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Over the past 18 months, the original COVID-19 vaccines — first as a two-dose series, then as boosters — have done an extraordinary job of protecting us from illness, hospitalization, and death. dead. Globally, they saved an estimated 20 million lives in 2021 alone. Even today, unvaccinated Americans are twice as likely as vaccinated Americans to test positive for COVID — and six times more likely to die from the disease.
But viruses evolve, and so do vaccines.
That was the big picture to take home from a crucial meeting this week of the U.S. Food and Drug Administration’s expert advisory panel. The question before them was simple: ahead of an expected winter surge, should vaccine makers modify their upcoming boosters to target Omicron – the ultra-infectious variant that has spent the last seven months spreading around the world under one form or another – or should they stick to the proven 2020 recipe?
The panel voted 19 to 2 on Tuesday in favor of Omicron boosters. The question now, however, is what version of Omicron, the next round of shots should aim.
For anyone who hasn’t been paying attention, the Omicron strain that started last winter’s massive wave of COVID (BA.1) is now extinct. In March it was supplanted by the even more transmissible BA.2…which was supplanted in May by the even more transmissible BA.2.12.1…which is now supplanted by the (you guessed it) BA.4 again more transmissible and BA.5.
Experts say BA.5 is the one to worry about: “The worst version of the virus we’ve seen,” as Dr. Eric Topol, founder of the Scripps Research Translational Institute, recently put it. Together, the closely related BA.4 and BA.5 now account for the majority of new COVID cases in the United States, according to the latest data from the Centers for Disease Control and Prevention – but BA.5 (36.6%) is spreading much faster than BA.4 (15.7%). At the beginning of July, this will be the dominant strain in the United States
This is annoying for several reasons. For our immune system, the distance between highly mutated BA.1 and BA.4 and BA.5 is “much greater”, writes Topol, than the distance between the original BA.1 viruses to previous hit variants such as Alpha and Delta, making them more difficult to recognize and combat. According to the latest research, this could mean:
None of this will bring the United States back to square one. Despite high case levels, there are now fewer US COVID patients in intensive care units than there were in previous phases of the pandemic, and the national death rate (about 300 to 400 per day) is close to an all-time low. Acquired immunity, multiple vaccination cycles and improved treatment options help a lot.
But combined with waning vaccine protection and disappointing booster uptake in the elderly, the virus’s accelerated evolution and aggressive new trajectory — toward greater transmissibility, evasion, and possibly pathogenicity — could lead to reinfections and significant disturbances if left untreated.
It could also put vulnerable Americans at risk in the months to come.
In late April, BA.5 hit Portugal; in June, more Portuguese were dying of COVID every day than during Omicron’s winter peak in the country. Admittedly, Portugal has a larger senior population (23%) than the United States (16%), but not by much. And the vaccination rate there is 87%, compared to only 67% in America. Portugal’s recall rate, on the other hand, is almost twice as high as ours. Infection and hospitalization rates are now rising in much of the rest of Europe as well.
At the FDA advisory meeting on Tuesday, Justin Lessler, an epidemiologist at the University of North Carolina at Chapel Hill, presented a series of projections for how the virus could affect the United States in the coming months. The most optimistic scenario? About 95,000 new deaths between March 2022 and March 2023. The most pessimistic? Over 200,000.
So given that BA.5 – which, again, outshines its cousin BA.4 – will soon be everywhere, it seems logical that the next version of the vaccine will be designed to combat it.
Still, that wasn’t necessarily the plan. Pfizer and Moderna have already launched clinical trials for redesigned drop boosters…but these boosters are optimized to counter the now nonexistent BA.1 rather than the soon to be dominant BA.5. According to data presented Tuesday by Pfizer, their existing BA.1 booster generated a significantly lower level of neutralizing antibodies against BA.4 and BA.5 than against BA.1.
Yet, in mice, at least, a booster containing BA.4 and BA.5 produced a higher neutralizing response to all Omicron variants (including BA.4 and BA.5) than the original vaccine.
Despite concerns about “sparse” data; know if bivalent boosters (original strain and Omicron in equal parts) work better than monovalent boosters (100% Omicron); and on whether it’s worth waiting for Novavax’s promising mRNA-free vaccine to hit the market, the panel generally agreed that the BA.4/5 reminders made sense. The FDA is also leaning in this direction. Pfizer said it was “ready” to ship the new boosters by the first week of October; Moderna, by the last week of October or early November – “assuming no clinical data is required”.
This means that there are no human trials, just animal trials and lab tests. It may sound scary to some, but regulators already use the same expedited process to update the flu vaccine every year — and there’s no mechanism by which minor mRNA changes will make Pfizer and Moderna revised less safe than billion doses administered. far around the world. Otherwise, the United States will miss its fall-winter deadline and the rapidly evolving virus will continue to overtake vaccines.
The FDA itself will decide “very quickly” what to recommend; manufacturers will follow their lead.
Going forward, looking for variants may not prove to be the most effective or efficient approach to COVID vaccination. As Topol put it, “by the time a booster of the BA.5 vaccine is potentially available, who knows which will be…the predominant strain”? That’s why it was good news on Wednesday when Pfizer and BioNTech announced that they planned to “begin human testing of next-generation vaccines that protect against a wide variety of coronaviruses in the second half of the year.” according to a Reuters report.
These include “T cell-enhancing injections, designed to protect primarily against severe disease if the virus becomes more dangerous” and “pan-coronavirus injections that protect against the extended virus family and its mutations”. Nasal vaccines intended to stop the infection before it starts also show promise.
But these are all longer-term proposals. This year, at least, a BA.5 booster is probably our best bet to minimize infections, illnesses and deaths during another likely winter surge.
“I expect further developments to occur in the coming months, but this development will most likely be above BA.4/BA.5 – and therefore [it] should not deter vaccine updates,” virologist Trevor Bedford of the Fred Hutchinson Cancer Research Center in Seattle wrote earlier this week. “I believe the decision-making process can be boiled down to: vaccine compositions that can be manufactured in time for fall distribution, which ones we hope will generate the highest [protection] against BA.4/BA.5? »
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