Pfizer and BioNTech say data show their COVID-19 vaccine is safe and protective in kids aged 5 to 11 - The Globe and Mail

Millions of Canadian children could become eligible to receive COVID-19 vaccinations within weeks, bringing a glimmer of hope to families amid the pandemic’s fourth wave.

Pfizer/BioNTech said in a press release Monday that its mRNA-based COVID-19 vaccine is safe and provides good protection against the virus among children aged 5 to 11.

“It’s significant news,” said Anne Pham-Huy, a pediatric infectious disease specialist at the Children’s Hospital of Eastern Ontario in Ottawa. “It’s definitely giving us a bit more hope.”

A spokeswoman for Pfizer Canada said the company can give a rolling submission to Health Canada, which would allow the department to approve the vaccine as the company continues to collect and submit new safety and effectiveness data.

The news comes as several provinces, notably Alberta and Saskatchewan, are contending with rises in the number of COVID-19 infections and hospitalizations, which have pushed their health care systems to the brink. Although children have generally fared much better than adults during the pandemic, they still face a small risk of severe illness and other long-term health problems linked to COVID-19. Experts say continued spread of the highly transmissible Delta variant will lead to more cases and more severe outcomes among children.

While it’s difficult to predict when the vaccine will become available for the 5 to 11 age group, experts expect authorization fairly quickly given the approval process of the vaccines to date, and say it could come as early as the end of October.

There are more than four million children in Canada under the age of 15, according to Statistics Canada.

Pfizer/BioNTech said the vaccine produced a “robust” antibody response in children aged 5 to 11, comparable to the antibody response seen in a previous trial of 16- to 25-year-olds, who were given a larger dose.

Both of the approved mRNA vaccines on the market, produced by Pfizer/BioNTech and Moderna, have been linked to a small but serious risk of myocarditis and pericarditis, particularly in young men.

It’s unclear what those risks look like in children aged 5 to 11. Pfizer/BioNTech did not release the full study data on Monday but said it would submit the trial to a scientific journal for publication.

Myocarditis, or inflammation of the heart muscle, and pericarditis, inflammation of the lining outside the heart, occur in 1-in-6,000 to 1-in-15,000 people, ages 12 and older who receive an mRNA vaccine for COVID-19, according to Isaac Bogoch, an infectious diseases physician at Toronto’s University Health Network.

Despite the rare chance of side effects, experts say children should still be vaccinated because the risks linked to COVID-19 are much greater.

Stephen Freedman, professor in the department of pediatrics at the Cumming School of Medicine at the University of Calgary, said children infected with COVID-19 have a much greater chance of experiencing severe illness, hospitalization or other severe outcomes compared to those with vaccine-induced heart inflammation.

“COVID infection in children poses multiple risks,” he said.

Dr. Freedman also highlighted the fact that chances of vaccine-induced heart inflammation seem to be much milder than those that occur as the result of a viral infection.

According to Health Canada, which updated the label on mRNA vaccines in June to reflect the risk, many cases of myocarditis and pericarditis are mild and require little to no treatment. Some severe cases may result in heart damage.

Symptoms usually begin within days of a second dose. Health Canada says anyone who experiences chest pain, shortness of breath or feelings of having a fast-beating or fluttering heart within days of being vaccinated should seek medical attention.

While a vaccine for 5- to 11-year-olds won’t bring an end to the pandemic, it can help Canada control rates of transmission and make schools much safer, Dr. Bogoch said.

“In general, I think these are going to be safe, effective vaccines. This will really help transform the pandemic,” he said.

Experts say officials should be planning their vaccine rollout now as well as developing communication strategies to communicate with parents about the small risks of vaccine side effects.

“I think for this group, the most important thing is to really ensure proper education and information to instill vaccine confidence and really vigilantly monitor for vaccine safety as we roll it out,” Dr. Pham-Huy said.

Pfizer/BioNTech say it expects results by the end of the year for two other age groups included in the study: 2- to 5-year-olds; and children aged six months to two years.

On Monday, Health Canada said it had not yet received a submission from Pfizer/BioNTech seeking to authorize use of the vaccine in children aged 5 to 11.

Christina Antoniou, director of corporate affairs for Pfizer Canada, said the company has been working closely with Health Canada throughout the pandemic and will submit the new data when they are available.

“We share the urgency to provide the data that could help support the decision by regulatory authorities to make the vaccine available to school-aged children as early as possible,” she said in an e-mail.

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Pfizer and BioNTech say data show their COVID-19 vaccine is safe and protective in kids aged 5 to 11 - The Globe and Mail
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