For the past 18 months, the original COVID-19 vaccine has done an extraordinary task of protecting us from illness, hospitalization and death, first as a two-dose series and then as a booster.Worldwide, they 2021 alone saved an estimated 20 million lives..Even today, unvaccinated Americans are twice as likely to test positive for COVID as vaccinated Americans — and 6 times more likely to die of illness..
But viruses should evolve and vaccines should evolve.
This was a big picture from this week’s key meeting of the US Food and Drug Administration’s Expert Advisory Board. Their previous question was simple: should vaccine manufacturers tweak their next booster shots to target Omicron prior to the expected winter surge? Do they stick to the proven 2020 recipe?
The panel voted 19-2 in favor of the Omicron booster on Tuesday.But the problem now is either version The next round of Omicron’s shots should be targeted.
For those who haven’t been noticed, the Omicron strain that caused the massive COVID wave (BA.1) last winter is now extinct. In March, it was replaced by the more transmissible BA.2. In May, it was replaced by the more transmissible BA.2.12.1. It is now being replaced by the more transmissible BA.4 (as you can imagine). BA.5.
According to experts, BA.5 is worried that it is “the worst version of the virus I have ever seen”. Dr. Eric Topol, Founder of the Scripps Research Translational Institute, Put it lately.. Together, closely related BA.4 and BA.5 now make up the majority of new USCOVID cases. Latest data from Centers for Disease Control and Prevention —But BA.5 (36.6%) spreads much faster than BA.4 (15.7%). By early July, it will become the dominant stock in the United States
It’s annoying for several reasons. For our immune system, the distance from BA.1 to highly mutated BA.4 and BA.5 is “Much bigger“Topol writes more than the distance from the original BA.1. Viruses against previous blockbuster variants such as Alpha and Delta — this makes them difficult to recognize and respond to. According to the latest research, that can mean the following:
None of this will bring the United States back into a square. Despite rising case levels, US COVID patients in the intensive care unit have fewer than before the pandemic, with the lowest national mortality rate (about 300-400 per day) in history. Is approaching. Acquired immunity, multiple vaccinations, and improved treatment options have helped — much more.
However, coupled with the decline in vaccine protection, Disappointing booster intake among the elderlyIf not addressed, the accelerated evolution of the virus and its aggressive new trajectory — towards greater infectivity, avoidance, and perhaps pathogenicity — can cause serious reinfection and confusion.
It can also endanger vulnerable Americans in the coming months.
In late April, BA.5 struck Portugal. By June More Portuguese died from COVID every day From during the winter Omicron peak in the country. Sure, Portugal has a larger elderly population (23%) than the United States (16%), but not so much. The vaccination rate is 87%, but only 67% in the United States.On the other hand, the booster rate in Portugal is Almost twice as high Like us.Infection and hospitalization rates are currently rising Even in many other parts of Europe..
At the FDA Advisory Board on Tuesday, Justin Lessler, an epidemiologist at the University of North Carolina at Chapel Hill, released a series of predictions about how the virus will affect the United States in the coming months. The most optimistic scenario? Between March 2022 and March 2023, there were approximately 95,000 new deaths. Are you the most pessimistic? Over 200,000.
Given that BA.5, which surpasses its cousin BA.4, will soon be ubiquitous, it is likely that the next version of the vaccine will need to be adjusted to fight it.
But that wasn’t always a plan. Both Pfizer and Moderna have already begun clinical trials of redesigned autumn boosters … but these boosters compete with BA.1, which no longer exists, rather than the soon-to-be-dominated BA.5. Optimized to do.Existing BA.1 booster, according to data presented by Pfizer on Tuesday Generates significantly lower levels Neutralizing antibodies against BA.4 and BA.5 rather than against BA.1.
But in mice, at least boosters containing BA.4 and BA.5 Brought about a higher neutralization reaction For all Omicron variants (including BA.4 and BA.5) than the original vaccine.
Despite concerns about “small” data, whether the divalent booster (where the original strain equals Omicron) works better than the monovalent booster (100% Omicron). And the panel almost agreed that the BA.4 / 5 booster made sense as to whether it was worth the wait for Novavax’s promising non-mRNA vaccine to hit the market. The FDA is also leaning that way. Pfizer said it was ready to offer a new booster by the first week of October. Moderna, by the last week of October or the beginning of November — “assuming no clinical data requirements”.
That is, there are no human trials, only animal trials and laboratory trials. It may sound scary to some, but regulators are already using the same accelerated process to update their flu vaccines each year. Also, there is no mechanism by which slight mRNA adjustments make modified Pfizer and Moderna shots less safe than the billions of doses administered. Much around the world. Otherwise, the United States will miss the fall-winter deadline and rapidly evolving viruses will continue to overtake vaccines.
The FDA itself decides what to recommend “very quickly.” Manufacturers will follow their lead.
In the future, tracking variants may not prove to be the most effective or efficient approach to COVID vaccination. As Topol said, “Who knows … what are the major strains by the time the BA.5 vaccine booster is potentially available?” So Pfizer and BioNTech said on Wednesday. Later this year, we will begin testing humans with next-generation shots that protect against a wide variety of coronaviruses, “was welcome news. According to a Reuters report..
These include “T cell-enhanced shots designed primarily to protect against serious disease when the virus becomes more dangerous” and “Pancoronaviruses that protect against a broader family of viruses and their mutations.” “Shot” is included. Nasal vaccines aimed at stopping the infection before it begins are also promising.
But they are all long-term suggestions. At least this year, BA.5 boosters are the best way to minimize infections, illnesses and deaths when there is a potential winter surge.
“I’m fully hoping for more evolution in the coming months, but this evolution is probably on top of BA.4 / BA.5. [it] Vaccine updates should not be discouraged, “said Trevor Bedford, a virologist at the Fred Hutchinson Cancer Research Center in Seattle. I wrote earlier this week.. “The decision-making process can be summarized as follows: It is expected to produce the best vaccine composition that can be manufactured in time for autumn distribution. [protection] Against BA.4 / BA.5? “