The Centers for Disease Control and Prevention’s independent panel on vaccines has recommended reformulated booster shots that target the latest omicron subvariants. The panel voted 13 to 1 Thursday in favor of the shots after reviewing available safety and effectiveness data in a meeting that lasted nearly seven hours. CDC Director Dr. Rochelle Walensky, has yet to give the final indication before pharmacies start dispensing the boosters, but the OK is expected to follow quickly. Pfizer’s omicron boosters are for people 12 years of age and older, while Moderna’s updated shots are for adults 18 years of age and older. Eligible age groups can receive the boosters at least two months after completing the main series or their most recent booster with the old shots. Pfizer plans to ask the Food and Drug Administration to also approve the new boosters for children ages 5 to 11 in early October, company officials told the committee Thursday. The original vaccines will no longer be used as boosters in people aged 12 and over now that the reformulated vaccines are coming online. Public health officials expect another wave of Covd infection this fall as immunity from old vaccines wanes, more contagious subtypes of the microbe spread and people spend more time indoors as the weather turns colder and families gather for the holidays. The CDC and FDA hope the new boosters will provide more durable protection against infections, mild illnesses, and severe illnesses. The reformulated shots target omicron BA.5, the dominant variant of Covid as well as the strain that emerged in China more than two years ago. The US has so far secured 171 million doses of new boosters from Pfizer and Moderna. More than 200 million people are eligible for the shots, according to the CDC. Dr. Sara Oliver, a CDC official, told the committee Thursday that there should be enough supply of the vaccine to meet demand this fall.
There are no human data for omicron BA.5
There’s no human test data for the new BA.5 boosters, so it’s unclear how they’ll perform in the real world. The CDC and FDA used data from human clinical trials for shots targeting the original version of omicron, BA.1, which elicited a stronger immune response than the old vaccines. Pfizer and Moderna initially developed omicron boosters to target BA.1, but the FDA asked the companies to switch gears in June and develop BA.5 shots instead after the subvariant became dominant. The decision to focus on BA.5 did not leave enough time to wait for data from human trials before the vaccine is released in the fall. The lack of human data on BA.5 vaccines has caused some controversy, but Dr. Peter Marks, a senior FDA official, said the agency followed the same process used for years with strain changes for flu vaccines. Marks said Wednesday that flu vaccine strains are also changing without human clinical data. Dr. Pablo Sanchez, the only panel member who voted against the firings, called the recommendation premature and said the U.S. should have waited for human data before moving forward with the boosters. “There’s already a lot of hesitancy about vaccines — we need the human data,” said Sanchez, a professor of pediatrics at Ohio State University. But Sanchez said he believes the new boosters are safe and will likely take them himself.
CNBC Health & Science
Read CNBC’s latest global health coverage: Committee member Dr. Oliver Brooks, chief medical officer at Watts HealthCare Corporation in Los Angeles, questioned why the FDA decided to use a BA.5 vaccine when clinical data are available for the BA.1 vaccines originally developed by vaccine manufacturers. Brooks ended up voting for the shots. But Dr Sarah Long, also a member of the panel, said there was no reason to expect the BA.5 boosters to be inferior to the old vaccines, as they also include the original Covid strain and have the potential to reduce hospitalizations and deaths leading to fall and winter. Long also voted in favor.
Mouse studies
FDA and CDC officials said the omicron BA.1 and omicron BA.5 boosters are similar enough that the immune response data from the BA.1 vaccine should provide a good indication of how well the BA.5 shots will perform. Omicron BA.1 and BA.5 are closely related with a difference of four mutations, according to Dr. Jacqueline Miller, who works in vaccine development at Moderna. Moderna completed clinical trial enrollment for the BA.5 shots last week and should have results by the end of the year, Miller told the CDC committee Thursday. Pfizer’s clinical trial is also ongoing, although the company has not said when it expects results. The health services also reviewed data on BA.5 intakes from mouse studies. Moderna presented data showing that the BA.5 shots boosted antibodies in mice more than four times compared to the old shots. Mice express the same cellular protein as humans that the virus infects. Pfizer’s BA.5 booster boosted antibodies 2.6-fold in mice compared to the original vaccine.
Security
The most common side effects from human trials of BA.1 shots were pain, redness, swelling at the injection site, fatigue, headaches, muscle pain, joint pain, chills, nausea, vomiting and fever, according to the FDA. Oliver, the CDC official, told the committee that health officials do not expect any difference in the safety profile of the BA.1 and BA.5 shots since the subvariants differ by only a few mutations. But Oliver noted that the risk of myocarditis after a BA.5 booster is unknown. There is an increased risk of myocarditis among young men and adolescent boys after the second dose of the Pfizer and Moderna vaccine, but the risk of myocarditis from a Covid infection is higher, according to the CDC. “We know that the risk of myocarditis is unknown, but we expect a similar risk to that seen after monovalent vaccines,” Oliver said. Monovalent vaccines are the old vaccines that have been given to millions of people in the US over the past two years.
Old vaccines lose their effectiveness
The original vaccines, which were first approved in December 2020, no longer provide substantial protection against infection because the virus has mutated so much over the past two years. The shots were developed against the first strain that appeared in China, so they are no longer suitable to target the micron subvariants that are spreading. Infections, hospitalizations and deaths have fallen dramatically since last winter’s huge wave of microbe infection, but have remained stubbornly high this summer. Omicron BA.5 is the most contagious and immune evasive variant to date, and as a result unprecedented infections are becoming more common. The effectiveness of the old vaccines against hospitalization also decreased after omicron BA.5 became dominant. A third dose was 77 percent effective in preventing hospitalization four months after receiving the vaccine, but protection declined after 120 days to as little as 34 percent, according to CDC data. A fourth dose in people aged 50 and over was 56% effective in preventing hospitalization after four months. Deaths and hospitalizations from Covid among people age 65 and older have increased since April, according to Heather Scobie, a CDC epidemiologist who presented data at Thursday’s meeting. Deaths have increased especially among people age 75 and older, Scobie said. The CDC has shifted to a more targeted public health response with an emphasis on protecting the most vulnerable — the elderly, people with serious medical conditions and those with weakened immune systems. Although there is no real-world data on the effectiveness of the new boosters, the US is moving quickly to make them available in hopes that they will protect people this fall.
title: “Cdc Panel Recommends New Omicron Covid Boosters With Shots Expected To Begin Next Week Klmat” ShowToc: true date: “2022-10-28” author: “Renee Rombough”
The Centers for Disease Control and Prevention’s independent panel on vaccines has recommended reformulated booster shots that target the latest omicron subvariants. The panel voted 13 to 1 Thursday in favor of the shots after reviewing available safety and effectiveness data in a meeting that lasted nearly seven hours. CDC Director Dr. Rochelle Walensky, has yet to give the final indication before pharmacies start dispensing the boosters, but the OK is expected to follow quickly. Pfizer’s omicron boosters are for people 12 years of age and older, while Moderna’s updated shots are for adults 18 years of age and older. Eligible age groups can receive the boosters at least two months after completing the main series or their most recent booster with the old shots. Pfizer plans to ask the Food and Drug Administration to also approve the new boosters for children ages 5 to 11 in early October, company officials told the committee Thursday. The original vaccines will no longer be used as boosters in people aged 12 and over now that the reformulated vaccines are coming online. Public health officials expect another wave of Covd infection this fall as immunity from old vaccines wanes, more contagious subtypes of the microbe spread and people spend more time indoors as the weather turns colder and families gather for the holidays. The CDC and FDA hope the new boosters will provide more durable protection against infections, mild illnesses, and severe illnesses. The reformulated shots target omicron BA.5, the dominant variant of Covid as well as the strain that emerged in China more than two years ago. The US has so far secured 171 million doses of new boosters from Pfizer and Moderna. More than 200 million people are eligible for the shots, according to the CDC. Dr. Sara Oliver, a CDC official, told the committee Thursday that there should be enough supply of the vaccine to meet demand this fall.
There are no human data for omicron BA.5
There’s no human test data for the new BA.5 boosters, so it’s unclear how they’ll perform in the real world. The CDC and FDA used data from human clinical trials for shots targeting the original version of omicron, BA.1, which elicited a stronger immune response than the old vaccines. Pfizer and Moderna initially developed omicron boosters to target BA.1, but the FDA asked the companies to switch gears in June and develop BA.5 shots instead after the subvariant became dominant. The decision to focus on BA.5 did not leave enough time to wait for data from human trials before the vaccine is released in the fall. The lack of human data on BA.5 vaccines has caused some controversy, but Dr. Peter Marks, a senior FDA official, said the agency followed the same process used for years with strain changes for flu vaccines. Marks said Wednesday that flu vaccine strains are also changing without human clinical data. Dr. Pablo Sanchez, the only panel member who voted against the firings, called the recommendation premature and said the U.S. should have waited for human data before moving forward with the boosters. “There’s already a lot of hesitancy about vaccines — we need the human data,” said Sanchez, a professor of pediatrics at Ohio State University. But Sanchez said he believes the new boosters are safe and will likely take them himself.
CNBC Health & Science
Read CNBC’s latest global health coverage: Committee member Dr. Oliver Brooks, chief medical officer at Watts HealthCare Corporation in Los Angeles, questioned why the FDA decided to use a BA.5 vaccine when clinical data are available for the BA.1 vaccines originally developed by vaccine manufacturers. Brooks ended up voting for the shots. But Dr Sarah Long, also a member of the panel, said there was no reason to expect the BA.5 boosters to be inferior to the old vaccines, as they also include the original Covid strain and have the potential to reduce hospitalizations and deaths leading to fall and winter. Long also voted in favor.
Mouse studies
FDA and CDC officials said the omicron BA.1 and omicron BA.5 boosters are similar enough that the immune response data from the BA.1 vaccine should provide a good indication of how well the BA.5 shots will perform. Omicron BA.1 and BA.5 are closely related with a difference of four mutations, according to Dr. Jacqueline Miller, who works in vaccine development at Moderna. Moderna completed clinical trial enrollment for the BA.5 shots last week and should have results by the end of the year, Miller told the CDC committee Thursday. Pfizer’s clinical trial is also ongoing, although the company has not said when it expects results. The health services also reviewed data on BA.5 intakes from mouse studies. Moderna presented data showing that the BA.5 shots boosted antibodies in mice more than four times compared to the old shots. Mice express the same cellular protein as humans that the virus infects. Pfizer’s BA.5 booster boosted antibodies 2.6-fold in mice compared to the original vaccine.
Security
The most common side effects from human trials of BA.1 shots were pain, redness, swelling at the injection site, fatigue, headaches, muscle pain, joint pain, chills, nausea, vomiting and fever, according to the FDA. Oliver, the CDC official, told the committee that health officials do not expect any difference in the safety profile of the BA.1 and BA.5 shots since the subvariants differ by only a few mutations. But Oliver noted that the risk of myocarditis after a BA.5 booster is unknown. There is an increased risk of myocarditis among young men and adolescent boys after the second dose of the Pfizer and Moderna vaccine, but the risk of myocarditis from a Covid infection is higher, according to the CDC. “We know that the risk of myocarditis is unknown, but we expect a similar risk to that seen after monovalent vaccines,” Oliver said. Monovalent vaccines are the old vaccines that have been given to millions of people in the US over the past two years.
Old vaccines lose their effectiveness
The original vaccines, which were first approved in December 2020, no longer provide substantial protection against infection because the virus has mutated so much over the past two years. The shots were developed against the first strain that appeared in China, so they are no longer suitable to target the micron subvariants that are spreading. Infections, hospitalizations and deaths have fallen dramatically since last winter’s huge wave of microbe infection, but have remained stubbornly high this summer. Omicron BA.5 is the most contagious and immune evasive variant to date, and as a result unprecedented infections are becoming more common. The effectiveness of the old vaccines against hospitalization also decreased after omicron BA.5 became dominant. A third dose was 77 percent effective in preventing hospitalization four months after receiving the vaccine, but protection declined after 120 days to as little as 34 percent, according to CDC data. A fourth dose in people aged 50 and over was 56% effective in preventing hospitalization after four months. Deaths and hospitalizations from Covid among people age 65 and older have increased since April, according to Heather Scobie, a CDC epidemiologist who presented data at Thursday’s meeting. Deaths have increased especially among people age 75 and older, Scobie said. The CDC has shifted to a more targeted public health response with an emphasis on protecting the most vulnerable — the elderly, people with serious medical conditions and those with weakened immune systems. Although there is no real-world data on the effectiveness of the new boosters, the US is moving quickly to make them available in hopes that they will protect people this fall.
