UPDATED:Waiting on the Next COVID-19 Booster? The Next Version Should be Available in September

From the New York Times: The Food and Drug Administration on Wednesday authorized the first redesign of coronavirus vaccines since they were rolled out in late 2020, setting up millions of Americans to receive new booster doses targeting Omicron subvariants as soon as next week.

The new formulation arrives as roughly 90,000 infections and 475 deaths are still being recorded daily around the United States, more than two years into a pandemic that has killed more than a million Americans and driven a historic drop in life expectancy.

With winter approaching and the BA.5 variant of Omicron still circulating widely, federal officials hope the redesigned shots will help slow the pandemic’s seemingly relentless march. Yet many Americans appear to have become indifferent to the virus and its risks, making the task tougher than ever.

The new boosters are “bivalent,” meaning they contain a combination of the original formulation and one targeting BA.5, now the dominant version of the virus, as well as a sister subvariant of Omicron. One is made by Pfizer and its German partner BioNTech for use in people as young as 12, and the other by Moderna, for those 18 and older.

Officials in the Biden administration have argued that even as researchers work to understand how protective the new shots might be, inoculating Americans again in the coming weeks could better equip adolescents and adults if cases surge again.

Even though case counts remain high, fewer than 40,000 people are hospitalized with the virus, a decrease of 10 percent since early August and far fewer than during the Delta-driven surge last summer or the Omicron-fueled wave last winter. Deaths have also remained somewhat flat in recent weeks, a sign that vaccines are helping to prevent the worst outcomes of Covid-19.

People who have been fully vaccinated are eligible for the updated shots, regardless of whether they have also received booster doses. But their last shot must have been at least two months ago.

The new boosters could be available in a few days, assuming that Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention, signs off, a decision that could come by Friday. The federal government was expected to start shipping doses to the states as soon as the F.D.A. acted.


The new booster could be available sometime in September, but will first need to get federal approval. By Rong-Gong Lin II and Luke Money for the LA Times.

The next generation of COVID-19 booster shots — tailored specifically to combat the super-infectious family of Omicron subvariants — could roll out early next month. ¶ The long-in-the-works offering would mark an ambitious new phase in the nation’s vaccination campaign and, officials say, give residents another option to protect themselves ahead of a possible coronavirus resurgence in the fall and winter. ¶ But who will be able to roll up their sleeves this time? And do those who have already received a booster, or two, really need to get another one? Here’s what we know.

When will the Omicron booster shot be available?

The new booster could be available sometime in September, White House COVID-19 response coordinator Dr. Ashish Jha said at a recent forum. But the shots will first need to be approved by the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention.

In a signal that the agencies may be close to an unveiling, the CDC’s Advisory Committee on Immunization Practices has scheduled a meeting Thursday and Friday. The committee typically meets to offer recommendations to the CDC director, Dr. Rochelle Walensky, before she gives recommendations on who should get the vaccine.

“We haven’t seen anything official just yet, but we are planning for whenever it comes out to get it to all of our vaccination providers,” Dr. Muntu Davis, Los Angeles County’s health officer, said of the new boosters’ timing.

Who would be eligible to get the shots?

Though the final call is still pending, the expectation is that eligibility will be broad.

Pfizer on Aug. 22 asked the FDA to authorize its new Omicron booster shot for people ages 12 and older. Moderna made the same request on Aug. 23 for adults for its booster.

What’s the benefit of getting the new booster?

The latest dominant Omicron subvariant, BA.5, differs in a number of ways from the original strain the vaccines were designed against, Jha said.

While the original vaccines still do relatively well in keeping people out of the intensive care unit and dying, he said, their effectiveness in preventing infection has declined over time because of the evolution of the Omicron strain.

BA.5, in particular, has proved to be not only highly transmissible but also able to reinfect those who recently got over a bout with a prior strain of the coronavirus.

The Omicron booster, Jha added, represents a potentially substantial upgrade in the vaccine “in terms of their ability to prevent infection, to prevent transmission, certainly to prevent serious illness and death.”

Dr. Peter Chin-Hong, a UC San Francisco infectious-disease expert, said the Omicron booster will help prevent people’s lives from being disrupted by an infection.

As of mid-July, unvaccinated Californians were seven times more likely to get COVID-19, nearly 12 times more likely to be hospitalized with the disease and 11 times more likely to die than their vaccinated-and-boosted counterparts, according to the latest data from the state Department of Public Health.

When should people get the new booster?

Generally, many officials and experts recommend getting a booster as soon as you’re eligible — particularly if you’re at higher risk of severe health consequences from COVID-19.

But others may decide to wait a bit, until October or November, as the booster’s potency will likely wane over time, as has been the case with other vaccine doses.

Peak effectiveness will likely be in the four or five months following the shot, with the maximum effectiveness one month after the injection, Chin-Hong said.

In the pandemic’s first fall and winter wave, coronavirus cases in California began increasing in November and accelerated sharply in December. In last year’s fall and winter wave, cases began spiking in December.

Federal officials have said that people who got a conventional booster shot earlier this year — including a second booster — will be eligible for the Omicron booster.

Should I get a conventional booster now or wait for the Omicron one? Since Omicron boosters could be mere weeks away, it depends.

Existing CDC guidance recommends most adults and children age 5 and older get a booster at least five months after completing their primary vaccination series. (Immunocompromised people should get their booster at least three months after the primary vaccination series.)
Adults 50 and up and immunocompromised people are recommended to get a second booster at least four months after their first booster.

People older than 65 who are past due for a booster should get the conventional shot now, according to Chin-Hong.
Getting a conventional booster now would also make sense for people who are, for instance, five or more months out from their last COVID-19 inoculation, are eligible for a booster and are about to go into a higher-risk situation, such as taking a trip abroad, he added.

“If you’re going to wander into places with a lot of exposure — like you’re going to Europe — you might want to consider getting the fourth shot sooner [rather] than later,” UC San Francisco epidemiologist Dr. George Rutherford said at a recent campus town hall. But getting a conventional booster now may mean you’ll have to wait before becoming eligible for the Omicron booster, he said.

Other people already overdue for a booster can reasonably decide to wait for the Omicron shot, he said.
What about children younger than 12?

Neither Pfizer nor Moderna has sought clearance to offer Omicron boosters to children younger than 12. That age group already lags well behind others in terms of vaccination rates.

Doctors recommend getting younger children vaccinated, even if it’s with the conventional vaccine, given its effectiveness in protecting against hospitalization.

Vaccinations are important, Chin-Hong said, because “you can’t really always predict who’s going to go to the hospital [from COVID-19] in the under-12 age group, and you don’t know what variant is coming. So I think that it behooves everybody to think seriously” about vaccinating children.

“We’ve been getting more and more data that it is effective for the most serious outcomes,” he said.
Chin-Hong cited a recent study of the Pfizer-BioNTech vaccine for children 5 to 11 during the first Omicron surge in Singapore, which found that completing the primary vaccination series was 83% effective against hospitalization.

“We have not seen serious side effects in kids ages 5-11” as a result of getting vaccinated, Dr. Rhea Boyd wrote on an American Academy of Pediatrics website. “It is safe and it works.”
Vaccinations also can reduce the chances of long-term side effects after experiencing COVID-19, including long COVID .