“Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases,’ said Patrizia Cavazzoni M.D., Acting Director of the U.S. FDA’s Center for Drug Evaluation and Research.
“In fact, in the past eight years, the FDA has approved more than twice as many drugs for rare diseases, often referred to as orphan drugs, as in the previous eight years.”
Excerpts from Dr. Cavazzoni’s press statement on January 4, 2021, are inserted below.

Israel based Scentech-Medical announced it had received approval from the Shamir Medical Center Review Board for a new clinical trial to demonstrate its ability to monitor the antibody levels and type of antibodies developed by the population of subjects getting vaccinated for the SARS-CoV-2 coronavirus.
Scentech, which is merging with NextGen Biomed Ltd, reports that using the test developed for the analysis and quantification of volatile compounds in breath can detect coronavirus patients, active, symptomatic, and asymptomatic carriers.

Moderna, Inc. published a supply update for the experimental Moderna COVID-19 Vaccine, stating the company is increasing its base-case global production estimate from 500 to 600 million vaccine doses for 2021. 
Furthermore, Moderna’s press statement added, ‘it is continuing to invest and add staff to build up to potentially 1 billion vaccine doses for 2021.’
The Company said it expects about 100 million doses to be available in the USA by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter.

“It has been a year like no other in recent memory for public health at the U.S. Food and Drug Administration (FDA), with much of our focus has been dominated by our response to the COVID-19 pandemic,” stated Stephen M. Hahn, M.D., Commissioner.

A Maryland-based biopharmaceutical company announced that it had enrolled the first patient in its multinational Phase 2 clinical trial of HepTcell, a novel peptide-based immunotherapeutic under development to treat chronic hepatitis B (CHB).
HepTcell is a novel immunotherapeutic composed of nine synthetic HBV-derived peptides formulated with IC31®, a TLR9-based adjuvant from Valneva SE. The HBV peptides are designed to drive T cell responses against all HBV genotypes in patients of diverse genetic backgrounds.

A Maryland-based biotechnology company announced the initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373, the Company’s COVID-19 vaccine candidate.
Novavax, Inc. stated on December 28, 2020; the Phase 3 trial has begun enrolling adult volunteers into the randomized, placebo-controlled trial, which intends to enroll approximately 30,000 people at about 115 sites.

To meet the yellow fever vaccination needs, the Stamaril vaccine will continue to be available in the USA into mid-2021.
As announced by Sanofi Pasteur in France on December 23, 2020, the U.S. FDA has agreed to authorize the distribution of Stamaril through an Expanded Access Program (EAP) during the YF-VAX vaccine shortage. This EAP is forecast to be effective through mid-2021.

A Phase II randomized clinical trial will evaluate a proprietary universal cancer vaccine, UV1, in patients with recurrent or metastatic head and neck cancer who will be treated with standard of care therapy pembrolizumab.
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase.
The trial will be conducted at ten sites across Germany and led by principal investigator Prof. Mascha Binder, M.D., Medical Director, and Head of the Immunological Tumor Group at University Medicine Halle, Germany.

'Will this COVID-19 shot be required for Texas schoolchildren,' was the headline of an article published by DallasNews.com on December 21, 2020.
In response to this headline, Texas Governor Gregg Abbott quickly posted on Twitter: 'No. In Texas, vaccines are always voluntary.'

A Massachusetts-based biopharmaceutical company announced that the U.S. Food and Drug Administrations (FDA) had approved the Company’s Investigational New Drug (IND) application to proceed with initiation of Phase 2 clinical trial of Brilacidin in hospitalized patients with COVID-19.
Brilacidin is a Host Defense Protein (HDP) mimetic representing a new class of drug with antiviral, anti-inflammatory, and anti-bacterial properties, said Innovation Pharmaceuticals.