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FDA approves latest COVID-19 vaccine

This story has been updated.

September 11, 2023 – The FDA today approved the most recent COVID-19 vaccine, the primary that doesn’t goal the unique or “original” strain of the virus.

Last 12 months, the FDA approved a bivalent vaccine that targets each the old and latest variants. This time, it’s a “monovalent,” or single-strain, vaccine with one foremost goal: to reduce health risks, hospitalizations and deaths related to newer variants equivalent to the XBB.1.5 Omicron subvariant. It can also be expected to supply some protection against related Variants currently in circulation.

The FDA approval applies to each Pfizer and Moderna vaccines.

So what does “some protection” mean? “It's hard to say based on the information I have so far,” says Dr. Beverly Sha, a professor of medication within the division of infectious diseases at RUSH University Medical College in Chicago.

The latest vaccine can neutralize antibodies produced by variants equivalent to EG.5 and BA.2.86, “which are the latest variants we are concerned about,” Sha said. Preliminary data show that the brand new vaccine “works well against EG.5 and BA.2.86,” but how strong the antibodies are in neutralizing these variants continues to be unknown.

But before you may get the booster shot at your doctor's office or pharmacy, two more steps are required. The CDC's Advisory Committee on Immunization Practices (ACIP) is predicted to vote on Tuesday to approve the brand new vaccine. Then the CDC's latest director, Mandy Cohen, MD, MPH, must give her approval.

Across the United States, COVID cases, hospitalizations and deaths are rising again. according to CDCHospital admissions rose 15.7 percent within the week ending August 26. Deaths rose 10.5 percent through September 2.

The FDA said the brand new vaccine must be available to everyone ages 5 and older, no matter previous vaccination status, so long as it has been greater than two months because the last COVID vaccination.

Children ages 6 months to 4 years who’ve received at the least one previous COVID vaccination are eligible to receive one or two doses of the brand new vaccine. You'll must refer to your pediatrician to verify dosing.

Children in the identical age group who’ve never received a COVID vaccine are eligible for 3 doses of the brand new Pfizer vaccine or two doses of the brand new Moderna formula.

“FDA is confident in the safety and effectiveness of these updated vaccines, and the agency's benefit-risk assessment shows that the benefits of these vaccines outweigh the risks for individuals 6 months of age and older,” the agency said in a press release.

“I think safety is still a big concern for people,” Sha said. She stressed that every thing about this vaccine is similar because the previous ones, aside from the genetic material that is particular to XBB1.5. “So all the safety data we've collected still shows us that these vaccines are very safe. Frankly, billions of doses have been given and this is very well researched.”

The risk of acute myocarditis also appears to be lower now, Sha added. “The problem of myocarditis in young men, particularly young boys, was much more likely to be a result when we gave two doses very close together, and that is no longer done.”
“Therefore, I think the risk of myocarditis is also much lower than initially thought,” Sha added.

The number of people that received the previous booster shot fell in need of expectations. In most parts of the United States, for instance, not more than 20% of the population has received the updated bivalent vaccine since its approval on September 1, 2022. Only in seven states and the District of Columbia is the proportion above 25%, in keeping with one study. CDC Map.

“Of course, we've seen cases start to rise again in the last few weeks,” Sha said. It's difficult to predict what might occur within the winter months, “but what I tell my own patients is that those who skipped the booster last year may now be 18 to 24 months since their last booster. We know your level of protection from your previous vaccinations is pretty low… and maybe there's more reason to think about it now.”

An enormous unknown is how the associated fee of the brand new booster shots, which aren’t any longer free, might affect their uptake. Manufacturers estimate that without medical insurance they are going to cost 110 to 130 USD per dose.

Sha has heard some reports that the federal government may provide some form of monetary assistance for the uninsured. But she added, “I expect it will be covered for anyone with Medicaid, Medicare or private insurance.”