{"id":263899,"date":"2020-08-03T07:34:24","date_gmt":"2020-08-03T11:34:24","guid":{"rendered":"https:\/\/canadianinquirer.net\/v1\/?p=263899"},"modified":"2020-08-03T07:34:24","modified_gmt":"2020-08-03T11:34:24","slug":"fauci-unfazed-as-scientists-rely-on-unproven-methods-to-create-covid-vaccines","status":"publish","type":"post","link":"https:\/\/canadianinquirer.net\/v1\/2020\/08\/03\/fauci-unfazed-as-scientists-rely-on-unproven-methods-to-create-covid-vaccines\/","title":{"rendered":"Fauci Unfazed as Scientists Rely on Unproven Methods to Create COVID Vaccines"},"content":{"rendered":"<figure id=\"attachment_263900\" aria-describedby=\"caption-attachment-263900\" style=\"width: 771px\" class=\"wp-caption alignnone\"><a href=\"https:\/\/canadianinquirer.net\/v1\/wp-content\/uploads\/2020\/08\/771px-Anthony_S._Fauci_M.D._NIAID_Director_26759498706.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-263900\" src=\"https:\/\/canadianinquirer.net\/v1\/wp-content\/uploads\/2020\/08\/771px-Anthony_S._Fauci_M.D._NIAID_Director_26759498706.jpg\" alt=\"\" width=\"771\" height=\"1079\" srcset=\"https:\/\/canadianinquirer.net\/v1\/wp-content\/uploads\/2020\/08\/771px-Anthony_S._Fauci_M.D._NIAID_Director_26759498706.jpg 771w, https:\/\/canadianinquirer.net\/v1\/wp-content\/uploads\/2020\/08\/771px-Anthony_S._Fauci_M.D._NIAID_Director_26759498706-214x300.jpg 214w, https:\/\/canadianinquirer.net\/v1\/wp-content\/uploads\/2020\/08\/771px-Anthony_S._Fauci_M.D._NIAID_Director_26759498706-768x1075.jpg 768w, https:\/\/canadianinquirer.net\/v1\/wp-content\/uploads\/2020\/08\/771px-Anthony_S._Fauci_M.D._NIAID_Director_26759498706-732x1024.jpg 732w\" sizes=\"auto, (max-width: 771px) 100vw, 771px\" \/><\/a><figcaption id=\"caption-attachment-263900\" class=\"wp-caption-text\">ICYMI: Anthony S. Fauci, M.D. (<a href=\"https:\/\/commons.wikimedia.org\/w\/index.php?curid=82983928\">Photo By NIAID &#8211; Anthony S. Fauci, M.D., NIAID Director, CC BY 2.0<\/a>)<\/figcaption><\/figure>\n<p>With millions of lives on the line, researchers have been working at an unprecedented pace to develop a COVID-19 vaccine.<\/p>\n<p>But that speed \u2014 and some widely touted breakthroughs \u2014 belie the enormous complexity and potential risks involved. Researchers have an incomplete understanding of the coronavirus and are using technology that\u2019s largely unproven.<\/p>\n<p>Among many worries: A <a href=\"https:\/\/harvard.zoom.us\/webinar\/register\/WN_WJB5sE0pQWGqWX2S7hp3og\">handful of studies<\/a> on COVID-19 survivors suggest that antibodies \u2014 key immune system proteins that fight infection \u2014 <a href=\"https:\/\/www.nature.com\/articles\/s41591-020-0965-6\">begin to disappear<\/a> within months. That\u2019s led scientists to worry that the protection provided by vaccines could fade quickly as well. Some even <a href=\"https:\/\/www.sfchronicle.com\/health\/article\/With-coronavirus-antibodies-fading-fast-focus-15414533.php\">question whether vaccines will really end<\/a> the pandemic. If vaccines produce limited protection against infection, experts note, people will need to continue wearing masks and social distancing even after vaccines roll out.<\/p>\n<p>Yet in an interview with KHN, the country\u2019s top infectious disease expert, Dr. Anthony Fauci, said he\u2019s \u201ccautiously optimistic\u201d that researchers will overcome such obstacles.<\/p>\n<p>\u201cWe know the body can make an adequate response against this virus\u201d after two shots of a vaccine being tested, Fauci said. \u201cThere\u2019s no reason to believe that we won\u2019t be able to develop a vaccine against it.\u201d<\/p>\n<p>Because <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2022483\">early-stage trials<\/a> began <a href=\"https:\/\/www.nih.gov\/news-events\/news-releases\/nih-clinical-trial-investigational-vaccine-covid-19-begins\">just a few months ago<\/a>, doctors don\u2019t know how long antibodies in vaccinated people will last, he said.<\/p>\n<p>Scientists will get answers to some of their questions from the country\u2019s <a href=\"https:\/\/www.nih.gov\/news-events\/news-releases\/phase-3-clinical-trial-investigational-vaccine-covid-19-begins\">first large-scale COVID-19 vaccine trial<\/a>, launched this week by the National Institutes of Health and Moderna at 89 locations around the country.<\/p>\n<p>\u201cOnce we get a protective response, we will see how long it lasts,\u201d Fauci said.<\/p>\n<p>\u201cIf we don\u2019t get as long a response as we want, we can always give a booster shot.\u201d<\/p>\n<p>The <a href=\"https:\/\/arstechnica.com\/science\/2020\/07\/meet-the-4-frontrunners-in-the-covid-19-vaccine-race\/\">leading vaccine candidates<\/a> are based on new approaches that have <a href=\"https:\/\/www.nationalgeographic.com\/science\/2020\/05\/moderna-coronavirus-vaccine-how-it-works-cvd\/\">never resulted in a licensed vaccine<\/a>. Moderna, a relatively young company, has yet to produce any approved vaccines.<\/p>\n<p>\u201cEven more so than usual, as we create vaccines, we\u2019re sailing in uncharted water,\u201d said Dr. William Schaffner, a professor at the Vanderbilt University School of Medicine.<\/p>\n<p>If approved, a COVID vaccine created by researchers at <a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(20)31604-4\/fulltext?dgcid=hubspot_email_newsletter_tlcoronavirus20_china&amp;utm_campaign=tlcoronavirus20&amp;utm_medium=email&amp;_hsmi=91828894&amp;_hsenc=p2ANqtz-_lphzqJSNoV-mtnj1h7JzFVTG-208NUSPPM9yuTQGVyfAFO77S9y4MiXdaQ5ytzWgpvAo0TfyLV3tVh63MT7g4RAxK0w&amp;utm_content=91810534&amp;utm_source=hs_email\">Oxford University and drugmaker AstraZeneca<\/a> would be the first licensed vaccine to use a virus that causes colds in chimpanzees but doesn\u2019t sicken people. Scientists use the cold virus to deliver key elements of the vaccine into a patient\u2019s body. In this case, the virus delivers the gene that instructs the cell to make the spike protein, which helps the novel coronavirus enter cells.<\/p>\n<p>Early studies show that the Oxford vaccine stimulates the immune system as intended. If the vaccine is successful, these antibodies and other immune cells will recognize and neutralize the spike protein if they encounter it again, protecting people from disease.<\/p>\n<p>Two other candidates \u2014 a vaccine from <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2022483\">Moderna<\/a> and another from <a href=\"https:\/\/www.cnbc.com\/2020\/07\/22\/us-government-taps-pfizer-to-produce-millions-of-doses-of-coronavirus-vaccine.html\">Pfizer and BioNTech<\/a>, a German company \u2014 were also developed with novel methods. They use genetic material from the coronavirus called <a href=\"https:\/\/horizon-magazine.eu\/article\/five-things-you-need-know-about-mrna-vaccines.html\">messenger RNA<\/a>, or mRNA.<\/p>\n<p>Unlike traditional vaccines, which expose the body to a viral protein to stimulate the immune system, <a href=\"https:\/\/energycommerce.house.gov\/sites\/democrats.energycommerce.house.gov\/files\/documents\/Testimony%20-%20Hoge%2020200721_0.pdf\">mRNA acts as an instruction kit,<\/a> telling the body how to construct the proteins itself. The immune system then responds to the viral protein by making antibodies.<\/p>\n<p>Moderna officials have said they were able to produce the COVID-19 vaccine so rapidly because they had developed experimental vaccines against two other lethal coronaviruses \u2014 those that cause <a href=\"https:\/\/energycommerce.house.gov\/sites\/democrats.energycommerce.house.gov\/files\/documents\/Testimony%20-%20Hoge%2020200721_0.pdf\">SARS and MERS<\/a> \u2014 which are closely related to the COVID-19 virus.<\/p>\n<p>When the pandemic emerged, Moderna tweaked those vaccines to target COVID-19, Fauci told KHN. Fauci\u2019s team contacted the company the day after China made the virus\u2019s genome public.<\/p>\n<p>Two months later, Moderna\u2019s vaccine was ready for a trial because \u201c98% of the scientific work had been done,\u201d Schaffner said. \u201cThey went back to these scientific methods and adapted them very quickly. That saves years of work.\u201d<\/p>\n<p>But there is a potential risk in relying so heavily on unproven techniques: New technology can sometimes cause unforeseen problems or side effects, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.<\/p>\n<p>For all their differences, most of the vaccines in development target the spike protein, Adalja said. That is likely a winning strategy, considering successful veterinary coronavirus vaccines also target the spike protein.<\/p>\n<p>But some scientists say this uniform approach could also leave us vulnerable.<\/p>\n<p>Ideally, scientists should diversify the portfolio of vaccines, in case targeting the spike protein doesn\u2019t work as well as researchers hope, Adalja said. Developing a vaccine that targets other key proteins might help scientists to hedge their bets.<\/p>\n<p>Researchers around the world are working on more than 165 vaccines; more than two dozen are already being tested in people. Early human studies focus on safety and finding the best dose. Later clinical trials are larger and measure a vaccine\u2019s effectiveness by comparing the outcomes of volunteers who receive the vaccine with those of people given a placebo.<\/p>\n<p>Fauci said he\u2019s reassured by <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2022483\">early studies<\/a> that showed the Moderna vaccine to be safe. Although some volunteers developed fevers and headaches after vaccination, these side effects were no worse than those caused by other licensed vaccines.<\/p>\n<p>\u201cThat\u2019s not a showstopper at all,\u201d he said.<\/p>\n<p><strong>A Perplexing Pathogen<\/strong><\/p>\n<p>Some of COVID-19\u2019s most important mysteries involve the immune system, said Dr. Paul Offit, director of the Vaccine Education Center at Children\u2019s Hospital of Philadelphia.<\/p>\n<p>Offit said he\u2019s mystified by the fact that a small fraction of people with COVID-19 don\u2019t make any antibodies against the virus. He knows of no other virus that does this.<\/p>\n<p>\u201cWe\u2019re only seven months into this and we\u2019ve had a lot of surprises,\u201d said Offit, a member of a <a href=\"https:\/\/www.nih.gov\/research-training\/medical-research-initiatives\/activ\">National Institutes of Health effort<\/a> to develop vaccines and drugs to treat COVID-19. \u201cThis virus does things that no other virus does.\u201d<\/p>\n<p>This is not like preventing measles. \u201cIt\u2019s easier to create a vaccine for diseases that confer long-term immunity,\u201d Offit said. People never catch measles more than once. The two-dose measles vaccine stimulates immunity, protecting 97% of people for life, Offit said.<\/p>\n<p>It\u2019s also not like strep throat or gonorrhea, which people can catch multiple times because the bacteria that cause them don\u2019t ignite lasting immunity. \u201cThat\u2019s why we don\u2019t have a vaccine for them,\u201d he said.<\/p>\n<p>Some coronaviruses cause more serious symptoms than others. Coronaviruses that cause the common cold don\u2019t stimulate lasting <a href=\"https:\/\/www.medrxiv.org\/content\/10.1101\/2020.05.11.20086439v2\">antibodies<\/a>, which is one reason people can catch colds repeatedly, Schaffner said.<\/p>\n<p>Studies show that antibodies against more lethal coronaviruses last a bit longer. Antibodies against the <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2851497\/\">severe acute respiratory syndrome<\/a> virus, which caused a pandemic in 2003, and the <a href=\"https:\/\/www.medscape.com\/viewarticle\/870592_1\">Middle East respiratory syndrome<\/a> virus, which appeared in 2011, appear to last two to three years.<\/p>\n<p>People with severe symptoms from COVID-19 tend to have higher antibody levels than those with milder cases.<\/p>\n<p>Some people fail to generate antibodies because they have compromised immune systems, said Mark Sangster, a research professor at the University of Rochester Medical Center.<\/p>\n<p>Even when people do generate antibodies against the novel coronavirus, studies suggest the antibodies may not last long.<\/p>\n<p>In a recent <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMc2025179\">New England Journal of Medicine<\/a> report on COVID-19 survivors, antibody levels dropped rapidly over three months, at a rate that could leave them <a href=\"https:\/\/www.cidrap.umn.edu\/news-perspective\/2020\/07\/study-covid-19-antibodies-decay-quickly-after-mild-illness\">without any antibodies within one year<\/a>. Those findings echo the results of a <a href=\"https:\/\/www.nature.com\/articles\/s41591-020-0965-6\">June report in Nature Medicine<\/a> that found antibody levels began to fall two to three months after infection.<\/p>\n<p>Such reports have <a href=\"https:\/\/www.sfchronicle.com\/health\/article\/With-coronavirus-antibodies-fading-fast-focus-15414533.php\">worried some scientists<\/a>, who fear that antibodies will decline just as rapidly among people vaccinated against COVID-19.<\/p>\n<p>\u201cOne wants a vaccine that lasts longer than two months,\u201d Schaffner said.<\/p>\n<p>Other antibody research has been more encouraging.<\/p>\n<p><a href=\"https:\/\/www.medrxiv.org\/content\/10.1101\/2020.07.14.20151126v1\">A July paper<\/a> found that COVID-19 infection \u201cinduces robust, neutralizing antibody responses that are stable for at least three months.\u201d Antibodies typically rise during an infection, then fall again as the immune system returns to normal, said Florian Krammer, co-author of the study, which was published online before undergoing peer review.<\/p>\n<p>\u201cWhat we found looks like a normal antibody response to a viral infection,\u201d said Krammer, a professor of microbiology at the Icahn School of Medicine at Mount Sinai in New York.<\/p>\n<p>Early studies of the Moderna vaccine suggest people mount a strong immune response after two doses, Fauci said. But because the earliest trials began just a few months ago, doctors don\u2019t yet know how long antibodies in vaccinated people will last.<\/p>\n<p>The United States has invested <a href=\"https:\/\/www.latimes.com\/science\/story\/2020-07-30\/warp-speed-coronavirus-vaccine-fda\">nearly $6 billion<\/a> in potential <a href=\"https:\/\/www.politico.com\/news\/2020\/07\/13\/vaccine-makers-profit-congress-360135\">COVID-19 vaccines<\/a>.<\/p>\n<p>Conflicting evidence on antibodies \u201cshouldn\u2019t interfere with efforts to develop a safe and effective vaccine,\u201d added Fauci, noting he\u2019s encouraged by the results of early clinical trials. \u201cThe durability of the vaccine may be quite good.\u201d<\/p>\n<p>Dr. Michael Watson, who is developing Moderna\u2019s COVID-19 vaccine, said he hopes vaccinated people will have a stronger immune response than those sickened by the coronavirus. He said it\u2019s possible the virus not only infects cells, but also dampens the immune system, suppressing antibody response.<\/p>\n<p>A vaccine that contains only one part of the novel coronavirus \u2014 a protein that allows it to enter cells \u2014 might be able to stimulate antibody production without suppressing the immune response, Watson said. Only large clinical studies will show whether this is the case.<\/p>\n<p><strong>Memories That Don\u2019t Fade<\/strong><\/p>\n<p>Yet there\u2019s more to the immune system than antibodies.<\/p>\n<p>The body is also protected by memory T-cells, which can recognize viral threats to stimulate the production of antibodies even after many years, said Dr. Jeffrey Klausner, professor of infectious diseases at UCLA. Memory T-cells can stimulate B-cells to make antibodies, while instructing other immune system players to fight the virus in different ways.<\/p>\n<p>\u201cThe T-cells are like the conductors of a symphony,\u201d Klausner said. \u201cThese multiple, complex arms of the immune system work together like a symphony to control infection.\u201d<\/p>\n<p>Even if antibodies dwindle over time, memory cells can often replenish the supply, preventing infected patients from developing dangerous symptoms, Sangster said.<\/p>\n<p><a href=\"https:\/\/www.sciencedaily.com\/releases\/2020\/05\/200504165738.htm\">New studies<\/a> suggest people who survive COVID-19 develop both <a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S0092867420306103\">memory T-cells<\/a> and <a href=\"https:\/\/www.biorxiv.org\/content\/10.1101\/2020.07.20.213298v1.full.pdf\">B-cells<\/a>. <a href=\"https:\/\/www.nature.com\/articles\/s41586-020-2550-z\">One paper <\/a>even documented memory T-cells \u2014which can instruct other cells to make antibodies \u2014 in <a href=\"https:\/\/directorsblog.nih.gov\/2020\/07\/28\/immune-t-cells-may-offer-lasting-protection-against-covid-19\/\">survivors of the 2003 SARS<\/a> pandemic.<\/p>\n<p>Fauci said it\u2019s too early to know what sort of role T-cells will play in defending against the novel coronavirus.<\/p>\n<p>Researchers will get more definitive answers about vaccine-induced immunity to COVID-19 in coming months, after they complete large, rigorous trials of tens of thousands of volunteers, Offit said. Vaccine makers have said they plan to study their products\u2019 safety and effectiveness even after approval, to measure long-term efficacy as well to detect rare side effects that don\u2019t appear in smaller, shorter studies.<\/p>\n<p>In addition to Moderna\u2019s trial, AstraZeneca said results from an ongoing study of 50,000 volunteers <a href=\"https:\/\/energycommerce.house.gov\/sites\/democrats.energycommerce.house.gov\/files\/documents\/Testimony%20-%20Pangalos%2020200721_0.pdf\">should be available this fall<\/a>.<\/p>\n<p>With so many vaccines in development, Adalja said, it\u2019s difficult to know which one will prove the safest and most effective.<\/p>\n<p>\u201cThe first vaccines may not be the ultimate vaccine that everybody uses,\u201d he said.<\/p>\n<p>And some vaccines may work better in certain populations than others, Offit said. For example, studies may find that one shot works particularly well in children, while another better protects older adults. \u201cThere is definitely a lot to learn,\u201d he said.<\/p>\n<p>Ideally, doctors would like all vaccines to be as successful as the measles shot, Offit said. But a COVID-19 vaccine could more closely resemble flu shots and rotavirus vaccines, which don\u2019t prevent all infections but dramatically reduce the risks of hospitalization and death. Although some people who receive a flu shot still get influenza, their infections tend to be much milder than those of people who aren\u2019t vaccinated.<\/p>\n<p>\u201cYou\u2019d like to have a vaccine that protects against severe disease, and it likely will,\u201d Offit said. \u201cBut people might still get mild infections and still shed the virus and still spread it\u201d even after being vaccinated.<\/p>\n<p>If that happens, Offit said, the vaccine may not slow the spread of the pandemic as much as people have hoped. \u201cYou\u2019d still need masks and social distancing\u201d to reduce the spread of the virus, Offit said. \u201cIt\u2019s going to take both \u2014 a vaccine and these hygienic measures \u2014 to defeat the virus.\u201d<\/p>\n<p><em>KHN editor Arthur Allen contributed to this story.<\/em><\/p>\n<p><a href=\"http:\/\/www.kaiserhealthnews.org\/\">Kaiser Health News<\/a> (KHN) is a national health policy news service. It is an editorially independent program of the <a href=\"http:\/\/www.kff.org\/\">Henry J. Kaiser Family Foundation<\/a> which is not affiliated with Kaiser Permanente.<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/ssl.google-analytics.com\/collect?v=1&amp;t=event&amp;ec=Republish&amp;tid=UA-53070700-2&amp;z=1596453645274&amp;cid=97737204-7089-4856-9bfe-fa5706cb3cda&amp;ea=https%3A%2F%2Fkhn.org%2Fnews%2Ffauci-unfazed-as-scientists-rely-on-unproven-methods-to-create-covid-vaccines%2F&amp;el=Fauci%20Unfazed%20as%20Scientists%20Rely%20on%20Unproven%20Methods%20to%20Create%20COVID%20Vaccines\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>With millions of lives on the line, researchers have been working at an unprecedented pace to develop a COVID-19 vaccine. &hellip;<\/p>\n","protected":false},"author":33,"featured_media":263900,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[37],"tags":[],"class_list":["post-263899","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health","mauthors-liz-szabo","mauthors-kaiser-health-news"],"_links":{"self":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/263899","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/users\/33"}],"replies":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/comments?post=263899"}],"version-history":[{"count":1,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/263899\/revisions"}],"predecessor-version":[{"id":263901,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/263899\/revisions\/263901"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/media\/263900"}],"wp:attachment":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/media?parent=263899"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/categories?post=263899"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/tags?post=263899"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}