Cdc Panel Greenlights New Covid 19 Boosters Ahead Of Fall Booster Campaign

The new booster vaccines have been updated to target two different strains of COVID in one shot — the current omicron subvariants, BA.4 and BA.5, which account for 99% of new cases in the US, and the original strain of COVID-19 . This is the first time that current vaccines against COVID-19 have had a major upgrade. In the future, experts expect vaccines will be able to be updated periodically to match current strains — similar to how the flu vaccine is slightly different each year. Public health officials have asked vaccine companies to create a bivalent vaccine — one that targets two different strains — in hopes that the collection will provide broader protection against COVID this fall and winter, as infections could increase with flu season, cold weather and more time indoors. “It depends on what’s out there right now. And the hope here is that by increasing the amount of antibodies that we have in that particular variant, we’ll restore the kind of protection that we had when we first saw these vaccines come out in the latter part of 2020, in early 2021, where we had very good protection against symptomatic disease,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters at a press conference Wednesday morning. “We don’t know yet if we’re going to get to the same level — but that’s the goal here. And that’s what we think the evidence that we’ve seen shows,” Marks said. Marks also emphasized that it’s not just about boosting antibodies to boost immediate protection, but about trying for annual shots instead of boosters every few months. He said he hoped the release of bivalent boosters now would neutralize an upcoming winter surge and “hopefully give us the protection we need through October, November, December to prevent another way that shuts down things like vacation plans.” The FDA issued the emergency use authorization for the updated booster shots Wednesday morning. On Thursday, the CDC advisory panel publicly reviewed the data before taking a vote around 4:30 p.m. Booster doses are being sent as soon as the FDA issues its licenses, but Walensky’s recommendation, expected Thursday or Friday, is the final step before the shots can become weapons. Dates could seriously pick up after the holiday weekend. The US government has bought about 171 million shots, between contracts with Pfizer and Moderna. Pfizer’s updated vaccine is approved for people 12 years of age and older, while Moderna’s vaccine is for people 18 years of age and older. Both bivalent vaccines are approved for use two months after individuals have received either the primary vaccine series or their last booster vaccine. The Moderna vial will have a dark blue cap and label with a gray border, while the Pfizer vial will have a gray cap and label with a gray border. Marks was hesitant to give an exact timeline for when downloads for under-12s would be allowed, but said he expected more data in a few months. “I can’t promise an exact time, but we expect to start seeing … that will drop into the younger age ranges within the next one to two months,” Marks said. “And so as we get submissions from the companies, we will act on them with all due diligence because we know that there are, particularly in the slightly older age groups of kids, some kids who come for souvenirs.” he said. Currently, everyone over the age of five is eligible for a booster shot five months after their primary vaccine series. People over 50 or immunocompromised can get a second booster four months after their first booster. If the CDC director signs off, people who are under 50 and have gotten their first reminder could now get a second. But anyone who hasn’t gotten a booster shot at all could also get the bivalent booster as the first booster — which officials urged. “Unfortunately, only about half of eligible Americans have received their first booster dose,” FDA Commissioner Dr. Bob Califf told reporters at the same news conference. “CDC data shows that those who are up-to-date about their vaccines have a 13 times lower risk of dying from COVID compared to those who were not vaccinated, and a three times lower rate of death than those who had only one booster compared to two. So this is a remarkable opportunity to improve our life expectancy and reduce the number of deaths in our population,” said Califf. Unlike the original vaccines and boosters, these new vaccines will not go through a lengthy clinical trial process where thousands of Americans receive doses of the vaccines to test their safety and long-term effectiveness. But federal health officials stress that these new vaccines will still be just as safe as the original vaccines because the underlying vaccine platform, mRNA, is the same and has gone through many different clinical trials. Part of that review was an evaluation of a clinical study of a different updated booster that vaccine companies had done during a previous wave of microns. The clinical trial of this booster, targeting the BA.1 variant and the original strain of COVID, was considered quite relevant to the bivalent vaccines targeting the BA.4/BA.5 variant and the original strain of omicron. Officials also said the decision not to use time-consuming clinical trials for each new vaccine is a strategic move in an effort to keep vaccines up-to-date with rapidly evolving variants — a process likely to mimic how the Flu vaccine is modified every year. “If we waited for all the evidence to come in, the wave would have passed us by now and the damage would have been done,” Kalief said. “It’s fair for people to raise questions. But this is really the best consensus we have among experts that this is the best way,” he added. Marks also repeatedly defended the data the FDA used to grant that authorization — clinical trial data for a bivalent vaccine that targeted a different subvariant omicron and the original strain of COVID-19, making it very similar to this booster vaccine that targets the BA.4 and 5 subvariant along with the original strain of COVID-19 — as well as real-world data from millions of people who have had the vaccines and mRNA boosters worldwide. “I think we’re pretty confident that what we have is very similar to the situation we’ve had in the past with flu strain changes where we don’t do clinical studies on them in the United States,” Marks said. “We know from the way the vaccine works and from the data we have that we can predict how well our vaccine will work,” Marks said.

title: “Cdc Panel Greenlights New Covid 19 Boosters Ahead Of Fall Booster Campaign Klmat” ShowToc: true date: “2022-11-27” author: “Cheryl Benjamin”

The new booster vaccines have been updated to target two different strains of COVID in one shot — the current omicron subvariants, BA.4 and BA.5, which account for 99% of new cases in the US, and the original strain of COVID-19 . This is the first time that current vaccines against COVID-19 have had a major upgrade. In the future, experts expect vaccines will be able to be updated periodically to match current strains — similar to how the flu vaccine is slightly different each year. Public health officials have asked vaccine companies to create a bivalent vaccine — one that targets two different strains — in hopes that the collection will provide broader protection against COVID this fall and winter, as infections could increase with flu season, cold weather and more time indoors. “It depends on what’s out there right now. And the hope here is that by increasing the amount of antibodies that we have in that particular variant, we’ll restore the kind of protection that we had when we first saw these vaccines come out in the latter part of 2020, in early 2021, where we had very good protection against symptomatic disease,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters at a press conference Wednesday morning. “We don’t know yet if we’re going to get to the same level — but that’s the goal here. And that’s what we think the evidence that we’ve seen shows,” Marks said. Marks also emphasized that it’s not just about boosting antibodies to boost immediate protection, but about trying for annual shots instead of boosters every few months. He said he hoped the release of bivalent boosters now would neutralize an upcoming winter surge and “hopefully give us the protection we need through October, November, December to prevent another way that shuts down things like vacation plans.” The FDA issued the emergency use authorization for the updated booster shots Wednesday morning. On Thursday, the CDC advisory panel publicly reviewed the data before taking a vote around 4:30 p.m. Booster doses are being sent as soon as the FDA issues its licenses, but Walensky’s recommendation, expected Thursday or Friday, is the final step before the shots can become weapons. Dates could seriously pick up after the holiday weekend. The US government has bought about 171 million shots, between contracts with Pfizer and Moderna. Pfizer’s updated vaccine is approved for people 12 years of age and older, while Moderna’s vaccine is for people 18 years of age and older. Both bivalent vaccines are approved for use two months after individuals have received either the primary vaccine series or their last booster vaccine. The Moderna vial will have a dark blue cap and label with a gray border, while the Pfizer vial will have a gray cap and label with a gray border. Marks was hesitant to give an exact timeline for when downloads for under-12s would be allowed, but said he expected more data in a few months. “I can’t promise an exact time, but we expect to start seeing … that will drop into the younger age ranges within the next one to two months,” Marks said. “And so as we get submissions from the companies, we will act on them with all due diligence because we know that there are, particularly in the slightly older age groups of kids, some kids who come for souvenirs.” he said. Currently, everyone over the age of five is eligible for a booster shot five months after their primary vaccine series. People over 50 or immunocompromised can get a second booster four months after their first booster. If the CDC director signs off, people who are under 50 and have gotten their first reminder could now get a second. But anyone who hasn’t gotten a booster shot at all could also get the bivalent booster as the first booster — which officials urged. “Unfortunately, only about half of eligible Americans have received their first booster dose,” FDA Commissioner Dr. Bob Califf told reporters at the same news conference. “CDC data shows that those who are up-to-date about their vaccines have a 13 times lower risk of dying from COVID compared to those who were not vaccinated, and a three times lower rate of death than those who had only one booster compared to two. So this is a remarkable opportunity to improve our life expectancy and reduce the number of deaths in our population,” said Califf. Unlike the original vaccines and boosters, these new vaccines will not go through a lengthy clinical trial process where thousands of Americans receive doses of the vaccines to test their safety and long-term effectiveness. But federal health officials stress that these new vaccines will still be just as safe as the original vaccines because the underlying vaccine platform, mRNA, is the same and has gone through many different clinical trials. Part of that review was an evaluation of a clinical study of a different updated booster that vaccine companies had done during a previous wave of microns. The clinical trial of this booster, targeting the BA.1 variant and the original strain of COVID, was considered quite relevant to the bivalent vaccines targeting the BA.4/BA.5 variant and the original strain of omicron. Officials also said the decision not to use time-consuming clinical trials for each new vaccine is a strategic move in an effort to keep vaccines up-to-date with rapidly evolving variants — a process likely to mimic how the Flu vaccine is modified every year. “If we waited for all the evidence to come in, the wave would have passed us by now and the damage would have been done,” Kalief said. “It’s fair for people to raise questions. But this is really the best consensus we have among experts that this is the best way,” he added. Marks also repeatedly defended the data the FDA used to grant that authorization — clinical trial data for a bivalent vaccine that targeted a different subvariant omicron and the original strain of COVID-19, making it very similar to this booster vaccine that targets the BA.4 and 5 subvariant along with the original strain of COVID-19 — as well as real-world data from millions of people who have had the vaccines and mRNA boosters worldwide. “I think we’re pretty confident that what we have is very similar to the situation we’ve had in the past with flu strain changes where we don’t do clinical studies on them in the United States,” Marks said. “We know from the way the vaccine works and from the data we have that we can predict how well our vaccine will work,” Marks said.