Pfizer

Clinical data from a Phase 2/3 trial showed a booster dose of Pfizer and BioNTech's 30-µg Omicron BA.1-adapted bivalent vaccine elicited a superior immune ...

This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including an EUA in the U.S. Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties. [www.pfizer.com](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.pfizer.com&esheet=52942220&newsitemid=20221011006028&lan=en-US&anchor=www.pfizer.com&index=14&md5=0c32cea7d53c6f974a652712ce9b181d). [www.vaers.hhs.gov/reportevent.html](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.vaers.hhs.gov%2Freportevent.html&esheet=52942220&newsitemid=20221011006028&lan=en-US&anchor=www.vaers.hhs.gov%2Freportevent.html&index=3&md5=77e06406b5d1d6eb24f468eec48ab6a0). - Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY® (COVID-19 vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of October 12, 2022. at [www.pfizersafetyreporting.com](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.pfizersafetyreporting.com&esheet=52942220&newsitemid=20221011006028&lan=en-US&anchor=www.pfizersafetyreporting.com&index=4&md5=3b5e6b76288f17d8a465927ff0c12d62) or by calling 1-800-438-1985 Additionally, pre-clinical data showed a booster dose of the 30-µg BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus. These may not be all the possible side effects of the vaccine. Pending recommendation from the Centers for Disease Control and Prevention (CDC), 10-µg doses will be shipped immediately. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S.

The regulator granted emergency-use authorization for children as young as five to receive the Covid-19 vaccines. Stock in Pfizer and Moderna gained.

[According to the FDA](https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-bivalent-covid-19-vaccines-for-use-as-a-booster-dose-in-younger-age-groups-301647452.html), the The [

Covid vaccine makers Pfizer Inc. and Moderna Inc. received US regulatory clearances for their omicron-targeted boosters for children as young as five.

The Pfizer shot can be given at least two months after primary or booster vaccination in children as young as five. While updated booster shots have already been authorized for use in children and adults from the age of 12 ... Moderna’s vaccine was authorized for use at least two months after completion of primary or booster vaccination in children down to six years of age, according to a statement Wednesday from theUS Food and Drug Administration.

Children as young as 5 years old can now receive an updated COVID-19 booster following a decision by the Food and Drug Administration to expand its ...

“We have seen an increase in COVID infections, hospitalizations, and deaths each of the last two winters,” said Ashish Jha, the White House’s COVID-19 response coordinator, in a press briefing Tuesday. Health officials have been concerned those numbers could creep back up with children starting school and people spending more time inside as the weather gets colder. Around 400 people die from the disease each day. The agency also reviewed data on the companies’ original booster doses, which have been widely used. Pfizer and BioNTech’s vaccine can now be used in children 5 years old and up, after previously being available for those 12 years or older. They are meant to be given at least two months after the primary two-dose series or initial booster vaccination of either shot.

The new Pfizer-BioNTech COVID-19 booster vaccine targets the BA.4 and BA.5 strains of the Omicron variant. Will you be rolling up your sleeves for this shot ...

As the informal findings of a survey presented to the readers of this site, they reflect the opinions of those readers who have chosen to participate. The survey is available online to anyone who is interested in taking it. The new Pfizer-BioNTech COVID-19 booster vaccine targets the BA.4 and BA.5 strains of the Omicron variant.

FDA vaccine chief Dr. Peter Marks said last week he expected a decision on boosters for that age group soon.

Shares of Pfizer Inc. climbed 2.2% and BioNTech SE hiked up 5.5% in morning trading Wednesday, after the companies said the U.S. Food and Drug ...

[MRNA,+8.47%](/investing/stock/MRNA?mod=MW_story_quote)has also submitted a request for its bivalent vaccine booster for children of ages 6 to 11, and for adolescents aged 12. [PFE,+0.72%](/investing/stock/PFE?mod=MW_story_quote)climbed 2.2% and BioNTech SE [BNTX,+5.10%](/investing/stock/BNTX?mod=MW_story_quote)hiked up 5.5% in morning trading Wednesday, after the companies said the U.S. Pfizer’s stock has lost 17.7% over the past three months and BioNTech shares have shed 15.2%, while the S&P 500 [SPX,-0.00%](/investing/index/SPX?mod=MW_story_quote)has lost 5.7%.

The FDA authorized Pfizer/BioNTech's (PFE/BNTX) bivalent COVID-19 booster for children ages 5-11 and Moderna's (MRNA) bivalent booster for ages 6-17, ...

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Tweaked boosters rolled out for Americans 12 and older last month, modified to target today's most common and contagious variant. The latest move may expand ...

For the updated booster made by Pfizer and its partner BioNTech, 5- to 11-year-olds would get a third of the dose that anyone 12 and older already receives. The updated boosters are "extremely important" for keeping kids healthy and in school, said Dr. Only people who've gotten their initial vaccinations — with any of the original-formula versions — qualify for an updated booster. That's partly because both companies already had studied experimental shots tweaked to target prior COVID-19 variants, including an earlier omicron version, and found they safely revved up virus-fighting antibodies. As of last weekend, only at least 13 million had gotten an updated booster, White House COVID-19 coordinator Dr. He hopes the updated shots will "re-energize interest in protecting children for the winter."

A senior Pfizer executive, Janine Small, has revealed that the Pfizer Covid-19 mRNA vaccine was never tested for transmission prevention.

Small went on to say that Dr. And I want a straight answer, yes or no, and I’m looking forward to it.” If not, please say it clearly.

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years ...

This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including an EUA in the U.S. [www.pfizer.com](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.pfizer.com&esheet=52942220&newsitemid=20221011006028&lan=en-US&anchor=www.pfizer.com&index=14&md5=0c32cea7d53c6f974a652712ce9b181d). Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties. [www.vaers.hhs.gov/reportevent.html](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.vaers.hhs.gov%2Freportevent.html&esheet=52942220&newsitemid=20221011006028&lan=en-US&anchor=www.vaers.hhs.gov%2Freportevent.html&index=3&md5=77e06406b5d1d6eb24f468eec48ab6a0). The information contained in this release is as of October 12, 2022. at [www.pfizersafetyreporting.com](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.pfizersafetyreporting.com&esheet=52942220&newsitemid=20221011006028&lan=en-US&anchor=www.pfizersafetyreporting.com&index=4&md5=3b5e6b76288f17d8a465927ff0c12d62)or by calling 1-800-438-1985 - Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY® (COVID-19 vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. Additionally, pre-clinical data showed a booster dose of the 30-µg BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus. These may not be all the possible side effects of the vaccine.

Faced with numerous questions from EU lawmakers on Monday (10 October), pharmaceutical giant Pfizer remained vague about the opacity of its vaccine purchase ...

When a German journalist asked for the text messages, the Commission replied that it did not have them. He was replaced by Janine Small, Pfizer’s regional president of the vaccines division and international developed markets. This was enough to raise the tension a notch. “It is not possible to conduct these negotiations via text messages”, as these negotiations are so complex, Small argued before concluding: “the contract followed the usual procedure”. Pfizer is “very transparent,” and all the contracts are “available to MEPs”, Small said. Faced with protests from MEPs in the room, Small said she was “sorry” for Bourla’s absence, and stressed she was the “best person” to answer their questions, but that was not enough to persuade everyone.