Tag: Merck

Combating the Novel Coronavirus (COVID-19): Week of Oct. 18

Member News, Issues in Healthcare, Top Issues - Healthcare
MHA Covid-19 update

MHA Covid-19 updateThe MHA continues to keep members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

CDC, FDA Approve Moderna and J&J Boosters, Mix and Match Strategy

The director of the Centers for Disease Control and Prevention (CDC) Oct. 21 formally endorsed the use of COVID-19 booster shots from Moderna and Johnson & Johnson (J&J) for some adults. This comes on the heels of the Oct. 20 approval from the Food and Drug Administration (FDA).

The actions authorize a Moderna booster for people 65 and older and for all adults who either have underlying conditions or work in settings where they’re more likely to be exposed to the virus. Those people may obtain the Moderna booster, which is half the size of each dose used for initial vaccination, six months after completing the primary vaccine series.

The agencies also recommended all adults who received the J&J single-shot vaccine get a booster at least two months post-immunization. In addition, the agencies agreed that people who are eligible can choose any type of booster, regardless of whether they initially received the Pfizer, Moderna or J&J version. This decision may help individuals who have a higher risk of side effects with a particular brand of vaccine.

Healthcare providers are encouraged to continue monitoring for email updates from the Michigan Department of Health and Human Services (MDHHS) and Health Alert Network for details regarding booster dose administration. The MDHHS has also posted updated fact sheets for the vaccines on its website for vaccinating providers.

The MHA continues to promote both factual and anecdotal messaging about the safety and effectiveness of COVID-19 vaccines. The association is also using messaging on flu vaccines, urging people to get vaccinated and practice smart preventive measures to help avoid “twindemic” status and add to the stress on the healthcare system.

Members with vaccine questions may contact Ruthanne Sudderth at the MHA.

MHA Urges Medicaid to Cover Merck COVID-19 Treatment Pill

The MHA submitted comments Oct. 18 to state Medical Services Administration officials, urging them to add molnupiravir, Merck’s new COVID-19 treatment pill, to the Medicaid Health Plan Common Formulary if it is approved by the FDA. The medication has been shown to effectively treat COVID-19 and reduce death and hospitalization. Importantly, it comes in pill form that the patient takes at home, unlike current antibody treatments that must be administered by health and hospital professionals, using time and resources that are currently scarce. The association will keep members apprised of the FDA’s review of the treatment and any action by the state to add it to the Common Formulary.

Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpage. Questions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC).

Combating the Novel Coronavirus (COVID-19): Week of Oct. 11

Member News, Issues in Healthcare, Top Issues - Healthcare
MHA Covid-19 update

MHA Covid-19 updateAs federal regulatory agencies evaluate COVID-19 vaccine and treatment possibilities, more than 5.5 million Michigan residents ages 16 and older have received at least one dose of a vaccine to protect them against the deadly disease, equating to 68.2% of that population as of Oct. 15. Meanwhile, despite the rate of new cases decreasing in many of the states that had been experiencing a surge in hospitalizations and deaths, cases in Michigan have been increasing. Nearly 8,300 new cases were reported for Oct. 14 and 15, with 2,010 adults and 29 children hospitalized in the state Oct. 15. Total deaths in Michigan attributed to confirmed cases of COVID-19 reached 21,563 Oct. 15.

The MHA continues to keep members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

Moderna Expiration Date Extended for Frozen Vaccines

The Michigan Department of Health & Human Services (MDHHS) announced Oct. 13 that Moderna received approval for a two-month extension of FROZEN Moderna COVID-19 vaccine. Some lots with an initial expiration of September or October will be extended if stored in frozen state. Seventy-eight lots are impacted by this extension.

The MDHHS does not have a list of these lot numbers, but Moderna is working diligently to get the extended lots updated in their tools and databases, with a priority on older lots first. To look up Moderna expiration, scan the QR code located on the carton or use the company’s expiration date lookup feature on its website. Healthcare providers are encouraged to continue checking these resources to determine whether they have lots that are impacted by this extension. Moderna vaccine should not be disposed of until an accurate expiration date is assessed.

Providers who have vaccines that are unexpired under the extension should update their outbreak inventory in the Michigan Care Improvement Registry (MCIR) with a new expiration date, following the instructions on the tip sheet How to Correct a COVID-19 Vaccine Expiration Date in the MCIR. Questions about the extension or the MCIR process can be directed to the MDHHS Division of Immunization team. Members with other vaccine-related questions may contact Ruthanne Sudderth at the MHA.

Merck Requests FDA Approval for COVID-19 Treatment Pill

Merck formally requested approval from the U.S. Food and Drug Administration (FDA) Oct. 13 for a groundbreaking antiviral medication that effectively treats COVID-19. Trials demonstrate the treatment regimen, which comes in pill form that patients can take themselves at home, reduced risk of hospitalization and severe illness by at least 50%.

Approval would add a new effective treatment to providers’ toolboxes in keeping patients with COVID-19 out of the hospital. Unlike currently available antibody treatments that require providers to set up and staff infusion clinics, the pill could help provide relief to providers struggling with staffing and other treatment resources. If approved, the MHA will advocate that all payers, both public and private, cover the drug for all covered lives.

The MHA will keep members apprised of developments on this issue.

CDC Releases Planning Information for Vaccinating 5- to 11-year-olds

The Centers for Disease Control and Prevention (CDC) recently issued an initial planning document for jurisdictions to prepare for the distribution of vaccines for children ages 5 to 11. The document provides initial information pertaining to pediatric COVID-19 vaccines, as well as several assumptions that can be made about the pediatric COVID-19 vaccination program. Specifically, the document highlights the packaging changes and storage requirements for the Pfizer pediatric COVID-19 vaccine for kids ages 5 to 11. The Pfizer vaccine for this age group is currently under review at the FDA, and a decision on whether an emergency use authorization (EUA) for the product will be granted is expected in the coming weeks.

Ordering of the Pfizer vaccine and any subsequent pediatric COVID-19 vaccines will begin when the FDA issues an EUA. Vaccine administration will begin once the CDC director makes a determination after reviewing recommendations from the Advisory Committee on Immunization Practices. The MHA will keep members apprised of developments on the vaccine for younger children. Members with questions may contact Ruthanne Sudderth at the MHA.

U.S. Homeland Security & Governmental Affairs Committee Requests Provider Input

Sen. Gary Peters (D-MI), chairman of the Committee on Homeland Security & Governmental Affairs, and the committee’s ranking member Sen. Rob Portman (R-OH) are seeking firsthand accounts from individuals and organizations (healthcare providers, state and local governments, first responders, etc.) who experienced challenges securing personal protective equipment and other medical products during the early months of the COVID-19 pandemic. Currently, the committee request is open-ended.

This is part of the committee’s ongoing oversight of federal pandemic preparedness and the COVID-19 response. The committee will examine reports of fraud, exploitation, and faulty equipment and medical supplies. To this end, providers can report issues about vendors, counterfeit medical products, price-gouging or other challenges obtaining supplies during the response. The information received will help inform the senators’ bipartisan oversight and efforts to strengthen U.S. medical supply chains, improve emergency preparedness, highlight new and successful supply chain methods, and prevent bad actors from taking advantage of future national crises. Members interested in submitting their experiences can do so online.

Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpage. Questions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC).