Coronavirus News Roundup: FDA Emergency Use Authorizations, Vaccine Candidate, and Virtual Blood Drives

April 3, 2020

Here's a roundup of the latest coronavirus-related news.

This week saw the ramping up of aggressive tactics to respond to the COVID-19 pandemic. The United States has surpassed 245,000 confirmed cases, which is the highest in the world; the US government, pharmacies, corporations, health care workers, and citizens are rising to the challenge of flattening the curve.

Here’s a roundup of the latest coronavirus-related news:

FDA Issues Emergency Use Authorization for ‘Game Changer’ COVID-19 Test

The FDA has issued Emergency Use Authorization (EUA) for a 5-minute point-of-care test for SARS-CoV-2, the virus that causes the novel coronavirus, according to a press release. The test could be available for use next week.

Abbott’s ID NOW COVID-19 test, the fastest available molecular point-of-care test, is the size of a small toaster, weighs 6.6 pounds, and is able to deliver positive results in as little as 5 minutes and negative results in 13 minutes.

In a press release, Abbott said that its COVID-19 test will be available next week to health care providers in US urgent care settings and assured that the company is currently working with the FDA to offer tests in areas in which they will have the greatest impact, ramping up production to deliver 50,000 tests a day.

FDA Permits Emergency Use of Experimental Treatments for COVID-19

Hydroxychloroquine sulfate and chloroquine phosphate have been granted Emergency Use Authorization (EUA) by the FDA for emergency use in hospitalized patients with COVID-19, according to the agency.

The EUA allows the US Biomedical Advanced Research and Development Authority (BARDA) to distribute donated hydroxychloroquine sulfate and chloroquine phosphate products to physicians. Physicians are permitted to use supplies of chloroquine and hydroxychloroquine from the Strategic National Stockpile (SNS) to treat adults and adolescents who weigh 50 kg or more and  have been hospitalized and are unable to participate in a clinical trial.

According to the Department of Health and Human Services (HHS), it has accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz and 1 million doses donated by Bayer Pharmaceuticals to the SNS.

Hydroxychloroquine sulfate and chloroquine phosphate are both approved by the FDA for other medical conditions, such as malaria, lupus, and rheumatoid arthritis, but not for COVID-19.

The letter establishes the FDA’s first EUA for a therapeutic product. To date, no treatments for COVID-19 have been approved by the FDA.

Johnson & Johnson Announces COVID-19 Vaccine Candidate

In partnership with the Biomedical Advanced Research and Development Authority (BARDA), Johnson & Johnson announced the development of a COVID-19 vaccine candidate, according to a company press release.

The manufacturer expects to initiate human clinical studies of its lead candidate at the latest by September 2020. First batches of a COVID-19 vaccine could be available for emergency use by early 2021.

“We are moving on an accelerated timeline toward phase 1 human clinical trials at the latest by September 2020 and, supported by global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in 2021,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer, Johnson & Johnson, said in a statement.

The first trial in humans for a COVID-19 vaccine was launched on March 16, with volunteers receiving the first injection. The investigational vaccine called mRNA-1273, developed by Moderna, is being studied over a 6-week period in a phase 1 federally sponsored study of 45 participants.

How Are Pharmacies Protecting Staff from COVID-19?

Retail pharmacists and technicians have already voiced their concerns in the media and in a Facebook support group about a lack of protection for themselves. One Walgreens pharmacy technician said she was told that there are no masks or gloves available for pharmacists, and no plexiglass has been installed.

However, Walmart, CVS, and other major retailers pledged to keep pharmacy staff and other employees safe with new plexiglass installation and other efforts.

In addition to other safety efforts, Walmart is installing sneeze guards in its pharmacy and register lanes, and floor decals at both the entrances and checkouts, to help customers maintain proper social distancing. It has also recently announced it will begin taking the temperatures of all associates, as well as asking basic health screening questions.

Publix will start installing plexiglass partitions on March 28 at all of its 1200 stores, spokesperson Maria Brous told The Lakeland Ledger. The partitions will be at registers, customer service desks, and pharmacies, she said.

Albertsons is installing designated waiting points through floor markers positioned throughout the store, “especially at check stands and stations where people most often congregate, like the service deli, bakeries, and pharmacy areas,” the retailer said in a press release.

“Since the beginning of the COVID-19 pandemic in the US, I can honestly say that we have received ZERO guidance from the higher-ups and NOTHING has been done to help protect employees or our patients,” said an anonymous Walgreens pharmacist in the Facebook support group, the New York Post reported.

Some pharmacists are hanging up plastic shower curtains to separate themselves from customers, while they wait for plexiglass to be installed, an individual reported in the Pharmacy Support for COVID-19 Facebook group.

What are you doing to protect your pharmacy staff? Send an email to jbarrett@mjhlifesciences.com to let us know.

RxSafe LLC Launches ViralGuardRx COVID-19 Protection

As coronavirus cases surge nationwide, retail pharmacies are facing incredibly difficult circumstances: they must continue to dispense vital medications to their patients, and fight the spread of COVID-19–while keeping both employees and patients as safe as possible. To address this challenge, RxSafe LLC launched ViralGuardRx™, a protective shield that creates a physical barrier to help prevent disease transmission at the pharmacy point-of-sale. Placed at pharmacy cash registers or pickup locations, ViralGuardRx helps reduce the risk of viral and bacterial transmission, protecting pharmacy staff and consumers from the spread of coronavirus.

"We immediately identified the need for essential pharmacy personnel to be protected from the coronavirus," said William Holmes, CEO of RxSafe.

"Pharmacists and pharmacy staff are on the front lines of this fight, encountering high numbers of potentially infectious customers every day. ViralGuardRx not only provides a tool to keep them healthy, but also helps protect patients."

Please Donate Blood!

During times like these, we must come together and help those in need. Amid the COVID-19 pandemic and in an effort to help our community, Drug Topics' parent company will be hosting the virtual MJH Life Sciences Sleeves Up Blood Drive from March 31 through April 30. Every pint of blood donated can save up to 3 lives.

Companies or groups interested in hosting virtual drives can go to https://sleevesup.redcrossblood.org/. Those who would like to donate can download the American Red Cross Blood Donor app.

Then please spread the word on social media that people can help the American Red Cross continue to deliver its lifesaving mission nationwide because of this public health emergency by texting REDCROSS to #90999 to make a $10 donation, visiting redcross.org, or calling 1-800-REDCROSS to donate.