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Pfizer to seek U.S. authorization for COVID booster shot as delta variant spreads – CBC.ca

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Pfizer plans to ask U.S. regulators to authorize a booster dose of its COVID-19 vaccine within the next month, the drugmaker’s top scientist said on Thursday, based on evidence of greater risk of reinfection six months after inoculation and the spread of the highly contagious delta variant.

In a joint statement, however, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) said that Americans who have been fully vaccinated do not need a booster COVID-19 shot at this time.

Some scientists have also questioned the need for booster shots.

Pfizer’s chief scientific officer, Mikael Dolsten, said the recently reported dip in the vaccine’s effectiveness in Israel was mostly due to infections in people who had been vaccinated in January or February. The country’s health ministry said vaccine effectiveness in preventing both infection and symptomatic disease fell to 64 per cent in June.

“The Pfizer vaccine is highly active against the delta variant,” Dolsten said in an interview. But after six months, he said, “there likely is the risk of reinfection as antibodies, as predicted, wane.”

Pfizer did not release the full set of Israeli data on Thursday, but said it would be published soon.

A youth receives a vaccination at a mobile vaccination centre in Tel Aviv, Israel. Israel’s health ministry said vaccine effectiveness in preventing both infection and symptomatic disease fell to 64 per cent in June. (Ammar Awad/Reuters)

“It’s a small data set, but I think the trend is accurate: Six months out, given that delta is the most contagious variant we have seen, it can cause infections and mild disease,” Dolsten said.

The FDA and CDC, in their joint statement, said: “We are prepared for booster doses if and when the science demonstrates that they are needed.”

Dolsten said Pfizer’s own data from the United States showed an erosion of the vaccine’s efficacy to the mid-80s after six months against the variants circulating there in the spring.

Promising protection

He stressed that data from Israel and Britain suggests that even with waning antibody levels, the vaccine remains around 95 per cent effective against severe disease.

The vaccine, developed with German partner BioNTech SE, showed 95 per cent efficacy in preventing symptomatic COVID-19 in a clinical trial the companies ran last year.

Dolsten said early data from the company’s own studies shows that a third booster dose generates antibody levels that are five- to 10-fold higher than after the second dose, suggesting that a third dose will offer promising protection.

He said multiple countries in Europe and elsewhere have already approached Pfizer to discuss booster doses, and some may begin administering them before a potential U.S. authorization.

A health-care worker prepares a dose of the Pfizer vaccine in Angers, France. Pfizer’s chief executive has said people will ‘likely’ need a third booster dose within 12 months and could need annual shots. (Stephane Mahe/Reuters)

Dolsten said he believes booster shots are particularly important in older age groups.

Dr. Eric Topol, a professor of molecular medicine and director of the Scripps Research Translational Institute in La Jolla, Calif., said basing the decision on waning antibody protection ignores the role of other parts of the immune response, including memory B cells, which can make antibodies on demand when challenged by the virus.

“You need better studies to be able to assert that. It isn’t just neutralizing antibodies,” Topol said.

Some scientists question need for booster

Pfizer has previously said people will likely need a booster dose, though some scientists have questioned when, or if, boosters will be needed.

Pfizer plans to soon launch a placebo-controlled efficacy trial of the booster with 10,000 participants. The study will run throughout the fall, Dolsten said, meaning it will not be completed ahead of the company’s filing with the Food and Drug Administration.

Dr. William Schaffner, a vaccine expert at Vanderbilt University Medical Center, said even if Pfizer succeeds in getting its booster authorized by the FDA, that would only be the first step. The booster would still need to be reviewed and recommended by advisers to the CDC.

A elderly woman receives a shot at an assisted living facility, in Netanya, Israel, in January. (Ronen Zvulun/Reuters)

“It’s not automatic by any means,” he said. Schaffner said realistically, most of the public health bandwidth in the United States is still focused on encouraging Americans to get their first and second doses of the vaccine.

Because boosters would drive increasing demand for vaccines while much of the world is still unvaccinated, Dolsten said Pfizer is looking at ways to boost production.

It is already targeting production of three billion doses this year and four billion next year. Dolsten declined to give a forecast of exactly how many more doses the company could add, but said, “We can step up billion after billion in ’22.”

Dolsten also said Pfizer and BioNTech are designing a new version of the vaccine targeting the delta variant, but said the companies do not believe that the current version will need to be replaced in order to combat the variant.

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Key COVID-19 numbers in the Ottawa area today – CBC.ca

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  • Ottawa reports three more COVID-19 cases Tuesday.
  • No local health authority reports a COVID-19 hospital patient.
  • A new outbreak makes up most new cases in the Belleville area.

Today’s Ottawa update

Ottawa Public Health (OPH) reported three more COVID-19 cases Tuesday and no new deaths. It removed two cases from its total, as it’s been doing from time to time as it double-checks its database (often due to residents living in other regions).

There are 42 known active cases in the capital.

Its medical officer of health said last week getting vaccinated and following familiar rules such as masking and distancing can stop COVID-19 from taking hold again.

Researchers measuring levels of the coronavirus in Ottawa’s wastewater have found them to be low and stable for about a month. (613covid.ca)

Numbers to watch

4: The weekly incidence rate, a rolling seven-day total of new COVID-19 cases expressed per 100,000 residents.

0: The number of Ottawa residents being treated for COVID-19 in an Ottawa hospital.

0: The number of COVID-19 patients reported by each of the Ottawa-Gatineau area’s seven health authorities as of noon ET Tuesday. Two of them have yet to report their long weekend numbers.

1.16: The number of people infected by a single COVID-19 case, or R(t). A number under one is a sign the spread is slowing.

0: The number of active COVID-19 outbreaks in Ottawa.

Across the region

There are currently fewer than 100 known active cases in eastern Ontario and western Quebec.

Most local health units are generally reporting an average of a new case or two per day and, in eastern Ontario, have met the province’s fully vaccinated threshold for the next reopening step.

Hastings Prince Edward Public Health reported eight more cases Tuesday in its first update since Friday, six of them linked to an outbreak in Frankford, north of Trenton.

The health unit for the Renfrew County area reported six more cases over the long weekend and in the Kingston area, four more cases.

Ontario is currently under Step 3 of the province’s pandemic reopening plan. All of Quebec is under green zone rules.

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Blizzard's President Brack Steps Down – Dark Horizons

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Blizzards President Brack Steps Down

J. Allen Brack, president of “Warcraft” and “Overwatch” creator Blizzard Entertainment, is leaving the company “to pursue new opportunities”.

Brack’s exit comes less than two weeks after Activision Blizzard was sued by the California Department of Fair Employment and Housing over the company’s alleged “pervasive frat boy workplace culture.”

In recent days, multiple horrific stories have emerged in the press of explosive allegations by employees who claimed to have been continuously subjected to sexual harassment, psychological harassment and discrimination within the company. A large crowd of more than a thousand employees rallied outside the company’s campus this past week, the incident making headline news around the world.

Brack was named in the lawsuit as being among the company executives who were allegedly aware of the systemic misconduct.

EVP of development Jen Oneal and EVP of platform and technology Mike Ybarra have now been appointed co-leaders of Blizzard. Oneal joined Blizzard in January, Ybarra came onboard from XBOX in 2019. Both have more than three decades of gaming industry experience between them.

A short statement released by the company’s COO Daniel Alegre says: “Both leaders are deeply committed to all of our employees; to the work ahead to ensure Blizzard is the safest, most welcoming workplace possible for women, and people of any gender, ethnicity, sexual orientation, or background; to upholding and reinforcing our values; and to rebuilding your trust.”

Source: Kotaku

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Ontario reports single new COVID-19 case in Ottawa Tuesday – CTV Edmonton

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OTTAWA —
Public Health Ontario is reporting a single new case of COVID-19 in Ottawa Tuesday.

A full, local snapshot from Ottawa Public Health is due this afternoon. Daily case counts from OPH often differ from those provided by Public Health Ontario because the two health agencies pull data for their respective daily snapshot reports at different times of the day.

Across the province, Public Health Ontario added 164 new infections on Tuesday and said one more Ontarian had died due to COVID-19. Another 151 cases are now considered resolved.

There was no formal update on the holiday Monday, but the province released the figures Tuesday, reporting an additional 168 new cases and another new death.

Across eastern Ontario, provincial health officials added five additional cases in the last two days.

COVID-19 VACCINES IN OTTAWA

Ottawa Public Health updates vaccine numbers on Mondays, Wednesdays and Fridays. As of Monday:

  • Ottawa residents with 1 dose (12+): 767,352 
  • Ottawa residents with 2 doses (12+): 661,965 
  • Share of population 12 and older with at least one dose: 83 per cent
  • Share of population 12 and older fully vaccinated: 72 per cent
  • Total doses received in Ottawa*: 1,333,790

**Total doses received does not include doses shipped to pharmacies and primary care clinics, but statistics on Ottawa residents with one or two doses includes anyone with an Ottawa postal code who was vaccinated anywhere in Ontario. 

CASES OF COVID-19 AROUND THE REGION

  • Eastern Ontario Health Unit: One new case Monday, zero new cases Tuesday
  • Hastings Prince Edward Public Health: Zero new cases Monday, two new cases Tuesday
  • Kingston, Frontenac, Lennox & Addington Public Health: One new case Monday, zero new cases Tuesday
  • Leeds, Grenville & Lanark District Health Unit: Zero new cases Monday, one new case Tuesday
  • Renfrew County and District Health Unit: Zero new cases Monday and Tuesday

This story will be updated. CTV News Ottawa will have the latest as it becomes available.

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