Pfizer (PFE) and BioNTech(BTNX) Partner With Eurofarma Laboratórios to Manufacture COVID-19 Vaccine in Latin America

Pfizer (PFE) Announces Positive Results from Phase 3 JADE DARE Trial Comparing the Efficacy of Abrocitinib and Dupilumab for Moderate to Severe Atopic Dermatitis

August 30, 2021 6:46 AM EDT

Pfizer Inc. (NYSE: PFE) today announced that JADE DARE (B7451050), a 26-week, randomized, double-blind, double-dummy, active-controlled, multi-center Phase 3 study, met its co-primary and key secondary efficacy endpoints. The study showed that abrocitinib was statistically superior compared to dupilumab in each evaluated efficacy measure and had a safety profile consistent with previous studies. The head-to-head study was... More

BioNTech SE (BNTX) Evaluates Vaccine Manufacturing Options in Rwanda and Senegal to Improve Long-Term Vaccine Supply

August 27, 2021 7:16 AM EDT

Founder of BioNTech in Berlin to discuss the development of sustainable vaccine production for Africa. The meeting resulted in a joint communiqué affirming BioNTechs intention to manufacture mRNA vaccines arising from its Malaria and Tuberculosis vaccine development programs on the African continent.

We would like to thank all participants for todays discussion and for the support and trust they put in us. Our goal is to develop vaccines in Africa and set-up sustainable vaccine production capabilities to jointly improve medical care, said Prof. Dr. Ugur Sahin, CEO and Co-founder of BioNTech. We are committed... More

Pfizer (PFE) Appoints Aamir Malik as Chief Business Innovation Officer

August 26, 2021 8:00 AM EDT

Pfizer Inc. (NYSE: PFE) today announced that Aamir Malik has joined the company as Executive Vice President and Chief Business Innovation Officer. Mr. Malik will be a member of Pfizers Executive Leadership Team reporting to Chairman and Chief Executive Officer, Albert Bourla. Mr. Malik joins Pfizer from McKinsey & Company, where he most recently served as the Managing Partner responsible for the firms U.S. operations. Previously, he led the firms Global Pharmaceuticals & Medical Products practice.

Mr. Malik succeeds John Young, Executive Vice... More

Biden Admin. Plans Covid-19 Boosters at Six Months, Had Previously Said Booster Would Start at Eight Months After Inoculation - DJ

August 25, 2021 3:24 PM EDT

Biden Admin. Plans Covid-19 Boosters at Six Months, Had Previously Said Booster Would Start at Eight Months After Inoculation - DJ

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Pfizer seeks U.S. approval for COVID vaccine booster

August 25, 2021 12:25 PM EDT

(Reuters) -Pfizer Inc on Wednesday said a booster dose of its two-shot COVID-19 vaccine spurs a more than threefold increase in antibodies against the coronavirus, as the company seeks U.S. regulatory approval for a third injection.

The drugmaker and its German partner BioNTech SE aim to complete the submission for use of booster shots in people aged 16 and over by the end of this week.

The U.S. government has said it was gearing up https://www.reuters.com/world/us/us-begin-offering-covid-19-vaccine-booster-shots-september-2021-08-18 to roll out the third shot of vaccines from both... More

Pfizer (PFE), BioNTech (BNTX) Confirm Rolling Submission of sBLA to U.S. FDA for Booster Dose of Covid-19 Vaccine

August 25, 2021 12:09 PM EDT

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of a booster (third) dose of COMIRNATY® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. The companies intend to complete submission of the sBLA by the end of this week.

The sBLA includes data from a Phase 3 clinical trial of 306 participants 18-55 years of age who received a booster (third)... More

Pfizer (PFE), BioNTech (BNTX) Start Rolling Submission to FDA for Booster - Bloomberg

August 25, 2021 12:01 PM EDT

(Updated - August 25, 2021 12:04 PM EDT)

Pfizer (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) started their rolling submission to the FDA for booster vaccines, Bloomberg reported. The companies intend to finish the sBLA submissions by... More

Pentagon makes Pfizer vaccine mandatory after FDA approval- memo

August 25, 2021 9:39 AM EDT

WASHINGTON (Reuters) -The Pentagon on Wednesday ordered all active-duty service members to be vaccinated with the Pfizer/BioNTech COVID-19 vaccine days after the Food and Drug Administration granted it full approval.

In a memo seen by Reuters, the Pentagon ordered the military to start the process immediately but did not put a specific timeline on when it... More

COVID vaccine protection wanes within six months - UK researchers

August 25, 2021 9:25 AM EDT

By William Schomberg and Ludwig Burger

LONDON (Reuters) -Protection against COVID-19 offered by two doses of the Pfizer/BioNTech and the Oxford/AstraZeneca vaccines begins to fade within six months, underscoring the need for booster shots, according to researchers in Britain.

After five to six months, the effectiveness of the Pfizer jab at preventing COVID-19 infection in the month after the second dose fell from 88% to 74%, an analysis of data collected in Britain's ZOE COVID study showed.

For the AstraZeneca vaccine, effectiveness fell from 77% to 67% after four to five months.

The study was... More

Taiwan to get BioNTech (BNTX) shots early as China Delays Approval -source - Reuters News

August 25, 2021 6:17 AM EDT

Taiwan to get BioNTech SE (NASDAQ: BNTX)shots early as China delays approval-source - Reuters News

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U.S. data show rising 'breakthrough' infections among fully vaccinated

August 24, 2021 2:27 PM EDT

(This August 24 story corrects figures in 5th paragraph to read: 0.5% admitted to intensive care, from 0.05%; and to 0.2% placed on a ventilator from 0.25%)

By Julie Steenhuysen

CHICAGO (Reuters) - Some 25% of SARS-CoV-2 infections among Los Angeles County residents occurred in fully vaccinated residents from May through July 25, a period that includes the impact of the highly transmissible Delta variant, U.S. officials reported on Tuesday.

The data, published in the U.S. Centers for Disease Control and Prevention's weekly... More