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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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B.C. mayors seek ‘immediate action’ from federal government on mental health crisis

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VANCOUVER – Mayors and other leaders from several British Columbia communities say the provincial and federal governments need to take “immediate action” to tackle mental health and public safety issues that have reached crisis levels.

Vancouver Mayor Ken Sim says it’s become “abundantly clear” that mental health and addiction issues and public safety have caused crises that are “gripping” Vancouver, and he and other politicians, First Nations leaders and law enforcement officials are pleading for federal and provincial help.

In a letter to Prime Minister Justin Trudeau and Premier David Eby, mayors say there are “three critical fronts” that require action including “mandatory care” for people with severe mental health and addiction issues.

The letter says senior governments also need to bring in “meaningful bail reform” for repeat offenders, and the federal government must improve policing at Metro Vancouver ports to stop illicit drugs from coming in and stolen vehicles from being exported.

Sim says the “current system” has failed British Columbians, and the number of people dealing with severe mental health and addiction issues due to lack of proper care has “reached a critical point.”

Vancouver Police Chief Adam Palmer says repeat violent offenders are too often released on bail due to a “revolving door of justice,” and a new approach is needed to deal with mentally ill people who “pose a serious and immediate danger to themselves and others.”

This report by The Canadian Press was first published Sept. 16, 2024

The Canadian Press. All rights reserved.

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Canada to donate up to 200,000 vaccine doses to combat mpox outbreaks in Africa

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The Canadian government says it will donate up to 200,000 vaccine doses to fight the mpox outbreak in Congo and other African countries.

It says the donated doses of Imvamune will come from Canada’s existing supply and will not affect the country’s preparedness for mpox cases in this country.

Minister of Health Mark Holland says the donation “will help to protect those in the most affected regions of Africa and will help prevent further spread of the virus.”

Dr. Madhukar Pai, Canada research chair in epidemiology and global health, says although the donation is welcome, it is a very small portion of the estimated 10 million vaccine doses needed to control the outbreak.

Vaccine donations from wealthier countries have only recently started arriving in Africa, almost a month after the World Health Organization declared the mpox outbreak a public health emergency of international concern.

A few days after the declaration in August, Global Affairs Canada announced a contribution of $1 million for mpox surveillance, diagnostic tools, research and community awareness in Africa.

On Thursday, the Africa Centres for Disease Control and Prevention said mpox is still on the rise and that testing rates are “insufficient” across the continent.

Jason Kindrachuk, Canada research chair in emerging viruses at the University of Manitoba, said donating vaccines, in addition to supporting surveillance and diagnostic tests, is “massively important.”

But Kindrachuk, who has worked on the ground in Congo during the epidemic, also said that the international response to the mpox outbreak is “better late than never (but) better never late.”

“It would have been fantastic for us globally to not be in this position by having provided doses a much, much longer time prior than when we are,” he said, noting that the outbreak of clade I mpox in Congo started in early 2023.

Clade II mpox, endemic in regions of West Africa, came to the world’s attention even earlier — in 2022 — as that strain of virus spread to other countries, including Canada.

Two doses are recommended for mpox vaccination, so the donation may only benefit 100,000 people, Pai said.

Pai questioned whether Canada is contributing enough, as the federal government hasn’t said what percentage of its mpox vaccine stockpile it is donating.

“Small donations are simply not going to help end this crisis. We need to show greater solidarity and support,” he said in an email.

“That is the biggest lesson from the COVID-19 pandemic — our collective safety is tied with that of other nations.”

This report by The Canadian Press was first published Sept. 13, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

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How many Nova Scotians are on the doctor wait-list? Number hit 160,000 in June

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HALIFAX – The Nova Scotia government says it could be months before it reveals how many people are on the wait-list for a family doctor.

The head of the province’s health authority told reporters Wednesday that the government won’t release updated data until the 160,000 people who were on the wait-list in June are contacted to verify whether they still need primary care.

Karen Oldfield said Nova Scotia Health is working on validating the primary care wait-list data before posting new numbers, and that work may take a matter of months. The most recent public wait-list figures are from June 1, when 160,234 people, or about 16 per cent of the population, were on it.

“It’s going to take time to make 160,000 calls,” Oldfield said. “We are not talking weeks, we are talking months.”

The interim CEO and president of Nova Scotia Health said people on the list are being asked where they live, whether they still need a family doctor, and to give an update on their health.

A spokesperson with the province’s Health Department says the government and its health authority are “working hard” to turn the wait-list registry into a useful tool, adding that the data will be shared once it is validated.

Nova Scotia’s NDP are calling on Premier Tim Houston to immediately release statistics on how many people are looking for a family doctor. On Tuesday, the NDP introduced a bill that would require the health minister to make the number public every month.

“It is unacceptable for the list to be more than three months out of date,” NDP Leader Claudia Chender said Tuesday.

Chender said releasing this data regularly is vital so Nova Scotians can track the government’s progress on its main 2021 campaign promise: fixing health care.

The number of people in need of a family doctor has more than doubled between the 2021 summer election campaign and June 2024. Since September 2021 about 300 doctors have been added to the provincial health system, the Health Department said.

“We’ll know if Tim Houston is keeping his 2021 election promise to fix health care when Nova Scotians are attached to primary care,” Chender said.

This report by The Canadian Press was first published Sept. 11, 2024.

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