FDA responds to shortages, plus other important updates.
The FDA is carefully tracking shortages of personal protective equipment (PPE) such as surgical masks, as well as pharmaceutical raw materials from China due to the novel coronavirus.1 This is just one of the important updates about coronavirus disease 2019, also known as COVID-19, that pharmacists need to know.
1. The FDA is “keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the US,” said FDA Commissioner Stephen M. Hahn, MD, in a statement.1
“We are not waiting for drug and device manufacturers to report shortages to us-we are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages," he said.
Although there are no vaccines, gene therapies, or blood derivatives licensed by the FDA that are manufactured in China, raw materials used in manufacturing do come from China and other locations in Southeast Asia, Hahn noted. “We are in contact with biologics manufacturers to gauge any supply concerns regarding raw materials,” Hahn said.
However, FDA has received reports of increased ordering of some essential medical devices through distributors, such as PPE (eg respirators and surgical gowns, gloves, and masks).
“If a potential shortage or disruption of medical products is identified by the FDA, we will use all available tools to react swiftly and mitigate the impact to US patients and health care professionals,” Hahn said.
“These tools include closely working with manufacturers and expediting review of alternate supply to prevent shortages, among other measures, with the common goal of minimizing any negative impact to public health in America.”
2. The Chinese CDC found that COVID-19 may be more contagious than the related viruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), according to new research published in the Chinese Journal of Epidemiology.2
The study, which is the largest of its kind, includes 72,000 confirmed and suspected cases of the coronavirus, CNN reported.2
However, the mortality rate is lower than SARS and MERS, according to the study. The Chinese CDC found a crude mortality rate of 2.3% among coronavirus patients, while SARS had a mortality rate of 9.6% during the 2003 outbreak3, and MERS has a case fatality of 35%.4
3. Sanofi Pasteur is developing a COVID-19 vaccine, in collaboration with the Biomedical Advanced Research and Development Authority (BARDA).5
Sanofi will leverage previous development work on a SARS vaccine, “which may unlock a fast path forward for developing a COVID-19 vaccine,” the vaccine unit of Sanofi said in a statement.
"Addressing a global health threat such as this newest coronavirus is going to take a collaborative effort, which is why we are working with BARDA to quickly advance a potential vaccine candidate," said David Loew, global head of vaccines at Sanofi. "While we are lending our expertise where possible, we believe the collaboration with BARDA may provide the most meaningful results in protecting the public from this latest outbreak."
In non-clinical studies, the SARS vaccine candidate was immunogenic and afforded partial protection as assessed in animal challenge models, Sanofi Pasteur said.
4. The Center for Science in the Public Interest (CSPI) said that the FDA and the FTC should take immediate action against televangelist Jim Bakker and his organization for making false claims about dietary supplement products.
According to CSPI, thejimbakkershow.com claims that the Silver Solution dietary supplement products on the website can cure the coronavirus “within 12 hours.”6
The preacher previously claimed the same product cures “all venereal diseases” and HIV.
“There’s no evidence that the element silver prevents or treats any condition, according to authorities such as the National Center for Complimentary and Integrative Health, part of the National Institutes of Health, and the Food and Drug Administration,” CSPI said in a statement.
5. Healthcare Ready (formerly Rx Response) launched a separate page on its website devoted to updating the industry on shortages related to the virus, emergency preparedness information and other news.7
Healthcare Ready is liaising with components of the supply chain to “better understand the current demands of supplies including pharmaceuticals and personal protective equipment (PPE),” the organization said on its website.
1. FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad [statement]. FDA’s website. https://www.fda.gov/news-events/press-announcements/fdas-actions-response-2019-novel-coronavirus-home-and-abroad.
2. Griffiths J, Gan N. Chinese CDC study finds Covid-19 virus to be more contagious than SARS or MERS. CNN. Published February 19, 2020. https://edition.cnn.com/2020/02/19/health/coronavirus-china-sars-mers-intl-hnk/index.html.
3. CDC. Update: Severe Acute Respiratory Syndrome – Worldwide and United States, 2003. MMWR Weekly. July 18, 2003. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5228a4.htm/
4. CDC. MERS Clinical Features. CDC’s website. https://www.cdc.gov/coronavirus/mers/clinical-features.html.
5. Sanofi joins forces with US Department of Health and Human Services to advance a novel coronavirus vaccine [news release]. Sanofi’s website. http://www.news.sanofi.us/2020-02-18-Sanofi-joins-forces-with-U-S-Department-of-Health-and-Human-Services-to-advance-a-novel-coronavirus-vaccine.
6. CSPI Urges FDA Enforcement Action on Televangelist Jim Bakker’s Fake Coronavirus “Cure” [news release]. CSPI’s website. https://cspinet.org/news/cspi-urges-fda-enforcement-action-televangelist-jim-bakkers-fake-coronavirus-cure-20200218.
7. Novel Coronavirus Outbreak: How We’re Responding to the Newly Identified Disease [news release]. Healthcare Ready’s website. February 6, 2020. https://healthcareready.org/novel-coronavirus-outbreak-how-were-responding-to-the-newly-identified-disease/.