Updated COVID vaccine expected to arrive in Michigan within days

A new COVID-19 vaccine retooled to protect against the latest versions of the Omicron variant should be available within days in Michigan now that the CDC has approved it, according to the state health department. 

The federal Food and Drug Administration on Wednesday signed off on the latest versions of the M-RNA vaccines developed by Pfizer/BioNTech and Moderna. The federal Center for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) gave its approval on Thursday, as did CDC Director Rochelle Walensky. 

"We are expecting the vaccine to be available in Michigan within days of ACIP and CDC approval and clinical guidance being available," said Lynn Sutfin, spokeswoman for the Michigan Department of Health and Human Services. "So, sometime early next week.

The vaccines are notable as the first retooling of the COVID-19 vaccines since they were granted emergency use authorization by the FDA in December 2020. They are also the first COVID-19 vaccines approved without human trials — though experts say safety has been assured by human testing of similar vaccines that were designed to fight related strains. 

The formulations are called "bivalent" vaccines because they're designed to protect against both the ancestral SARS-CoV-2 virus and the latest subvariants of Omicron, called BA.4 and BA.5.

The FDA authorized the Moderna bivalent vaccine for use as a single booster dose for individuals 18 years of age and older, and the Pfizer/BioNTech bivalent vaccine as a single booster for individuals 12 years of age and older.  Either must be administered at least two months after the person's latest dose of COVID-19 vaccine, whether that was a primary vaccination or a booster shot.  

Both companies' initial COVID-19 vaccines, called monovalent because they were designed to protect against the first iteration of the virus, remain authorized for use in the first or primary immunization series, or as a single booster dose for children ages 5 through 11 years old. 

"We were allocated up to 189,900 Pfizer doses and 73,100 Moderna doses for initial orders with additional doses available for ordering soon," Sutfin added. "We have opened ordering to all COVID-19 providers in the state who will serve ages 12 and over to order and receive the booster doses.

"Pharmacies will also be receiving vaccine through the federal pharmacy program. We do not have insight on their allocations. Individuals seeking the updated booster shots should visit Vaccines.gov."

The FDA's move to approve the vaccines without human testing is not unique, said Dr. Arnold Monto, a University of Michigan epidemiology professor and acting chair of the FDA's Vaccines and Related Biological Products Advisory Committee. The committee is charged with advising the federal agency on whether to approve vaccines.

"It doesn't matter, because a very similar variant, the BA.1, has been tested in humans, and the BA.5 is very similar — and we wanted the most recent variant to be clearanced," Monto said. "We know it will behave in exactly the same way."

The situation is similar to that of the flu vaccine, which the FDA greenlights annually without human testing in order to be effective against the latest flu variants, Monto said. In the length of time it would take to test the vaccine on humans, the virus would move on to a new version of itself, and "We'll never catch up," he said. 

"The question is, do we want to wait when we're having cases?" Monto said. "The answer is no, because we know from experience that it shouldn't make a difference because they're very closely related variants.

"It's intended to give you better protection against the newer variants," he said of the updated vaccines. "That is the only difference — but it's an important difference because we're not getting as good protection against the variants as we were getting to the ancestral virus."

Time is also of the essence, Monto added, because most Americans haven't been vaccinated or boosted since April. Even that limited protection is wearing off — not a good thing as people move indoors this fall, increasing risks of exposure to the virus, he said.  

"It's pertinent to get boosted now because we know that people who had the full series of vaccines including boosters have been getting infected with the disease — but this ups the ability to be protected," Monto said.

"It's the luck of the draw," he added. "Some people will get very mild illness but some people will get sick.

"The one good thing is that in general hospitalization and mortality rates have been going down, which shows the effects of the vaccine. But on an individual basis, you don't know who is going to get more sick, so you really want to protect yourself." 

kbouffard@detroitnews.com

Twitter: @kbouffardDN