Coronavirus News Roundup: Progress in Vaccine Development, Clarification on Pharmacist-Provided Testing
Here's a roundup of the latest coronavirus-related news.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), has infected an estimated 4,800,000 individuals worldwide. This week, progress has been made on the vaccine development front, domestic manufacturing, and new federal guidance.
Here’s a roundup of the latest coronavirus-related news:
AstraZeneca Receives $1 Billion for Development of University of Oxford Vaccine for COVID-19
AstraZeneca has received funds exceeding $1 billion from the US Biomedical Advanced Research and Development Authority for the development, production, and delivery of the University of Oxford’s COVID-19 vaccine candidate.
According to a press release, AstraZeneca has concluded the first agreements for at least 400 million doses and has secured total manufacturing capacity for 1 billion doses, with anticipated deliveries beginning in September 2020. The development program for the vaccine includes a phase 3 clinical trial with 30,000 participants and a pediatric trial.
HHS-Industry Partnership to Expand US Stockpile of Essential Drug Ingredients During Pandemic
The US Department of Health & Human Services (HHS) announced the start of their partnership with private industry members led by Phlow Corporation in order to increase US manufacturing of active pharmaceutical ingredients needed to produce essential medicines during the COVID-19 pandemic.
The team will provide “immediate, US-based capacity” to produce critical medicines, including those for the pandemic response, to help alleviate or prevent drug shortages.
HHS Overrides State Barriers to Pharmacist-Provided COVID-19 Testing
A new guidance from the US HHS paves the way for pharmacists nationwide to administer COVID-19 tests. The
guidance, issued on May 19, overrides state and local rules preventing pharmacists from administering COVID-19 diagnostic tests.
“We have received requests from pharmacists, pharmacies, and one trade association asking the Office of the General Counsel (OGC) whether the Public Readiness and Emergency Preparedness (PREP) Act preempts state licensing laws that restrict the ability of pharmacists to order and administer COVID-19 diagnostic tests where the Department of Health and Human Services (HHS) has expressly authorized pharmacists, under the PREP Act, to order and administer those tests,” HHS said.
Pharmacist, Technician Safety and Mental Health Amid COVID-19
Mike Johnston, founder and chief executive officer of the National Pharmacy Technician Association joined Drug Topics® to discuss their latest survey, which pinpointed where pharmacists are feeling most unprotected and unsafe at their workplaces during the pandemic.
Sorting Out Remdesivir Supplies Amid COVID-19
Following the FDA’s Emergency Use Authorization (EUA) for remdesivir for treatment of severely ill patients with COVID-19 on May 1st, initial distribution of the drug caused confusion about how the supplies were being allocated to hospitals, which left many health care providers urging for more transparency.
As a result, US HHS offered more details: state health agencies would be responsible for allocating their remdesivir supplies to the hospitals that they see as needing it most, since “state and local health departments have the greatest insight into community-level needs in the COVID-19 response, including appropriate distribution of a treatment in limited supply.”
Health care providers are responsible for contacting their state health department to receive remdesivir supplies, according to HHS’ news release.
NACDS COVID-19 Report: Top Reopening Priorities and How Pharmacies Can Help
Rapid COVID-19 testing, contract tracing, and preparing for vaccines and treatments are the 3 key priorities as the United States reopens, NACDS said in a new report.
In the report, Pharmacies: A Vital Partner in Reopening America, NACDS outlined 3 key operational considerations for President Donald J. Trump’s Administration, Congress, and governors as they develop reopening and recovery plans. The organization also urged that additional steps should be taken to ensure that pharmacists and pharmacies are fully utilized to support this national effort.
Moderna Reports Positive Early Data for COVID-19 Vaccine Candidate
Moderna announced new interim clinical data results for its COVID-19 vaccine candidate from a phase 1 study.
The investigational vaccine, called mRNA-1273, was launched in volunteers on March 16, making it the first trial to be started in humans for a vaccine for this virus. The study is funded by the National Institute of Allergy and Infectious Diseases.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
