Vaccines

The complexity of the RNA production process creates challenges.

Nicole Lewis, PVP Program Manager at Boston Children's Hospital, discusses the science behind precision vaccines, a form of personalized vaccines.

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.

The COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage.

The COVID-19 pandemic has led to many changes and shifts in the pharmaceutical industry, specifically with how pharmaceutical companies develop vaccines.

The COVID-19 pandemic has led to many changes and shifts in the pharmaceutical industry, specifically with how pharmaceutical companies develop vaccines.

This new pioneering phase of mRNA is loaded with potential, but also obstacles and false dawns.

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

Inhaled vaccines must resist degradation and penetrate the mucosal lining in the airways and lungs.

In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.

The approval is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial.

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.

One can improve method precision and productivity by replacing one step in sample preparation with an automated approach.

Unique solutions are required to protect inherently unstable messenger RNA.

Replacing a step in sample preparation with an automated approach improves both method precision and productivity.

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.

South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.

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

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

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

Moderna is suing Pfizer and BioNTech for allegedly infringing on patents the company filed from 2010 to 2016.

The option of using prefilled syringes for vaccinations is not (yet) available for all types of vaccines. Stakeholders are working to expand that option while also pursuing other non-traditional routes of administration.

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.

Technological advances are progressing pharmaceutical packaging to overcome the challenges of the future.

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.