine.”

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April 22nd to 30th is Immunization Awareness Week – Oldies 107.7

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<!–April 22nd to 30th is Immunization Awareness Week | Oldies 107.7

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AHS confirms case of measles in Edmonton – CityNews Edmonton

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Alberta Health Services (AHS) has confirmed a case of measles in Edmonton, and is advising the public that the individual was out in public while infectious.

Measles is an extremely contagious disease that is spread easily through the air, and can only be prevented through immunization.

AHS says individuals who were in the following locations during the specified dates and times, may have been exposed to measles.

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  • April 16
    • Edmonton International Airport, international arrivals and baggage claim area — between 3:20 p.m. and 6 p.m.
  • April 20
    • Stollery Children’s Hospital Emergency Department — between 5 a.m. to 3 p.m.
  • April 22
    • 66th Medical Clinic (13635 66 St NW Edmonton) — between 12:15 p.m. to 3:30 p.m.
    • Pharmacy 66 (13637 66 St NW Edmonton) — between 12:15 p.m. to 3:30 p.m.
  • April 23
    • Stollery Children’s Hospital Emergency Department — between 4:40 a.m. to 9:33 a.m.

AHS says anyone who attended those locations during those times is at risk of developing measles if they’ve not had two documented doses of measles-containing vaccine.

Those who have not had two doses, who are pregnant, under one year of age, or have a weakened immune system are at greatest risk of getting measles and should contact Health Link at 1-877-720-0707.

Symptoms

Symptoms of measles include a fever of 38.3° C or higher, cough, runny nose, and/or red eyes, a red blotchy rash that appears three to seven days after fever starts, beginning behind the ears and on the face and spreading down the body and then to the arms and legs.

If you have any of these symptoms stay home and call Health Link.

In Alberta, measles vaccine is offered, free of charge, through Alberta’s publicly funded immunization program. Children in Alberta typically receive their first dose of measles vaccine at 12 months of age, and their second dose at 18 months of age.

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U.S. tightens rules for dairy cows a day after bird flu virus fragments found in pasteurized milk samples – Toronto Star

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Infected cows were already prohibited from being transported out of state, but that was based on the physical characteristics of the milk, which looks curdled when a cow is infected, or a cow has decreased lactation or low appetite, both symptoms of infection.

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