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Pfizer/BioNTech say data show COVID-19 vaccine safe and protective in kids

Stock MarketsSep 20, 2021 01:41PM ET
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© Reuters. FILE PHOTO: A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in front of displayed Pfizer logo in this illustration taken, October 30, 2020. REUTERS/Dado Ruvic

By Michael Erman

(Reuters) -Pfizer Inc and BioNTech SE (NASDAQ:BNTX) said on Monday their COVID-19 vaccine induced a robust immune response in 5 to 11 year olds, and they plan to ask for regulatory authorization as soon as possible to use the shot in children in that age range in the United States, Europe and elsewhere.

The companies said their two-dose vaccine generated an immune response in the 5-to-11 year olds in a Phase II/III clinical trial that matched what was previously observed in 16-to-25 year olds. The safety profile was also generally comparable to the older age group, they added.

"Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. - underscoring the public health need for vaccination," Pfizer (NYSE:PFE) Chief Executive Albert Bourla said in a news release.

"These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency," Bourla added.

The Pfizer/BioNTech vaccine already has won U.S. regulatory authorization for people age 12 and up, including full Food and Drug Administration approval https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine last month for ages 16 and up.

Top U.S. health officials believe regulators could make a decision https://www.reuters.com/business/healthcare-pharmaceuticals/exclusive-us-decision-pfizer-covid-19-shot-kids-age-5-11-could-come-october-2021-09-10 on whether the shot is safe and effective in younger children within three weeks of the companies submitting a request for authorization, two sources told Reuters this month. A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.

COVID-19 hospitalizations and deaths have surged in the United States in recent months due to the highly contagious Delta variant, especially in areas with low vaccination rates even as President Joe Biden implores vaccine holdouts to get their shots. Pediatric cases are also up, particularly as children under 12 are all unvaccinated, but there is no indication that, beyond being more transmissible, the Delta virus is more dangerous in kids.

FDA acting Commissioner Janet Woodcock said that once the agency receives the application, its process for determining if the vaccine is safe and effective for children in the younger age group includes verifying the manufacturing processes for the lower concentrations of the shots and any study of its safety.

"We'll look at the clinical data and make sure that children responded to the vaccine the way we would expect," Woodcock said during an appearance on former Biden administration official Andy Slavitt's podcast.

Pfizer shares fell 1.3% to $43.28 before the bell on Monday amid broader market weakness.

DATA FOR YOUNGER CHILDREN

The Pfizer/BioNTech vaccine, called Comirnaty, is authorized for use in children as young as 12 in many countries in addition to the United States. It was originally authorized for emergency use in people 16 or older in the United States in December 2020.

The 5-to-11 year olds were given two shots of a 10-microgram dose of the vaccine, a third the dose size given to people 12 and older.

In addition, the companies said they expect data on how well the vaccine works in children ages 2-to-5 years and children ages 6 months-to-2 years as soon as the fourth quarter of this year.

Unlike the larger clinical trial that the drugmakers previously conducted in adults, the 2,268-participant pediatric trial was not primarily designed to measure the vaccine's efficacy by comparing the number of COVID-19 cases in vaccine recipients to those who received a placebo.

Instead, it compares the amount of neutralizing antibodies induced by the vaccine in the children to the response of older recipients in the adult trial.

A Pfizer spokesperson said the companies may later disclose vaccine efficacy from the trial but there have not been enough cases of COVID-19 yet among the participants to make that determination.

The vaccine was around 95 percent effective in the adult clinical trial, but Pfizer has said that immunity wanes some months after the second dose. U.S. regulators are expected to authorize a third, booster dose of the vaccine for older and high-risk Americans early this week.

The companies said the vaccine was well-tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.

The Pfizer/BioNTech vaccine is one of three shots authorized in the United States, along with Moderna (NASDAQ:MRNA)'s two-dose vaccine and Johnson and Johnson's one-dose shot. The Moderna and J&J (NYSE:JNJ) shots have not yet received full FDA approval for any age groups.

Both the Pfizer and Moderna vaccines have been linked by regulators to rare cases of heart inflammation in adolescents and young adults, particularly young men. Pfizer said they did not see any instances of heart inflammation in the trial participants.

Pfizer/BioNTech say data show COVID-19 vaccine safe and protective in kids
 

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Comments (6)
Bernard Devlin
Bernard Devlin Sep 20, 2021 9:03PM ET
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Big pharma companies have been marking their own homework for far too long. Children aged 5-11 years are at a virtual ZERO risk of getting serious symptoms if they contract the Covid-19 virus.
Scot House
Scot House Sep 20, 2021 5:53PM ET
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Irresponsible if you let your child get the vaccine. Their immune system works fine.
Felipe Daniel
Felipe Daniel Sep 20, 2021 1:24PM ET
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WHO CDC do not care about your health you are only serfs to them
Kenneth Gold
Kenneth Gold Sep 20, 2021 11:23AM ET
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Newly created billionaires, with big pharma backgrounds, need more money.
HD HD
HD HD Sep 20, 2021 7:48AM ET
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Coronavirus first hit America through LAX airport and people travelling from China and New York travel from Europe. New York through high density living was hardest hit early on flowing into Rhode Island, New Jersey and Massachusetts.Mississipi has almost no international tourism or business travel from Covid hotspots. They are made up of medium to low density living where social distancing is a lot easier. Their climb up to the deadliest state in America with 3K deaths per million is a testament to MAGA and the GOP of that state. Blue states with low tourism and low density like Vermont, Hawaii, Washington and Maine have under 1K deaths per millions. Two thirds of the over 6000 Mississipi dead are because of MAGA.Their current death rate is actually climbing to the pre vaccine peak - Jan/Feb when MAGA stubborness was peaking. The fact that we now have multiple effective vaccines and Mississipi is dying at the same rates as before the vaccines is astonishing.
Felipe Daniel
Felipe Daniel Sep 20, 2021 7:48AM ET
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You have serious mental illness
Llewellyn Kruger
Llewellyn Kruger Sep 20, 2021 7:47AM ET
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What about the children who died and those who are now disabled with myocarditis?
Baris Duzalan
Baris Duzalan Sep 20, 2021 7:47AM ET
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You don't know what you're talking about.🤣
Josh Davis
Josh Davis Sep 20, 2021 7:47AM ET
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Baris Duzalan actually this is 100% correct.
 
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