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Health Canada on track to approve AstraZeneca COVID-19 vaccine by mid-February – SooToday

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OTTAWA — Health Canada is on track to give the green light to a third COVID-19 vaccine within the next two weeks and a fourth may not be far behind, offering a glimmer of hope at the end of a week of nothing but vaccine vexation.

Eric Morrissette, chief of media relations at Health Canada, said Friday the regulatory team that has been reviewing an application from AstraZeneca since Oct. 1, is now doing its final assessment of the vaccine’s clinical data.

It’s a back-and-forth process with the manufacturer answering any questions the review team has.

AstraZeneca was the first to apply for approval for a COVID-19 vaccine in Canada and has been greenlit in 15 jurisdictions including the United Kingdom, Mexico, India, and as of Friday, the entire European Union.

Dr. Supriya Sharma, Health Canada’s chief medical adviser, said earlier this month the review was “a bit more complicated” because in AstraZeneca’s trials, some volunteers only received a half dose at first.

A big trial underway in the United States is supposed to provide more clarity, but Morrissette said Friday that trial won’t report findings until March and Health Canada’s team has decided it has all the clinical data it needs. It also has all the information it needs on the manufacturing processes.

A fourth vaccine could be close at hand as well, after Johnson and Johnson reported Friday that Phase 3 clinical trial results — typically the last before a drug is approved for wide use — showed its vaccine is about 85 per cent effective against serious illness from COVID-19. Johnson and Johnson, which submitted an application to Canada for approval Nov. 30, offers the only single-dose vaccine thus far.

Health Canada approved Pfizer-BioNTech’s vaccine on Dec. 9. and Moderna’s on Dec. 23, each time about three weeks after Phase 3 trial results were publicly reported.

Canada has pre-ordered 10 million doses from Johnson and Johnson with the potential to get 28 million more, and 20 million doses from AstraZeneca. But the federal government has not said when those doses would be delivered, and recent days have shown deliveries for COVID-19 vaccines are constantly subject to change.

Moderna became the third vaccine-maker in two weeks Friday, to announce production delays will cut into its upcoming deliveries.

The Massachusetts-based biotech firm shipped more than 340,000 doses to Canada in the last month, but next week’s shipment is getting cut by about one-fifth, or 50,000 fewer doses, because of slower-than-expected production of the drug components by Moderna’s manufacturing partner, Lonza. Similar reductions are affecting Europe.

Moderna’s Canadian country manager Patricia Gauthier said the company will ship all two millions doses its contract stipulates by the end of March. Canada bought 40 million doses from Moderna overall, with most of them contracted to arrive between April 1 and Sept. 30.

Canada’s budding vaccination effort shrivelled this week when a temporary production slowdown caused Pfizer and BioNTech to cancel an entire shipment of more than 208,000 doses, after cutting last week’s shipment by about 20 per cent. The next two weeks’ deliveries will be cut by about 80 per cent before mostly being restored the week of Feb. 15.

Pfizer is also now asking Canada to agree each of its vials contains six doses, rather than five, which would allow it to ultimately ship fewer vials to meet its obligation of four million doses by the end of March, and 40 million by the fall.

AstraZeneca is cutting deliveries to Europe by 60 per cent through the end of March because of production problems in Belgium. That, coupled with Pfizer’s delays, prompted the European Union to require vaccine makers to report on how many doses are being produced and exported from Europe.

All of Canada’s Pfizer and Moderna vaccine doses are made in Europe. Canadian officials won’t say where Canada’s doses from AstraZeneca are to be made, but insist they will be unaffected by the European production problems.

Canada is not among more than 120 countries exempted on paper from the export controls, but Prime Minister Justin Trudeau said European Commission President Ursula von der Leyen assured him in a phone call Wednesday that the export controls won’t affect Canada.

Despite the production hiccups, Trudeau insisted Friday Canada’s vaccine program is on track, noting production problems when the world is trying to build manufacturing lines for new products in massive demand are not a surprise.

Canada’s current vaccination plan says there will be three million people vaccinated by the end of March and another 10 million by the end of June, and that anyone else who wants to be immunized will be by the end of September.

Conservative Leader Erin O’Toole said the government needs to be more transparent about its vaccine contracts. Canada has contracts with seven COVID-19 vaccine-makers but has never published any details, including prices or delivery timelines.

The United States released redacted versions of contracts it has, and the European Commission Friday released a redacted AstraZeneca contract and said it wants to release the rest as soon as possible. It has to negotiate doing so with the companies.

Trudeau said Friday Canada will try to do that too but won’t jeopardize getting vaccines to Canadians as quickly as possible.

This report by The Canadian Press was first published Jan. 29, 2021.

Mia Rabson, The Canadian Press

Note to readers: This is a corrected story. An earlier version said the manufacturing data for Astrazeneca was still to be submitted.

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Whooping cough is at a decade-high level in US

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MILWAUKEE (AP) — Whooping cough is at its highest level in a decade for this time of year, U.S. health officials reported Thursday.

There have been 18,506 cases of whooping cough reported so far, the Centers for Disease Control and Prevention said. That’s the most at this point in the year since 2014, when cases topped 21,800.

The increase is not unexpected — whooping cough peaks every three to five years, health experts said. And the numbers indicate a return to levels before the coronavirus pandemic, when whooping cough and other contagious illnesses plummeted.

Still, the tally has some state health officials concerned, including those in Wisconsin, where there have been about 1,000 cases so far this year, compared to a total of 51 last year.

Nationwide, CDC has reported that kindergarten vaccination rates dipped last year and vaccine exemptions are at an all-time high. Thursday, it released state figures, showing that about 86% of kindergartners in Wisconsin got the whooping cough vaccine, compared to more than 92% nationally.

Whooping cough, also called pertussis, usually starts out like a cold, with a runny nose and other common symptoms, before turning into a prolonged cough. It is treated with antibiotics. Whooping cough used to be very common until a vaccine was introduced in the 1950s, which is now part of routine childhood vaccinations. It is in a shot along with tetanus and diphtheria vaccines. The combo shot is recommended for adults every 10 years.

“They used to call it the 100-day cough because it literally lasts for 100 days,” said Joyce Knestrick, a family nurse practitioner in Wheeling, West Virginia.

Whooping cough is usually seen mostly in infants and young children, who can develop serious complications. That’s why the vaccine is recommended during pregnancy, to pass along protection to the newborn, and for those who spend a lot of time with infants.

But public health workers say outbreaks this year are hitting older kids and teens. In Pennsylvania, most outbreaks have been in middle school, high school and college settings, an official said. Nearly all the cases in Douglas County, Nebraska, are schoolkids and teens, said Justin Frederick, deputy director of the health department.

That includes his own teenage daughter.

“It’s a horrible disease. She still wakes up — after being treated with her antibiotics — in a panic because she’s coughing so much she can’t breathe,” he said.

It’s important to get tested and treated with antibiotics early, said Dr. Kris Bryant, who specializes in pediatric infectious diseases at Norton Children’s in Louisville, Kentucky. People exposed to the bacteria can also take antibiotics to stop the spread.

“Pertussis is worth preventing,” Bryant said. “The good news is that we have safe and effective vaccines.”

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AP data journalist Kasturi Pananjady contributed to this report.

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The Associated Press Health and Science Department receives support from the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

The Canadian Press. All rights reserved.

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Scientists show how sperm and egg come together like a key in a lock

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How a sperm and egg fuse together has long been a mystery.

New research by scientists in Austria provides tantalizing clues, showing fertilization works like a lock and key across the animal kingdom, from fish to people.

“We discovered this mechanism that’s really fundamental across all vertebrates as far as we can tell,” said co-author Andrea Pauli at the Research Institute of Molecular Pathology in Vienna.

The team found that three proteins on the sperm join to form a sort of key that unlocks the egg, allowing the sperm to attach. Their findings, drawn from studies in zebrafish, mice, and human cells, show how this process has persisted over millions of years of evolution. Results were published Thursday in the journal Cell.

Scientists had previously known about two proteins, one on the surface of the sperm and another on the egg’s membrane. Working with international collaborators, Pauli’s lab used Google DeepMind’s artificial intelligence tool AlphaFold — whose developers were awarded a Nobel Prize earlier this month — to help them identify a new protein that allows the first molecular connection between sperm and egg. They also demonstrated how it functions in living things.

It wasn’t previously known how the proteins “worked together as a team in order to allow sperm and egg to recognize each other,” Pauli said.

Scientists still don’t know how the sperm actually gets inside the egg after it attaches and hope to delve into that next.

Eventually, Pauli said, such work could help other scientists understand infertility better or develop new birth control methods.

The work provides targets for the development of male contraceptives in particular, said David Greenstein, a genetics and cell biology expert at the University of Minnesota who was not involved in the study.

The latest study “also underscores the importance of this year’s Nobel Prize in chemistry,” he said in an email.

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

The Canadian Press. All rights reserved.

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