This story has been updated.
September 11, 2023 – The FDA today approved the newest COVID-19 vaccine, the primary that doesn't goal the unique or “ancestral” strain of the virus.
Last yr, the FDA approved a bivalent vaccine that targets each the old and the brand new. This time it's a “monovalent” or single-strain vaccine with one major goal: to reduce health risks, hospitalizations and deaths related to newer variants similar to the XBB.1.5 Omicron subvariant. It can also be expected to supply some protection against related diseases variants currently in circulation.
The FDA approval applies to vaccines from Pfizer and Moderna.
So what does “some protection” mean? “It's hard to say given the information published so far,” said Beverly Sha, MD, professor of drugs, division of infectious diseases, RUSH University Medical College, Chicago.
The latest vaccine can neutralize antibodies produced by variants similar to EG.5 and BA.2.86, “which are the newest ones we're concerned about,” Sha said. Preliminary data shows that the brand new vaccine “looks good against EG.5 and BA.2.86,” but how much neutralizing activity the antibodies have against these variants stays unknown.
However, before you'll be able to receive the booster vaccination at your local doctor's office or pharmacy, there are two more steps required. The CDC's Advisory Committee on Immunization Practices (ACIP) is anticipated to vote on approval of the brand new vaccine on Tuesday. Then the CDC's latest director, Mandy Cohen, MD, MPH, must log off.
COVID cases, hospitalizations and deaths are rising again within the US. according to CDCIn the week ending Aug. 26, hospitalizations rose 15.7%. The variety of deaths rose by 10.5% through September 2nd.
The FDA said the brand new vaccine ought to be available to everyone age 5 and older, no matter previous vaccination status, so long as greater than two months have passed since vaccination.
Children ages 6 months to 4 years who've received not less than one previous COVID vaccination are eligible to receive one or two doses of the brand new vaccine. You have to refer to your pediatrician to verify the dosage.
Children in the identical age group who've never received a COVID vaccine are eligible to receive three doses of the brand new Pfizer vaccine or two doses of the brand new Moderna formula.
“The 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 for people 6 months and older outweigh their risks,” the agency said in an announcement.
“I think safety is still very important to people,” Sha said. She emphasized that on this vaccine every thing is identical as within the previous ones, apart from the genetic material specific to XBB1.5. “So all the safety data that we've collected still shows us that these vaccines are very safe. Frankly, billions of doses have been administered and it’s very well studied.”
The risk of acute myocarditis also appears to be lower now, Sha added. “The problem of myocarditis in young men, particularly young boys, was more a result of us giving two doses very close together, and that is no longer done.”
“So I think the risk of myocarditis is also significantly lower than what we initially saw,” Sha added.
The number of people that received the previous booster vaccination fell wanting expectations. For example, in most places within the United States, 20% or less of the population has received the updated bivalent vaccine since its authorization on September 1, 2022. According to 1 study, the proportion is above 25% in just seven states and the District of Columbia CDC map.
“Obviously in the last few weeks we've seen cases start to increase again,” Sha said. It's hard to predict what might occur within the winter months, “but what I tell my own patients is, for those who skipped the booster last year, 'You know, it's been maybe 18 to 24 months since your last booster.' . We know your level of protection is quite low compared to your previous vaccinations… and there may be even more reasons to think about getting the vaccination now.”
A big unknown is how the cost of the new boosters, which are no longer free, might affect their acceptance. Manufacturers estimate they will cost without health insurance $110 to $130 for each dose.
Sha has heard some reports that the federal government may provide some type of funding for uninsured people. But she added, “I assume everyone with Medicaid, Medicare or private insurance is roofed.”