Woman holding self-testing swab, taking rapid COVID-19 home test

COVID-19 Updates: CDC Advises COVID-19 and Flu Vaccines Together, New COVID-19 Home Test Authorized for Emergency Use

Woman holding self-testing swab, taking rapid COVID-19 home test

At least 238.8 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday, Oct. 11, including nearly 4.9 million deaths. Healthcare officials in the United States have reported more than 45.2 million positive COVID-19 cases and more than 733,000 deaths. Source: www.worldometers.info/coronavirus 

At least 6.52 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday evening, including at least 402 million in the United States. Source: GitHub

Questions about the vaccine? Learn more about the process of vaccine development in our recent interview with noted virologist Dr. Angela Rasmussen.

CDC now advises COVID-19 and flu vaccines together

Officials with the Centers For Disease Control and Prevention (CDC) are alerting healthcare providers that patients can safely receive both the coronavirus and influenza vaccinations at the same time.

Specifically, the CDC also recommends that patients be encouraged to get their COVID-19 shots as soon as possible, and to get the flu vaccine before the end of October. While limited data exist on combining COVID-19 vaccines with other vaccines, including the flu vaccine, prior experience with giving other vaccines together has shown that the development of protection and possible side effects happen consistently whether vaccines are administered alone or with other vaccines.

However, the CDC does emphasize that flu vaccination should be deferred if a patient is acutely ill. (This may be different for patients who are already being cared for in a medical setting as compared to patients who are isolating at home.) In a medical setting, the timing for vaccination is a matter of clinical discretion, the CDC says. In general, patients who are isolating at home should wait until they meet criteria for leaving isolation (even if they have no symptoms) to come to a vaccination setting in order to avoid spreading virus to others.

When administering vaccinations, curbside and drive-through clinics could provide the best option for staff and patient safety during the pandemic in communities with high transmission, the CDC suggests.

Guidance on drive-through vaccination clinics can be found online.

Explore the current and historical impact of vaccines in our course, Staying Healthy: Vaccine-Preventable Diseases.

New COVID-19 home test authorized for emergency use

The Flowflex™ COVID-19 Antigen Home Test has been authorized for emergency use by the U.S. Food and Drug Administration (FDA).

Manufactured by ACON Laboratories, Inc., San Diego, CA, the COVID-19 home test is conducted with a nasal swab test which will be available for purchase without a prescription in major retail stores and online, according to company officials. It is available to those ages 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old.

In contrast to other home tests, Flowflex has been authorized for use as a single test by individuals with or without symptoms and does not require testing twice within a 2-3-day period, which is expected to allow for the distribution of more affordable single-test packaging and result in greater access to home testing.

The tests are available in many countries, including widespread distribution in the United Kingdom through the National Health Service (NHS).

Molnupiravir submitted for Emergency Use Authorization

Officials at Merck and Ridgeback Biotherapeutics have announced that an application to the U.S. Food and Drug Administration (FDA) has been submitted for an Emergency Use Authorization (EUA) for the use of molnupiravir, an investigational oral antiviral medicine that treats mild-to-moderate COVID-19 in adults who are at risk for severe illness and/or hospitalization.

The companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months, officials said. If authorized, molnupiravir could be the first oral antiviral medicine for COVID-19 treatment.

Molnupiravir inhibits the replication of the causative agent of COVID-19 and has been shown to be active in several preclinical models of the virus, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common variants.

The submission is based on positive results from a planned interim analysis from a Phase 3 clinical trial, which evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at risk for progressing to severe illness and/or hospitalization.

At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received placebo.

The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). The incidence of drug-related adverse events was also comparable (12% and 11%, respectively), and fewer subjects in the molnupiravir group discontinued therapy due to an adverse event compared to the placebo group (1.3% and 3.4%, respectively).

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” said Robert M. Davis, chief executive officer and president at Merck. “We are grateful to the patients and investigators in our study, and of course to our own colleagues who have exemplified Merck’s high standards of scientific excellence and our unwavering commitment to patients. We look forward to working with the FDA on its review of our application and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”

Molnupiravir is also being evaluated for post-exposure prophylaxis in the Phase 3 study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households. More information is available online.

Strict COVID-19 vaccine mandate coming to LA

One of the most strict vaccine mandates in the United States has been issued in Los Angeles. The measure reportedly requires inoculation for entering bars, restaurants, nail salons, gyms, and other venues, according to a report by the Associated Press.

The City Council voted 11-2 in favor of the ordinance that will take effect Nov. 4. Mayor Eric Garcetti signed the order Oct. 6.

“Vaccinating more Angelenos is our only way out of this pandemic, and we must do everything in our power to keep pushing those numbers up,” Garcetti said in a prepared statement. “These new rules will encourage more people to get the shot, and make businesses safer for workers and customers — so that we can save more lives.”

Some critics charge that a mandate would amount to segregation of those who cannot or refuse to be vaccinated, the report states. Negative coronavirus tests within 72 hours of entry to those places would be required for people with religious or medical exemptions for vaccinations. Customers without proof can still use outdoor facilities and can briefly enter a business to use a restroom or pick up a food order.

COVID-19 cases are declining, but the county recently reported 31 new deaths and nearly 1,500 new cases. California health officials have reported more than 5,000 new cases statewide, mostly among the unvaccinated. Nearly 85% of eligible Californians have received at least one vaccine dose.

Learn more about vaccine efficacy in the recent webinar by Dr. Margaret Fitzgerald: Moving from COVID-19 Pandemic to COVID-19 Endemic.

Stay up-to-date on the latest coronavirus news developments. Visit our Resource Center each week for new COVID-19 updates—plus a variety of other resources for healthcare professionals.