Pfizer

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.

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.

The Food and Drug Administration has given a green light for elementary school-age kids to get the updated booster doses, too -- one made by Pfizer for 5- ...

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. Only people who’ve gotten their initial vaccinations -- with any of the original-formula versions -- qualify for an updated booster. The updated boosters are “extremely important” for keeping kids healthy and in school, said Dr. 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.” “We want to have the best of both worlds,” Pfizer’s Dr.

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.

Moderna vaccine has been approved for children six years and older, while children as young as five can get Pfizer.

Many parents expressed concerns regarding the safety of the vaccines and its effectiveness when the vaccine initially came out. Both vaccines have been approved in their bivalent form, and following today’s announcement, the monovalent version of the Pfizer-BioNTech vaccine is no longer qualified for a booster dose. [under the age of five](https://www.theguardian.com/world/2022/sep/22/covid-child-vaccination-rates-us-low).

Pfizer exec Janine Small spoke about the vaccine's transmission test during early stages of the pandemic at a hearing in European Parliament.

She soon moved on to a marketing manager role, followed by a number of more senior managerial positions in Russia, Slovakia and Poland. I think Dr Bourla, even though he’s not here, would turn around and say to you himself, ‘If not us then who?’” “If not, please say it clearly.

Amid what one member of the European Parliament called “SMS-gate,” a Pfizer executive on Monday denied that the company's vaccine deal with the bloc could ...

The texts reportedly led to Pfizer’s European deal for 1.8 billion vaccine doses, the New York Times Amid what one member of the European Parliament called “SMS-gate,” a Pfizer executive on Monday denied that the company’s vaccine deal with the bloc could have been negotiated via text message. The news comes months after the European Ombudsman condemned the Commission’s handling of requests for text messages between president Ursula von der Leyen and Pfizer CEO Albert Bourla.

Merck is hoping to go where Pfizer, Takeda and Lundbeck were unable to with a phosphodiesterase 10A inhibitor, or PDE10A. The aim is to target an enzyme that ...

Pfizer [ditched the program](https://endpts.com/pfizer-dumps-a-failed-phii-huntingtons-drug-in-latest-pipeline-pruning/) in a 2017 pipeline culling. [an approved prevention for cytomegalovirus infection](cytomegalovirus%20infection), for [$220 million in 2020](https://www.royaltypharma.com/news-releases/news-release-details/royalty-pharma-acquires-partial-royalty-interest-prevymistm). [reported a late-stage win in schizophrenia](https://endpts.com/karunas-schizophrenia-drug-passes-a-closely-watched-phii-test-will-head-to-fda-in-mid-2023/), largely unheard of these days in drug R&D. “We are always looking for ways to optimize our R&D spending to ensure we are able to pursue the broadest set of opportunities and generate the highest possible returns,” a Merck spokesperson said in an emailed statement to Endpoints News. [This time around](https://clinicaltrials.gov/ct2/show/NCT04624243?term=MK8189&draw=2&rank=4), Merck is investigating three doses of the oral tablet — 8 mg, 16 mg and 24 mg — and comparing it to placebo and risperidone, a med for treating schizophrenia, bipolar disorder and irritability. A competitor, albeit behind in development stages, [secured financing on the backs of Karuna’s data](https://endpts.com/cerevel-takes-the-public-offering-route-with-a-twist-raising-big-money-thanks-to-rival-data/) as well. Merck is hoping to go where Pfizer, Takeda and Lundbeck were unable to with a phosphodiesterase 10A inhibitor, or PDE10A. There’s also [diabetes med](https://endpts.com/merck-celebrates-another-win-in-januvia-patent-battle-against-viatris/) [Januvia](https://www.royaltypharma.com/news-releases/news-release-details/astellas-prosidion-subsidiary-sells-dipeptidyl-peptidase-iv-dpp), rotavirus vaccine [RotaTeq](https://www.biospace.com/article/releases/royalty-pharma-ag-acquires-royalty-interest-in-rotateq-r-for-182-million-/?s=61), and the rheumatoid arthritis and ulcerative colitis med [Remicade](https://www.biospace.com/article/releases/royalty-pharma-ag-acquires-a-portion-of-new-york-university-s-royalty-interest-in-remicade-r-for-650-million-/). Patients remain on the drug for 12 weeks. The mid-stage readout is likely to happen toward the end of 2023 or early 2024. [after determining](https://clinicaltrials.gov/ct2/show/NCT02342548?term=PF-02545920&draw=2&rank=3) [efficacy would unlikely be met](https://clinicaltrials.gov/ct2/show/NCT01939548?term=PF-02545920&draw=2&rank=2). [a Phase IIa with 224 patients](https://clinicaltrials.gov/ct2/show/study/NCT03055338), Merck kicked off the Phase IIb in December 2020 and plans to enroll 576 people in the trial.

A senior Pfizer executive has admitted that the drug company did not know whether its Covid vaccine prevented transmission of the virus when it began ...

They have been absolutely clear that we have the best vaccines in the world — safe, effective and thoroughly tested.” However, If you reduce the risk of any disease, you reduce the risk of transmission because that person didn’t get Covid in the first place to pass it to others. However, there was a greater emphasis on being vaccinated to protect others because that is what the data showed at the time. “The TGA acknowledges that research is ongoing to directly assess the impacts of the more recent variants of concern on transmission, noting that vaccines to address viral variants are still under development. And we believe we have the best medical authorities in the world. “Data from real-world studies complement the clinical trial data and provide additional evidence that the vaccine provides effective protection against severe disease. With better targeted vaccines, we may again see greater capacity to reduce transmission.” “The trials had a primary outcome of reducing risk of any disease and severe disease, but not transmission. If you reduce your symptoms you tend to pass on less virus to others too.” I think Dr Bourla, even though he’s not here, would turn around and say to you himself, ‘If not us then who?’” “If not, please say it clearly. And I really want a straight answer, yes or no, and I’m looking forward to it.”

Pfizer and its German partner BioNTech said their COVID-19 vaccine booster, adapted for the BA.4 and the BA.5 subvariants, generated a strong immune ...

Food and Drug Administration has focused its response for immunity against the fast spreading Omicron variant only on BA.4/5-adapted shots. The preliminary data on Thursday also showed that, in the age group of adults older than 55, the new bivalent shot triggered a better neutralizing antibody response against the Omicron BA.4/5 subvariant than the established shot based on the initial form of the virus. Register now for FREE unlimited access to Reuters.com [(MRNA.O)](https://www.reuters.com/companies/MRNA.O) have already been given the green light by several countries, including in the United States for adults and, more recently, for children as young as 5 years. In a joint statement on Thursday, the companies said data from a trial in adult patients showed the booster dose led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after one week. [(PFE.N)](https://www.reuters.com/companies/PFE.N) and its German partner BioNTech said their COVID-19 vaccine booster, adapted for the BA.4 and the BA.5 subvariants, generated a strong immune response and was well tolerated in testing on humans.

Pfizer and German partner BioNTech say their adapted COVID-19 vaccine booster generates a strong immune response against BA.5 and BA.4 subvariants of ...

The preliminary data on Thursday also suggested that the bivalent vaccine was likely to provide better protection against the Omicron subvariants than the original vaccine. But, that US authorisation was based on the safety and effectiveness of the original vaccine, and not the BA.4/BA.5-tailored shots. The companies said on Thursday that data from a trial in adult patients showed that the booster dose led to a substantial increase in neutralising antibody levels against the BA.4/BA.5 variants.

Pfizer Inc. and its German Covid vaccine partner said their booster shot tailored to the latest omicron variants appears to offer better protection than the ...

Together, these data suggest a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine is anticipated to provide better protection against the ...

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 12 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. - 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. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). Sera were collected 7 days post second booster dose from participants aged older than 55 (40 participants in each age group) and compared to 7-day post sera from 40 participants older than 55 years of age that had received three prior doses of BNT162b2 encoding the wild-type spike-protein of SARS-CoV-2 and a second booster with BNT162b2 Wild-Type. A 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine has been authorized for emergency use by the U.S. When comparing responses in individuals older than 55 years of age who received either the bivalent vaccine, or the original vaccine, a 30-µg booster dose of the Original Pfizer-BioNTech COVID-19 Vaccine (also referred to as BNT162b2 Wild Type) elicited more limited increases in the neutralizing antibody response against the Omicron BA.4/BA.5 variants. These data will be used to support potential full licensure and global registration of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Sera were also collected at 7 days post second booster dose from participants 18 to 55 years of age who received the Omicron BA.4/BA.5-adapted bivalent booster (n=40) to compare bivalent vaccine responses in younger and older adults. The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY®), which are based on BioNTech’s proprietary mRNA technology, were developed by both BioNTech and Pfizer. “The current dominance of BA.4/BA.5 and related sublineages, underscores the importance of our data and science-based approach to develop a vaccine which is adapted to these prevalent strains of the virus and make it available in a timely manner.” A 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine demonstrated a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels based on sera taken 7 days after administration, with similar responses seen across individuals aged 18 to 55 years of age and those older than 55 years of age (40 participants in each age group). “Since the earliest days of the pandemic, we have strived to transparently share data regarding our COVID-19 vaccines in the interest of public health,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

Janine Small, Pfizer's president of international developed markets, told a European Parliament hearing that at the time the firm was rolling out Covid ...

[Rob Roos](/topic/rob-roos)about the vaccine's capability to prevent virus transmission. [European Parliament](/topic/european-parliament)'s special Covid committee in place of Pfizer CEO [Albert Bourla](/topic/albert-bourla), who pulled out of the appointment. [Pfizer](/topic/pfizer)has made a shocking admission that the company had no information whether its Covid-19 vaccine prevented transmission of the SARS-CoV-2 virus when it started to release the jabs.

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. Around 400 people die from the disease each day. They are meant to be given at least two months after the primary two-dose series or initial booster vaccination of either shot. 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. [first authorized](https://www.biopharmadive.com/news/fda-updated-covid-booster-shot-pfizer-moderna/630776/) omicron boosters for adults and, in the case of Pfizer and BioNTech’s, older children at the end of August.

Pfizer Inc. and its German vaccine partner said their booster tailored to the latest omicron variants raised more antibodies against the dominant strains of ...

Blood from 80 volunteers collected seven days after the booster shot showed an increase in neutralizing antibodies against the BA.4 and BA.5 subvariants in a study, Pfizer andBioNTech SEsaid in astatementThursday. Pfizer Inc.and its German vaccine partner said their booster tailored to the latest omicron variants raised more antibodies against the dominant strains of Covid-19 when compared with the original shot designed to fight the form of the virus. Pfizer Says Booster Lifts Antibodies for Omicron Variants (2)