BioNTech is set to request approval across the globe to use its COVID-19 vaccine in children as young as five over the next few weeks and preparations for a launch are on track, the biotech firm’s two top executives told newspaper Der Spiegel.
“Already over the next few weeks we will file the results of our trial in five to 11 year olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Chief Medical Officer Oezlem Tuereci told the news weekly.
The confident statements underscore the lead that BioNTech, which collaborates with Pfizer, holds in the race to win broad approval to vaccinate children below the age of 12 in Western countries.
BioNTech has said it expected to file its regulatory dossier on the five to 11 year olds in September. It has also laid out plans to seek approval in children aged 6 months to 2 years later this year.
Tuereci also told Spiegel that final production steps were being adjusted to bottle a lower-dose pediatric version of its established Comirnaty vaccine. It is currently approved for adults and youngsters at least 12 years of age.
The raw trial data was now being prepared for a regulatory filing and “things are looking good, everything is going according to plan,” Chief Executive Ugur Sahin told Der Spiegel.
Runner-up Moderna said on Thursday a trial testing its shot in children between six and 11 years was now fully enrolled and that it was working on the best dosage in another study involving infants as young as six months.
China has been ahead in lowering the age limit of its immunization campaign. The country’s health authorities in June approved emergency use of Sinovac’s vaccine in children as young as three years.
Chile, which has relied heavily on Sinovac’s shot, this month approved use of the vaccine in children over 6 years of age.
Israel’s health ministry said in July that children as young as five can get the Pfizer-BioNTech shot if they suffer from conditions that make them particularly vulnerable to COVID-19.
(Reporting by Ludwig Burger, editing by Emma Thomasson, Douglas Busvine, Elaine Hardcastle)
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Health Canada approves new Pfizer COVID-19 vaccine
Health Canada has given its stamp of approval to Pfizer-BioNTech Comirnaty’s new COVID-19 vaccine that targets the Omicron XBB.1.5 subvariant.
The health department says it received Pfizer-BioNTech’s submission on June 29, 2023 and decided to authorize the shot’s use for individuals aged six months and older after “a thorough and independent review of the evidence.”
Health Canada says the vaccine is authorized as a one-dose vaccine for individuals five years of age and older, regardless of their COVID-19 vaccination history.
Infants and children between six months and less than five years of age, who have not previously received a complete COVID-19 primary series, should receive three doses. If they have completed a primary series, officials say they should receive one dose.
Moderna’s COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant was authorized(opens in a new tab) by Health Canada earlier this month.
The department says it’s currently reviewing a submission from Novavax for its COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant for people 12 years of age and older.
The National Advisory Committee on Immunization (NACI) is anticipated to provide guidance on the rollout of the newly approved COVID-19 vaccines in the coming months.
“Canada will have ample supply of the new formulation of mRNA vaccines available in fall 2023,” Health Canada said in a news release Thursday.
“Vaccination continues to be one of the most effective ways to protect ourselves against COVID-19. Evidence indicates that vaccines approved for use in Canada are effective at preventing severe illness, hospitalization and death from COVID-19.”
Hyundai and Kia recalling 603,176 vehicles in Canada due to fire risk
Hyundai and Kia are recalling more than 600,000 vehicles in Canada and millions more in the U.S. due to a problem with the anti-lock braking system that can start a fire.
Documents posted by U.S. safety regulators on Wednesday say the anti-lock brake control module can leak fluid and cause an electrical short. That can touch off a fire while the vehicles are parked or being driven.
Hyundai says 326,942 vehicles in Canada are impacted, including:
- 77,571 model year 2012-2015 Hyundai Accent vehicles
- 153,026 model year 2011-2015 Hyundai Elantra vehicles;
- 4,403 model year 2013-2015 Hyundai Elantra Coupe vehicles;
- 85 model year 2014-2015 Hyundai Equus vehicles;
- 7,789 model year 2011-2015 Hyundai Genesis Coupe vehicles;
- 8,507 model year 2013-2015 Hyundai Santa Fe vehicles;
- 24,795 model year 2013 Hyundai Santa Fe Sport vehicles;
- 46,318 model year 2010-2013 Hyundai Tucson vehicles;
- 4,448 model year 2010-2012 Hyundai Veracruz vehicles.
An additional 1,642,551 of those and other makes and models are being recalled in the U.S.
The company says it is aware of 21 fires linked to the default in the United States, as well as 22 “thermal incidents,” including visible smoke, burning and melting, but Hyundai Canada told CBC News in a statement that there are “no crashes, injuries, or fatalities attributable to this condition.”
Kia Canada says 276,225 vehicles in Canada are impacted, including:
- 2010-2011 Borregos;
- 2015-2016 Cadenzas;
- 2010-2013 Fortes;
- 2010-2013 Forte Koups;
- 2015 K900s;
- 2010-2015 Optimas;
- 2012-2017 Rios;
- 2010-2017 Rondos,
- 2011-2014 Sorrentos;
- 2011-2013 Souls;
- 2010 Sportages;
An additional 1.7 million Kias in the U.S. are included in the recall.
In a statement, the U.S. National Highway Traffic Safety Administration said that “until these recalled vehicles have been repaired … the safest place to park them is outside and away from homes and other structures.”
It said that “fires can occur whether the vehicle is parked and turned off or while driving.”
Dealers will replace the anti-lock brake fuse at no cost to owners, but owners won’t be notified by mail until November.
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