И что теперь?
С вакцинацией от ковида вот такой примерно расклад, как рассказьівается в этой статье.
[Spoiler (click to open)]Omicron, and especially its subvariants, is so different from Wuhan-Hu-1 that it is most adept at evading the immune response generated by current vaccines. Even so, studies have shown that the prototype COVID-19 vaccines still reduce the risk of serious illness and death from Omicron. Updating COVID-19 vaccines is easier said than done, and some observers question whether it’s the best way to tackle the unpredictable, ever-changing virus.
In a May 2 JAMA Viewpoint, FDA officials called circulating SARS-CoV-2 “the new normal,” likely requiring consideration of annual updates of COVID-19 vaccines, as is done with influenza vaccines. “[A] greater depth and duration of protection might be achieved with a vaccine covering currently circulating variants,” wrote coauthors Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER)
“The challenge is we don’t know the rules of how this virus [SARS-CoV-2] behaves. For seasonal flu, we know the rules,” John Beigel, MD, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID), explained in an interview. “Omicron kind of came out of nowhere. A year ago, we wouldn’t have predicted something like Omicron.”
One thing for sure, VRBPAC member Paul Offit, MD, said in an interview, boosting people every 6 months “is not a reasonable public health strategy.”
he WHO conducts influenza surveillance 24/7 year-round.
Twice annually, in February for the Northern Hemisphere and in September for the Southern Hemisphere, the WHO convenes a panel of experts to review the surveillance data to see whether new influenza strains are circulating and infecting people.
If so, the panel must decide whether current vaccines protect against the new circulating strains and, if not, whether the vaccines need to be updated with antigens that are a better match. About a week after that decision is made, the FDA convenes VRBPAC to make recommendations for the composition of US vaccines for the upcoming flu season.
Determining the composition of the vaccine must be done months in advance of flu season to give manufacturers enough time to produce tens of millions of doses.
When the vaccine is well-matched to circulating viruses, it is approximately 60% effective for the overall population, the FDA’s Jerry Weir, PhD, director of the Division of Viral Products in CBER’s Office of Vaccine Research and Review, told VRBPAC panelists at their April meeting.
Sometimes the vaccine isn’t well-matched, though. For example, preliminary, interim estimates for the 2021-2022 flu season show that the vaccine didn’t reduce the risk of mild or moderate illness from influenza A viruses, according to the CDC. Reasons vary for why the flu vaccine might not be well-matched, Weir explained at the VRBPAC meeting. Sometimes antigenically distinct viruses emerge after the vaccine composition has been decided.. Sometimes manufacturing issues can’t be resolved in time to produce a well-matched vaccine, Weir said. And that’s with a vaccine against a virus that has a long track record.
Updating vaccines against SARS-CoV-2 presents special challenges, Weir noted at the VRBPAC meeting. While most influenza vaccines have similar platforms with similar time frames needed for updating them, that’s not the case with COVID-19 vaccines, he pointed out. Not only do COVID-19 vaccine platforms differ from each other, but there’s been no coordination among manufacturers, who are at various stages in clinical trials with updated vaccines of varying compositions, Weir said. Although some manufacturers are considering a combination annual vaccine against both COVID-19 and seasonal influenza, “it’s premature to combine them,” Subbarao told JAMA.
“We don’t know how often we’ll have to vaccinate against COVID.” Plus, she said, whether SARS-CoV-2 follows the same seasonal pattern as influenza isn’t yet clear.
The advisory group will recommend methods to assess the impact of variants of concern on COVID-19 vaccines, interpret available evidence on the effects of those variants on vaccines, and provide guidance on whether vaccine composition should be adjusted to protect against variants of concern, Subbarao told VRBPAC members at their April 6 meeting.
If the FDA decides to grant Emergency Use Authorization (EUA) of investigational vaccines that contain antigenic material from SARS-CoV-2 variants, manufacturers may be hard-pressed to manufacture enough doses to meet demand by the fall. (Given the relatively low number of people who’ve received a second booster, just what the demand might be for a third one represents another as-yet unanswered question.)
“It’s not hard to change it,” Beigel said of current COVID-19 vaccines. “It’s hard to scale it and deliver 100 million doses.”
Although he’s 71 and, therefore, eligible for a second booster shot, Offit, chair of vaccinology at the University of Pennsylvania’s Perelman School of Medicine, hasn’t yet opted to get one. He’s healthy, and research has clearly shown that 3 doses would reduce the risk of serious illness if he were to contract COVID-19, he explained.
Offit, citing a lack of evidence showing that an Omicron-based booster would provide more protection than the prototype vaccines do, said, “I don’t understand the thinking behind it.”
By adding a booster against variants to the vaccine arsenal, “What are you really doing for the pandemic: Protecting people who are already protected?” Offit asked. A wiser investment would be to ship the prototype vaccines overseas to vaccinate the unvaccinated, he said.
Protection against serious illness isn’t enough for many people, Offit acknowledged. Concerned about the possibility of long COVID, many people don’t want to get infected with SARS-CoV-2, period, he said, adding that he’d like to see more rigor in defining long COVID.
Offit questioned whether preventing infection completely was an attainable goal for vaccines against SARS-CoV-2.
“Is it realistic to expect that we can protect against all illness with this virus?” Offit asked. “I feel like this is much ado about little. This is not flu. You get a flu vaccine every year because you’re still not protected against serious disease” even if vaccinated the previous year. If the goal is to prevent all SARS-CoV-2 infections, even the mild ones, “I think we’re going to drive ourselves a little crazy,” he said.
SARS-CoV-2,..is a mucosal infection with a short incubation period, giving vaccine-generated immunity a relatively brief window of opportunity to completely block infection.people vaccinated against SARS-CoV-2 can still get sick with COVID-19, Offit explained. In contrast, measles is a viral infection with an average incubation period of 11 or 12 days-more than twice that of SARS-CoV-2. On top of that, there’s only 1 antigenic type of measles, which has barely changed over time, so vaccine-induced immunity against it is thought to be lifelong.
By expecting the same from COVID-19 vaccines as from measles vaccines, “we’re setting [COVID-19] vaccine up for failure,” Offit said. The wording used to describe SARS-CoV-2 infections in vaccinated and boosted individuals hasn’t helped lower expectations for COVID-19, he added. “We damned it when we used the term ‘breakthrough infection.’”
“We do need to encourage the development of COVID-19 vaccines that will have an impact on prevention of infection and transmission, in addition to protecting against severe illness and death.”
Developing variant-based injectable vaccines might seem like a game of whack-a-mole.argeting Omicron with a vaccine assumes that there will be an Omicron resurgence, but by the time such a vaccine is ready to be used, the circulating variant could be Beta or Delta, both significantly different from Omicron and Alpha, Beigel told VRBPAC members.
A multivalent COVID-19 vaccine, containing antigens from multiple SARS-CoV-2 variants of concern, would be the next step after a monovalent vaccine, but, as with the quadrivalent seasonal flu vaccines, manufacturers would have to prove that antigens from multiple variants combined were just as immunogenic as each alone, Subbarao said.
o cover as many bases as possible, vaccine makers have set their sights on multivalent COVID-19 vaccines,..
Meanwhile, the NIAID is conducting a phase 2 trial, the COVID-19 Variant Immunologic Landscape (COVAIL) study, to compare different vaccine regimens in adults who’ve already received their primary COVID-19 vaccination and a booster. Researchers will compare the innate, cellular, and humoral immune responses of each group to help figure out how best to cover new variants as they emerge.
Instead of trying to smack down 1 variant just as another pops up, researchers and funders should prioritize creating nasal vaccines and pan-SARS-CoV-2 or even pan-sarbecovirus (the viral subgenus that contains SARS-CoV-2 and SARS-CoV) vaccines, some scientists say.
Omicron-based boosters are a “done deal,” though, because Moderna and Pfizer-BioNTech have already invested heavily in them.. And yet, he pointed out in a May 15 online column, those boosters are directed against BA.1, the original flavor of Omicron, and might not be as effective against newer Omicron subvariants or other SARS-CoV-2 variants yet to come.
[Spoiler (click to open)]Omicron, and especially its subvariants, is so different from Wuhan-Hu-1 that it is most adept at evading the immune response generated by current vaccines. Even so, studies have shown that the prototype COVID-19 vaccines still reduce the risk of serious illness and death from Omicron. Updating COVID-19 vaccines is easier said than done, and some observers question whether it’s the best way to tackle the unpredictable, ever-changing virus.
In a May 2 JAMA Viewpoint, FDA officials called circulating SARS-CoV-2 “the new normal,” likely requiring consideration of annual updates of COVID-19 vaccines, as is done with influenza vaccines. “[A] greater depth and duration of protection might be achieved with a vaccine covering currently circulating variants,” wrote coauthors Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER)
“The challenge is we don’t know the rules of how this virus [SARS-CoV-2] behaves. For seasonal flu, we know the rules,” John Beigel, MD, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID), explained in an interview. “Omicron kind of came out of nowhere. A year ago, we wouldn’t have predicted something like Omicron.”
One thing for sure, VRBPAC member Paul Offit, MD, said in an interview, boosting people every 6 months “is not a reasonable public health strategy.”
he WHO conducts influenza surveillance 24/7 year-round.
Twice annually, in February for the Northern Hemisphere and in September for the Southern Hemisphere, the WHO convenes a panel of experts to review the surveillance data to see whether new influenza strains are circulating and infecting people.
If so, the panel must decide whether current vaccines protect against the new circulating strains and, if not, whether the vaccines need to be updated with antigens that are a better match. About a week after that decision is made, the FDA convenes VRBPAC to make recommendations for the composition of US vaccines for the upcoming flu season.
Determining the composition of the vaccine must be done months in advance of flu season to give manufacturers enough time to produce tens of millions of doses.
When the vaccine is well-matched to circulating viruses, it is approximately 60% effective for the overall population, the FDA’s Jerry Weir, PhD, director of the Division of Viral Products in CBER’s Office of Vaccine Research and Review, told VRBPAC panelists at their April meeting.
Sometimes the vaccine isn’t well-matched, though. For example, preliminary, interim estimates for the 2021-2022 flu season show that the vaccine didn’t reduce the risk of mild or moderate illness from influenza A viruses, according to the CDC. Reasons vary for why the flu vaccine might not be well-matched, Weir explained at the VRBPAC meeting. Sometimes antigenically distinct viruses emerge after the vaccine composition has been decided.. Sometimes manufacturing issues can’t be resolved in time to produce a well-matched vaccine, Weir said. And that’s with a vaccine against a virus that has a long track record.
Updating vaccines against SARS-CoV-2 presents special challenges, Weir noted at the VRBPAC meeting. While most influenza vaccines have similar platforms with similar time frames needed for updating them, that’s not the case with COVID-19 vaccines, he pointed out. Not only do COVID-19 vaccine platforms differ from each other, but there’s been no coordination among manufacturers, who are at various stages in clinical trials with updated vaccines of varying compositions, Weir said. Although some manufacturers are considering a combination annual vaccine against both COVID-19 and seasonal influenza, “it’s premature to combine them,” Subbarao told JAMA.
“We don’t know how often we’ll have to vaccinate against COVID.” Plus, she said, whether SARS-CoV-2 follows the same seasonal pattern as influenza isn’t yet clear.
The advisory group will recommend methods to assess the impact of variants of concern on COVID-19 vaccines, interpret available evidence on the effects of those variants on vaccines, and provide guidance on whether vaccine composition should be adjusted to protect against variants of concern, Subbarao told VRBPAC members at their April 6 meeting.
If the FDA decides to grant Emergency Use Authorization (EUA) of investigational vaccines that contain antigenic material from SARS-CoV-2 variants, manufacturers may be hard-pressed to manufacture enough doses to meet demand by the fall. (Given the relatively low number of people who’ve received a second booster, just what the demand might be for a third one represents another as-yet unanswered question.)
“It’s not hard to change it,” Beigel said of current COVID-19 vaccines. “It’s hard to scale it and deliver 100 million doses.”
Although he’s 71 and, therefore, eligible for a second booster shot, Offit, chair of vaccinology at the University of Pennsylvania’s Perelman School of Medicine, hasn’t yet opted to get one. He’s healthy, and research has clearly shown that 3 doses would reduce the risk of serious illness if he were to contract COVID-19, he explained.
Offit, citing a lack of evidence showing that an Omicron-based booster would provide more protection than the prototype vaccines do, said, “I don’t understand the thinking behind it.”
By adding a booster against variants to the vaccine arsenal, “What are you really doing for the pandemic: Protecting people who are already protected?” Offit asked. A wiser investment would be to ship the prototype vaccines overseas to vaccinate the unvaccinated, he said.
Protection against serious illness isn’t enough for many people, Offit acknowledged. Concerned about the possibility of long COVID, many people don’t want to get infected with SARS-CoV-2, period, he said, adding that he’d like to see more rigor in defining long COVID.
Offit questioned whether preventing infection completely was an attainable goal for vaccines against SARS-CoV-2.
“Is it realistic to expect that we can protect against all illness with this virus?” Offit asked. “I feel like this is much ado about little. This is not flu. You get a flu vaccine every year because you’re still not protected against serious disease” even if vaccinated the previous year. If the goal is to prevent all SARS-CoV-2 infections, even the mild ones, “I think we’re going to drive ourselves a little crazy,” he said.
SARS-CoV-2,..is a mucosal infection with a short incubation period, giving vaccine-generated immunity a relatively brief window of opportunity to completely block infection.people vaccinated against SARS-CoV-2 can still get sick with COVID-19, Offit explained. In contrast, measles is a viral infection with an average incubation period of 11 or 12 days-more than twice that of SARS-CoV-2. On top of that, there’s only 1 antigenic type of measles, which has barely changed over time, so vaccine-induced immunity against it is thought to be lifelong.
By expecting the same from COVID-19 vaccines as from measles vaccines, “we’re setting [COVID-19] vaccine up for failure,” Offit said. The wording used to describe SARS-CoV-2 infections in vaccinated and boosted individuals hasn’t helped lower expectations for COVID-19, he added. “We damned it when we used the term ‘breakthrough infection.’”
“We do need to encourage the development of COVID-19 vaccines that will have an impact on prevention of infection and transmission, in addition to protecting against severe illness and death.”
Developing variant-based injectable vaccines might seem like a game of whack-a-mole.argeting Omicron with a vaccine assumes that there will be an Omicron resurgence, but by the time such a vaccine is ready to be used, the circulating variant could be Beta or Delta, both significantly different from Omicron and Alpha, Beigel told VRBPAC members.
A multivalent COVID-19 vaccine, containing antigens from multiple SARS-CoV-2 variants of concern, would be the next step after a monovalent vaccine, but, as with the quadrivalent seasonal flu vaccines, manufacturers would have to prove that antigens from multiple variants combined were just as immunogenic as each alone, Subbarao said.
o cover as many bases as possible, vaccine makers have set their sights on multivalent COVID-19 vaccines,..
Meanwhile, the NIAID is conducting a phase 2 trial, the COVID-19 Variant Immunologic Landscape (COVAIL) study, to compare different vaccine regimens in adults who’ve already received their primary COVID-19 vaccination and a booster. Researchers will compare the innate, cellular, and humoral immune responses of each group to help figure out how best to cover new variants as they emerge.
Instead of trying to smack down 1 variant just as another pops up, researchers and funders should prioritize creating nasal vaccines and pan-SARS-CoV-2 or even pan-sarbecovirus (the viral subgenus that contains SARS-CoV-2 and SARS-CoV) vaccines, some scientists say.
Omicron-based boosters are a “done deal,” though, because Moderna and Pfizer-BioNTech have already invested heavily in them.. And yet, he pointed out in a May 15 online column, those boosters are directed against BA.1, the original flavor of Omicron, and might not be as effective against newer Omicron subvariants or other SARS-CoV-2 variants yet to come.