Federal officials have reportedly scrapped plans to expand access to second COVID-19 booster doses this summer, instead to pressure vaccine makers Moderna and Pfizer-BioNTech to release their next-generation BA.5 targeting boosters even faster than to be produced before, possibly in September.
Currently, people 50 and older, as well as people 12 and older with certain health conditions, can receive a second COVID-19 booster dose. But with the ultra-transmissible BA.5 wave threatening more infections and reinfections at a time when vaccine protection is fading, officials earlier this month toyed with the idea of opening second boosters to all adults. At the time, they were expected to decide the case within the following weeks.
That decision window is now closed. And while BA.5 is still raging, the Biden administration has reportedly abandoned the plan to focus instead on the new booster vaccines for those 12 and older, which were previously expected to roll out in October and November.
In June, the Food and Drug Administration advised vaccine makers to create a next-generation bivalent booster for a fall rollout that could thwart a winter wave of infection. The bivalent shot would again target the spike protein of the ancestral strain of SARS-CoV-2, but also the mutated spike protein shared by the BA.4 and BA.5 subvariants. The regulator thought – along with its committee of independent expert advisors – that the bivalent booster targeting BA.4/5 would likely provide better protection against the currently circulating sub-variants.
Insecurity
But this bivalent booster plan is a gamble. There is little to no data to indicate that the BA.5-targeted bivalent booster will be significantly better than the current booster in preventing infection and disease. It is also unclear how long BA.5 will remain the dominant subvariant. While there is as yet no clear successor chasing BA.5, waves of omicron subvariants have come in rapid succession in recent months, with BA.5 being the third omicron subvariant to achieve dominance since March. , when BA.2 reigned, followed by the rise of BA.2.12.1. It’s conceivable that BA.5 will go into decline by the time the next generation of boosters are available, even with the accelerated timeline of a rollout from early to mid-September.
In June, vaccine makers suggested a rollout from October to November would be a heavy burden. But unnamed officials in the administration have told reporters that the companies have now given assurances that they can get them earlier, in September.
The officials offered some insight into the administration’s deliberations. For example, top infectious disease expert Anthony Fauci and White House Pandemic Response Coordinator Ashish Jha both advocated offering more second boosters now, in the summer, while transmission is high and protection is declining.
But the FDA and the Centers for Disease Control and Prevention have reportedly pushed for focus on the fall campaign. Their thinking is that a booster ride in the summer so close to fall could confuse Americans about when to restore protection and potentially cause some to lose confidence in the shots if boosters are offered so quickly. There is also the scientific concern that yet another vaccine dose targeting the ancestral strain — which is no longer circulating — could affect immune responses in a way that makes them less effective at warding off variants. (Although this argument has not been used to deter people over 50 from getting a second booster.)
Finally, there’s also the time constraint: if people get second boosters now, it could lead to them not getting the bivalent booster in the fall. Or, if people have two boosters close together — a month or two apart — the second shot can become useless.
“You can’t get a vaccine on August 1 and get another vaccine on September 15 and expect the second injection to do something,” Shane Crotty, a virologist at the La Jolla Institute for Immunology, told The New York Times. “You have so many antibodies around, if you get another dose, it won’t do anything.”
mixed messages
Still, it’s unclear why fall booster availability could not extend over several months to accommodate different boosting windows. That is, for those who want a second boost now, why couldn’t they just wait until November or December to get the bivalent booster? In a press conference earlier this month, CDC director Rochelle Walensky argued directly for this scenario: that late summer shots wouldn’t rule out fall boosters.
“While we’ve looked at the cadence from where we needed to get boosts before, it’s been four, five months,” Walensky said. “We expect that to be a similar cadence. We also really want to emphasize that there are a lot of people at high risk right now who are waiting until October/November for their boost – when in fact their risk is in the moment – is not good plan,” she added. “So we really want to say, ‘Give you a boost now. We’re confident that the data will indicate that you’re eligible for a [bivalent] boost in the fall.'”
Expert opinion on the booster plan is mixed. Some experts are joining federal officials’ plan to focus on the fall, creating an easier, possibly more impactful booster drive. “I think this is the right decision,” Dr. Celine Gounder, a senior fellow at the Kaiser Family Foundation, told NPR. “If you get a booster now with the original formulation of the vaccine, it could actually be counterproductive.”
But others have now called for expanded access to boosters. Eric Topol, director of the Scripps Research Translational Institute, posted a series of critical questions on Twitter, including why unused boosters that would otherwise be lost aren’t being offered to people at higher risk, such as health professionals under the age of 50.
Robert Wachter, chair of the department of medicine at the University of California, San Francisco, is also in favor of offering more second boosters now. “You’re talking about, you know, literally hundreds of millions of people who are at higher risk than they should be for months,” Wachter told NPR. “And that means potentially millions of preventable infections, certainly thousands of preventable hospitalizations and probably hundreds of preventable deaths.”
Currently, the US is registering an average of nearly 130,000 new COVID-19 cases per day, although that is certainly a significant undercount considering the use of home testing. Hospital admissions average about 44,000 per day, up 11 percent in the past two weeks. Intensive care stays have increased by 13 percent to more than 5,000 a day. And the average daily number of deaths is 438, according to data tracking by The New York Times.
