Tag: booster

Combating the Novel Coronavirus (COVID-19): Weeks of Dec. 20, Dec. 27 and Jan. 3

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

MHA Covid-19 updateAccording to the Centers for Disease Control and Prevention (CDC) COVID Data Tracker, the omicron variant of COVID-19 is now the dominant strain across the U.S. The CDC’s model indicates that more than 95% of cases in the nation as of Jan. 1 may be due to omicron.

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.

President Announces Updated Testing and Military Personnel Strategy

President Joe Biden Dec. 21 announced the federal government will make 500 million at-home rapid tests available to Americans and will deploy roughly 1,000 military personnel to hospitals across the U.S. to help ease the stress the current COVID-19 surge has placed on providers.

The rapid tests will be free of charge and available via an online request form, after which they will be delivered to residents’ homes. The plan also includes opening new federal testing sites and sending out hundreds of federal vaccinators. These tactics will begin in January according to the White House fact sheet on this effort.

Members are encouraged to review the entire fact sheet, which discusses other elements of the plan, including the distribution of more ventilators, production increases for supplies, federal testing sites and more.

The MHA will keep members apprised as more information becomes available about what assistance will be directed to Michigan as a result of this announcement. Members with questions about federal actions may contact Laura Appel at the MHA.

Boosters Expanded to 12- to 15-year-olds; Waiting Period Shortened

The federal Food and Drug Administration (FDA) and the CDC have announced that children aged 12 to 15 may now receive booster doses of the Pfizer and Moderna COVID-19 vaccines. The agencies also approved a shortened waiting period from six months to five months to receive a booster following a primary series of either of the two vaccines. In addition, certain immunocompromised children aged 5 to 11 are eligible for a booster and may receive it 28 days after the completion of their initial series.

The two-month booster interval recommendation for people who received the Johnson & Johnson vaccine has not changed.

The FDA reached its decision after reportedly reviewing data from Israel, which included information on 6,300 people ages 12-15 who received a booster shot at least five months after their initial two-dose series. The data showed no new cases of two possible side effects that had been observed in some young people who received the vaccine — myocarditis and pericarditis.

Urge Senate to Support Healthcare Staffing Funds

The MHA issued an action alert before the holidays, urging all members to contact their state senators and ask that they support critical healthcare staffing funding, which passed the state House with bipartisan support in December. As lawmakers prepare to return to session the week of Jan. 10, it is important to continue advocacy efforts.

House Bill 5523 would appropriate $300 million for healthcare retention and recruitment, which could help hospitals and other providers navigate the serious worker shortages that currently exist amid a pandemic surge. The MHA Legislative Action Center provides key messages on this issue and contact information for senators. Members with questions may contact Adam Carlson at the MHA.

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 Michigan Department of Health and Human Services Community Health Emergency Coordination Center (CHECC).

Combating the Novel Coronavirus (COVID-19): Week of Nov. 15

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

MHA Covid-19 updateMichigan is once again among the states with the highest numbers of COVID-19 cases in the nation, with the New York Times reporting that Michigan and Minnesota lead the country in cases per capita. On Nov. 19, there were 3,424 adults hospitalized with confirmed cases of COVID-19, in addition to 50 children. Meanwhile, 60.3% of Michiganders aged 5 and older had been fully vaccinated as of Nov. 19.

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.

FDA Amends EUA to Allow Booster Shots to Fully Vaccinated People Aged 18 and Up

The Food and Drug Administration (FDA) amended the COVID-19 vaccine emergency use authorizations (EUAs) Nov. 19 to allow all individuals 18 years of age and older to receive booster shots of both the Pfizer and Moderna vaccines. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) was scheduled to meet later that day to discuss additional clinical recommendations.

In its news release, the FDA said the expanded authorization for the booster doses is based on its analysis of immune response data that supported use in the previously authorized populations for boosters. Groups previously included in the EUAs were fully vaccinated individuals who are 65 years of age and older and who are 18 through 64 years of age at high risk of severe COVID-19 and/or experience frequent exposure to the coronavirus through living situations or workplaces.

Prior to the FDA announcement, Gov. Gretchen Whitmer encouraged residents to plan to get the booster doses as soon as they are authorized. The governor noted that more than a million booster doses have been administered within the state and urged everyone to get vaccinated and receive the booster shot.

Booster doses should be administered at least six months after the second dose of either the Pfizer or Moderna vaccine and at least two months following the single-dose Johnson & Johnson vaccine. Updated information for both the Pfizer and Moderna vaccines are available on the FDA website that provide details on the booster shots.

Members with questions on vaccines may contact Ruthanne Sudderth at the MHA.

MDHHS Announces Face Mask Advisory for Holiday Season

As both COVID-19 and influenza cases rise throughout the state, the Michigan Department of Health and Human Services (MDHHS) will issue a face mask advisory and offer guidance to prevent the spread of respiratory diseases during the holidays.

The department’s news release indicates it recommends everyone over the age of 2 wear a face mask at indoor gatherings regardless of their vaccination status. Establishments are also urged to implement policies to ensure that customers, employees and visitors wear masks. The advisory will remain in effect until further notice.

During a Nov. 19 news conference, MDHHS Director Elizabeth Hertel, Chief Medical Executive Natasha Bagdasarian, MD, and others also urged Michigan residents to get vaccinated against COVID-19 and the flu as soon as possible. The two vaccines can be administered simultaneously. Darryl Elmouchi, MD, MBA, president of Spectrum Health West Michigan, shared information about the unprecedented numbers of patients hospitals are seeing. He said Spectrum Health has 370 patients hospitalized with COVID-19, 86% of whom are unvaccinated against the disease.

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. 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 Sept. 20

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

MHA COVID-19 UpdateThe number of confirmed COVID-19 cases in Michigan since the beginning of the pandemic surpassed 1 million Sept. 20 and has continued to rise, hitting 1,008,069 by Sept. 24. Hospitalizations due to confirmed COVID-19 cases in the state have increased from 1,356 adults and 17 children Sept. 17 to 1,467 adults and 27 children Sept. 24. The percentage of Michiganders ages 16 and above who have received at least one dose of a COVID-19 vaccine has risen slowly in recent weeks to 67.4% as of Sept. 24.

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.

Weekly Allocation Model Set for Monoclonal Antibody Therapy

According to an alert shared Sept. 21 by the Michigan Department of Health and Human Services (MDHHS), the U.S. Department of Health and Human Services (HHS) has announced it will transition to a weekly allocation strategy for the distribution of monoclonal antibody therapy. The direct ordering feature through AmerisourceBergen has been suspended and will no longer accept orders. Sites that are actively administering monoclonal antibody therapy and need resupply must complete the updated mAb Allocation Request Form in its entirety. The form should be obtained from the MDHHS and submitted to the same address by noon ET each Wednesday to be considered to receive a supply. Submitting sites will be informed of approved product type and quantities upon review.

All sites requesting supply will be required to comply with the following data collection tools. Accurate utilization and inventory data will not only inform the MDHHS allocations and decision making, it will also impact allocations being made at the federal level.

The alert also contained information on redistribution of excess supplies of either of the approved monoclonal antibody therapy products, as well as the following topics.

  • Importance of Racial Equity and Monoclonal Antibody Therapy.
  • Emergency Use Authorization for Bamlanivimab + Etesevimab Expanded to Include Post-Exposure Prophylaxis.
  • Guidelines on Subcutaneous Administration of REGEN-COV Monoclonal Antibody Therapy.
  • Public Readiness and Emergency Preparedness Act Declaration: 9th Amendment.
  • U.S. Food and Drug Administration (FDA) Authorizes Shelf-Life Extension for Bamlanivimab.

MHA members may contact Ruthanne Sudderth at the MHA for more information.

Federal Agencies Grant Full Approval for Booster Shots for Older and At-risk Americans

The FDA and the Centers for Disease Control and Prevention (CDC) completed the approval processes for providing Pfizer COVID-19 booster shots Sept. 24, authorizing them for people aged 65 and older, long-term care facility residents, people aged 18-64 years old with underlying medical conditions that raise their chances of severe COVID-19, and people at risk because of on-the-job exposure, including healthcare workers.

The FDA earlier officially accepted the recommendations of its independent review panel, which voted to approve the extra shot of Pfizer. The CDC’s Advisory Committee on Immunization Practices (ACIP) voted Sept. 23 to recommend the Pfizer booster, but voted against allowing the booster for those at risk because of on-the-job exposure, which differed from the FDA’s decision Wednesday to allow the booster for people with high-risk jobs. However, the CDC Director made the rare decision to contradict the ACIP’s recommendation and endorsed the use of Pfizer COVID-19 booster shots for workers at high risk of severe COVID-19, while formally accepting the remaining recommendations of ACIP for people 65 and older, nursing-home residents and people between 18 and 64 with underlying health conditions.

The CDC stated that providers may administer the booster dose of Pfizer to previous recipients of the Pfizer two-dose series who qualify (by age or health/risk status). The booster dose shouldn’t be administered until at least six months have passed since the recipient completed the two-dose primary series. Healthcare workers do qualify based on their regular exposure to the virus. There is no specific definition of healthcare worker in the authorization. Healthcare organizations and facilities have discretion to determine who in their settings should be able to receive the booster.

At this time, no other brand of vaccine is approved for an additional dose, though that is likely to change in the months ahead as more data becomes available.

The MDHHS has advised that health systems/hospitals should work to provide the booster to their own employees and to their patients to whatever degree is possible. Members should watch for MI Health Alert Network communications in the coming days for more information about the rollout of these Pfizer doses. Members can also regularly check the CDC’s Pfizer website for updated clinical information about the booster and the administration of these doses.

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

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 Aug. 16

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

MHA COVID-19 UpdateThe delta variant of COVID-19 has created crises in many parts of the nation and caused Michigan’s case numbers to climb, with nearly 930,000 confirmed cases that have led to over 20,000 deaths as of Aug. 20. Hospitalizations due to confirmed cases of COVID-19 in the state Aug. 20 totaled 912 adults and eight children. Meanwhile, the Centers for Disease Control and Prevention’s data tracker indicated 65% of Michigan residents ages 16 and above had received at least one dose of vaccine as of Aug. 18.

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.

Federal Agencies Announce Plans for Third and Booster Shots

The Centers for Disease Control and Prevention (CDC) recently announced it recommends a third dose of mRNA vaccines (Pfizer and Moderna) for individuals with moderately to severely compromised immune systems. At this time, a second dose of the Johnson & Johnson vaccine has not been recommended. The CDC advises that people talk to their healthcare provider about their medical condition and whether getting an additional dose is appropriate for them.

In addition, the Biden administration plans to offer COVID-19 booster shots starting Sept. 20 to all Americans ages 18 and older who received Pfizer or Moderna vaccines. This is due to growing evidence that a third dose of the vaccine will be needed to maintain strong immunity, which experts have long expected would be necessary. The recommendation will include waiting until eight months after becoming fully vaccinated to receive a booster, meaning healthcare workers and nursing home residents would likely be first in line.

The administration shared that this booster dose policy depends on authorization from the U.S. Food and Drug Administration and a review by the CDC’s vaccine advisory committee. Administration officials said they anticipate also offering booster shots to people who received the one-shot Johnson & Johnson vaccine but are waiting for further data before officially making that recommendation. The recommendations are based on several studies showing effectiveness of the mRNA vaccines may decline by as much as 30% around the eight-month mark.

There is an important nuance in the language used to describe these additional doses: the “third dose” is used to describe the dose given to immunocompromised individuals, while a “booster” is used to describe the additional dose given to all other recipients.

Vaccines administered by Michigan providers have increased recently to an average of 39,000 first doses per week, rising from averages in the 20,000s in June and early July. Members with questions may contact Ruthanne Sudderth at the MHA.

MDHHS Launches Vaccination Record Website for Public

The Michigan Department of Health and Human Services (MDHHS) has launched the Michigan Immunization Portal, a website that allows any individual 18 or older who has been immunized in the state of Michigan to check and obtain a copy of their vaccination record online. Once an individual provides the necessary information, their immunization record will be pulled from the Michigan Care Improvement Registry and provided to them. This function may be especially useful for providers who are contacted by individuals who have misplaced their COVID-19 vaccination cards. Members may promote this tool to their patients and the public as appropriate. Questions may be directed to Ruthanne Sudderth at the MHA.

Changes Coming to Payer Policies for COVID-19 Coverage

Health insurers in Michigan have begun announcing that, in the coming months, they will no longer cover the full cost of COVID-19 treatments. Beneficiaries of Blue Cross Blue Shield of Michigan, for example, will resume taking responsibility for their cost sharing for any necessary COVID-19 care after Sept. 30, 2021. It should be noted that COVID-19 vaccines will remain available at no cost to patients in the U.S. The MHA will continue to urge the public to take advantage of free and low-cost preventive measures like masks and vaccines to avoid the risk of hospitalization, death and preventable healthcare costs. Members with questions may contact Ruthanne Sudderth at the MHA.

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).