Contagion&reg Editorial Staff

Operation Warp Speed Agencies Reveal Vaccine Rollout Strategy

Federal agencies, including the Department of Health and Human Services (HHS) and the Department of Defense (DoD), have detailed plans to carry out a key future step in 

: the initial distribution of a SARS-CoV-2 vaccine.

As stated in the report, the “principal purpose and objective of Operation Warp Speed (the US accelerated vaccine program)” is “ensuring that every American who wants to receive a COVID-19 vaccine can receive one, by delivering safe and effective vaccine doses to the American people beginning January 2021.”

The plan suggests that the federal government intends for the vaccine to be provided at no cost to individuals who request it.

The report is addressed to congress, and authors state that federal funding enabled “strong progress” toward a “safe and effective COVID-19 vaccine with multiple candidates in phase 3 clinical trials.”

 was approved before formal phase 3 trial results were gathered.

Vaccine development is currently being led by experts from HHS.

Phase 2 Data Shows Monoclonal Antibody Reduces COVID-19 Hospitalization Rates

Eli Lilly’s investigational IgG1 monoclonal antibody (mAb) therapy, LY-CoV555, showed a reduced rate of hospitalizations for COVID-19 patients in the outpatient setting.  

This comes from interim analysis of its phase 2 BLAZE-1 clinical trial for LY-CoV555. Rate of hospitalizations and ER visits was 1.7 percent (5/302) for LY-CoV555 versus 6 percent (9/150) for placebo—a 72 percent risk reduction in this limited population. Most hospitalizations in the study occurred in patients with underlying risk factors (age or BMI), suggesting a more pronounced treatment effect for patients in these higher-risk groups.

"These interim data from the BLAZE-1 trial suggest that LY-CoV555, an antibody specifically directed against SARS-CoV-2, has a direct antiviral effect and may reduce COVID-related hospitalizations," Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories, said. "The results reinforce our conviction that neutralizing antibodies can help in the fight against COVID-19."

MIT Scientists Propose CRISPR Testing for SARS-CoV-2

An editorial advocating a new method of CRISPR testing was published in 

by a team of scientists from MIT, University of Washington, and Brigham & Women’s Hospital.

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A quick debrief of the week’s top FDA approvals, FDA authorizations, or other infectious disease pipeline developments from the past week.

The ID Pipeline: Drug Development Debrief | Week of September 13, 2020

The US Food and Drug Administration has provided an updated and extended list of hand sanitizers consumers should avoid.

FDA urges consumers not use certain hand sanitizer products

The following outlines the information on hand sanitizer labels for consumers to use to identify a product that:

Has been tested by FDA and found to contain methanol or 1-propanol.

Has been tested and is found to have microbial contamination.

Is being recalled by the manufacturer or distributor.

Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride.

Is purportedly made at the same facility as products that have been tested by FDA and found to contain methanol or 1-propanol .

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid, Thyroid Tablets, USP Due to Sub Potency

Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). More information can be found at www.npthyroid.com/product-updatesExternal Link Disclaimer.

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. To date, Acella has received four reports of adverse events for these lot numbers possibly related to this recall.

NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. See product images.

Each week, the FDA posts relevant recalls and other patient safety information. We highlight some of these notices that may be clinically relevant.

FDA Provides Extended List of Hand Sanitizer Recalls

The US Food and Drug Administration (FDA) regularly posts updates on recalls, outbreak investigations, and related regulatory activities like these.

Weekly, we identify which of those announcements might be most clinically relevant. 

(Below are excerpts taken from official FDA postings)

RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid® and WP Thyroid with Current Expiry Due to Sub Potency

RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in all strengths, all counts of product within current expiry to the consumer level.

The products are being recalled because testing of samples from  six (6) lots  by the U.S. Food and Drug Administration found the samples to be sub potent.

The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid® or WP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.

There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development.

In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. RLC Labs, Inc. has not received any reports of adverse events related to this recall.

Nature-Throid® and WP Thyroid® (thyroid tablets, USP) is composed of liothyronine and levothyroxine, and are used to treat hypothyroidism (underactive thyroid). The products subject to recall are packaged in 30, 60, 90, 100 and 1,000 count bottles.

Open Book Extracts Issues Voluntary Nationwide Recall of All Lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that are Labeled to Contain Methanol

Open Book Extracts (OBX) is voluntarily recalling to the consumer level all lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that are labeled to contain methanol.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

OBX sources hand sanitizer from a leading global chemical and ingredient distributor, and has verified through a third-party lab that the hand sanitizer does not contain reportable levels of methanol. The supplier updated the Safety Data Sheet (SDS) to remove methanol since it is below the reportable level, and we updated the labels accordingly.

Weekly, we identify which FDA recall announcements might be most clinically relevant.
 

Recalls Radar: "Always Be Clean" Hand Sanitizer & More

FDA Grants Emergency Use to Convalescent Plasma for COVID-19

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the use of convalescent plasma in treating coronavirus 2019 (COVID-19).

The authorization comes after a week of cyclical debate among public health officials and legislators, as well as clinical appraisal among investigators—which have both come to highlight most agents granted emergency authorization by the FDA.

In a release Sunday evening, the FDA stated its decision is based on available scientific evidence indicating convalescent plasma may be beneficial for COVID-19, and that the known and potential product benefits outweigh its understood risks.

“Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing,” the FDA stated.

In a statement accompanying the decision, FDA Commissioner Stephen Hahn, MD, expressed encouragement from “early promising data” for convalescent plasma.

“The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” Hahn said. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”

Remdesivir Receives EUA for Patients With Moderate COVID-19

The FDA today announced it had expanded its Emergency Use Authorization (EUA) for remdesivir (Veklury) enabling its use to treat all hospitalized patients with coronavirus 2019 (COVID-19).

Previously, the last EUA for the medication issued back in May only included he treatment of hospitalized patients with severe COVID-19.

“With the growing understanding of the utility of Veklury to help improve outcomes for a range of patients with COVID-19, we welcome the FDA’s decision to expand emergency use authorization,” Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, said. “As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease. Today’s action by the FDA enables physicians to consider a broader range of eligible patients to potentially receive Veklury.”

The expanded EUA is based on results from the Phase 3 SIMPLE trial evaluating remdesivir in hospitalized patients with moderate COVID-19 pneumonia, as well as results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalized patients with a range of disease severity.

A refresher on the week's developments in the infectious disease drug & medical device FDA approval pipeline.

FDA Pipeline: EUA Granted for Plasma, Remdesivir Expands to Moderate Cases

offers daily coverage of developments in the infectious disease drug and medical device approval pipeline. Here’s some of what we reported on the past week:

FDA's COVID-19 Plasma Authorization On Hold, Still Possible

Convalescent plasma is donated by survivors of COVID-19. The treatment was found safe in recent studies, but as with many COVID-19 therapeutics the exact efficacy is still an open question.

The US FDA was said to be considering an emergency authorization for COVID-19 plasma just last week. For now, the authorization is being halted.

According to H. Clifford Lane, MD, the clinical director at the National Institute of Allergy and Infectious Diseases, the authorization is on hold while more data are reviewed.

How to Read an FDA Emergency Use Authorization

Since the start of the COVID-19 pandemic, many diagnostics have been authorized by the US FDA. While releases tend to highlight the benefits an authorized company sees in the approval of a new test, they can be difficult to parse for information. Rodney E. Rohde, a clinical laboratory specialist at Texas State University, helps break down how carefully they must be read.

FDA Grants Emergency COVID-19 Authorization to Yale's Open Source Method of Saliva Testing

SalivaDirect does not require a particular type of swab or collection device; any sterile container is suitable for saliva collection with the test.

The ID Pipeline: Plasma Authorization Paused, COVID-19 Saliva Test Gets EUA

The US Food and Drug Administration (FDA) is working with local health agencies to investigate an outbreak of 

The outbreak has been tentatively linked to bagged peaches sold at ALDI.

Most people with salmonellosis only develop diarrhea, fever, and abdominal cramps. 

In elderly or very immune-suppressed patient populations, however, severe infections can be fatal. In this outbreak, no deaths have been reported.

The FDA updated the status of the investigation in a recent 

The Wawona-brand peaches have been sold in ALDI stores between June 1, 2020 until the present. 

The link to Wawona-brand peaches was established through interviews with those who have fallen ill as well as whole genome sequencing.

As of mid-August, the US Centers for Disease Control and Prevention (CDC) is reporting a total of 68 cases and 14 hospitalizations across 9 states.

Consumers, restaurants, and retailers have been advised not to eat, sell, or serve affected products. 

FDA also recommends that those who received the peaches from ALDI clean and sanitize any surfaces that may have come in contact with the produce.

FDA is working with local partners to continue the outbreak investigation.

Contagion&reg Editorial Staff

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