Health officials say that the Centers for Disease Control and Prevention will now sign off on it amid rising cases of Covid across the US.
The FDA said in a statement on Monday that anyone over the age of five is eligible to receive a single dose of the updated vaccine if it is at least two months since their last dose of any Covid vaccine.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
The drugmakers were asked by the FDA in June to develop this year’s boosters to tackle the XBB.1.5 subvariant, which was dominant at the time.
Although the CDC say that strain only accounted for 3 per cent of new Covid cases during the week ending September 2, other strains are closely related to it.
A CDC advisory committee is set to meet on Tuesday to vote on recommendations for who should get the booster. People can start to get the boosters after CDC Director Dr Mandy Cohen signs off on the recommendations.
The updated boosters are each approved for those aged 12 and older and authorised for emergency use for children between ages six months and 11 years.
For those aged six months to four years who have previously been vaccinated, the FDA says they are eligible to receive one or two booster doses. For unvaccinated individuals of this age, the FDA says they are eligible for three doses.
The federal government, for the first time since Covid shots became available, will not cover their cost, but most people with public and private health insurance should be able to get the $100 booster in-network at no out-of-pocket cost.
The 30 million Americans who do not have health insurance should be able to get the shot for free at community health centres and the White House says that anyone without insurance will be able to receive the shot for free until the end of next year.
While Covid numbers have been increasing in the US, experts are quick to point out that they are still lower than a year ago.
Covid-related hospital admissions rose to more than 17,000 for the week ending 26 August, while the total for the same tie in 2022 was almost 37,000, according to the CDC.
Meanwhile, there were 658 Covid deaths, compared to nearly 3,000 in the same period last year.