A new COVID booster has FDA approval. Here’s when doses could get to Kansas City

The U.S. Food and Drug Administration (FDA) expanded its emergency use authorization on Wednesday to include new “bivalent” COVID-19 booster shots made by Pfizer-BioNTech and Moderna.

The CDC then recommended the boosters for use on Thursday. The agency recommended Pfizer’s booster for people age 12 and older, and Moderna’s for people age 18 and older.

Kansas and Missouri both already in the process of getting dosese ready to distribute to vaccine providers in the area.

What does bivalent mean?

A bivalent vaccine protects against two diseases, or two strains of the same disease. In this case, the two strains tackled by these new booster shots are the original COVID-19 strain and an omicron strain that represents an overlap between the BA.4 and BA.5 subvariants.

Including protection for the original version of COVID-19 in this booster may help defend against future variants that have more in common with the first virus strain than with omicron.

Who is eligible for a bivalent booster shot?

If you are over 12 years old, you are eligible to get a bivalent booster two months after your most recent vaccine or booster. You can get the bivalent shot as your first, second or even third booster dose depending on how many you have received already, but not as your initial COVID-19 vaccination.

These new boosters are not being restricted to those with compromised immune systems.

If you have never been vaccinated against COVID-19, you will need to get an initial round of vaccination before you can get one of these new boosters.

How many boosters will be available?

The federal government has already ordered around 171 million doses of the new bivalent booster shots.

Missouri has an allocation of 68,300 doses in the first “batch” from the federal government, and 91,200 in the following “batch,” according to the state health department.

Kansas currently has access to 74,400 doses, according to the state health department.

Both states soon will begin distributing the boosters at the regional and local level.

How will local clinics and doctors get booster doses from the state?

In Missouri, vaccine providers place order requests with the state every week. The state then orders only the number of vaccines that providers have requested from the federal government.

Missouri health department spokesperson Lisa Cox told The Star that pre-orders for the new booster shots began last week, and will continue every week moving forward. The state expects to place its first orders for boosters in the coming days.

Cox added that orders usually don’t strain the state’s allocation, meaning there will be plenty of boosters to go around.

Kansas, by contrast, stockpiles its full allocation of doses and asks providers to order them directly from the state. Providers can place orders on the KDHE website until 5 p.m. on Friday, Sept. 7.

“There will be a limited number of doses available and KDHE will fill orders as equitably as possible,” said KDHE spokesperson Philip Harris in an email to The Star.

When and where can I get a bivalent booster shot?

Now that the CDC has recommended the boosters, they are expected to arrive in Missouri clinics as soon as late next week.

In Kansas, Harris said that vaccine providers will receive booster doses during the week of Sept. 12.

“Individuals (in Kansas) are encouraged to check the Vaccines.gov website for locations near them that are providing COVID-19 vaccines and boosters,” Harris said. “They can also check with their primary health care provider or the local health department in their community.”

In Missouri, Cox said that booster appointment information will be available by around Tuesday, Sept. 6 on the state’s vaccination website, MoStopsCovid.com.

Is it true that the new boosters were only tested on mice?

So far, yes. The FDA’s emergency use authorization and the CDC’s recommendation are allowing the new bivalent boosters onto the market without requiring human clinical trials first. That’s because the new vaccine is extremely similar to previous vaccines, and was made in the same way.

While some worry that the lack of human trials could lead to skepticism about this booster, the government’s approval is meant to get the new boosters into arms before a new variant overtakes the current BA.4 and BA.5 strains. It isn’t uncommon to approve new versions of vaccines without extensive human testing — in fact, that’s why a new flu shot is ready every year around flu season.

How do we know the new boosters work?

The FDA considered data from three sources when approving the new boosters for emergency use: clinical data showing the effectiveness of the original COVID vaccines, clinical data showing the effectiveness of a BA.1 variant vaccine currently being approved in the UK, and lab data on mRNA vaccines designed to fight the omicron variant.

“Based on the data supporting each of these authorizations, the bivalent COVID-19 vaccines are expected to provide increased protection against the currently circulating omicron variant,” the agency wrote in its Wednesday press release.

Do you have more questions about staying safe from COVID-19 in Kansas City? Ask the Service Journalism team at kcq@kcstar.com.