Vaccine Development and Manufacturing

mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age.

Steriline will be exhibiting its vial filling and capping machine (VFCM100) under double-wall isolator for aseptic filling at CPHI 2022 in Frankfurt, Germany, on Nov. 1–3, 2022.

Increasing molecular diversity is creating a need for the reinvention of process development and control strategies.

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.

Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.

This article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.

Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.

Wacker is investing more than €100 million (US$100.5 million) to expand its Halle, Germany, site with an mRNA competence center.

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.

The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

Batavia Biosciences is expanding its headquarters and R&D capabilities in its Netherlands facility.

The expansion at Seqirus’ Holly Springs, N.C., manufacturing facility will support the formulation and fill/finish of influenza vaccines.

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

Advances in therapeutic modalities and an increase in molecular complexity have led to the need for an evolution in drug delivery approaches over the years.

GeoVax has received a patent for its malaria vaccine from the US Patent and Trademark Office.

The European Investment Bank has provided €15 million to fund coronavirus research at IRBM.

ReiThera and Exothera are collaborating to develop a large-scale, low-cost-per-dose manufacturing process to deliver novel vaccines to low and middle-income countries.

IAVI and Moderna have announced a new collaboration to employ mRNA technology to meet the challenge of a range of global health issues.

Catalent has acquired the Vaccine Manufacturing Innovation Centre in Harwell, Oxford to expand its biologics capabilities across the UK and Europe.

Merck has expanded its manufacturing facility in Elkton, Va. to further increase its HPV vaccine supply.

UK government has awarded chemical producer Croda a £15.9 million grant to increase the UK’s capacity to manufacture key vaccine ingredients.

KeyPlants has shipped a first-of-its-kind vaccine manufacturing facility to Senegal in West Africa.