In a strategic initiative to streamline operations, Pfizer said it would close facilities in Durham and Morrisville, North Carolina. The company aims to cut at least $3.5 billion in costs. The company now employs more than 80,000 people worldwide, with roughly 4,000 based in North Carolina. The closures will not affect Pfizer’s two largest facilities…
Developers of Pfizer/BioNTech COVID-19 vaccine to establish Asia-Pacific mRNA R&D center
mRNA Victoria announced today that the developers of the Pfizer/BioNTech COVID-19 vaccine will establish a clinical R&D center in the Asia-Pacific region. The center enables Victorian and Australian researchers to advance the next generation of mRNA vaccines and therapies. The R&D center aims to facilitate partnerships on scientific mentoring, business development advice and drug design.…
Pfizer and Moderna seek FDA nod for omicron-adapted COVID boosters in children
Pfizer/BioNTech (NYSE:/PFE, Nasdaq BNTX) and Moderna (Nasdaq:MRNA) have both won emergency use authorizations in the U.S. for bivalent vaccine boosters based on BA.4/BA.5. Pfizer is aiming to win authorization to use its updated COVID-19 vaccine in children aged 5 through 11 years. Moderna has requested that FDA greenlight the use of its omicron booster in…
Pfizer and BioNTech get positive CHMP opinion for updated bivalent BA.4/BA.5-adapted COVID-19 vaccine booster
Pfizer (NYSE: PFE) and its partner BioNTech (Nasdaq:BNTX) could potentially win authorization to market a 30-µg booster dose of their omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine after the Committee for Medicinal Products for Human Use (CHMP) backed the vaccine for individuals 12 and older. The European Commission will likely make a final decision on the updated…
Pfizer and BioNTech seek EMA authorization for COVID-19 vaccination in young children
Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq: BNTX) have filed paperwork with the European Medicines Agency (EMA) requesting permission to use the Comirnaty COVID-19 vaccine in children aged 6 months to 5 years old. As in the U.S., the companies are attempting to win authorization for a 3-µg dose vaccine administered as a three-dose series.…
Will COVID-19 vaccines be updated by fall?
FDA advisors are slated to meet to discuss the prospect of updating the first generation of COVID-19 vaccines for use as boosters this fall and winter. But it remains unclear whether updating the COVID-19 vaccines will be necessary. Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) have updated vaccines in the works. Pfizer and Moderna have both said…
Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children
Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data support a three-dose primary series of their COVID-19 vaccine in young children. Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial in young children evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong…
Pfizer and BioNTech file for EUA for COVID-19 vaccine booster in kids 5 to 11
Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application with the FDA for emergency use authorization (EUA) for a 10-µg booster dose of their BNT162b2 COVID-19 vaccine in children aged 5 to 11. The companies included data in the application from a Phase 2/3 study that tested a booster dose in children between…
Rentschler Biopharma begins work on new facility in Greater Boston
The contract development and manufacturing organization Rentschler Biopharma (Laupheim, Germany) has begun constructing a new facility in Milford, Massachusetts, next to an existing facility. The new 22,000-ft2 facility will boost the company’s cGMP manufacturing capacity and its ability to produce complex molecules for U.S.-based clients. Once completed, the facility will contain space for manufacturing, single-use…
Israeli advisory committee backs fourth dose of COVID-19 vaccine
Israel could be one of the first countries to begin administering a fourth dose of COVID-19 vaccine to individuals over 18 after a positive advisory committee decision. Before the decision becomes binding, the director of Israel’s Ministry of Health, Nitzan Horowitz, must sign off on the recommendation. If implemented, Israeli adults would be eligible for…