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CDC Panel Says J&J COVID-19 Vaccine Benefits Outweigh Risks – Healthline

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  • The CDC’s vaccine advisory committee reviewed cases of a rare neurological disorder seen in some people who received the Johnson & Johnson vaccine.
  • As of June 30, there have been 100 cases of Guillain-Barré syndrome reported through the CDC’s vaccine safety monitoring system for Johnson & Johnson.
  • This comes out to 8.1 cases per million doses administered, which is higher than the 1.6 cases per million doses expected in the general population.

Despite reported cases of a rare, but serious, neurological disorder after vaccination, an advisory group for the Centers for Disease Control and Prevention (CDC) said on Thursday the benefits of Johnson & Johnson’s COVID-19 vaccine “continue to outweigh the risks.”

As of June 30, there have been 100 cases of Guillain-Barré syndrome reported through the CDC’s vaccine safety monitoring system.

This comes out to 8.1 cases per million doses administered, which is higher than the 1.6 cases per million doses expected in the general population, according to slides presented at the Advisory Committee on Immunization Practices (ACIP) meeting on Thursday.

It is also about eight times the rate of Guillain-Barré syndrome seen with the Pfizer-BioNTech and Moderna-NIAID vaccines.

Cases reported to the Vaccine Adverse Event Reporting System (VAERS) still need to be reviewed in depth to confirm that they fit the definition of this neurological condition.

Guillain-Barré syndrome is a rare disorder in which the immune system mistakenly attacks the body’s nerves.

Symptoms include weakness and tingling in the extremities, difficulty with facial movements or walking, vision problems, and difficulty controlling the bladder or bowel.

This condition can also occur after a respiratory or digestive tract infection, including after infection with SARS-CoV-2, the coronavirus that causes COVID-19.

Of the 100 cases of Guillain-Barré syndrome reported through VAERS, 95 people were hospitalized, according to slides presented on Thursday. Ten patients were intubated and/or required mechanical ventilation and one person died. The other five cases were not serious.

Most of the cases occurred within 42 days following vaccination and in people 18 to 64 years old. In addition, 61 percent occurred in men.

ACIP member Dr. Pablo Sanchez, a pediatrician at The Ohio State University, said during the meeting that although he agrees the benefits of the J&J vaccine outweigh the risks, based on current data he would recommend an mRNA vaccine over the J&J vaccine.

However, “I have no problem continuing to have the [J&J] product available,” he added. “But I think that those risks have got to be stated up front to the person who’s receiving that vaccine.”

The ACIP’s review of these cases comes about a week after the Food and Drug Administration (FDA) updated the fact sheets for the J&J vaccine to include a warning about the risk of Guillain-Barré syndrome within 42 days after vaccination.

On July 12, the FDA updated the fact sheets for both recipients and caregivers, and healthcare providers.

ACIP chair Dr. José Romero said the one-dose J&J vaccine is an important tool for addressing the recent surge of COVID-19 cases and hospitalizations — almost all in unvaccinated people.

“Having access to a single-dose vaccine is very important to move us out of this situation,” he said, noting there are “individuals who will not come back for a second dose” of an mRNA vaccine.

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the FDA, said in a video on Twitter that the benefits of getting vaccinated greatly outweigh the risks of rare side effects such as Guillain-Barré syndrome.

“COVID-19 is very real, and it’s unfortunately very much still with us. It is making a comeback [in the United States],” he said. “So if you’re not vaccinated, particularly if you’re in a community where there are low vaccination rates, it’s a good idea to get vaccinated.”

The CDC’s vaccine advisory committee also discussed the possibility of COVID-19 vaccine booster doses for people who are immunocompromised.

These people are at higher risk of severe COVID-19 and may not generate as robust an immune response to the standard vaccine dose regimen.

During Thursday’s meeting, CDC staff suggested that both regulatory and non-regulatory approaches will be needed to help keep immunocompromised people safe from COVID-19.

Currently, the FDA’s emergency approvals allow people to receive one dose of the J&J vaccine or two doses of an mRNA vaccine.

The FDA would need to modify its current emergency use authorization (EUA) to allow a booster dose to be given. Another route would be full FDA approval, which would allow doctors to recommend a booster dose “off-label.”

FDA liaison Dr. Doran Fink said during the meeting that the agency does not yet have the data on the vaccines to support regulatory actions that would allow for booster doses.

Several studies have already looked at the benefits of booster doses for immunocompromised people.

The ACIP reviewed some studies during the meeting which found that among immunocompromised people who didn’t have a detectable antibody response to two doses of an mRNA vaccine, 33 to 50 percent did after a third dose.

However, without a decision from the FDA on boosters, some immunocompromised people are “taking matters into their own hands” and “proceeding with additional vaccine doses as they see fit,” said ACIP member Dr. Camille Kotton, of Massachusetts General Hospital in Boston.

Until booster doses are available to immunocompromised people in the U.S. — and maybe even after — the CDC recommends that these people continue to take other precautions, such as wearing a face mask while in indoor public spaces, physical distancing, and avoiding crowds.

The agency also says that family members and close friends can help protect immunocompromised people by getting vaccinated against COVID-19 themselves.

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Vancouver Island opens up five ICU beds for COVID-19 patients from Northern Health region – Victoria Buzz

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During a COVID-19 press conference today, BC health officials announced that in order to prevent an overrun ICU in the Northern Health region, they would be opening five ICU beds on Vancouver Island and ten beds in the Lower Mainland.

Also during the conference, on whether Northern BC COVID-19 response could end up similar to what is happening in Alberta, Dr. Bonnie Henry said that BC is not at the same point as our neighbours to the east.

Henry also noted that due to BC’s current COVID-19 response, the province would not be able to handle taking on Alberta residents into their ICU care.

“We are not at a breaking point [like Alberta]. We are in a different place. But sadly, as a country, especially in BC, we cannot take people from Alberta into our [BC’s] ICU care,” Dr. Bonnie Henry said.

This begs the question of where Vancouver Island health services are at.

Earlier this month, Victoria Buzz reported a story about a father pleading for people to get vaccinated after his son was waiting for an ICU bed at the Royal Jubilee Hospital ICU due to what he saw was overrun with COVID-19 cases.

“He [Joel] is in a coma, and they’ve tried bringing him out. He’s still in CCU, and he’s on a ventilator. He’s just waiting for a bed in the ICU,” Roberts said.

“Before he had his episode, I felt that yes, people need to get vaccinated. But this has made that sentiment stronger. Stop thinking about yourself and start thinking about everyone else.”

Victoria Buzz spoke to Island Health to get a better grasp of how Vancouver Island has been handling this fourth wave of the pandemic, and how ICUs in Victoria are holding up.

A representative for Island Health confirmed that they are seeing an increasing impact on hospitals and critical care units amidst the fourth wave.

They said that since the beginning of the pandemic, Royal Jubilee, Victoria General, and Nanaimo Regional General hospitals were the core facilities supporting COVID-19 patients.

Despite occupancy varying day-to-day, last week’s average occupancy of critical care beds was 73%, according to Island Health. In comparison, Alberta’s ICU capacity is 88%.

In order to support additional critical care needs beyond base capacity Island Health has now implemented surge critical care beds and an inpatient unit at Victoria General Hospital for non-critical care patients.

In a statement to Victoria Buzz, Island Health expressed their willingness to do what they can to support the province, but also acknowledged what British Columbians could do as well: get vaccinated.

“In addition to supporting the increasing critical care needs of Vancouver Island residents, we have supported over a dozen critical care patients from other health authorities,” the Island Health representative told Victoria Buzz.

“Our health-care teams need every eligible resident of Island Health to get vaccinated today if they haven’t already, and follow public health guidance, in order to protect our health-care system and our teams.”

As of this publication, 87% of all eligible British Columbians have been vaccinated and there are currently 540 active cases on Vancouver Island.

Of the 353 British Columbians who have been hospitalized from September 6th to September 19th due to COVID-19, 279 (79%) were unvaccinated.

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Quebec man punches nurse in face for giving wife COVID-19 vaccine – Campbell River Mirror

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Police in Quebec say they are looking for a man who is alleged to have repeatedly punched a nurse in the face because he was angry she had vaccinated his wife against COVID-19.

Police say a man between the ages of 30 and 45 approached the nurse on Monday morning at a pharmacy in Sherbrooke, Que., about 150 kilometres east of Montreal.

They say he accused the nurse of vaccinating his wife against her consent and repeatedly punched the nurse before leaving the store.

Police say the nurse had to be treated in hospital for serious injuries to her face.

Quebec’s order of nurses tweeted today that the alleged assault was unacceptable and wished the nurse a full recovery.

Sherbrooke police are asking for the public’s help in finding the assailant, who they say has short dark hair, dark eyes, thick eyebrows and a tattoo resembling a cross on his hand.

—The Canadian Press

RELATED: ‘Go the hell home’: B.C. leaders condemn anti-vaccine passport protests

RELATED: ‘Stay away from children!’: Premier denounces protesters who entered Salmon Arm schools

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Sask. children's hospital ICU accepts adults in COVID-19 surge plan – CTV News Saskatoon

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SASKATOON —
The Saskatchewan Health Authority (SHA) is shuttling some adult intensive care patients to the province’s children’s hospital in the face of surging COVID-19 cases.

“Critical care capacity is under strain and all avenues of support need to be explored to so we can continue to care for extremely ill patients,” Chief Medical Officer Dr. Susan Shaw said in a news release.

Adult patients requiring an ICU bed will be considered for admission to Jim Pattison Children’s Hospital in Saskatoon, according to the health authority.

Patients are selected through a clinical review by the adult and pediatric critical care physicians.

Pediatric patients will continue to be prioritized for critical care at the hospital’s PICU (pediatric intensive care unit) and no pediatric patients will be displaced, according to the SHA.

The change is effective immediately and is part of a larger SHA surge plan announced Sept. 17 to prepare for a growing number of COVID patients throughout the health system.

The PICU will be able to surge to 18 critical care beds, including six additional flex beds for both pediatric and selected adult patients.

Staffing plans have been developed and continue to be secured for the additional beds, much of which will come through service slowdowns.

The SHA’s normal (ICU) capacity is 79 beds. To increase ICU capacity, the SHA has also added 22 surge beds.

As of Tuesday afternoon, 78 of the 101 available ICU beds were full and two adult COVID infectious patients had been admitted to JPCH.

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