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Pfizer, BioNTech ask U.S. regulators to OK COVID-19 vaccine for kids – Windsor Star

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WASHINGTON — Pfizer Inc and BioNTech SE have asked U.S. regulators to authorize emergency use of their COVID-19 vaccine for children ages 5 to 11, a group for whom no shot is currently allowed, Pfizer said on Thursday.

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The U.S. Food and Drug Administration has set a date of Oct. 26 for its panel of outside advisers to meet and discuss the application, making it possible for children in this age group – numbering around 28 million – to begin receiving the two-dose Pfizer/BioNTech vaccine shortly afterward.

“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer wrote on Twitter.

The vaccine already has won U.S. emergency use authorization in teens ages 12 to 15 and is fully approved by regulators for people ages 16 and up.

The Pfizer/BioNTech vaccine is one of three in use in the United States, along with the two-dose Moderna vaccine and the single-dose Johnson & Johnson version, neither of which has won full regulatory approval for any age group.

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A rapid authorization of the Pfizer/BioNTech vaccine in young kids could help mitigate a potential surge of cases in the coming weeks and months, with schools open nationwide and colder weather driving activities indoors. If given regulatory authorization, the two-dose Pfizer/BioNTech vaccine would become the first COVID-19 shot made available to children 5 to 11 in the United States.

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The Pfizer/BioNTech vaccine has been shown to induce a strong immune response in 5 to 11 year olds in a 2,268-participant clinical trial, the companies said on Sept. 20.

The two drugmakers are also testing the vaccine in children ages 2 to 5 years old and children ages 6 months to 2 years, with data expected in the fourth quarter.

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The vaccine could be ready for roll out as early as November pending approval from federal regulatory health agencies, White House COVID-19 response coordinator Jeffrey Zients said on CNN.

Once the authorization is granted, Zients said: “We are ready. We have the supply. We’re working with states to set up convenient locations for parents and kids to get vaccinated including pediatricians’ offices and community sites.”

The United States leads the world in COVID-19 cases and deaths.

Children currently make up about 27% of all U.S. coronavirus cases and an increasing percentage of hospitalizations, according to the American Academy of Pediatrics. That reflects the high contagiousness of the coronavirus Delta variant among unvaccinated people.

While children are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations more at risk of severe illness.

A Pfizer spokesperson said the application to the FDA has been completed.

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B.C. doctors group calls on province to focus on COVID-19 aerosol transmission – CTV News Vancouver

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VANCOUVER –

A group of doctors in British Columbia is calling on the province to re-evaluate its approach to combating COVID-19.

The group, called Protect our Province B.C., is made up of a range of doctors and medical researchers, and held a panel discussion Wednesday highlighting how the virus is spread through aerosol transmission.

Dr. Victor Leung, an infectious disease physician and medical microbiologist, says the province and public health have been too slow to amend mandates to limit the spread of the virus.

He says the province should focus on improving air flow in buildings and continue strong mask mandates.

Health Minister Adrian Dix says the province has made an “enormous” amount of information on the virus available to the public, while he defended provincial health officer Dr. Bonnie Henry’s approach to the pandemic.

He says Henry is a world leader in pandemic management and she has always been committed to learning and adapting the province’s COVID-19 response.

“I encourage people to get involved in the debate, ours is a science-led strategy,” Dix said. “We continue to adapt, listen and learn and do better.”

B.C. reported 696 new cases of COVID-19 on Wednesday, bringing the number of active cases to 4,888.

Six more people have died, lifting the death toll to 2,092.

Leung says many of the guidelines from the province are focused on battling a virus that is spread by droplets and touch, but those mandates don’t address the main mode of transmission for COVID-19: aerosols.

“This is an overly dispersed virus,” he says. “Not everyone will affect 10 people, one person might infect 80 people, while another may not infect anyone.”

He said learning about how the virus is spread and transmitted will also help in future pandemics.

This report by The Canadian Press was first published Oct. 20, 2021.

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BC health officials report 715 new cases of COVID-19 on Thursday, October 21st – Victoria Buzz

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Dr. Bonnie Henry (Colin Smith Takes Pics)

The BC Ministry of Health reported 715 new cases of COVID-19 on Thursday, October 21st. 

There have been 200,249 cases of COVID-19 since the pandemic began.

New cases were reported in these health regions:

  • Vancouver Coastal Health: 60
  • Fraser Health: 285
  • Island Health: 61
  • Interior Health: 137
  • Northern Health: 172
  • Resident outside Canada: 0

There are currently 4,965 active cases of COVID-19 in the province.

192,819 people who tested positive have recovered.

There are now a total of 377 people in hospital due to COVID-19, 136 of whom are in critical care — ICU or acute care units.

4 new people have died from COVID-related causes, making the provincial death toll 2,096.

Data by Vaccination Status: 

From Oct. 13-19, people not fully vaccinated accounted for 66.4% of cases and from Oct. 6-19, they accounted for 76.2% of hospitalizations.

Past week cases (Oct. 13-19):

  • Total: 4,351
  • Not vaccinated: 2,561 (58.9%)
  • Partially vaccinated: 325 (7.5%)
  • Fully vaccinated: 1,465 (33.7%)

Past two weeks cases hospitalized (Oct. 6-19):

  • Total: 445
  • Not vaccinated: 314 (70.6%)
  • Partially vaccinated: 25 (5.6%)
  • Fully vaccinated: 106 (23.8%)

Past week, cases per 100,000 population after adjusting for age (Oct. 13-19):

  • Not vaccinated: 308.7
  • Partially vaccinated: 95.6
  • Fully vaccinated: 34.5

Past two weeks, cases hospitalized per 100,000 population after adjusting for age (Oct. 6-19):

  • Not vaccinated: 53.9
  • Partially vaccinated: 11.0
  • Fully vaccinated: 2.4

Outbreaks

There have been two new health-care facility outbreaks at Deni House (Interior Health) and Bulkley Valley District Hospital (Northern Health).

There are a total of 26 active outbreaks, including:

Long-Term Care: Willingdon Care Centre, Westminster House, Magnolia Gardens, Manoah Manor, Cherington Place, West Shore Laylum, Queens Park Care Centre, Heritage Village (Fraser Health), Amica Lions Gate (Vancouver Coastal Health), Cottonwoods Care Centre, Overlander, Village by the Station, Haven Hill Retirement Centre, Deni House (Interior Health) and Wrinch Memorial Hospital (Northern Health).

Acute Care: Mission Memorial Hospital (Fraser Health), University Hospital of Northern BC, GR Baker Memorial Hospital, Bulkley Valley District Hospital (Northern Health) and Tofino General Hospital (Island Health).

Assisted or Independent Living: Sunset Manor, Evergreen Manor, Menno Terrace West, The Emerald at Elim Village, Swedish Assisted Living Residence (Fraser Health) and Cooper Place (Vancouver Coastal Health).

Island Health:

Island Health reported 61 new cases of COVID-19 in the Vancouver Island region and 431 active cases.

Breakdown of cases on Vancouver Island:

  • South Vancouver Island  Active cases: 178 │Total Cases: 4274
  • Central Vancouver Island Active cases: 217 │ Total Cases: 4525
  • North Vancouver Island  Active cases: 36 │Total Cases: 1232

52 people remain in hospital with 24 in ICU. 

There were no new deaths reported in the Island Health region today, and a total of 84 deaths on Vancouver Island.

Vaccinations

As of Thursday, Oct. 21, 2021, 89.4% of eligible people 12 and older in B.C. have received their first dose of COVID-19 vaccine and 83.8% received their second dose.

In addition, 89.8% of all eligible adults in B.C. have received their first dose and 84.4% received their second dose.

To date, 8,103,896 (+15,582) doses of the COVID-19 vaccine have been administered in BC; 3,883,585 (+7,006) of which are second doses.

Some links include:

At the time of this publication, 243,159,888 cases of COVID-19 had been recorded worldwide. 4,942,780 have died, and 220,368,547 have recovered.

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Pfizer-BioNTech booster shot '95 per cent effective' – The National

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Trial results have found that having a third or “booster” dose of the Pfizer-BioNTech Covid-19 vaccine is more than 95 per cent effective at preventing disease.

The clinical trial findings, released by the two companies that developed the shot, are described as the first efficacy results from a “randomised, controlled Covid-19 vaccine booster trial”.

There were more than 10,000 participants in the trial, all of whom had completed an initial two-dose programme with the vaccine.

Half the participants then received a third dose of the vaccine, and half were given a placebo, with the third dose given an average of 11 months after the second.

For the next few years, it does look like especially the older population will need top-up immunisation. Whether that will be twice-yearly or yearly we don’t know

Prof David Taylor, University College London

Researchers recorded whether participants subsequently developed symptomatic Covid-19 at least seven days after the booster was given, with individuals followed up for an average of 2.5 months.

In the boosted group there were just five Covid-19 cases, while in the non-boosted group 109 cases were recorded, which gives an efficacy – or effectiveness at preventing disease – of 95.6 per cent.

Prof David Taylor, professor emeritus of pharmaceutical and public health policy at University College London, said the results indicated “having a booster is an extremely sensible idea” for people in at-risk groups.

“The message to everybody, including if you’re 50 or 60 or over, is having a booster dose after six months or longer is extremely sensible,” he said.

In a statement, Ugur Sahin, the chief executive and co-founder of BioNTech, said the results added to the “body of evidence” that the vaccine protected “a broad population of people from this virus and its variants”.

“Based on these findings we believe that, in addition to broad global access to vaccines for everyone, booster vaccinations could play an important role in sustaining pandemic containment and a return to normalcy,” he said.

Pfizer and BioNTech said detailed analysis of the results indicated that efficacy of a booster did not vary with age, sex, race, ethnicity, or any other serious medical conditions a person has.

The companies plan to share the results with regulators, including the Food and Drug Administration in the US and the European Medicines Agency.

A booster programme using the Pfizer-BioNTech vaccine that began in Israel in July has been credited with helping the country overcome its fourth wave of Covid-19 infections.

Infection rates fell faster in over-80s, who were given boosters first, than in other age groups, indicating that the third doses were improving immunity, which may have waned over time after the second dose.

Other countries are also launching booster programmes, including the UK, which began a programme last month focused on over-50s and other vulnerable groups.

In August, Abu Dhabi mandated a third dose of the Sinopharm vaccine for people who had previously received the Chinese-developed shot.

More recently, at the beginning of this month, the UAE authorised booster shots of the Pfizer-BioNTech and Russian-developed Sputnik vaccines for over 60s and members of other vulnerable groups, with the third dose to be given at least six months after the second.

Prof Taylor said it was unclear at the moment whether people would need to have Covid-19 vaccination boosters indefinitely.

“For the next few years, it does look like especially the older population will need top-up immunisation. Whether that will be twice-yearly or yearly we don’t know,” he said.

Updated: October 22nd 2021, 3:20 AM

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