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Yahoo News
\nANDREW ROMANO<\/p>\n
The hardest-hit parts of the United States may be past the peak of the pandemic. Other places may be lifting their lockdown restrictions. But deadly pathogens don\u2019t eradicate themselves; once Americans stop staying home, the coronavirus will continue to spread.<\/p>\n
The expectation is the U.S. won\u2019t return to normal until there\u2019s an effective vaccine against COVID-19\u00a0\u2014 and almost everyone in the country has been vaccinated.<\/p>\n
When and how that will occur has been the subject of speculation since the start of this crisis. But in recent days that chatter has intensified amid the news that Oxford researchers might have an effective vaccine ready by September<\/a> and reports that President Trump has ordered a \u201cManhattan Project-style effort\u201d<\/a>called Operation Warp Speed that aims to inoculate almost all Americans by year\u2019s end.<\/p>\n But can the U.S. really rush-release a COVID-19 vaccine this year? To understand how unprecedented that challenge is \u2014 and what the odds of overcoming it actually are \u2014 you need to understand a few key numbers.<\/p>\n 300 million: <\/strong>The number of doses of COVID-19 vaccine that Operation Warp Speed reportedly aims to deliver in the U.S. by January 2021, according to Bloomberg News<\/a>. The plan is to mobilize pharmaceutical companies, government agencies and military researchers to streamline and accelerate the conventional process of developing, testing, approving, regulating and licensing a vaccine.<\/p>\n 12 to 18: <\/strong>The number of months Dr. Anthony Fauci, the nation\u2019s top infectious disease expert, had previously estimated it would take to complete this process.<\/p>\n Four: <\/strong>The number of years it took, back in the 1960s, to bring a mumps vaccine to market. No vaccine has ever been released faster. For comparison, it took 28 years to deliver the varicella vaccine; 28 years to release FluMist; 15 years for the HPV vaccine; 15 years to deliver the rotavirus vaccine; and 11 years for the first pediatric combination. A vaccine for the Ebola virus that went into clinical trials in 2014 only just received approval from U.S. regulators in December \u2014 a five-year effort considered remarkable for its speed. \u201cWhen Dr. Fauci said 12 to 18 months, I thought that was ridiculously optimistic,\u201d Dr. Paul Offit, the co-inventor of the rotavirus vaccine, recently told CNN<\/a>.<\/p>\n Eight: <\/strong>The number of months between now and January 2021. On Wednesday, Fauci shortened his most \u201caspirational\u201d timeline, telling NBC\u2019s \u201cToday\u201d show<\/a> that January is \u201cdoable if things fall in the right place.\u201d<\/p>\n \u201cI mean, I\u2019m obviously part of the team that\u2019s involved in that,\u201d Fauci added.<\/p>\n 102:<\/strong> The number of coronavirus vaccines<\/a> now in development, according to the World Health Organization.<\/p>\n Eight to 10: <\/strong>The number of those potential vaccines that \u201clook particularly promising,\u201d according to Microsoft founder Bill Gates<\/a>. Gates\u2019s philanthropic foundation has spent several decades (and tens of billions of dollars) strengthening the global health system. He is now investing billions more to help seven makers of possible coronavirus vaccines start developing facilities and manufacturing doses<\/a> before any one of them is approved by the Food and Drug Administration.<\/p>\n Roughly 80 percent: <\/strong>The amount of genetic overlap<\/a> between SARS and SARS-CoV-2, the official name of the coronavirus that causes COVID-19.<\/p>\n This is important \u2014 and encouraging \u2014 because the first step in developing a successful vaccine is identifying one that\u2019s potentially effective. Unusually, scientists at Oxford\u2019s Jenner Institute<\/a> have already done that, with the advantage of a head start. By the time news broke in January that Chinese scientists had identified the genetic code of a mysterious virus in Wuhan, the Oxford team was already developing a vaccine against a similar coronavirus (Middle East respiratory syndrome, or MERS) and proving its safety. It immediately switched over to SARS-CoV-2.<\/p>\n Six: <\/strong>The number of rhesus macaque monkeys inoculated with single doses of the Oxford vaccine in March at the National Institutes of Health\u2019s Rocky Mountain Laboratory<\/a>. The first step in a conventional trial is to test a vaccine on animals to see if it works. In Montana, all six of the monkeys were exposed to heavy quantities of SARS-CoV-2 \u2014 exposure that had \u201cconsistently sickened other monkeys in the lab.\u201d<\/p>\n Six:<\/strong> The number of inoculated rhesus macaque monkeys that were still healthy more than 28 days later.<\/p>\n Three: <\/strong>The number of phases required for a conventional clinical trial.<\/p>\n Phase I tests for safety by giving a small group of healthy volunteers different dosages; the goal is to create the strongest immune response at the lowest effective dose \u2014 without serious side effects.<\/p>\n Phase II tests that dosage on a larger group of volunteers \u2014 typically hundreds of people of various ages and levels of health \u2014 to make sure they develop the proper antibodies.<\/p>\n Phase III pits the vaccine against a placebo by giving both to thousands of volunteers, who then go about their daily lives. If after a long time the vaccinated group turns out to be less likely to get sick than the placebo group (in a statistically significant way), the vaccine is deemed effective. Licensing and production follow.<\/p>\n Again, this process has never taken less than four years from start to finish.<\/p>\n 1,100: <\/strong>The number of volunteers participating in Oxford\u2019s phase I clinical trial, which began last week. \u201cArmed with safety data from their human trials of similar vaccines for Ebola, MERS and malaria,\u201d reported<\/a> the New York Times, \u201cscientists at Oxford\u2019s institute persuaded British regulators to allow unusually accelerated trials while the epidemic is still hot around them.\u201d This trial should determine whether the fast-tracked vaccine will trigger serious problems or side effects.<\/p>\n The biggest worry is disease enhancement, a boomerang effect in which the vaccine not only fails to offer protection but can also lead to a more severe disease. During the Ford administration, a rushed vaccine for swine flu caused several dozen deaths and damaging side effects.<\/p>\n 5,000: <\/strong>The number of volunteers slated to participate in Oxford\u2019s combined phase II and phase III trial later this month. Early readouts of Oxford\u2019s human trials will become available in May, and researchers \u201chope to get some signal about whether it\u2019s working by the middle of June,\u201d John Bell, a professor of medicine at the University of Oxford, told the BBC\u2019s \u201cToday\u201d radio program<\/a> Thursday. While other teams in China and Germany are currently conducting phase I and phase II trials, only Oxford is ready to test for effectiveness.<\/p>\n But that raises an important question: How effective does a COVID-19 vaccine need to be? What\u2019s the goal here?<\/p>\n Around 45 percent:<\/strong> The measured effectiveness of this year\u2019s flu vaccine<\/a>, according to the U.S. Centers for Disease Control and Prevention.<\/p>\n 70 percent:<\/strong> The effectiveness likely required of COVID-19 vaccine in order \u201cto stop the outbreak,\u201d according to Bill Gates<\/a>.<\/p>\n \u201cAlthough you\u2019d ideally want a vaccine to have 100 percent efficacy, many don\u2019t,\u201d Gates wrote Thursday. \u201cA 60 percent effective vaccine is usable, but we might still see some localized outbreaks. Anything under 60 percent is unlikely to create enough herd immunity to stop the virus.\u201d<\/p>\n One or two: <\/strong>The threshold number of cases that will determine the effectiveness of the Oxford vaccine in its upcoming trial. If no more than two of the participants who received the vaccine become sick, compared with an expected dozen in the placebo group, \u201cthen we have a party and tell the world,\u201d the director of Oxford\u2019s Jenner Institute told the Times.<\/p>\n But that\u2019s the best-case scenario.<\/p>\n Less than 10 percent: <\/strong>The share of all drugs<\/a> in clinical trials that later end up getting FDA approval. The rest are declared ineffective or unsafe. Also, no one has ever created and released a successful human vaccine for any of the other coronaviruses in circulation, including several that cause the common cold.<\/p>\n 40 years: <\/strong>The amount of time scientists have been trying \u2014 and failing \u2014 to develop an HIV vaccine. The best they\u2019ve done? A few phase III trials. One made the disease worse. Another had a success rate of just 30 percent.<\/p>\n But assuming the Oxford vaccine \u2014 or the German vaccine, or the Chinese vaccine, or another vaccine, or more than one of the above \u2014 actually works and isn\u2019t dangerous, how would the Trump administration ensure that all Americans can get vaccinated? Especially by January<\/em>?<\/p>\n 100 million: <\/strong>The number of doses of the Oxford vaccine that British drugmaker AstraZeneca is aiming to produce by the end of 2020, according to a partnership announced Thursday<\/a>. Supply would be prioritized in the U.K., however \u2014 not the U.S.<\/p>\n Zero (so far): <\/strong>The number of U.S. drugmakers who have partnered with the Oxford team. Why no takers? \u201cBecause the major pharmaceutical companies [here] typically demand exclusive worldwide rights before investing in a potential medicine,\u201d the Times explains. Meanwhile, \u201cother scientists involved in the project are working with a half-dozen drug manufacturing companies across Europe and Asia to prepare to churn out billions of doses as quickly as possible if the vaccine is approved. None have been granted exclusive marketing rights.\u201d<\/p>\n 10 million to 20 million:<\/strong> The number of doses of a coronavirus vaccine being developed by Germany\u2019s BioNtech that U.S. drugmaker Pfizer is aiming to produce by the end of 2020, its global head of vaccines said Thursday<\/a>. Those doses would be earmarked for \u201cemergency use\u201d (i.e., for health professionals).<\/p>\n 300 million:<\/strong> Again, the number of doses Trump reportedly wants to deliver in the U.S. by January 2021. Which is where Operation Warp Speed comes in. There are a few American companies that either have started or will soon start clinical trials on potential vaccines of their own. If those vaccines pan out perfectly or U.S. drugmakers strike partnerships with successful researchers overseas, and if\u00a0Warp Speed works as planned<\/a> \u2014 by indemnifying the major pharmaceutical and biotechnology companies from liability; by spending billions to pre-manufacture multiple candidate vaccines before their safety or efficacy has been proved; and by consolidating competing efforts into one huge, coordinated trial \u2014 then it\u2019s theoretically possible that Trump\u2019s plan could work.<\/p>\n It\u2019s also possible \u2014 perhaps more possible \u2014 that it won\u2019t, and that it will be \u201cmore harmful to set an unreasonably short deadline that might result in a faulty vaccine than to wait for one that is proved safe and effective,\u201d as some officials are reportedly telling the president<\/a>.<\/p>\n Still, no crisis has so demanded a \u201cManhattan Project-style effort\u201d since the Manhattan Project itself. If executed safely and skillfully, Operation Warp Speed is almost certainly worth a try \u2014 assuming American officials keep one final number in mind.<\/p>\n 7.8 billion: <\/strong>The current global population. \u201cIn order to stop the pandemic\u201d \u2014 which doesn\u2019t respect borders \u2014 \u201cwe need to make the vaccine available to almost every person on the planet,\u201d Gates wrote Thursday. Only then will the world, the U.S. included, \u201cbe able to get back to normal \u2014 and to hopefully make decisions that prevent us from being in this situation ever again.\u201d<\/p>\n\n<\/div>\n<\/div>\n