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Johnson & Johnson vaccine gets the go-ahead for rollout ~ shows promise against variants

Canada’s top scientific and medical vaccine advisory group is set to give the full go-ahead to the newest vaccine available to Canadians, the Jannsen COVID-19 vaccine, made in the United States, and also known as the Johnson & Johnson vaccine.

NACI, the National Advisory Committee on Immunization, is an independent committee of experts that provides evidence based advice on vaccines to Health Canada.

The Janssen COVID-19 vaccine is a single dose, viral vector vaccine authorized for use in Canada for adults 18 years of age and over. Health Canada has determined that it is a safe and effective vaccine.

Dr. Shirley Deeks, a member of the NACI committee, said Monday that Canada’s provinces and territories consider NACI advice when planning their own vaccine rollout programs.

“Vaccination is essential to end the COVID-19 pandemic,” Deeks told the briefing. “NACI encourages Canadians to get vaccinated to protect themselves, their families and their community from illness, hospitalizations and death from COVID-19.

“NACI’s guidance is being issued now as the vaccine becomes available in Canada,” she said.

Deeks also reported that the Jannsen vaccine can be transported and stored at normal refrigeration temperatures. Also, she said, clinical trial data shows the single-dose Janssen vaccine is 67-per-cent effective against moderate to severe symptomatic COVID-19 infection across all age groups, at least two weeks after receiving the vaccine. The vaccine was also highly efficacious in preventing critical illness and hospitalization, she said.

Deeks reported there is evidence the Jannsen jab will also protect against the B.1.351 variant of concern first identified in South Africa, and the P.2 variant of interest first identified in Brazil. She said there is no data on the P.1 variant of concern, also identified in Brazil.

Deeks said data also indicated there is a side effect, a blood clotting condition that is considered extremely rare. These are confirmed reports of Vaccine-Induced Immune Thrombotic

Thrombocytopenia (VITT) after administration of the Janssen vaccine, as also seen with the AstraZeneca viral vector vaccine.

She said that as of April 23, there were 17 cases following more than eight million doses of the Jannsen in the U.S. Deeks said the American table of vaccine experts concluded that the benefits of the vaccine outweighed any risk. (0.0002125 per cent).

She said based on the evidence, NACI is recommending the Jannsen be offered to Canadians 30 years of age and older.

One of the obvious benefits said Deeks is the fact that Jannsen is a single-dose medication, meaning it will be useful for situations where vaccine recipients are not easily able to show up for the second dose. Currently in Canada, the Pfizer BioNTech, the Moderna and the AstraZeneca vaccines all require the recipients to get a second dose, up to 16 weeks apart.

Deeks also said on Monday that COVID vaccines are recommended for pregnant women, preferably one of the mNRA COVID-19 vaccines such as Pfizer or Moderna, provided the individual can make a decision with her health care provider to determine that the benefits outweigh the risk for herself and the fetus.

Deeks said a recent study in the U.S. showed no issues or adverse events when an mNRA vaccine during pregnancy.

Despite all this information provided by NACI, Health Canada has put a hold on the shipment of Jannsen vaccines that arrived in Canada last week. There was an ingredient added to some of the Jannsen vaccines at the company’s Baltimore plant, that resulted in a mistake being discovered, that caused several million doses to be ruined.

The hold by Health Canada is to check back to ensure that none of the doses destined for Canada had any problems.

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“As with all vaccines imported into Canada, the Janssen vaccines will only be released for distribution once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy,” said a statement from Health Canada.

Deeks said it is expected that Health Canada will discover the shipment from Jannsen is okay and that the formal approval will be granted soon.

Len Gillis is a Local Journalism Initiative reporter at Sudbury.com, covering health care in Northern Ontario. The Local Journalism Initiative is funded by the federal government.
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