Us Deletes Updated Covid Boosters Targeting Newer Variants

The Food and Drug Administration’s move alters the recipe for shots made by Pfizer and rival Moderna that have already saved millions of lives. The hope is that the modified boosters will dampen yet another winter surge — and help reduce the BA.5 omicron congener that continues to spread widely. “These updated boosters give us an opportunity to pre-empt” the next wave of COVID-19, said FDA Commissioner Dr. Robert Califf. Until now, vaccines for COVID-19 have targeted the original strain of the coronavirus, even as vastly different mutants emerged. The new US boosters are combination or “bivalent” shots. They contain half of this original vaccine recipe and half of the protection from the newer versions of the omicron, BA.4 and BA.5, which are considered the most contagious yet. The combination aims to increase cross-protection against multiple variants. “It really provides the broadest opportunity for protection,” Pfizer vaccine chief Annaliesa Anderson told The Associated Press. Updated boosters are only intended for people who have already had the original vaccinations, using the original vaccines. The doses made by Pfizer and its partner BioNTech are for anyone 12 years and older, while Moderna’s updated shots are for adults — if it’s been at least two months since their last primary vaccination or their last booster. They should not be used for primary vaccinations. There’s one more step before a fall booster campaign begins: The Centers for Disease Control and Prevention must recommend who should get the extra shot. An influential CDC advisory panel will discuss the evidence Thursday — including whether people at high risk of COVID-19 should go first. The US has purchased more than 170 million doses from the two companies. Pfizer said it could ship up to 15 million of those doses by the end of next week. Moderna did not immediately say how many doses were ready to ship, but that some would be available “in the coming days.” The big question is whether people tired of vaccinations will roll up their sleeves again. Just half of vaccinated Americans received the first recommended booster dose, and only a third of those 50 and older who were told to receive a second booster did so. Here’s the rub: The original vaccines still offer strong protection against serious illness and death from COVID-19 for generally healthy people, especially if they received that important first booster dose. It’s unclear how much more benefit an updated booster would bring — beyond a temporary jump in antibodies capable of warding off a microbe infection. However, “people need to realize that this is a different kind of amplifier than what was previously available. It will work better at protecting against the microbe,” said virologist Andrew Pekosz of the Johns Hopkins Bloomberg School of Public Health. Even people who had an older version of omicron can still be reinfected, so “you should definitely go for the booster even if you’ve been infected in the last year,” Pekosz added. He thinks that “if we can get good buy-in to use it, we might really be able to make a dent” in cases of COVID-19. The FDA cleared the changes ahead of human studies, a step toward eventually handling vaccine updates for COVID-19 more like annual changes to flu shots. The FDA’s vaccine chief, Dr. Peter Marks, stressed that the agency considered “the totality” of the evidence. Pfizer and Moderna have previously made doses of vaccines that have been updated to match previous mutants — including the omicron strain called BA.1 that hit last winter — and tested them in humans. These previous recipe changes were safe, and the BA.1 version significantly boosted virus-fighting antibodies—more than another dose of the original vaccine—though fewer than recognized today’s genetically distinct BA.4 and BA.5 strains. But instead of using those BA.1 shots, the FDA ordered the companies to make even more updated doses that target these newer microbe mutants, sparking a race to market them. Instead of waiting a few more months for additional human studies on this very similar prescription sting, Marks said animal tests showed the latest update promotes “a very good immune response.” “Someone has to prime the immune system with what’s actually circulating,” Marks said. That’s why the FDA no longer approves boosters made with the original prescription for people 12 years of age and older. The hope, Marks said, is that a vaccine that matches the current variants that are spreading might do a better job of fighting infection, not just severe disease, at least for a while. What’s next? Even as modified plans are released, Moderna and Pfizer conduct human studies to help assess their value, including how they hold up if a new mutant emerges. And for children, Pfizer plans to ask the FDA to allow updated boosters for children ages 5 to 11 in early October. It’s the first U.S. update to the COVID-19 vaccine prescription, an important but expected next step — much like how flu vaccines are updated each year. And the US is not alone. Britain has recently decided to offer adults over 50 a different booster option from Moderna, a composite download that targets this initial strain BA.1 omicron. European regulators are considering whether to approve one or both of the updated formulas.

AP Health writer Matthew Perrone contributed to this report.

The Associated Press Health and Science Section is supported by the Howard Hughes Medical Institute Science Education Division. AP is solely responsible for all content.

title: “Us Deletes Updated Covid Boosters Targeting Newer Variants Klmat” ShowToc: true date: “2022-11-24” author: “Joseph Spanton”

The Food and Drug Administration’s move alters the recipe for shots made by Pfizer and rival Moderna that have already saved millions of lives. The hope is that the modified boosters will dampen yet another winter surge — and help reduce the BA.5 omicron congener that continues to spread widely. “These updated boosters give us an opportunity to pre-empt” the next wave of COVID-19, said FDA Commissioner Dr. Robert Califf. Until now, vaccines for COVID-19 have targeted the original strain of the coronavirus, even as vastly different mutants emerged. The new US boosters are combination or “bivalent” shots. They contain half of this original vaccine recipe and half of the protection from the newer versions of the omicron, BA.4 and BA.5, which are considered the most contagious yet. The combination aims to increase cross-protection against multiple variants. “It really provides the broadest opportunity for protection,” Pfizer vaccine chief Annaliesa Anderson told The Associated Press. Updated boosters are only intended for people who have already had the original vaccinations, using the original vaccines. The doses made by Pfizer and its partner BioNTech are for anyone 12 years and older, while Moderna’s updated shots are for adults — if it’s been at least two months since their last primary vaccination or their last booster. They should not be used for primary vaccinations. There’s one more step before a fall booster campaign begins: The Centers for Disease Control and Prevention must recommend who should get the extra shot. An influential CDC advisory panel will discuss the evidence Thursday — including whether people at high risk of COVID-19 should go first. The US has purchased more than 170 million doses from the two companies. Pfizer said it could ship up to 15 million of those doses by the end of next week. Moderna did not immediately say how many doses were ready to ship, but that some would be available “in the coming days.” The big question is whether people tired of vaccinations will roll up their sleeves again. Just half of vaccinated Americans received the first recommended booster dose, and only a third of those 50 and older who were told to receive a second booster did so. Here’s the rub: The original vaccines still offer strong protection against serious illness and death from COVID-19 for generally healthy people, especially if they received that important first booster dose. It’s unclear how much more benefit an updated booster would bring — beyond a temporary jump in antibodies capable of warding off a microbe infection. However, “people need to realize that this is a different kind of amplifier than what was previously available. It will work better at protecting against the microbe,” said virologist Andrew Pekosz of the Johns Hopkins Bloomberg School of Public Health. Even people who had an older version of omicron can still be reinfected, so “you should definitely go for the booster even if you’ve been infected in the last year,” Pekosz added. He thinks that “if we can get good buy-in to use it, we might really be able to make a dent” in cases of COVID-19. The FDA cleared the changes ahead of human studies, a step toward eventually handling vaccine updates for COVID-19 more like annual changes to flu shots. The FDA’s vaccine chief, Dr. Peter Marks, stressed that the agency considered “the totality” of the evidence. Pfizer and Moderna have previously made doses of vaccines that have been updated to match previous mutants — including the omicron strain called BA.1 that hit last winter — and tested them in humans. These previous recipe changes were safe, and the BA.1 version significantly boosted virus-fighting antibodies—more than another dose of the original vaccine—though fewer than recognized today’s genetically distinct BA.4 and BA.5 strains. But instead of using those BA.1 shots, the FDA ordered the companies to make even more updated doses that target these newer microbe mutants, sparking a race to market them. Instead of waiting a few more months for additional human studies on this very similar prescription sting, Marks said animal tests showed the latest update promotes “a very good immune response.” “Someone has to prime the immune system with what’s actually circulating,” Marks said. That’s why the FDA no longer approves boosters made with the original prescription for people 12 years of age and older. The hope, Marks said, is that a vaccine that matches the current variants that are spreading might do a better job of fighting infection, not just severe disease, at least for a while. What’s next? Even as modified plans are released, Moderna and Pfizer conduct human studies to help assess their value, including how they hold up if a new mutant emerges. And for children, Pfizer plans to ask the FDA to allow updated boosters for children ages 5 to 11 in early October. It’s the first U.S. update to the COVID-19 vaccine prescription, an important but expected next step — much like how flu vaccines are updated each year. And the US is not alone. Britain has recently decided to offer adults over 50 a different booster option from Moderna, a composite download that targets this initial strain BA.1 omicron. European regulators are considering whether to approve one or both of the updated formulas.

AP Health writer Matthew Perrone contributed to this report.

The Associated Press Health and Science Section is supported by the Howard Hughes Medical Institute Science Education Division. AP is solely responsible for all content.