It seems that everyone returning from Europe has either Covid 19 or some respiratory illness. I had another case this morning. My view may be skewed as the well ones don’t call me, but it did prompt me the get another vaccine before an upcoming trip abroad to reduce my risk.
Here are a couple of news items about the current variant, vaccine variant selection and a flu/Covid vaccine combo preliminary result.
New COVID variant KP.3 climbs to 25%, now largest in CDC estimates
The new KP.3 variant has climbed to 1 in 4 new COVID-19 cases nationwide, the Centers for Disease Control and Prevention estimated Friday, making it now the dominant strain of the virus nationwide.
KP.3’s ascent comes as the CDC has tracked key metrics of spread from the virus now starting to trend up. Previous years have seen surges of the virus peak around August.
Data from CDC’s wastewater surveillance has tracked levels of the virus starting to accelerate in the West. Emergency room visits for COVID-19 have inched up in recent weeks for all ages. COVID-19 infections are likely growing in 30 states and territories, the CDC now estimates.
“Very, very similar” to JN.1
KP.3 is now estimated to be outpacing the KP.2 variant, a so-called “FLiRT” strain that this week inched up to 22.5% of cases. KP.2 had risen to dominance in previous weeks, but its growth has now slowed.
Both KP.3 and KP.2 are “very, very similar” to the JN.1 variant that had dominated this past winter’s wave of infections.
“When you look at KP.2 and KP.3, they’re nearly identical to each other with really one difference between the two of them,” Natalie Thornburg, the chief lab official at the CDC’s Coronavirus and Other Respiratory Viruses Division, said Wednesday.
Thornburg was speaking at a Food and Drug Administration meeting debating what strains should be targeted by this fall’s vaccines.
This difference is smaller than previous jumps in the virus, like when JN.1’s parent – the highly mutated BA.2.86 variant – first emerged last year.
However, KP.2 and KP.3 are also not identical. Early data suggests KP.3’s mutations might be better at evading immunity.
“JN.1 and KP.2-like viruses, they’re really, really on top of each other. And KP.3 is very close, but not absolutely on top of it,” Thornburg said.
Picking out new COVID-19 vaccines
KP.3’s rise comes as the FDA said Friday that it had decided to call for shots this fall to be updated for the JN.1 variant that was dominant earlier this year, effectively turning down a newer formula aimed at the KP.2 variant.
“Yes, we always say we shouldn’t be chasing strains, but we’re paying an incredibly high premium for mRNA vaccines to be able to have the freshest vaccines,” the FDA’s Peter Marks had told the meeting.
Moderna had presented data from animal studies suggesting its KP.2-targeted shot offered similar protection against the latest variants, compared to a shot designed for JN.1. Pfizer’s shot for KP.2 triggered better antibody responses for JN.1 variants, including KP.3.
“If this evolves further in the fall, will we regret not having been a little bit closer,” Marks said.
But the FDA ultimately decided to pass on the KP.2 shots, after the agency’s advisers worried it might not do a better job at broadening immunity for future strains compared to JN.1.
Here are some news items about preliminary reports of a new flu/Covid 19 vaccine combo. This is a preliminary report that has not been peer reviewed. It suggests that that the combination may be greater than the sum of it’s parts. The concern has been that combining vaccines might reduce the response to each component. Apparently, this is not the case. The other interesting part of this study is that it uses an mRNA flu vaccine which is something new. I wonder whether a combination vaccine would be well received as mRNA vaccines have been vilified by some groups. It would certainly make it easier to get two vaccines at once. It would make it difficult for physician’s offices to order vaccine not knowing whether people would take the combination or just want flu vaccine. Ordering vaccine involves a significant capital outlay.
Moderna’s COVID-19/Influenza Combination Vaccine Superior To Separate Shots In Trial
Reuters (6/10, Wingrove) reports Moderna announced “on Monday its combination vaccine to protect against both COVID-19 and influenza generated a stronger immune response in adults aged 50 and over when compared to separate shots against the viruses in a late-stage trial.” In the trial, “the combination using messenger RNA technology generated greater antibodies than currently marketed traditional flu vaccines and Moderna’s Spikevax mRNA COVID shot, the company said.”
CNN (6/10, Christensen) reports, “Moderna’s Phase 3 trial was a randomized, observer-blind, active control study, meaning that even the clinicians giving the shots didn’t know who got which vaccines. The trial studied the vaccine in two different age groups” – those 65 and older, and those between 50 and 65 – “with about 4,000 adults in each age category.”
ABC News (6/10, Benadjaoud) reports, “There are still multiple steps required before the shot would become available. Moderna would need to apply to the FDA for approval, which may require input from the FDA’s independent panel of experts.” And the CDC would have to sign off before it could be distributed.
Covid-flu combination vaccine shows positive results in late-stage trial, Moderna says
There could be a combined Covid-19 and flu shot in our future, although it won’t be ready for this year’s flu season.
On Monday, vaccine maker Moderna announced positive late-stage trial results for its Covid-flu combination vaccine it calls mRNA-1083.
Calling the outcome of the late-stage trial “breakthrough results,” Moderna’s Chief Medical Affairs Officer Francesca Ceddia told CNN that people in the trial who got mRNA-1083 showed an improved immune response compared with those who got the standalone flu and Covid vaccines that are available now. The results were true even for people in the trial who were 65 years and older. Generally, older people don’t mount as robust a response to vaccines as younger people do.
Other companies have been testing a combined Covid-flu vaccine, but Moderna is the first to announce positive late-stage trial results.
Public health leaders say the world could use more ways to protect people from both viruses. Millions of people get sick with the flu and now Covid every year. For the last flu season, the US Centers for Disease Control and Prevention estimates 35 to 64 million people got sick with the flu in the United States. Between 390,000 and 810,000 people were so sick they were hospitalized and up to 71,000 people died. Just for last fall and winter, Covid sent more than a half-million people in the US to the hospital and killed 40,000, according to data presented last week to the US Food and Drug Administration’s independent vaccine advisers, who were discussing how to update Covid vaccines for the fall.
Moderna’s Phase 3 trial was a randomized, observer-blind, active control study, meaning that even the clinicians giving the shots didn’t know who got which vaccines. The trial studied the vaccine in two different age groups with about 4,000 adults in each age category.
For one part of the study, Moderna compared the immune reaction of adults 65 and older who got mRNA-1083 and another group with the same age range who got a co-administered Covid-19 vaccine, Moderna’s Spikevax, and an enhanced flu vaccine, Fluzone HD. Doctors recommend seniors get more powerful flu vaccines due to their inhibited immune systems.
For the other part of the trial, researchers compared how slightly younger adults, ages 50 to 64, did when they got the mRNA-1083 vaccine to another group within the same age range who got Spikevax and a standard dose flu vaccine called Fluarix.
Study results showed that in both age groups, the experimental combination vaccine elicited a statistically significant higher immune response against three strains of the flu and against Covid-19, compared with the co-administered shots.
In terms of safety, the combined vaccine was well-tolerated, Moderna said, and the adverse reactions were similar to what people experienced with the co-administered vaccines. The most common complaints were pain at the injection site, tiredness, muscle pain and headaches.
The study isn’t peer-reviewed yet, but Moderna said it plans to present data from this late-stage trial at an upcoming medical conference and it will also submit the trial for publication. Moderna also said it will talk to the FDA about possible next steps.
“We need to engage with regulators but our aspiration is to have it approved for fall 2025,” Moderna CEO Stéphane Bancel told CNN.
Sue Peschin, the president and CEO of the Alliance for Aging Research, a nonprofit dedicated to improving aging and health that encourages more equitable access to vaccines, said a combined shot could be a significant help to public health.
In addition to intensifying vaccine hesitancy in the US, people have developed a kind of vaccine fatigue after the pandemic, Peschin said. Peschin pointed to the drop in the uptake in standard vaccines such as the MMR vaccine, as well as in seasonal vaccines.
Few people got the latest Covid shot, studies show. Only about 25% of the eligible population has received the latest Covid-19 vaccine, according to a presentation to the FDA last week. Many more adults got the flu shot with nearly half of the adult population getting one last season, according to the CDC, a number that was slightly higher than the year before.
“We want to see that go up and if there’s a way to do that by combining the vaccines, then that’s better for everyone because it helps protect everyone in the community,” Peschin said. “We would love to see the combination vaccines come to market if the FDA deems them safe and effective.”
CNN’s Meg Tirrell contributed to this report.
