New COVID shot approved, could be in Michigan this week. What to know
- A newly designed COVID vaccine will arrive within days, just as the respiratory season gets underway
- Experts worry about the triple respiratory threat of flu, COVID, and RSV.
- Experts told the federal advisory panel Tuesday that the vaccine will likely protect against recent variants
Updated COVID shots will be available to Michiganders in the coming days after the U.S. Centers for Disease Control and Prevention on Tuesday approved their use for nearly all adults and children.
Dr. Mandy Cohen, the CDC’s new director, signed off on the recommendation Tuesday by the CDC’s Advisory Committee on Immunization Practices. That means there will now be shots available to protect Michiganders against all three major respiratory perils this fall: COVID, flu and RSV. The vaccines are considered most crucial for older adults and others within higher-risk groups.
The Tuesday afternoon vote by the CDC’s vaccine advisors followed a decision Monday by the U.S. Food and Drug Administration Monday to approve the newly formulated COVID vaccines by Moderna and Pfizer for people who are 12 and older and authorize the shots for infants six months and older through age 11.
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The latest COVID vaccine is formulated to more closely target currently circulating variants. The advisory panel heard from experts on the benefits and risks of the latest COVID vaccine during a six-hour meeting, then decided to follow the FDA approval from the previous day, making shots available to anyone six months or older.
More specifically, anyone 5 years or older — whether or not they’ve previously received the COVID vaccine — are eligible to receive a single dose of the new shot, as long as it has been at least two months since the last dose of any COVID vaccine. Younger children, those six months through four years old, also are eligible, but the number of doses depends on whether they’ve already had a COVID vaccine and the timing of the last dose.
The committee voted 13-1 to issue the broad recommendation for the shots by drugmakers Moderna and Pfizer.
Dr. Pablo Sanchez, a professor of pediatrics at Ohio State University’s Nationwide Children’s Hospital, said he voted no — not because he is against vaccines — but because he was concerned about “extremely limited” data about the vaccine’s effect among children and about the lingering questions about potential side effects of COVID vaccines.
Cohen's sign-off releases national distribution of the vaccine, with the shot likely available within days, at least at larger pharmacy chains.
“As a provider, it's exciting to see us being able to offer substantial protection to individuals that need it,” Chris Altman, national director of immunization and clinical programs for Rite Aid, told Bridge Michigan on Tuesday.
The shots will arrive as Michigan experiences a small but steady uptick in confirmed COVID-19 cases and, more significantly, hospitalizations. The case numbers are likely a dramatic undercount, given how few people now report positive cases to their doctor or health officials. Still, the number of newly reported COVID cases rose to 3,666 for the week as of Tuesday, up 45 percent from 2,528 a week earlier. Newly confirmed deaths rose to 20 from six a week earlier, according to state data.
The end of the federal public health emergency earlier this year means a significant shift in how COVID vaccines will now be distributed.
Doctors, hospitals, pharmacies and other providers will order new COVID vaccines directly from the manufacturer — a dramatic change from the first COVID vaccines when limited supplies were purchased by the federal government, allocated to state health departments, then distributed to local providers.
Many already have orders in.
“If we have doses in stores by the end of the week, we're ready to start administering,” said Altman of Rite Aid.
CVS pharmacies also may have shots as early as the end of this week, according to a statement emailed to Bridge by a CVS spokesperson.
No-cost for most
Shots will likely remain free for most people.
Commercial insurers generally cover costs for recommended vaccines, and the vaccines on a federal level will be provided at no cost for those covered by Medicare Part B and Part D and Medicaid, according to information presented to the ACIP panel Tuesday.
Additionally, the Michigan Department of Health and Human Services will be able to free vaccines through the federal Bridge Access Program for underinsured and uninsured people. Doses will be distributed to local health departments, federally qualified health centers, migrant health centers and tribal health centers.
The state health department, which will receive an initial allocation of nearly 30,000 doses as early as next week, also will provide vaccines through the Michigan Adult Vaccine Program, or MI-AVP and the Vaccines for Children program, according to MDHHS spokesperson Chelsea Wuth.
Strictly speaking, not really boosters
While they are being called “boosters,” the new vaccines are really new formulas, designed to protect against XBB.1.5, one of the variants descended from the omicron variant that fueled a deadly COVID surge in 2022. The virus since then has morphed with a slew of other variants, including EG.5.1, dubbed Eris and FL.1.5.1. or “Fornax.”
Experts told the panel the new shots appear to protect against nearly all currently circulating viruses, because most of them are descended from XBB.1.5.
But the panel also heard that the vaccines will likely protect against the particularly worrisome BA.2.86, also known as “Pirola.” In the U.S. it was detected first in Michigan, and then in Ohio.
Drugmakers Moderna and Pfizer, have announced that lab tests show the vaccine is effective against the BA.2.86 variant, and the FDA suggested in its own Monday announcement that the new vaccine is a “good match” against newer variants.
A “trifecta” respiratory threat
The COVID vaccine arrives just as doctors and pharmacists offer protection for the annual respiratory season.
The CDC recommends nearly everyone six months and older receive an annual flu vaccine. Vaccine manufacturers expect to supply at least 156 million doses during the 2023-2024 season, according to the CDC.
The website, vaccines.gov, also tracks flu vaccine providers and is searchable by zip code.
Last year, nearly 3.2 million Michiganders received a flu vaccine, about 79 percent of the state’s goal of 4 million people, according to the state’s flu vaccine dashboard.
Being protected against RSV, the third threat, is a bit more complex. While the flu and COVID vaccines are available for nearly all age groups, the RSV products — actually three of them — are specific to the most vulnerable age groups, which generally is limited to very young children and seniors.
For babies, the CDC recommended in August a monoclonal antibody injection, Nirsevimab, also known by its trade name, Beyfortus. The injection reduces the risk for babies under eight months old and some older babies at increased risk of severe illness caused by RSV. The shot received FDA approval in July.
The injection provides infants and toddlers with antibodies to protect against severe RSV illness.
On the other end of the age spectrum, Michiganders 60 and older now are eligible for two new vaccines — Arexvy and Abrysvo — that can protect them against lung infections, such as pneumonia, related to RSV. One dose can protect a person for two seasons, though the effectiveness wanes by the second season, according to the CDC.
Last month, the FDA also approved Abrysvo for pregnant women. However, ACIP, which recommended the vaccine’s use among older adults earlier this year, isn’t scheduled to discuss whether it will recommend Abrysvo for pregnant people until it meets again in October.
With all the vaccine news this year and recommendations that can vary by age group, however, it’s easy to be confused, Altman said.
“You've got great pharmacists that are available to answer these questions, pharmacists that stay on top of this information and … are that source of truth,” he said.
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