The first COVID-19 vaccine tested in the U.S. revved up people's immune systems just the way scientists had hoped, researchers reported Tuesday. The shots are poised to begin key final testing.
"No matter how you slice this, this is good news," Dr. Anthony Fauci, the U.S. government's top infectious disease expert, told The Associated Press.
The experimental vaccine, developed by Fauci's colleagues at the National Institutes of Health and Moderna Inc., will start its most important step around July 27: A 30,000-person study to prove if the shots really are strong enough to protect against the coronavirus.
But Tuesday, researchers reported anxiously awaited findings from the first 45 volunteers who rolled up their sleeves back in March. Sure enough, the vaccine provided a hoped-for immune boost.
Those early volunteers developed what are called neutralizing antibodies in their bloodstream molecules key to blocking infection at levels comparable to those found in people who survived COVID-19, the research team reported in the New England Journal of Medicine.
"This is an essential building block that is needed to move forward with the trials that could actually determine whether the vaccine does protect against infection," said Dr. Lisa Jackson of the Kaiser Permanente Washington Research Institute in Seattle, who led the study.
There's no guarantee but the government hopes to have results around the end of the year record-setting speed for developing a vaccine.
"Our goal is to have a vaccine available for broad distribution by year-end or early next year," Moderna president Stephen Hoge told "CBS This Morning" in May, after seeing preliminary data on the Phase 1 trial. "If we and others build data that shows that the vaccine has a potential for benefit, that it's safe and has a potential for efficacy, then, of course, there are circumstances where the vaccine could be deployed to high-risk populations earlier under something called an Emergency Use Authorization. Really though, that's a decision that regulators, in particular the FDA, have to make."
The vaccine requires two doses, a month apart.
There were no serious side effects. But more than half the study participants reported flu-like reactions to the shots that aren't uncommon with other vaccines fatigue, headache, chills, fever and pain at the injection site. For three participants given the highest dose, those reactions were more severe; that dose isn't being pursued.
Some of those reactions are similar to coronavirus symptoms but they're temporary, lasting about a day and occur right after vaccination, researchers noted.
"Small price to pay for protection against COVID," said Dr. William Schaffner of Vanderbilt University Medical Center, a vaccine expert who wasn't involved with the study.
He called the early results "a good first step," and is optimistic that final testing could deliver answers about whether it's really safe and effective by the beginning of next year.
"It would be wonderful. But that assumes everything's working right on schedule," Schaffner cautioned.
And Tuesday's results only included younger adults. The first-step testing later was expanded to include dozens of older adults, the age group most at risk from COVID-19. Those results aren't public yet but regulators are evaluating them, and Fauci said final testing will include older adults, as well as people with chronic health conditions that make them more vulnerable to the virus and Black and Latino populations likewise affected.
Nearly two dozen possible COVID-19 vaccines are in various stages of testing around the world. Candidates from China and Britain's Oxford University also are entering final testing stages.
The 30,000-person study will mark the world's largest study of a potential COVID-19 vaccine so far. And the NIH-developed shot isn't the only one set for such massive U.S. testing, crucial to spot rare side effects. The government plans similar large studies of the Oxford candidate and another by Johnson & Johnson; separately, Pfizer Inc. is planning its own huge study.
Already, people can start signing up tovolunteerfor the different studies.
People think "this is a race for one winner. Me, I'm cheering every one of them on," said Fauci, who directs NIH's National Institute of Allergy and Infectious Diseases.
"We need multiple vaccines. We need vaccines for the world, not only for our own country."
Around the world, governments are investing in stockpiles of hundreds of millions of doses of the different candidates, in hopes of speedily starting inoculations if any are proven to work.
Johnson & Johnson said Thursday it plans to begin the first human studies of its experimental coronavirus vaccine next week, as it races to make the shot available starting early next year.
The New Brunswick, N.J., companys initial study will aim to enroll more than 1,000 healthy adults, starting first in Belgium on July 22 and then the following week in the U.S. Researchers will assess the vaccines safety and ability to induce an immune response, J&J Chief Scientific Officer Paul Stoffels said Thursday on a conference...
As the Centers for Disease Control and Prevention (CDC) is exploring race as a factor for consideration in the prioritization of COVID-19 vaccination receipt, the agency must use lessons from its own past to help guide communication efforts.
In 2001 when letters containing anthrax were mailed to Sens. Tom Daschle (D-S.D.) and Patrick LeahyPatrick Joseph LeahyHouse panel wraps up lightning-fast appropriations for 2021 CDC has to get the messaging right with the COVID-19 vaccine Finger-pointing, gridlock spark frustration in Senate MORE (D-Vt.), two vastly different populations were affected in Washington, DC Brentwood Post office employees, who were predominately Black, and Hart Senate Office staff, who were mostly white.
Focus groups with these two groups revealed stark differences in their perception of the CDCs public health response. Many of the Brentwood postal workers felt significant racial and economic disparities in treatment, often due to simple issues of miscommunication.
When a vaccine for anthrax was offered, it was viewed with significant mistrust often due to inconsistent public health messaging, especially among the postal worker population.
Undoubtedly, anthrax is very different from COVID-19. For anthrax, there was an effective antibiotic treatment with a previously developed vaccine offered only as an alternative after exposure.
The COVID-19 vaccine, if successfully developed, will be a new approach to prevention. However, both diseases involve changing recommendations in the face of uncertainty and hence require nuanced public health responses.
A number of factors affect the decision to receive a vaccine, including risk perception, safety concerns and availability. However, mistrust plays a major role in vaccine uptake, especially when that vaccine is considered novel without a history of prior use.
Much of the mistrust in the medical system existing within communities of color has roots in another CDC led project the Tuskegee Syphilis Study. In Tuskegee, 399 Black men were left untreated with latent syphilis for 40 years, even after the discovery of penicillin, safe and effective treatment of the disease. This study and others have left a long legacy affecting the willingness of people of color to obtain life-saving medical treatment for a wide variety of conditions ranging from cancer to HIV.
Today, 40 percent of Blacks cite that they would not get the COVID-19 vaccine if offered, despite the virus exhibiting a significant toll on this population.
Blacks have been previously shown to be less likely to participate in drug trials.
However, blacks are overrepresented in studies that do not require informed consent, based on a 1996 Food and Drug Administration exception allowing enrollment in cases of incapacitation.
This is not necessarily a bad thing. Such exceptions are needed to make advances for potentially life-saving therapies when a patient is critically ill. However, the discrepancy in these statistics highlights a significant finding. When it comes to communities of color, efforts for recruitment may be blunted unless in the most convenient of cases and the benefits of cutting edge research may be one-sided.
In the case of COVID-19, we must ensure that the knowledge gained from the early use of the vaccine is universal. This includes recruiting diverse participants to clinical trials of the vaccine to understand whether it is equally effective across race, ethnicity, gender, and among groups with various co-morbid medical conditions.
This involves taking the time to have a thoughtful discussion with individuals about the study process, including the use of culturally appropriate approaches to recruitment and the employment of diverse research staff. It is also critical that communities of color be engaged in giving input about such recruitment early in the planning process.
Once the vaccine has been proven to be effective and is available, we must provide equitable access to the vaccine to these same communities. This should not be simply based on who has the strongest lobbying power but instead take into consideration those individuals who may benefit from the vaccine, yet whose voices may not be represented among special interest groups.
I have faith that the CDCs intentions are good, however, more than ever it is important for the agency to invest in a significant public health communication strategy directed at individuals of all racial and ethnic backgrounds. The CDC has an opportunity to make a difference. Lets make sure we get the messaging right this time.
Janice Blanchard, M.D., Ph.D., is a professor of emergency medicine at George Washington University. The opinions expressed are her own.
CLEVELAND Cleveland is among dozens of cities where researchers need volunteers to participate in a Phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19, according to ClinicalTrials.gov.
The lead sponsor of the study, ModernaTX, Inc. announced it needs 30,000 participants from various cities, including Cleveland and Cincinnati.
A Phase III trial is the final phase in a vaccine's development before it is approved and licensed, during which the vaccine is given to thousands of people and tested for efficacy and safety, according to the CDC.
The study is scheduled to begin on July 27, with an estimated completion date on October 27, 2022.
Anyone 18 and up is eligible to participate in the study. Other criteria includes:
Inclusion Criteria:
Rapid Medical Research is the only local place participating in the Moderna study. It says it will be actively recruiting 300 people from Northeast Ohio.
"You could really be part of a life-saving, world saving vaccination, said Jade Svoboda, the recruitment manager at Rapid Medical Research.
Each participant will meet with a team of doctors seven times over 25 months, according to Svoboda. The Beachwood based company does compensate its clients.
To get in touch with Rapid Medical Research call 216-508-4400 or head to their website.
To find more information about this study, including exclusion criteria, click here.
If you are interested in participating in the study, contact Moderna Clinical Trials at 855-663-6762 or at clinicaltrials@modernatx.com.
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Reuters reports that the leading USexpert on infectious diseases, Dr. Anthony Fauci, predicted on Wednesday the country will meet its goal of a coronavirus vaccine by year's end and was unmoved by the prospect that China would get there first.
While there are no guarantees,
I feel good about the projected timetable,
Fauci told Reuters in an interview.
His comments follow promising early-stage data for the Moderna Inc's coronavirus vaccine, released on Tuesday, that was developed by scientists at the National Institute of Allergy and Infectious Diseases, which Fauci directs.
Fauci also said Moderna's results were especially promising because the vaccine appeared to offer the type of protection seen in a natural infection.
One of the things that you hope for is that your vaccine induces a response that's comparable to a natural infection, because theoretically, the best vaccine you could possibly ever get is a natural infection.
Reuters explained that "Moderna's candidate, which is set to enter the last stage of testing on July 27, is just one of more than a hundred vaccines in development globally, but only one of a few contenders that have earned millions of dollars in backing from Operation Warp Speed, the White House program that aims to deliver more than 300 million doses of a safe and effective COVID-19 vaccine by January."
The market reaction to these comments from Fauci was muted considering the news dropped yesterday that there are promising signs with the vaccine following results of the test on 45 volunteers which revved-up andimproved their immune systems.
Many experts see a safe and effective vaccine as the only way out of the pandemic that has infected millions and killed more than 575,000 people worldwide.
However, the statements made todayshould cement the improved risk-on themes in markets as we run into key economic data released today from China and ahead of US Retail Sales and the European Central Bank, likely playing second fiddle, however, to the EU summit this weekend.
Inflation pressures will be the theme fs the vaccine rubber hits the road, a topic discussed in the following usual suspectsearlier today:
Gold prices march-on above a key support structure as inflation expectations ramp-up
Enrollment in the program could begin within the next month, according to Pryor. The screening process will take 3 to 4 months, and the study will take another two years. Patients will also receive free medical care related to the study, including COVID-19 testing, antibody testing, EKGs, blood and lab work, physical assessments and more. To participate, patients must meet certain criteria, including: no cancer in the last five years, no previous diagnosis of COVID-19, no autoimmune disorders or unmanaged pre-existing conditions and being an adult under the age of 85. Other restrictions may apply. Those who qualify will also be financially compensated.
First COVID-19 vaccine tested in US produced antibodies in all patients during trial FOX 32 Chicago
TUCSON (KVOA) - Quality of Life Medical and Research Center in Tucson is one of 87 national clinics to be conducting trials of a COVID-19 vaccine.
As of Tuesday, Arizona has reported 128,097 confirmed cases of COVID-19, and 2,337 known deaths.
Moderna's mRNA-1273 COVID-19 vaccine is set to begin its third phase of trials at 87 clinics throughout the country. The study aims to look at 30,000 people who are at high-risk for contracting the new coronavirus.
The vaccine is being developed to prevent COVID-19 by producing antibodies to the virus.
If you would like to take part in the study, contact your doctor along with Quality of Life Medical Research Center in Tucson at COVID19@QLMC.com or at 520-731-2333.
For more information on COVID-19 studies, visit Clinicaltrials.gov.
TheWest Virginia Department of Health and Human Resources (DHHR)reports as of 5:00 p.m., on July 15, 2020, there have been 217,786total confirmatorylaboratory results received for COVID-19, with 4,557 totalcases and 98 deaths.
DHHR has confirmed the death of a 77-yearold male from Wood County. Thepassing of this West Virginian is reported with great sadness and we extend oursympathies to his loved ones, said Bill J. Crouch, DHHR Cabinet Secretary.
In alignment with updated definitions fromthe Centers for Disease Control and Prevention, the dashboard includes probablecases which are individuals that have symptoms and either serologic (antibody)or epidemiologic (e.g., a link to a confirmed case) evidence of disease, but noconfirmatory test.
CASESPER COUNTY (Case confirmed by lab test/Probable case):Barbour(23/0), Berkeley (531/19), Boone (46/0), Braxton (5/0), Brooke (32/1), Cabell(197/7), Calhoun (4/0), Clay (13/0), Fayette (89/0), Gilmer (13/0), Grant(20/1), Greenbrier (74/0), Hampshire (45/0), Hancock (47/3), Hardy (47/1),Harrison (131/0), Jackson (148/0), Jefferson (256/5), Kanawha (442/12), Lewis(23/1), Lincoln (12/0), Logan (41/0), Marion (116/3), Marshall (71/1), Mason(26/0), McDowell (12/0), Mercer (67/0), Mineral (68/2), Mingo (34/2),Monongalia (624/14), Monroe (14/1), Morgan (19/1), Nicholas (19/1), Ohio(158/0), Pendleton (17/1), Pleasants (4/1), Pocahontas (37/1), Preston (86/21),Putnam (93/1), Raleigh (83/3), Randolph (192/2), Ritchie (2/0), Roane (12/0),Summers (2/0), Taylor (22/1), Tucker (7/0), Tyler (10/0), Upshur (31/2), Wayne(136/1), Webster (1/0), Wetzel (38/0), Wirt (6/0), Wood (186/9), Wyoming (7/0).
As case surveillance continues at thelocal health department level, it may reveal that those tested in a certaincounty may not be a resident of that county, or even the state as an individualin question may have crossed the state border to be tested.
Pleasenote that delays may be experienced with the reporting of information from thelocal health department to DHHR.
Please visit thedashboard at www.coronavirus.wv.gov for more detailed information.
Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY
Hopes are dimming that "herd immunity" can help stamp out the tenacious globalpandemic amid growing concerns that people can be reinfected with COVID-19.
Experts agree that claimsofrecurring infectionsrequire more study since we are only months into the health crisisand evidence has been anecdotal.But if it's proventhat recovered patients can "catch" the virus a second time, it would affecttheir own immunity while also complicating efforts to obtain the Holy Grail of currentmedical research: effective vaccines.
Recovery from the disease provides antibodies to fight off the infection. Theshelf life of those antibodies, however, may be insufficient to protect a patient for very longor promote long-term immunity across populations.
"Thepossibility of reinfection is certainly real," Dr. Robert Glatter, an emergency physician atLenox Hill Hospital in New York City, told USA TODAY. "And one that I am seeing repeatedly on the front lines."
Glatter says he has cared for a "number of patients" who suffer onlymild initial infections, get better and actually test negative for the virus before experiencing a recurrence of symptoms. Theintensity can be worse the second time, he says.
"These patients develop difficulty breathing, leading to hypoxia, aches, chest pain, with recurrent and unrelenting fevers and chills," he said, adding that they then test positive again.
Experts caution that it's been only a few months since the first surge of cases in China and around the world. The frequency and severity of reinfections won't be known until cases rise in the areas where there were a significant number of infections last winter, said Dr. Daniel Griffin, chief of infectious diseases atProHEALTH Care in New York.
"We are months away from knowing for certain if reinfections are possible or a significant issue," Griffintold USA TODAY.
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Physicians don't know for sure whether people who appear ill a second time are suffering from a resurgence of their first infection,Griffin said. But hetells the story of a man he treated for COVID-19 as an outpatient in March. Four months later, he was sick again, this time hospitalized with fevers and chills. He tested positive, the high level of antibodies he had displayed after his illness barely detectable.
Griffin noted that work on other coronaviruses demonstrated people were just as likely to be reinfected a year later as people who were never infected. Studies show COVID-19 antibodiesdecliningin all patients after two months and becoming negative in a high percentage of patients, he said.
"It's concerning for those of us who hope this virus is just a one-and-done for our patients," Griffin said.
Dr. Monica Gandhi,professor of medicine and infectious disease expert at the University of California, San Francisco, isn't so sure.
We have not seen a single convincing case of reinfection," she said. "Thats the proof in the pudding that being infected confers immunity."
In London, Kings College researchers have found that antibodies peaked up to three weeks after onset of symptoms before declining. The study of 90 patients and health care workerswas published in in apreprint paperin medRxivand has not yet been the subject of scrupulous peer review.
But the research supports the possibilitythat COVID-19 could reinfect people repeatedly. Blood tests revealed that while 60% of people presented a potent antibody response while battling thevirus, only 17% retained that potency three months later.
All of which could prove the death knell for the hope of herd immunity through a one-shot vaccine or community spread of the virus.
People wait in their vehicles in line at a COVID-19 testing site on July 14, 2020, in Houston.(Photo: David J. Phillip, AP)
Melissa Nolan,an infectious disease expert and professor at the University of South Carolina, says other studies indicate that peoplewho were infected but presented no symptoms likely never had sufficient viral loads in their pulmonary tract to generate a sufficient antibody response.
In contrast, people with severe symptoms likely had a higher volume of virus deep in their lungs that "sparked an immunologic chain reaction" resulting in the generation of antibodies.Still, one study showed 13% of symptomatic cases had lost immunity and were susceptible to reinfection at two months post-infection.
"My clinical interpretation from these new studies is that until we have a vaccine that is widely available, societies will not naturally develop their own herd immunity," Nolan said. "These new findings suggest that persons might get reinfected."
Ogbonnaya Omenka, a public health expert and assistant professor atButler University, emphasizes that more research is required. Natural individual immunity has been shown to be a key factor of vaccine development, he says, so the absence of protection after recovering from COVID-19 could make the vaccine process more complicated.
Achieving herd immunity would require nearly 75% of the population to be either infected or vaccinated a goal that may prove to be elusive in light of inconsistent antibody responses and waning levels, Glatter said.
"This raises important issues going forward when we begin vaccinating the population," he said. "Its likely we will need a booster shot to bolster immunity. We certainly need more data and larger studies to confirm this finding."
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Omenka said it remains unclear whether the reinfections represent a common public health phenomenon or they are "outliers"possibly even victims of inaccuratetesting, he said.
Testing accuracy remains a problem. A group of federal lawmakers sent a letter this week to Food and Drug Administration Commissioner Stephen Hahn raising concerns about lowered standards for COVID-19 test reliability under an Emergency Use Authorization.
While no diagnostic test will ever be 100% accurate, these lower standards for determining reliability ... could affect our understanding of COVID-19s spread within a community and across the United States, the lawmakers said.
The number of known reinfection cases is too low to constitute significant data when compared withthe millionsof people who have tested positive for COVID-19, Omenka said.
"Either way, these new findings need to be taken seriously due to their public health implications," he said.
Efforts to end the pandemic remain hinged on three approaches public health strategies such as facial coverings, handwashing and physical distancing, improved medical therapiesand the push to develop an effective vaccine. The latest findings on antibodies and immunity highlight the need to continue the public health strategies as the primary approach until other effective options become available, Omenka stressed.
"Individual or herd immunity derived from recovering from COVID-19 would be a very useful factor in the fight against the disease," Omenka said."However, it would not be helpful to bank on this possibility without any clear, generalizable, supporting evidence."
Contributing:Elizabeth Weise
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