'He's in our hearts': Family and friends still seek answers one year after Nathan Wise’s disappearance
It’s been a year since Nathan Wise went missing and his family is no closer to finding out what happened to him.
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)
It’s been a year since Nathan Wise went missing and his family is no closer to finding out what happened to him.
Dozens of Ontarians are expressing frustration in the province’s health-care system after their family doctors either dropped them as patients or threatened to after they sought urgent care elsewhere.
An Ottawa pizzeria is being recognized as one of the top 20 deep-dish pizzas in the world.
Amazon's paid subscription service provides free delivery for online shopping across Canada except for remote locations, the company said in an email. While customers in Iqaluit qualify for the offer, all other communities in Nunavut are excluded.
The fire burning near Fort McMurray grew from 25 hectares to 5,500 hectares over the weekend.
Russia’s President Vladimir Putin began a Cabinet shakeup on Sunday, proposing the replacement of Sergei Shoigu as defence minister as he begins his fifth term in office.
Police are searching for a male suspect after a man was “slashed in neck” on Sunday morning in downtown Toronto and died.
There were some scary moments for several people on a northern Ontario highway caught on video Thursday after a chain reaction following a truck fire.
Health Canada announced various product recalls this week, including electric adapters, armchairs, cannabis edibles and vehicle components.
English, history, entertainment, math and geography: high school trivia teams could be quizzed on any of it when they compete at the Reach for the Top Nationals in Ottawa in June.
An Ottawa pizzeria is being recognized as one of the top 20 deep-dish pizzas in the world.
A family of fifth generation farmers from Ituna, Sask. are trying to find answers after discovering several strange objects lying on their land.
A Listowel, Ont. man, drafted by the Hamilton Tigercats last week, is also getting looks from the NFL, despite only playing 27 games of football in his life.
The threat of zebra mussels has prompted the federal government to temporarily ban watercraft from a Manitoba lake popular with tourists.
A small Ajax dessert shop that recently received a glowing review from celebrity food critic Keith Lee is being forced to move after a zoning complaint was made following the social media influencer’s visit last month.
The Canada Science and Technology Museum is inviting visitors to explore their poop. A new exhibition opens at the Ottawa museum on Friday called, 'Oh Crap! Rethinking human waste.'
The Regina Police Service says it is the first in Saskatchewan and possibly Canada to implement new technology in its detention facility that will offer real-time monitoring of detainees’ vital health metrics.
Just as she had feared, a restaurant owner from eastern Quebec who visited Montreal had her SUV stolen, but says it was all thanks to the kindness of strangers on the internet — not the police — that she got it back.