LANSING, Mich. (Michigan News Source) – The Michigan Department of Health and Human Services (MDHHS) is recommending the “updated” 2023-2024 COVID-19 vaccine for everyone six months and older which they say is “designed to protect against severe disease this fall and winter season.” This recommendation follows the Food and Drug Administration (FDA) and the U.S. Centers for Disease Control (CDC) and Prevention Advisory Committee on Immunization Practices (ACIP) approval and authorization for emergency use of the updated vaccine.
The CDC panel of advisers approved the new vaccines by a vote of 13-1. According to ABC-7 Chicago, the no vote came from a panel member who had argued that the new shots should initially be recommended only for older people and others at greatest risk of severe illness. The CDC signed off on the broader use of the vaccines unlike many others, including most European countries, who have issued guidance to prioritize the vaccines for people aged 60 and older as well as specific populations that are most likely to benefit.
Regardless of the approval and authorizations of the vaccines in America, there are several things to know about the new vaccines. First of all, as reported by the New York Times and other media outlets, the vaccines are monovalent – that is to say that they were designed to protect against just one variant: XBB.1.5, nicknamed “Kraken” – a recent descendant of Omicron that emerged earlier in the year. The only problem is that, because the virus mutates routinely, the Kraken variant is no longer the most common strain in circulation.
According to the CDC website, the most dominant COVID-19 variant in the United States is EG.5, nicknamed “Eris” (21.5%); followed by FL.1.5.1, nicknamed “Fornax” (14.5%); and many others that are listed at 9.2% and below. The XBB.1.5 Kraken variant is only 3.5% of the COVID-19 variants currently circulating in the country – and in Michigan, that number is 3.1%.
Although the vaccines are often being referred to as “boosters” they are, in fact, new formulas that were created by Pfizer and Moderna – and there have been no human trials done for these vaccines. NBC News reports that these are, in fact, the first Covid shots to be distributed without human trials. They went on to say that because the Biden administration was pushing to have the vaccines ready this September, there was no time to test the results in people. They only tested the vaccine on mice. The FDA’s approval of the drug is relying on the mice trial and a human trial done on a similar vaccine that targeted the variant BA.1.
Dr. Celine Gounder, an infectious disease specialist at NYU Langone Health in New York City says about the new vaccines, “There’s no reason to think they’ll be unsafe. But whether they’ll provide significantly more protection than the original vaccines? Of that I’m skeptical.”
It looks like the FDA might agree with Gounder, according to the language on their website. Instead of definitive terminology, the website seems to be filled with opinions, using phrases that say things like the neutralization against the variants “appears to be” similar to prior versions which “suggests” that the vaccines are a “good match” for protecting against the current circulating COVID-19 variants.
Even the MDHHA says in their press release that the vaccine is formulated and “expected” to provide protection against severe COVID-19 disease from currently circulating variants.
The vaccines that will be available soon, and are recommended by MDHHS to give alongside the flu and RSV vaccines, continue to be mRNA vaccines. These types of vaccines were used for the first time on humans at the beginning of the pandemic and have been reported to be linked to myocarditis and pericarditis among young men.
Additionally, in a Florida health alert on mRNA COVID-19 Vaccine Safety, they point to a study published on the National Institute of Health website where mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events, including coagulation disorders, acute cardiac injuries, Bell’s palsy and encephalitis. The Florida Dept. of Health said that the risk described above was 1 in 550 individuals, which is much higher than other vaccines. Also found in presentation slides that were used for the recent CDC meeting about the vaccines, it said, “In the subgroup aged 12–39 years, the rate ratio for myocarditis/pericarditis was elevated after both Pfizer and Moderna during days 0-21 after vaccination, and especially during days 0-7.”
The Florida Surgeon General, Joseph Ladapo, said in his “Guidance for COVID-19 Boosters” that there are safety concerns and more research is needed into the new vaccines – and that just like the initial mRNA COVID-vaccines, “the federal government has failed to provide sufficient data to support the safety and efficacy of the COVID-19 vaccines.” He reiterated his concerns on X/Twitter saying, “CDC & FDA continue to push COVID vaccines that are not backed by clinical evidence, but blind faith alone with ZERO regard for widespread immunity.”
Still, without definitive results on whether the new vaccines will be effective (or safe), Dr. Natasha Bagdasarian, MDHHS chief medical executive is recommending them and says about the new vaccines now and in the future, “Updated COVID-19 vaccines are going to be the way we protect ourselves and our loved ones each fall and winter virus season. It is important to make sure our families are up-to-date on all routine vaccines to prevent the spread of severe illness and disease. Now is a great time to check with your health care provider to make sure you are up-to-date on all your vaccines.”
As of September 12th, the weekly COVID-19 confirmed and probable cases in Michigan are reported to be 6,071 with an average of 867 daily confirmed and probable cases. According to state health data, the number of people hospitalized from August 11th to September 11th more than doubled from 175 to 396. However, keep in mind that they aren’t necessarily hospitalized because of Covid. It means they tested positive for the virus while in the hospital.