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BioNTech SE (BNTX)
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BOFA maintained price target of $341 for BNTX yesterday. Berenberg $400 a few days ago. Goldman Sachs $433. Canaccord Genuity $450. …
Wall Street Journal: Pfizer-BioNTech Covid-19 Vaccine for Young Kids Satisfied FDA Criteria, Agency Says
Pfizer-BioNTech Covid-19 Vaccine for Young Kids Satisfied FDA Criteria, Agency Says -- Update
The Food and Drug Administration said the Covid-19 vaccine from Pfizer Inc.(PFE) and BioNTech SE(BNTX) met the agency's criteria for immune responses in a study in children ages 5 to 11 years.
In a report released Friday, the agency flagged the risk of heart-inflammation conditions including myocarditis associated with the vaccine but said the overall benefits, in preventing Covid-19 disease and hospitalizations, would outweigh the risk of the heart conditions.
The FDA assessment could support the agency's authorization of the vaccine in children in the coming days or weeks, but the myocarditis risk is likely to be a topic of debate among advisers to the FDA who are scheduled to first review the application.
The agency confirmed data, which the companies had released earlier in the day, showing the vaccine was 90.7% effective at preventing symptomatic Covid-19 in a study of 5- to 11-year-olds, information that health authorities will likely factor as they weigh whether to authorize the shots for use.
The vaccine was found to be safe and tolerable, the companies said in a document they submitted to the FDA and the agency posted online Friday morning.
In early October, Pfizer and BioNTech asked the FDA to authorize the vaccine for children 5 to 11 years old.
The documents were posted ahead of a meeting scheduled for Tuesday of a committee of vaccine experts advising the FDA.
The panel, the Vaccines and Related Biological Products Advisory Committee, will meet to review the evidence of the vaccine's safety and effectiveness in children, and vote to recommend whether the FDA should authorize the use.
If the vote is in favor, FDA authorization could follow within days. And if the Centers for Disease Control and Prevention subsequently signs off, millions of younger children could get a Covid-19 vaccine for the first time.
There are more than 28 million children ages 5 to 11 in the U.S., according to the American Academy of Pediatrics.
The risk of severe Covid-19 is much lower in children than in adults. Yet many have been hospitalized, and at least 691 children under 18 years have died from Covid-19, including 146 deaths in the 5- to 11-year age group, according to the FDA.
Vaccination may also help prevent children from transmitting the virus, according to many health experts.
Pfizer and BioNTech said in September that their vaccine was generally well-tolerated and induced strong immune responses in a study of nearly 2,270 children 5 to 11. Each child received two doses three weeks apart, and each shot contained one-third of the dosage used for adolescents and adults.
The vaccine induced neutralizing antibody levels in younger children that were comparable to those seen in people ages 16 to 25 who served as a control group in the study, the companies said.
The Pfizer-BioNTech document had new data from the same study showing that the immune responses appeared to protect children from disease. Researchers found that three children who received the vaccine became sick with Covid-19, compared with 16 cases who received a placebo, resulting in 90.7% efficacy, according to the companies.
Researchers didn't find any cases of heart-inflammation conditions including myocarditis in children in the study. The companies, however, said the study was too small to detect this potential risk.
Health authorities have said there is an increased risk of myocarditis with Covid-19 vaccines from Pfizer and Moderna Inc., particularly in males under 30 years.
The FDA said in its document that it conducted a risk-benefit analysis in light of the myocarditis risk. The FDA said it modeled the risk of myocarditis associated with the vaccine dose in children 5 to 11 years assuming the risk would be the same as the estimated risk in adolescents 12 to 15 years.
When the incidence of Covid-19 is low, like it was in June, the predicted number of vaccine-associated myocarditis cases resulting in hospitalizations was greater than the predicted number of Covid-19 hospitalizations prevented for males and for both sexes combined, the agency said.
Yet when Covid-19 was more prevalent, such as in September, the benefits of the vaccine outweighed the risks, the agency said.
And even when incidence of the disease is low, other factors favored the vaccine, including its potential to prevent Covid-19 that causes complications in nonhospitalized children, the FDA said.
Pfizer's vaccine was authorized in December 2020 for people 16 years of age and older, an authorization expanded in May to adolescents 12 and older.
Not bad. BNTX for the week up $28, Moderna down $3. So the separation hopefully has begun.
Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine
First results from any randomized, controlled COVID-19 vaccine booster trial demonstrate a relative vaccine efficacy of 95.6% against disease during a period when Delta was the prevalent strain
In trial with more than 10,000 participants 16 years of age and older, COVID-19 booster was found to have a favorable safety profile
Companies plan to submit these data to FDA,
Going towards 300$ in Germany 💪🏻 🙏 😁
Delta Plus covid mutations spreading to UK, Russia, China, India and Japan. Combined with possibly new autumn and winter (covid)waves coming. This will trigger bigger deals and contracts for Pfizer/Bntx. I foresee upgraded higher forecasts on bigger future earnings and profits for 2022.
Strong Finish 💪
With hardly 1% SI, why would you sell when approval is at hand and stock has already formed a base around $250. I expect this stock to go to $350-400 in a few weeks. Hold on for BIG gains!!!
People start buying BTNX 👍🏼…
Not to offend the bulk of good respectable investors on this board, but some investors here are really a very sad bunch who never learn that rooting for Moderna's failure is like shooting themselves on the foot. I won't mention names but those active here surely know who they are. Time and time again, some of you get all excited with negative news on Moderna only to find yourself also down with Moderna, not unlike Willy Coyote in the cartoon Road Runners. If you want to refute my observation that the two mirror each other, I invite you to overlay the SP chart for Moderna and Biontech and see how their shape coincide with each other. Learn to be happy without wish bad on others. You'll be a happier more decent human beings that way. And you'll have better Karma. GL and I am sure the stock will soar again up because objectively the fundamentals are getting better and better by the day. Objectively at present it has the best momentum of all covid stocks.
We all may want to visit the Barron's message board from time to time. There are six responses to the Deutsche Bank analyst's commentary about his downgrade of MRNA, five of them very well thought out. We could use a bit of the same here on this board instead of the mindless BS, SP guessing, and GIF postings.
Do you think all the companies requiring vaccines, and the government, in 6 months will also require the boosters?
better volume than yesterday. Still far from July's
Some will say today was a good day for our stock, I don't feel it was. With all the news and future plans in the works, I expected more especially in light of NVAX news. The move into earnings should have begun.
not selling till over 600 dollars
Whales were taking us to higher ground ((300+) when the whale who pegs both mRNA companies together tugged us along with Moderna’s sell off. The trend toward earnings is still up. 💎🤚
Bought 400 shares today with average of $282 shares. Hope next week will be a good week. Good luck to all!
Children ages 5 to 11 will soon be able to get a COVID-19 shot early November along with Q3 ER on November 9. This stock will be back in the $300+ in 2 weeks
A look at the price changes of homes near MRT stations in Q2 and Q3 2021
Which smartphones do tech billionaires use? iPhone, Android or some other?
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