'A beautiful soul': Funeral held for baby boy killed in wrong-way crash on Highway 401
A funeral was held on Wednesday for a three-month-old boy who died after being involved in a wrong-way crash on Highway 401 in Whitby last week.
The U.S. Food and Drug Administration said on Wednesday it plans to move quickly to add a warning about rare cases of heart inflammation in adolescents and young adults to fact sheets for the Pfizer/BioNTech and Moderna COVID-19 vaccines.
U.S. Centers for Disease Control and Prevention (CDC) advisory groups, meeting to discuss reported cases of the heart condition after vaccination, found the inflammation in adolescents and young adults is likely linked to the vaccines, but that the benefits of the shots appeared to clearly outweigh the risk.
Moderna shares closed down 4.2%, while Pfizer fell 1.4%.
Pfizer, whose vaccine has been authorized for use in Americans as young as 12, said in a statement that it is aware of the reports of myocarditis and pericarditis after mRNA vaccination. It said that the benefit risk profile of the Pfizer/BioNTech vaccine "remains positive."
Moderna said it is aware of reports of heart inflammation cases following administration of mRNA vaccines and is working with regulators.
Health regulators in several countries have been investigating whether the Pfizer/BioNTech and Moderna shots using new mRNA technology present a risk and, if so, how serious.
The CDC said that patients with heart inflammation following vaccination generally recover from the symptoms and do well.
The U.S. Department of Health And Human Services, joined by leading U.S. doctors groups and public health officials, put out a statement underscoring that the vaccines are safe and effective and that the heart side effect is "extremely rare."
"We strongly encourage everyone age 12 and older who are eligible to receive the vaccine under Emergency Use Authorization to get vaccinated," it said.
Doctors and hospitals have been warned by the CDC to watch for symptoms of myocarditis or pericarditis, and the FDA warning will further raise awareness.
Concerns about the more highly transmissible Delta coronavirus variant taking hold in the United States, and its impact on younger people, have added to the urgency to increase vaccinations even as the inoculation effort here has slowed considerably.
The number of Americans receiving their first dose of COVID-19 vaccine is down about 85% since peaking in mid-April, and will likely fail to meet President Joe Biden's goal to have delivered at least one shot to 70% of adults by July 4.
WARNING WARRANTED
"Based on the available data, a warning statement in the factsheets for both healthcare providers and vaccine recipients and caregivers would be warranted," FDA official Doran Fink said at the advisory committee meeting.
Fink, deputy director of the agency's vaccines division, said the FDA expects to move quickly to add the warning after the meeting concludes.
The cases of heart inflammation appear to be notably higher in the week after the second vaccine dose and in males. The CDC identified 309 hospitalizations from the heart inflammation in persons under the age of 30, of which 295 have been discharged.
Dr. Tom Shimabukuro, deputy director of the CDC's Immunization Safety Office, said in a presentation that data from one of the agency's safety monitoring systems - Vaccine Safety Datalink (VSD) – suggests a rate of 12.6 cases per million in the three weeks after the second shot in 12- to 39-year-olds.
"We're observing this in the younger age groups, mainly in people in the teens and early 20s, and observing it more in males, compared to females," Shimabukuro said. "This effect largely kind of disappears once you get into these older age groups - individuals 50 and over."
The CDC has been investigating heart inflammation cases mainly in young men for several months. The Israeli health ministry earlier this month said it saw a possible link between such cases and Pfizer's COVID-19 vaccine.
The CDC said it was still assessing the risk from the condition and did not specifically confirm a causal relationship between the vaccines and the heart issue.
It did, however, say that a much-higher-than expected number of young men between the ages of 12 and 24 have experienced heart inflammation after their second vaccine dose.
According to data from the U.S. Vaccine Adverse Event Reporting System (VAERS), there were 347 observed cases of heart inflammation in the week after the second vaccine dose in males aged 12 to 24. That compares with expectations of 12 or fewer cases for males in that age range based on U.S. population background incidence rates, the CDC said.
Over 138 million Americans have so far been fully vaccinated with one of the two mRNA vaccines, according to CDC data as of Monday.
(Reporting by Michael Erman in New Jersey and Manojna Maddipatla in Bengaluru; Editing by Bill Berkrot and Daniel Wallis)
A funeral was held on Wednesday for a three-month-old boy who died after being involved in a wrong-way crash on Highway 401 in Whitby last week.
There has been a "sophisticated" cybersecurity breach detected on B.C. government networks, Premier David Eby confirmed Wednesday evening.
Toronto police say a man was taken into custody outside Drake's Bridle Path mansion Wednesday afternoon after he tried to gain access to the residence.
U.S. President Joe Biden said for the first time Wednesday he would halt shipments of American weapons to Israel, which he acknowledged have been used to kill civilians in Gaza, if Prime Minister Benjamin Netanyahu orders a major invasion of the city of Rafah.
Rookie goalie Arturs Silovs will start in net for the Canucks as Vancouver kicks off a second-round series against the Edmonton Oilers Wednesday night.
One of the Indian nationals accused of murdering British Columbia Sikh activist Hardeep Singh Nijjar says in a social media video that he received a Canadian study permit with the help of an Indian immigration consultancy.
Pfizer has agreed to settle more than 10,000 lawsuits about cancer risks related to the now discontinued heartburn drug Zantac, Bloomberg News reported on Wednesday, citing people familiar with the deal.
Quebec Premier Francois Legault is defending his comments about a new history museum after he was accused by a prominent First Nations group of trying to erase their history.
Independent U.S. presidential candidate Robert F. Kennedy Jr. had a parasite in his brain more than a decade ago, but has fully recovered, his campaign said, after the New York Times reported about the ailment.
The stakes have been set for a bet between Vancouver and Edmonton's mayors on who will win Round 2 of the Stanley Cup playoffs.
A grieving mother is hosting a helmet drive in the hopes of protecting children on Manitoba First Nations from a similar tragedy that killed her daughter.
A chicken farmer near Mattawa made an 'eggstraordinary' find Friday morning when she discovered one of her hens laid an egg close to three times the size of an average large chicken egg.
A P.E.I. lighthouse and a New Brunswick river are being honoured in a Canada Post series.
An Ontario man says he paid more than $7,700 for a luxury villa he found on a popular travel website -- but the listing was fake.
Whether passionate about Poirot or hungry for Holmes, Winnipeg mystery obsessives have had a local haunt for over 30 years in which to search out their latest page-turners.
Eighty-two-year-old Susan Neufeldt and 90-year-old Ulrich Richter are no spring chickens, but their love blossomed over the weekend with their wedding at Pine View Manor just outside of Rosthern.
Alberta Ballet's double-bill production of 'Der Wolf' and 'The Rite of Spring' marks not only its final show of the season, but the last production for twin sisters Alexandra and Jennifer Gibson.
A mother goose and her goslings caused a bit of a traffic jam on a busy stretch of the Trans-Canada Highway near Vancouver Saturday.