Pfizer

Pfizer and BioNTech have been granted Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for a 10µg booster dose of their ...

Similar applications are also planned for submission with regulatory authorities around the world in the coming weeks, the companies said in a statement. The booster has already been granted EUA by the FDA for ages 12 years and older. The authorisation is supported by safety and immunogenicity data from the Pfizer/BioNTech 30µg Omicron BA.1 adapted bivalent vaccine, as well as pre-clinical data which demonstrated a booster dose of the Pfizer/BioNTech Omicron BA.4/BA.5-adapted bivalent vaccine generated a ‘strong neutralising antibody response’ against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. The companies have also submitted an application to the European Medicines Agency (EMA) requesting a variation of the companies’ marketing authorisation in the EU to include a 10µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in this age group. The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein – present in the original Pfizer/BioNTech COVID-19 vaccine – together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. Pfizer and BioNTech have been granted Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for a 10µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children aged five to 11 years.

Sera collected from participants 7 days after administration of a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine showed a ...

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. 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 the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and early data from an ongoing phase 2/3 clinical trial, potential full licensure, a Phase 1/2/3 study in children aged 6 months through 11 years of age, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. [www.pfizer.com](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.pfizer.com&esheet=52941174&newsitemid=20221010005742&lan=en-US&anchor=www.pfizer.com&index=19&md5=93f0ab5927212d0212ac534508849476). - 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. [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=52941174&newsitemid=20221010005742&lan=en-US&anchor=www.vaers.hhs.gov%2Freportevent.html&index=6&md5=5ca55062a2a218c12efbda2d1deb331e). 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. 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. 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. Additional data measuring responses at one-month post-administration of the Omicron BA.4/BA.5 bivalent vaccine booster are expected in the coming weeks. “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).

Pfizer Inc and its German partner BioNTech say their Omicron-adapted COVID-19 vaccine booster generates a strong immune response...

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 German partner BioNTech SE said Thursday early data from a Phase 2/3 clinical trial of their omicron BA.4/BA.5-adapated bivalent booster...

“These early data suggest that our bivalent vaccine is anticipated to provide better protection against currently circulating variants than the original vaccine and potentially help to curb future surges in cases this winter.” The companies expect to provide additional data at 1-month post administration in the coming weeks. The data suggest that the bivalent booster provides better protection against BA.4 and BA.5, the dominant variants globally, than the original vaccine in younger and older adults. [PFE,+0.26%](/investing/stock/PFE?mod=MW_story_quote)and German partner BioNTech SE [BNTX,+5.53%](/investing/stock/BNTX?mod=MW_story_quote)said Thursday early data from a Phase 2/3 clinical trial of their omicron BA.4/BA.5-adapated bivalent booster showed positive results in treating individuals aged 18 and older.

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 ...

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. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. Food and Drug Administration (USFDA) has 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. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. government. Pending recommendation from the Centers for Disease Control and Prevention (CDC), 10-µg doses will be shipped immediately. "Anticipating this need, we manufactured millions of booster doses, which will be made available, pending CDC recommendation, to help families stay up to date with COVID-19 vaccinations." "This milestone is important to be able to provide access to variant-adapted vaccines to a broader population," said Prof. The authorization of the bivalent COVID-19 vaccine for children 5 through 11 years of age is supported by safety and immunogenicity data from Pfizer and BioNTech's 30-µg Omicron BA.1-adapted bivalent vaccine, non-clinical and manufacturing data from the companies' 10-µg Omicron BA.4/BA.5-adapted bivalent vaccine, and pre-clinical data from the 30-µg Omicron BA.4/BA.5-adapted bivalent vaccine. 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 response against the Omicron BA.1 subvariant compared to the companies' original COVID-19 vaccine, with a favorable safety profile. and BioNTech SE have announced that the U.S.

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 ...

Omicron-tailored shots made by Pfizer and Moderna Inc have already been greenlit by several countries, including in the US for adults and, more recently, ...

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)

The FDA has authorized Pfizer's boosters without direct human data on how they perform against the omicron BA.5 subvariant.

The agency relied instead on human data from a similar shot developed by Pfizer against the original version of omicron, called BA.1, as well as data from animal studies that directly looked at how the shots perform against BA.5. The Food and Drug Administration authorized the omicron shots without direct human data on how they perform against omicron BA.5, which is causing most infections in the U.S. The first generation shots were developed only against the first strain of the virus. Pfizer and BioNTech said they will release more immune response data on the shots in the coming weeks. The participants who received the first generation vaccine saw a limited increase in antibodies against BA.5, according to the companies. Both age groups saw a substantial increase in antibodies that block the BA.5 subvariant from invading human cells, according to the companies.

When Rady Johnson contemplates the importance of diversity and inclusion in the workplace, he thinks of his son, Michael. Michael, who is 31, has worked as ...

Accenture, in partnership with Disability: IN and The American Association of People with Disabilities. He’s seen the benefits, first hand, with Michael and his work. Studies show that the benefits of a diverse workforce ripple through the company, and the greater community. For a healthcare company like Pfizer, there’s another reason to prioritize diversity: “Everything we do is about patients and their families,” says Rady. “People with disabilities are underemployed and underrepresented in workforces for lots of different reasons,” he says. Researchers at Accenture analyzed 140 companies and found that about one-third of those companies (45) excelled in areas related to disability and inclusion.2 Those companies also achieved 30% higher economic profit margins over a four-year period and were twice as likely to outperform the others in shareholder returns. “It gives you a purpose.” Through hiring pilot programs at 10 sites in the U.S., Europe, and Asia-Pacific regions, 60 individuals with disabilities have begun work. Through a global summer worker program, Pfizer collaborated with partners to identify student candidates with disabilities in an effort to support their path toward future employment. Rady's experience as a parent of a child living with an intellectual disability shifted his world view. In the United States, he stabilized with medical treatment. As he grew older, it was clear that he struggled with learning.

Sera collected from participants 7 days after administration of a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine showed a ...

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. 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 the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and early data from an ongoing phase 2/3 clinical trial, potential full licensure, a Phase 1/2/3 study in children aged 6 months through 11 years of age, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. [www.pfizer.com](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.pfizer.com&esheet=52941174&newsitemid=20221010005742&lan=en-US&anchor=www.pfizer.com&index=19&md5=93f0ab5927212d0212ac534508849476). [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=52941174&newsitemid=20221010005742&lan=en-US&anchor=www.vaers.hhs.gov%2Freportevent.html&index=6&md5=5ca55062a2a218c12efbda2d1deb331e). - 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. 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. 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. 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. Additional data measuring responses at one-month post-administration of the Omicron BA.4/BA.5 bivalent vaccine booster are expected in the coming weeks. “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).

Pfizer and BioNTech released early data Thursday morning from a Phase II/III trial assessing an Omicron-specific booster that showed it provided significant ...

The Phase II/III study assessed a 30-µg dose of the Omicron BA.4/BA.5-adapted bivalent booster in adults 18 and up. Doses from this vaccine will be shipped to providers following a green light from the CDC. Development of the booster came at the urging of the FDA, which asked vaccine makers to produce boosters that target these two strains. Pfizer and BioNTech anticipate additional data related to responses at one-month post-administration in the coming weeks. The booster dose was given the nod from the regulatory agency without the in-human data. It suggests the booster will provide better protection against Omicron BA.4/BA.5 sublineages than the original vaccine across younger and older adults, the companies announced in a joint announcement.

US FDA and CDC authorise Omicron BA.4/BA.5 COVID-19 booster vaccines from Pfizer/BioNTech and Moderna for use in children and adolescents.

The UD federal government has urged all eligible Americans to get a shot by 31 October in order to be fully protected before the holiday season. It said the vaccine showed a “substantial increase” in Omicron BA.4/BA.5 neutralising antibodies above pre-booster levels at that timepoint, with a similar safety profile to its original Comirnaty jab. Pfizer’s shot was

Pfizer released its first human data results on the bivalent omicron booster, which showed an increase in antibodies, but more data is needed to show how ...

officials have said they expect that the new shots will perform better than the first iteration of the vaccines, which only targeted the original coronavirus strain. Anthony Fauci, the White House's chief medical adviser, told NBC News in an interview this week that scientists won't know how well the new vaccines work in the real world for several more months. The FDA also authorized Moderna's updated booster based on similarly limited data. At the time, Dr. The results are based on blood samples taken from adults one week after they received the updated booster. Bill Hanage, an associate professor of epidemiology at Harvard’s T.H.

Preliminary results from a phase 2/3 trial suggest Pfizer-BioNTech's Omicron BA.4/BA.5 bivalent COVID-19 booster vaccine provides better protection for ...

Sera collected 7 days after bivalent booster administration showed a substantial increase in Omicron BA.4/BA.5 neutralizing antibody response. The participants 12-17 years of age received a 30-µg vaccine dose. Preliminary results suggest one 30-µg dose of the Omicron BA.4/BA.5 bivalent vaccine significantly raised antibody titers above pre-booster levels. The participants had received at least 3 doses of an authorized COVID-19 vaccine at the time of enrollment. “While we expect more mature immune response data from the clinical trial of our Omicron BA.4/BA.5-adapted bivalent vaccine in the coming weeks, we are pleased to see encouraging responses just one week after vaccination in younger and older adults.” “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 Omicron BA.4/BA.5 variants than the original vaccine for younger and older adults,” Pfizer said in a

Preliminary results in 80 humans showed that Pfizer/BioNTech's recently authorized Omicron vaccine substantially increased neutralizing antibodies against ...

[phase II/III trialopens in a new tab or window](https://www.globenewswire.com/Tracker?data=cC9sux6BEDyn9D5Fba684Nh7PTPcV0BKncl8BYiF64iIZwIubsiUkvI2JwmSuKLSNByo3CdBgeEO4SMsVU7Qlm7qTeSsuLS5PerECOKIEyl0rv3PU-OlK4-KyMKJeMZv) has enrolled approximately 900 participants ages 12 and up who have received at least three doses of an authorized COVID-19 vaccine. "These preliminary findings are consistent with our preclinical data showing a substantial increase in the neutralizing antibody response against the Omicron sublineages BA.4 and BA.5," said Ugur Sahin, MD, CEO and co-founder of BioNTech, in a statement. Antibody levels were not disclosed in the release. "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." Pfizer/BioNTech said that early data showed that their bivalent vaccine -- which was designed with components that target BA.4 and BA.5 along with the original strain -- was well tolerated, "indicating a favorable safety profile, similar to that of the original vaccine." "While we expect more mature immune response data from the clinical trial of our Omicron BA.4/BA.5-adapted bivalent vaccine in the coming weeks, we are pleased to see encouraging responses just one week after vaccination in younger and older adults," said Albert Bourla, PhD, chairman and CEO of Pfizer.