Vaccine Development and Manufacturing

The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.

The agency’s human medicines committee approved an additional site in West Point, Pa. in the United States for the manufacture of Janssen’s COVID-19 vaccine.

The intranasal route of administration is showing clinical promise, particularly for COVID-19, but there are multiple hurdles to overcome to ensure successful formulation.

Researchers in China report test results for a microneedle patch for COVID-19 vaccine delivery.

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.

New data finds J&J COVID-19 vaccine and booster to provide increased protection against COVID-19.

The topline data from Pfizer and BioNTech’s trial suggests that a 10 µg vaccine is safe and effective among the 5 to 11 age group.

Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.

FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.

Moderna’s newest insights include an overall efficacy review, a study on breakthrough infections, and a study on long-term immunity.

The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.

Moderna’s new single-dose vaccine will be a booster for both COVID-19 and the flu.

Alternative materials, as well as supply-chain planning, are essential to ensure a reliable supply for parenteral drug packaging.

Models of biopharmaceutical processes can be used for speeding development and improving process control.

Scientific advances open the way to alternatives to animal testing and in-vivo assays.

FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.

Primates inoculated with CV2CoV show improved immune response and protection from various COVID variants.

Biotage’s new facility in Cardiff, UK, will produce lipids using large-scale flash purification.

PNI expands global headquarters with a new 75,000-square-foot facility, which will include multiple GMP suites for manufacturing RNA therapeutics and vaccines.

The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.

A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.

A collaboration between Aldevron and Ginkgo Bioworks has resulted in a manufacturing enhancement that can improve production of an enzyme used for mRNA therapeutics.

Moderna will build an mRNA vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.

Nobelpharma has come to terms on an agreement to use ProBioGen’s vaccine manufacturing platform AGE1.CR.plX.

EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.