The next phase of Moderna's omicron-specific booster trial has begun. Here's the latest

GULSTAN: THE WHITE HOUSE COVID RESPONSE TEAM IS TALKING ABOUT NEW WAYS TO COMBAT MULTIPLE CORONAVIRUSES, WHILE SAYGIN WE’RE NOT IN THE CLEAR YEWITHT THIS PANDEMIC. EDIE: THE NATIONAL INSTITUTES OF HEALTH HAS SPENT BILLIONS OF DOLLARS SINCE THE START OF THE PANDEMIC. MUCH OF THAT MONEY HAS GE ONTO VACCINE STUDIES. DOCTOR ANTHONY FAUCI SAYS ONE LONG-TERM PROJECT IS LOOKING AT A UNIVERL SACORONAVIRUS VACCE. BUT WHITE HOUSE EXPERTS STSSRE THE VACCINES WE HAVE NOW ARE EFFECTE.IV AND WHILE WE’RE IN A BETTER POSITION THAN WE WERE A AR AGO, THEY SAY THE PANDEMIC IS STILL A THREAT. >> WHEN YOU HAVE OVER 2000 DEATHS, 150,000 HOSPITALIZATIONS AND YOU HAVE PEOPLE WHO ARE KNOW GETTING INFECTED TO THE TUNE OF 700,000 A DA WY,E ARE NOT THERE YET. ED:IE PUBLIC HEALTH EXPERTS DETECTED A NEW OMICRON SUB-VARIANT, AND RIGHT NOW THEY’RE STUDYING ITS IMPA.CT SO WHAT DO WE KNOW ABOUT THIS URGING SUB-VARIANT? GULSTAN: LET’S TALK TONIGHT WITH DOCTOR DEAN BLUMBERG WITH U.C. DAVIS HEAL.TH IT IS GREAT TO GET YOUR INT PUON THIS. LET’S TALK. WE HEARD ABOUT OMICRON AROUND THANKSGIVING, NOW THIS SUB-VARIANT. PEOPLE ARE LIKE, WHAT IS HIS MEAN, HOW ABOUT THIS, AND ARE YOU EVEN SURPRISED BY THIS? >> THESE VARIASNT WILL ALWAYS COME AUTBO AS THE VIRUS CONTINUES TO BE TRANSMITTED AND REPLICATED .IT IS DIFFICULT TO PUT THEM INT PERSPECTIVE. WITH THIS VARIANT, IT WAS DISCOVERED AROUND CHRISTMAS. IT HAS 28 DIFFERENT MUTATIONS OMFR THE ORIGINAL OMICRON STRAIN. IT HAS 32 MUTATIONS THAT ARE SIMILAR, BUT IT HAS INCREASED IN NMDEARK, NORWAY, GERMANY, SOUTH AFRICA, ANDHE T PHILIPPINES. IN DENMARK, IT ACCOUNTS FOR 50% OF THE CIRCULATING STRAINS. >> FROM WHAT WE HAVE SEEN, DO WE OWKN WHETHER THIS IS AFFECTING SOME GROUPS OF PEOPLE MORE THAN OTHERS? >> NE O OF THE CONCERNS IN DENMARK WHERE IT’S BECOMING THE PREDOMINANT STRAIN IS THE HIGHESRAT TE OF HOSPITALIZATION IS OCCURRING IN CHILDREN FROM BIRTH TO TWO YEARS OF AGE. THSEE COND MOST EFFECTIVE GROUP IS THOSE OVER 80 YEARS OF AGE. WE HAVE NOT SEEN THAT BEFORE. AS A PEDIATRICIAN, THAT DEEPLY CONCERNS ME. GULSTAN: SO WHY IS THE SUB-VARIANT GETTING SO MUCH ATTENTION? WHAT >> IS THE BIG DEAL? BECAUSE IT HAS INCREEDAS SO RAPIDLY IN SO MANY CASES, AND WE HAVE NOT SEEN THE LEVELING OFF LIKE WE HAVE SEEN HERE IN CALIFORNIA AND IN SOME OTHER COUNTRIES WHERE THIS HAS BEEN DETECTED, SUCH AS DENMARK AND ISRAEL. THEY ARE STILL SEEING SKYROCKENGTI RATES OF CASES, SO THE CONCERN IS THAT ITAY M BE 40% MORE TRANSMISSIBLE COMPARED TO THE PREVIOUS OMICRON STRAIN. ED:IE WHICH SPREAD REALLYTRAIN. QUICKLY AROUND THE GLOBE. IS IT NORMAL FOR THE SUB VA RIANCE TO EMERGE ANTOD BE THIS CONTAGIOUS, AND I DON’T KNOW IF THERE’S A NORMAL RIGHT NOW. THIS IS ALL NEW. >> I AGREE. IT IS HARD TO KNOW WHAT NORMAL INIS THE AGE OF COVID, ISN’T IT? WE KEEP GETTING SURPRISING KEEP GETTING THESE MUTATIONS. UNTIL WE GET A HIGH RATE OF IMMUNITY AROUND THE WORLD, WE WILL GET DEVELOPMENT OF NEW STRAINS, NEW VARIASNT, AND NEW SURPRISES. GULSTAN: I HAVE A CLOSE LOVED ONE WHO JUST WENT THROUGH GETTING COVID, PRETTY SURE THEY HAD THE OMICRON VARIANT, OR BECAUSE OF THAT, DOES THAT MEAN THAT TYHE HAVE, THAT NATURAL IMMUNITY TO THAT SUBPERIOD, OR IT’S LIKE COMING HERE WE GO AGAIN, AND YOU CAN HAVE ANOTHER INFECTION? >> THERE HAVE ALREADY BEEN REPORTOFS PATIENTS INFECTED WITH THE ORIGINAL OMICRON STRAIN, AND WITHIN A MONTH GETTING INFECTED WITH THIS STINRA, SO THERE IS SOME SUGGESTION IT’S DIFFERENT ENOUGH FROM THE PREVIOUS TRAIN THAT IT IS POSSIBLE THAT PREVIOUS INFECTION-INDUCED IMMUNITY MAY NOT PROVIDE THAT MUCH PROTECTION. ED:IE ANOTHER QUESTION THAT COMES UP IS WHAT IS REALLY THE FFDIERENCE WHEN WE HAVE A NEW VARIANT FROM THE SUB-VARNTIA IF THIS IS ATTH DIFFICULT -- DIFFERENT FROM THE OMICRON VARIANT? SOME PEOPLE HAVE COLD IT ONE THING, AND OTHERS THINK THAT SUPPORT NAME. WE CAN DETECT IT WITH OUR CURRENTLY AVAILABLE DIAGNOSTIC TESTS, OR WHETHER THIS ENDS UP INBEG A SEPARATE VARIANT OR IT GETS A NEW GREEK LETTER, WE WOULD JUST HAVE TO SEE WHAT THE WORLD HEALTH ORGANIZATION SAYS. GULSN:TA IT IS GREAT TO G YETOUR EXPERTISE. I CANNOT WAIT UILNT WE CAN STOP BUGGING YOU ALL

Moderna announced Wednesday that the first participant has been dosed in the company's Phase 2 clinical trial of a coronavirus vaccine booster shot that is specific to the omicron variant.Moderna is advancing the trial into its next phase as research published Wednesday in the New England Journal of Medicine found that a booster dose of the vaccine remained durable against the omicron variant but did show signs of waning antibody protection."We are reassured by the antibody persistence against omicron at six months after the currently authorized 50 μg booster of mRNA-1273. Nonetheless, given the long-term threat demonstrated by omicron's immune escape, we are advancing our omicron-specific variant vaccine booster candidate and we are pleased to begin this part of our Phase 2 study," CEO Stéphane Bancel said in a news release. "We are also evaluating whether to include this omicron-specific candidate in our multivalent booster program."Moderna said it expects to enroll about 600 people in the study, which will take place at up to 24 sites in the U.S. Some participants will have already received two doses of Moderna's vaccine, and some will have received a booster shot.Moderna promises to share its data from the trial with public health leaders so they can make evidence-based decisions on the best booster strategy against the coronavirus going forward.Pfizer and BioNTech, makers of the other major mRNA COVID-19 vaccine, announced Tuesday that they had begun their own omicron-specific vaccine trials.Omicron currently accounts for 99.9% of U.S. COVID-19 infections, the U.S. Centers for Disease Control and Prevention said Tuesday. The delta variant makes up the remaining 0.1%.Tracking the omicron surgeWhat we know about 'stealth' version of omicron variant Despite Supreme Court ruling, some companies are keeping vaccine mandates in place Federal vaccine mandate to kick in for first wave of health care workers The new study says the Moderna COVID-19 booster shot remains durable against the omicron variant, but the antibody protection wanes and is six times lower six months after getting boosted.The study also found that the neutralizing antibody levels declined against the omicron variant much more rapidly than against the dominant strain of the virus that was circulating two years ago.Research teams from Moderna, Duke University, Emory University, the Fred Hutchinson Cancer Research Center, the Baylor College of Medicine, the University of Maryland School of Medicine and the National Institutes of Health looked at blood samples of people who had received Moderna's COVID-19 vaccine.Two doses of the vaccine elicited detectable neutralizing antibodies against the omicron variant in 85% of the people one month after the second dose, but after seven months, neutralization of the variant was detected in only 55% of people.Getting a third booster dose of 50 micrograms of vaccine resulted in a 20-fold rise in omicron neutralization levels within four weeks after the boost was administered, but after six months, those levels fell 6.3-fold. By comparison, the durability of neutralization against the ancestral strain of the coronavirus fell only 2.3-fold after six months."While the antibody levels in study participants who received the boost continued to offer strong neutralizing activity, the levels of these antibodies declined faster for omicron than for the early SARS-CoV-2 virus that was circulating two years ago," the researchers said in a news release.The study had a few limitations. It included a small sample size, so it may not completely reflect how well the vaccine neutralizes the virus in diverse populations or in varying lengths of time before a person gets a booster.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These were also not real-life studies, and scientists looked only at antibodies generated in blood. Studies indicate that levels of antibodies correlate with real-world protection, however.Dave Montefiori, a co-author of the study and a professor in Duke University's Department of Surgery, said the drop in antibodies for the booster is very similar to the drop in antibodies to the delta variant that was noted six months after the second dose of vaccine, which prompted the advent of booster doses."This is not uncommon, for mRNA vaccines or for vaccines in general," Montefiori said. "Antibodies go down because the body figures it does not need to maintain them at that high level. It doesn't mean there is no protection. There is immunologic memory."Montefiori said that the concern is that the virus might change enough that the vaccine needs to be modified, and he noted Moderna's omicron-specific booster trial.But for now, he said, the data is not there yet, and the vaccines "are still working, and the boost is helping it to work better, even against omicron."Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases and a professor of medicine at Vanderbilt University, was cautiously optimistic about the findings. "The good news is that Moderna, when boosted, will give very high levels of antibodies, and of course, that's very encouraging," said Schaffner, who was not involved in the new study. "But as we've learned with these Covid viruses, the antibody levels begin after a period of about six months to decline."We've seen it before, Schaffner said, but we don't exactly know how this translates into real-world performance. "It's not clear whether this translates into reduced protection particularly for severe disease," he said.Large population data shows that two doses of the vaccine plus a booster provides rigorous protection against severe disease, even against the omicron variant."I think this study reinforces that basically, what was seen with the Pfizer vaccine plus boosting is replicated with Moderna also, and it may also be a harbinger or an early sign that at some interval down the road, as we get over this pandemic and get to a truce with this virus, that we may well have to get a periodic booster in order to maintain protection."

Moderna announced Wednesday that the first participant has been dosed in the company's Phase 2 clinical trial of a coronavirus vaccine booster shot that is specific to the omicron variant.

Moderna is advancing the trial into its next phase as research published Wednesday in the found that a booster dose of the vaccine remained durable against the omicron variant but did show signs of waning antibody protection.

"We are reassured by the antibody persistence against omicron at six months after the currently authorized 50 μg booster of mRNA-1273. Nonetheless, given the long-term threat demonstrated by omicron's immune escape, we are advancing our omicron-specific variant vaccine booster candidate and we are pleased to begin this part of our Phase 2 study," CEO Stéphane Bancel said in a news release. "We are also evaluating whether to include this omicron-specific candidate in our multivalent booster program."

Moderna said it expects to enroll about 600 people in the study, which will take place at up to 24 sites in the U.S. Some participants will have already received two doses of Moderna's vaccine, and some will have received a booster shot.

Moderna promises to share its data from the trial with public health leaders so they can make evidence-based decisions on the best booster strategy against the coronavirus going forward.

Pfizer and BioNTech, makers of the other major mRNA COVID-19 vaccine, announced Tuesday that they had begun their own omicron-specific vaccine trials.

Omicron currently accounts for 99.9% of U.S. COVID-19 infections, the U.S. Centers for Disease Control and Prevention said Tuesday. The delta variant makes up the remaining 0.1%.

Tracking the omicron surge

The new study says the Moderna COVID-19 booster shot remains durable against the omicron variant, but the antibody protection wanes and is six times lower six months after getting boosted.

The study also found that the neutralizing antibody levels declined against the omicron variant much more rapidly than against the dominant strain of the virus that was circulating two years ago.

Research teams from Moderna, Duke University, Emory University, the Fred Hutchinson Cancer Research Center, the Baylor College of Medicine, the University of Maryland School of Medicine and the National Institutes of Health looked at blood samples of people who had received Moderna's COVID-19 vaccine.

Two doses of the vaccine elicited detectable neutralizing antibodies against the omicron variant in 85% of the people one month after the second dose, but after seven months, neutralization of the variant was detected in only 55% of people.

Getting a third booster dose of 50 micrograms of vaccine resulted in a 20-fold rise in omicron neutralization levels within four weeks after the boost was administered, but after six months, those levels fell 6.3-fold. By comparison, the durability of neutralization against the ancestral strain of the coronavirus fell only 2.3-fold after six months.

"While the antibody levels in study participants who received the boost continued to offer strong neutralizing activity, the levels of these antibodies declined faster for omicron than for the early SARS-CoV-2 virus that was circulating two years ago," the researchers said in a news release.

The study had a few limitations. It included a small sample size, so it may not completely reflect how well the vaccine neutralizes the virus in diverse populations or in varying lengths of time before a person gets a booster.

These were also not real-life studies, and scientists looked only at antibodies generated in blood. Studies indicate that levels of antibodies correlate with real-world protection, however.

Dave Montefiori, a co-author of the study and a professor in Duke University's Department of Surgery, said the drop in antibodies for the booster is very similar to the drop in antibodies to the delta variant that was noted six months after the second dose of vaccine, which prompted the advent of booster doses.

"This is not uncommon, for mRNA vaccines or for vaccines in general," Montefiori said. "Antibodies go down because the body figures it does not need to maintain them at that high level. It doesn't mean there is no protection. There is immunologic memory."

Montefiori said that the concern is that the virus might change enough that the vaccine needs to be modified, and he noted Moderna's omicron-specific booster trial.

But for now, he said, the data is not there yet, and the vaccines "are still working, and the boost is helping it to work better, even against omicron."

Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases and a professor of medicine at Vanderbilt University, was cautiously optimistic about the findings. "The good news is that Moderna, when boosted, will give very high levels of antibodies, and of course, that's very encouraging," said Schaffner, who was not involved in the new study. "But as we've learned with these Covid viruses, the antibody levels begin after a period of about six months to decline."

We've seen it before, Schaffner said, but we don't exactly know how this translates into real-world performance. "It's not clear whether this translates into reduced protection particularly for severe disease," he said.

Large population data shows that two doses of the vaccine plus a booster provides rigorous protection against severe disease, even against the omicron variant.

"I think this study reinforces that basically, what was seen with the Pfizer vaccine plus boosting is replicated with Moderna also, and it may also be a harbinger or an early sign that at some interval down the road, as we get over this pandemic and get to a truce with this virus, that we may well have to get a periodic booster in order to maintain protection."

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