WEDNESDAY, Dec. 9, 2020 (HealthDay News) — Two new COVID-19 vaccines, developed at record-setting speed, are soon to be assessed by U.S. agencies for emergency use in combating the ongoing pandemic.
Advisory panels of infectious disease experts this week will assess a vaccine developed by pharmaceutical company Pfizer and German biotech firm BioNTech — a vaccine that Britain began administering to its most vulnerable citizens on Tuesday. The committees will then turn their attention next week to a second vaccine developed by Moderna. Approval of either or both vaccines will begin the largest vaccination effort ever undertaken. The transition from hazy lab science to a very real vaccine-laden needle raises many questions for Americans. But experts have some answers:
When will the first Americans get their vaccines?
U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention advisory committees will review the Pfizer-BioNTech vaccine this week, and if the nod is given then the vaccine rollout could commence at startling speed, said Dr. William Schaffner, a professor of infectious disease with the Vanderbilt University Medical Center in Nashville, Tenn. “It could well be that the first people to get the vaccine could be within the next week or week and a half,” Schaffner said. Because Operation Warp Speed paid manufacturers to start producing doses even as their vaccine candidates underwent clinical trials, there will be stockpiles of both the Pfizer-BioNTech and Moderna vaccines that are ready to ship the second the green light is given, Schaffner said. Warp Speed paid Pfizer nearly $2 billion to manufacture and deliver 100 million doses, and Moderna received about $1.5 billion for 100 million doses of its vaccine. “We’ve stored a lot of vaccine already. It’s one of the reasons we were able to move so quickly. We didn’t wait until the trials were completed to start making and storing the vaccine,” Schaffner said.
Who’s in charge of distributing the vaccine?
Operation Warp Speed and the CDC will oversee national distribution of the vaccine, working in conjunction with the pharmaceutical companies, Schaffner said. However, each state’s health department will identify the specific locations that will receive the vaccine prior to individuals receiving their inoculation, Schaffner said. Because the first two vaccines are based on highly fragile messenger RNA (mRNA), they need to be kept frozen at extremely low temperatures. “The Pfizer vaccine has to be kept so cold, almost minus 100 degrees Fahrenheit, in really deep freeze, otherwise it begins to degrade,” Schaffner said. “It will be going to a relatively small number of institutions, usually hospitals, where they have the facilities to deal with that and they have personnel who can be trained to administer the vaccine.” Upcoming vaccine candidates produced using more traditional methods are expected to be more hardy, and those likely will be distributed directly to pharmacies and the offices of participating physicians, Schaffner said.
How quickly can the vaccine be produced?
One advantage of the mRNA vaccines produced by Pfizer-BioNTech and Moderna is that they are fully lab-manufactured, said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “It’s a synthetic molecule. You just make it in the lab. You don’t have to worry about growing it up in cells, as is true for more classic vaccines,” Offit said. Because of this, Offit is hopeful that large amounts of these vaccines can be quickly churned out. “The Pfizer vaccine is a 30-microgram dose. A microgram is a millionth of a gram. You can make kilograms of this stuff,” Offit said.
However, there are 7.8 billion people in the world. Even with manufacturers working at a fast clip, it will take months to produce two doses for every adult on the planet. And the United States will have to wait in line with other nations competing for the same resource. Pfizer has told the Trump administration that, because other countries have rushed to buy up most of its supply, substantial additional doses above the 100 million the U.S. government purchased earlier this year will not be available to the United States until late June or July, the Washington Post reported Tuesday. Other vaccine candidates receiving approval in subsequent months could speed up efforts to immunize everyone, but at this point it’s not clear how soon those will receive their turn at bat. U.S. officials expect to have about 40 million doses of vaccines from Pfizer-BioNTech and Moderna distributed by the end of the year — just enough to immunize 20 million people with the two-dose vaccine, the Post said.
Who will get the vaccine first, and in what order?
The CDC has decided that health care workers and people working or living in long-term care facilities will be the first folks to get the COVID-19 vaccine. There are about 21 million health care workers and about 3 million people at long-term care facilities, so their inoculations will account for the first 48 million doses of the two-dose vaccine. It’s not clear who will be next in line. The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet in the coming weeks to make recommendations for the groups to be included in subsequent waves. The next phase of priority vaccinations could focus on essential workers such as educators, food and agriculture workers, utility workers, police, firefighters, corrections officers and transportation employees, according to a slideshow presented at the Dec. 1 meeting of the ACIP.
This represents about 87 million people, and also would promote vaccination among minority communities that have been hit hard by the pandemic, the Post reported. After that, people aged 65 and older (about 53 million) and adults with high-risk medical conditions (about 100 million) could be next in line for vaccination, the presentation noted. The CDC likely will decide as part of its rollout strategy which high-risk conditions should be placed at higher priority than others, Schaffner said. For example, health officials will have to weigh placing people with compromised immune systems like cancer patients and transplant recipients in line ahead of people with heart or lung ailments, diabetics or folks who are obese.
How will I know when it’s my turn and where I should go to get my shot?
Average folks probably will learn it’s their turn for the COVID-19 vaccine from their local media, Schaffner said. “State and local health departments will communicate that through TV, newspapers, radio and the like,” Schaffner explained. Health care workers are being advised by their employers that they will constitute the first wave of immunization, said Susan Mashni, chief pharmacy officer for the Mount Sinai Health System in New York City. “We’ve already started internally town halls and huddles and manager meetings with staff to let them know they’re going to be in the first wave of folks who are eligible,” Mashni said of Mount Sinai. Doctors who care for high-risk patients also are likely to promote outreach to those people when their turn comes, Mashni added. “We will be doing outreach to our patient population, to let them know they’re in that category and that we’ve received vaccine and are ready to accept the patients,” Mashni said. “Physician groups within Mount Sinai have been advocating for their patients, to make certain that when we’re getting the allocations that we’re aware who the highest risk patients are.”
Will I get some proof that I got the vaccine, like a vaccine certificate?
It’s expected that people who receive the COVID-19 vaccine will receive some sort of paperwork. The form of that documentation will be described in the emergency use authorization that each vaccine receives from the FDA, Mashni said. “I believe we’ll be giving people a card that shows the lot number of the vaccine they received,” Mashni said. “Then we’ll make certain at the time they get their first vaccine that they are also scheduled for their second vaccine.” One important reason for this paperwork is that a person must get the same vaccine from the same manufacturer for their first and second doses, Mashni and Schaffner explained. The paperwork also will help health officials track vaccine distribution and make sure all doses are being efficiently disbursed, Schaffner added. “Every dose of vaccine will have to be accounted for,” Schaffner said. “The state health departments are going to be very tough about that. They will want to know that vaccine is not remaining unused in a refrigerator and they will want to know who received the vaccine, and which vaccine they received so that you can plan rigorously the second dose.”
How long will I have to wait between doses?
The good news is that Pfizer’s vaccine offers strong protection after the first dose, The New York Times reported. The efficacy of the vaccine after the first dose is about 52%, and after the second dose, that rises to about 95%. But you will have to wait three to four weeks between your first and second dose, depending on whether you get the Pfizer or Moderna vaccine. “If you miss and you come in later, no problem, you don’t have to repeat the first dose,” Schaffner said. “We just don’t want you to get the dose too soon. That’s not optimal for your immune system.”
If I’ve already had COVID-19, do I need to get the vaccine?
People who’ve had COVID-19 will need to receive the vaccine same as everyone else, Schaffner said. “They will be asked to stand in line and get a vaccine also,” Schaffner said. “There will be no distinction made, in part because we think there’s no adverse event that will occur, and also the protection from the vaccine actually may be more long-lived, of longer duration than that you get from the natural infection.” Coronaviruses are notorious for promoting short-lived immunity in humans, explained Dr. Greg Poland, director of the Vaccine Research Group at the Mayo Clinic, in Rochester, Minn. “With the four seasonal beta coronaviruses that circulate and cause all the upper respiratory infections you see in your practice, those people lose immunity in months to a year or two,” Poland said. That’s why people fall prey to the common cold again and again.
This happens because the body uses a relatively simple strategy to fight off common cold coronaviruses, and this strategy does not appear to make a lasting impression on immune system memory, Poland said. There’s a chance people who had asymptomatic or mild cases of COVID-19 did not build up any lasting immunity; at this point it is unclear what sort of immunity is conferred even by severe cases. More threatening coronavirus diseases like SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome) appear to produce immunity that potentially lasts longer, but the data is limited because both viruses have infected far fewer people than COVID-19, experts said. “This virus is so new that we don’t know very much about levels of protection and their duration. We’re all together on this, learning as we go along,” Schaffner said.
How should I expect to feel after I get the vaccine?
The two-dose Pfizer-BioNTech and Moderna vaccines use what’s called a “prime/boost” strategy, Schaffner said. “The first inoculation kind of alerts the immune system, and it’s the second inoculation that really gets the immune system worked up,” Schaffner said. People should not be surprised if they feel under the weather after receiving either dose, but especially the booster, Schaffner and Offit said. “When your immune response is activated you have certain symptoms, which can be things like low-grade fever, headache, muscle ache and fatigue, enough so that you could actually miss a day of work,” Offit said. “I wish the immune system had a better public relations team working for it. This is just a natural consequence of having an activated immune system.” When it’s your turn to get either dose, make sure you don’t make any plans for the next day, Schaffner advises. “This is not COVID. This is merely the immune system revving up and responding to the vaccine. But it is sufficient that some people might not want to go to work that next day,” Schaffner said. Hospitals are taking this into account when scheduling vaccinations for their employees, Offit said. “You’re not going to vaccinate your whole emergency department and have them potentially be out the next day,” Offit said.
Do I get to resume normal life after receiving the vaccine?
Vaccination might produce delightful thoughts of throwing your mask away and hugging dear friends, but you will have to resist the urge. People will still need to maintain infection control habits even after they’ve received their shots. “The trials have shown us that the vaccine prevents the occurrence of disease and severe disease. They were not designed to tell us whether it prevents infection,” Schaffner said. Given that, a person who received the vaccine might well be able to spread the novel coronavirus even though their risk of falling seriously ill with COVID-19 is low. “You could be infected and you could be contagious even though you had the vaccine,” Schaffner said. “We don’t know that, but we don’t know it’s not true. We are going to ask everyone to keep masking and observing social distancing until we are complete.”
How many Americans will need to be immunized before we achieve herd immunity?
The COVID-19 coronavirus has a transmission rate greater than three, meaning that every infected person can be expected to spread the virus to three other folks unless infection control measures are maintained. “The goalpost for herd immunity has to be fairly high because this is a highly contagious virus,” Schaffner said. “I would anticipate around 70%. That is a very high goal post, trying to get 70% of the United States population vaccinated to really flatten the curve of transmission.”
More information
The U.S. Food and Drug Administration has more about COVID-19 vaccines https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
SOURCES: William Schaffner, MD, professor, infectious disease, Vanderbilt University Medical Center, Nashville, Tenn.; Paul Offit, MD, director, Vaccine Education Center, Children’s Hospital of Philadelphia; Susan Mashni, PharmD, chief pharmacy officer, Mount Sinai Health System, New York City; Greg Poland, MD, director, Vaccine Research Group, Mayo Clinic, Rochester, Minn.
Author: directorsblog
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Avoid the ‘Twindemic:’ Get Your Flu Shot Now
By Dennis Thompson
HealthDay Reporter
TUESDAY, Sept. 22, 2020 (HealthDay News) — The best time to get your flu shot is now if you want to protect yourself against a potential “twindemic” infection of influenza and COVID-19, experts say.
“Early September, at the very least early October, is the best time to get your flu shot. That really allows your body to build up the appropriate immune response in time for the peak prevalence of influenza in the community,” Dr. Nadia Eltaki, director of clinical operations for Sibley Memorial Hospital in Washington, D.C., said during an HD Live! interviewon Tuesday.
A massive effort is underway to get as many people as possible inoculated with the seasonal flu vaccine, to reduce the risk of combination influenza/COVID-19 epidemics overwhelming local or regional health systems in the United States.
The “twindemic” risk to individuals is twofold, Eltaki said.
Infection with either virus will deal your immune system such a blow that you will be more susceptible to a more savage follow-up bout with the other, Eltaki said.
“One virus can weaken your immune system enough to make you susceptible to the other virus or any other respiratory virus or illness,” Eltaki said. Your body will be less able to stave off initial infection or to hold the line against a cascading viral onslaught throughout your body, she said.
Worse, some people could be unlucky enough to contract both viruses at the same time, Eltaki added.
“Unfortunately, it is possible to contract both the influenza virus and the novel coronavirus,” she said. “If you are infected with both viruses together, the resulting impact could lead to even more severe outcomes than either infection independently.”
The flu and COVID have strikingly similar symptoms, including fever, runny nose, sore throat, cough, body aches, headaches and GI upset, Eltaki said. The only major symptom that definitely points toward COVID rather than flu is the loss of smell and taste.
“We ask that if you have any of those symptoms to call your physician, explain your symptoms and self-quarantine until you know exactly what you have,” Eltaki said.
Public outreach regarding the importance of this year’s flu shot is crucial. Doctors have seen a decline in immunizations, health screenings and other types of patient visits, because people are afraid they’ll contract COVID-19 if they go to a doctor, Eltaki said.
Doctor’s offices and clinics have put a number of infection-control measures in place to protect people, she said. These include pre-appointment screening questionnaires, universal masking of patients and staff, temperature screenings upon arrival, and strict disinfecting procedures between patients.
People still not reassured by these measures have other options, Eltaki added. Major grocery store and commercial pharmacy chains not only offer quick and easy flu shots, but some have been offering coupons or gift cards for people who get the shot during their shopping trip.
Some folks also might be reluctant to get the flu shot because of some of the myths that have cropped up around the inoculation, Eltaki noted.
The most common misperception is that you’ll get the flu from the flu shot.
“The flu shot is made from a dead virus. You cannot get the flu from getting the flu shot,” Eltaki said.
“However, you can experience some symptoms, which is the result of your body mounting an immune response,” Eltaki continued. “You may have a low-grade fever or body aches, but that’s not the flu, that’s just your body matching the appropriate immune response to the flu shot.”
There also is no evidence that a flu shot increases a person’s risk of contracting COVID-19 or any other respiratory virus, the U.S. Centers for Disease Control and Prevention said.
Flu shots are needed every year because influenza virus mutates so quickly that humans cannot mount a lasting preventive immunity against it.
Each year, doctors make their best prediction regarding the strains of flu most likely to circulate widely in humans. The annual flu vaccine protects against either three or four of the leading contenders, depending on which vaccine you get.
“Studies have shown that the influenza vaccine is about 60% effective in preventing the flu,” Eltaki said. “Even though those odds are fair, we know if you do get the flu and you have received the flu shot, the severity, length, intensity and duration of your symptoms will still be less than the person who has not received a flu shot and gets the flu. There is some protective effect.”
You should get the flu shot rather than the nasal spray vaccine, Eltaki added.
“More and more, health care practitioners are steering away from the nasal mist because of presumed better efficacy of the shot,” she said. “Any child above the age of 6 months should get a flu shot.”
Pregnant women, the elderly and the immune-compromised also would do better with a flu shot than the nasal spray, Eltaki said.
More information
The U.S. Centers for Disease Control and Prevention has more about flu vaccine misconceptions.
SOURCE: Nadia Eltaki, M.D., director, clinical operations, Sibley Memorial Hospital, Washington, D.C.
Copyright © 2020 HealthDay. All rights reserved.
Coronavirus Vaccine Plan for Americans Announced
By Robin Foster and E.J. Mundell
HealthDay Reporters
THURSDAY, Sept. 17, 2020 (Healthday News) — The details of a plan to rapidly deliver a future coronavirus vaccine to Americans were unveiled by federal officials on Wednesday.
Two of the key parts of the plan are to begin distributing a vaccine with 24 hours of any approval or emergency authorization and offering the vaccine for free, The New York Times reported.
Officials from Operation Warp Speed — the multiagency effort to quickly vaccinate Americans against coronavirus — also said the timing of a vaccine was still unclear, the Times reported. That despite repeated statements from President Donald Trump that a shot could be ready before the election on Nov. 3.
“We’re dealing in a world of great uncertainty. We don’t know the timing of when we’ll have a vaccine, we don’t know the quantities, we don’t know the efficacy of those vaccines,” Paul Mango, the deputy chief of staff for policy at the U.S. Department of Health and Human Services, told the Times. “This is a really quite extraordinary, logistically complex undertaking, and a lot of uncertainties right now. I think the message we want you to leave with is, we are prepared for all of those uncertainties.”
Who will get the vaccine first? Initial distribution of a vaccine, possibly on an emergency basis, would to a limited group of high-priority people, such as health care workers, in the final three months of this year and into next year, the Times reported. The Department of Defense is providing logistical support for shipping and storing the vaccine, and for keeping track of who has gotten a vaccine and whether they got the full two doses, the newspaper said.
To achieve this, existing databases would be linked up so that, for example, a patient who received a vaccine at a public health center in January could go to a CVS pharmacy 28 days later in another state and be assured of getting the second dose of the right vaccine, the Times reported.
Right now, three drug makers are testing vaccine candidates in late-stage trials in the United States. One of those companies, Pfizer, has said that it could apply for emergency authorization as early as October, while the other two, Moderna and AstraZeneca, have said they hope to have something before the end of the year.
In a sign that the Pfizer vaccine trials are moving along smoothly, German pharmaceutical company BioNTech, which is developing a coronavirus vaccine with Pfizer, announced Thursday it was buying a new production plant so it can ramp up production of a COVID-19 vaccine when needed, CNN reported.
The vaccine plant in Marburg, Germany, would produce tens of millions more vaccine doses a month — pending regulatory approval, CNN reported. The plant should be up and running by the first half of 2021, BioNTech said in a statement, and the company will retain a highly skilled workforce of 300 employees following the transfer of the plant from Novartis later this year.
“In full production operations the production plant will increase BioNTech’s capacity to produce vaccines by about 750 million doses per year or more than 60 million doses per month,” BioNTech said.
New Drug May Help Prevent Severe COVID
A single infusion of an experimental drug dramatically lowers levels of coronavirus in the bodies of newly infected patients and cuts their chances of hospitalization, the drug’s maker reported Wednesday.
Eli Lilly’s announcement did not include detailed data and hasn’t been peer-reviewed or published yet, the Times reported.
The news comes from interim results of a trial sponsored by Eli Lilly and the U.S. National Institutes of Health. NIH officials would not comment on the announcement until they have seen more detailed data from the trial, the Times reported.
How does the drug work its magic? It is a monoclonal antibody, a manmade copy of an antibody produced by a patient who recovered from COVID-19, the Times reported. Scientists around the world have high hopes that that monoclonal antibodies will prove to be powerful coronavirus treatments, but they come with a caveat: They are difficult to manufacture, and would take time to produce, the Times reported.
In the trial, 452 newly diagnosed COVID patients received the monoclonal antibody or a placebo infusion. Some 1.7 percent of those who got the drug were hospitalized, compared with 6 percent of those who received a placebo — a 72 percent reduction in risk, Eli Lilly said.
At the same time, blood levels of the coronavirus plummeted among those who received the drug, and their symptoms were fewer and milder, the Times reported.
This is the first treatment aimed at patients who are not already seriously ill and hospitalized, the newspaper added.
Dr. Myron Cohen, director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill, told the Times he was impressed by the findings.
“It’s exciting,” said Cohen, who was not involved in the study. The trial appears to be rigorous, and the results are “really compelling,” he added. Other monoclonal antibody drugs to combat the coronavirus are in development, he noted.
“This is the opening of a door,” Cohen said.
Most Americans doubt Trump’s vaccine comments
In a sign that Americans are becoming more wary about the safety of a new coronavirus vaccine, a new poll shows a majority of adults don’t trust what President Donald Trump has said on vaccine development.
More than half (52%) of adults said they don’t trust the president’s vaccine comments, the NBC News/Survey Monkey poll found, while just 26% say they do. Twenty percent said they were “not aware” whether they trust what the president has said about a vaccine, NBC News reported.
Those polled were also more skeptical about whether they or their families would get a government-approved coronavirus vaccine if one became widely available, NBC News reported.
The poll’s latest data show that just 39% said they would get it, 23% said they wouldn’t and 36% say they weren’t sure. Just a month ago, 44% of Americans said they would get a government-approved vaccine, 22% said they wouldn’t, and 32% said they weren’t sure.
The highest level of confidence in a coronavirus vaccine came during the week of Aug. 17 to Aug. 23, when 45% polled said they would get a vaccine.
Despite public hesitancy, President Trump has promised a “safe and effective vaccine this year,” and the U.S. Centers for Disease Control and Prevention has advised states to prepare for “large-scale” vaccine distribution by Nov. 1.
Public health experts have questioned that aggressive timeline. Dr. Anthony Fauci, the nation’s leading infectious diseases expert, has said that he feels “cautiously optimistic” that a safe and effective vaccine would be found by the end of the year but that doing so by Nov. 3 was “unlikely,” NBC News reported.
Cases keep mounting
By Thursday, the U.S. coronavirus case count passed 6.6 million as the death toll passed 196,600, according to a Times tally.
According to the same tally, the top five states in coronavirus cases as of Thursday were: California with nearly 773,000; Texas with more than 706,000; Florida with over 671,000; New York with more than 451,000; and Georgia with over 282,000.
Curbing the spread of the coronavirus in the rest of the world remains challenging.
By Thursday, India’s coronavirus case count had passed 5.1 million, just one month after hitting the 3 million mark, the Times reported.
More than 83,000 coronavirus patients have died in India, but when measured as a proportion of the population, the country has had far fewer deaths than many others. Doctors say this reflects India’s younger and leaner population.
The country’s public health system is severely strained, and some sick patients cannot find hospital beds, the newspaper said. Only the United States has more coronavirus cases.
Meanwhile, Brazil posted over 4.4 million cases and over 134,000 deaths as of Thursday, the Times tally showed.
Cases are also spiking in Russia: The country’s coronavirus case count has passed 1 million, the Times reported. As of Thursday, the death toll in Russia was 18,996.
Worldwide, the number of reported infections passed 29.8 million on Thursday, with nearly 941,000 deaths, according to the Hopkins tally.
More information: The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.
SOURCES: The New York Times; CNN; Associated Press;
Copyright © 2020 HealthDay. All rights reserved.
FDA Approves New Rapid Coronavirus Test
By Robin Foster and E.J. Mundell
HealthDay Reporters
THURSDAY, Aug. 27, 2020 (HealthDay News) — The first rapid coronavirus test that doesn’t need any special computer equipment to produce results was approved by the U.S. Food and Drug Administration on Wednesday.
Made by Abbott Laboratories, the 15-minute test will sell for $5, giving it an edge over similar tests that need to be popped into a small machine, the Associated Press reported. No larger than a credit card, the Abbott test is based on the same technology used to test for the flu, strep throat and other infections.
BinaxNOW is the fourth rapid test in the United States that detects COVID-19 antigens, proteins found on the surface of the coronavirus, rather than the virus itself, the AP reported. It’s considered a faster, but less precise, screening method.
Abbott’s entry into the rapid COVID-19 test market offers yet another option to expand testing, the APreported. The FDA also recently gave its blessing to a saliva test from Yale University that bypasses some of the supplies that have led to testing bottlenecks, the wire service said. Neither test can be performed at home.
But several companies are developing rapid at-home tests, though none have yet won FDA approval, the APreported. Abbott’s new test still requires a nasal swab be taken by a health worker, like most older coronavirus tests. The Yale saliva test eliminates the need for a swab, but can only be run at high-grade laboratories.
Roughly 690,000 Americans are now being tested per day, down from a peak of 850,000 daily tests late last month, the AP reported. But many public health experts believe the country will soon need to test vastly more people as schools reopen and the flu season arrives.
Since the start of the pandemic, nasal swab tests that are sent to a lab have been the standard for COVID-19 screening. While considered highly accurate, the tests rely on expensive, specialized machines and chemicals. Shortages of those supplies have led to repeated delays in reporting results, the AP reported.
“Those [rapid] screening tests are what we need in schools, workplaces and nursing homes in order to catch asymptomatic spreaders,” Dr. Jonathan Quick, of wire service. The nonprofit group has called for the United States to conduct about 4 millions per day by October, mostly rapid, point-of-care tests.
Thousands of cases reported on college campuses
More testing could not come soon enough: Just weeks after colleges across the United States began to reopen their campuses for the fall semester, thousands of coronavirus infections are cropping up in students and staff alike.
More than 1,500 American colleges and universities were tallied in The New York Times survey. That included every four-year public institution, every private college that competes in NCAA sports and others that identified cases. The case total: At least 26,000 cases and 64 deaths have been reported since the pandemic began, the Times reported.
The trend is unfolding everywhere. The University of North Carolina at Chapel Hill sent most undergraduates home after COVID-19 clusters popped up in campus housing. In-person classes were delayed at Notre Dame as students tested positive by the hundreds. Clemson, Baylor, Louisville and dozens of other Division I universities have confirmed COVID-19 cases in their athletic departments. And aggressive testing of students moving into dorms turned up scores of cases at Iowa State, the Times reported.
Meanwhile, the potential of convalescent plasma as a treatment for severe COVID-19 was still unclear Tuesday, as the World Health Organization cautioned the therapy remains experimental and American scientists challenged a key statistic cited by U.S. officials as grounds for emergency approval of the treatment.
In announcing the approval this week, President Donald Trump and two of his top health officials stirred controversy when they used the same statistic — that the treatment had reduced deaths by 35 percent, the Times reported.
Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, went so far as to say that 35 out of 100 COVID-19 patients “would have been saved because of the administration of plasma.”
Levels of risk
But many scientists, including one researcher from the Mayo Clinic study from which the statistic was supposedly gleaned, said Monday they could not ascertain where the number came from, and that Hahn had appeared to overstate the treatment’s benefits, the Times reported.
“Do I know where the 35 percent comes from?” said Dr. Arturo Casadevall, one of the May Clinic study’s main authors who hails from Johns Hopkins University in Baltimore. “No.”
The actual data from the Mayo Clinic study shows that, among a group of more than 35,000 patients, when plasma was given within three day of diagnosis, the death rate was about 22 percent, compared with 27 percent when it was given four or more days after diagnosis, the Times reported.
But Hahn seemed to have instead mixed up absolute risk and relative risk in a small subgroup of patients in the study, the Washington Post reported.
On Monday night, Hahn acknowledged in a tweet that he had misspoken during the Sunday news briefing about the findings of the plasma study.
“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” Hahn wrote. “What I should have said better is that the data show a relative risk reduction, not an absolute risk reduction.”
What is the actual benefit? Eric Topol, director of the Scripps Research Translational Institute, said on Twitter Monday that data gathered on the use of plasma in COVID-19 patients indicates that 3 people out of 100 would be saved at seven days of treatment and 5 at 30 days not 35.
Parents overwhelmed as school year starts
Meanwhile, a new survey shows most parents are feeling overwhelmed and abandoned as the school year starts.
Just 1 in 7 parents said their children would be returning to school full time this fall, and most children need help with remote schooling, Times survey released recently found. Yet, 4 in 5 parents said they would have no help in that endeavor, whether from relatives, neighbors, nannies or tutors. As well, more than half of parents said they will be taking on this burden while still holding down paid jobs.
Of course, when both parents are wage earners who need to work outside the home, they cannot be in two places at once. But three-fourths of these parents said they will be overseeing their children’s education, and nearly half plan to handle child care, according to the survey of more than 1,000 parents polled between Aug. 4 and Aug. 8.
Of the parents who are both working remotely during the pandemic, 80 percent will also handle child care and education, the survey showed. One in five are considering hiring a private teacher or tutor to help with remote learning.
“All the choices stink,” Kate Averett, a sociologist at the University at Albany in New York who has been interviewing parents since the spring, told the Times. “There is a lot of stress, a lot of anxiety. Parents tell me about not being able to sleep because they’re so anxious, or tell me they’ve been crying a lot. There’s been a lot of actual crying during interviews.”
By Thursday, the U.S. coronavirus case count passed 5.8 million as the death toll passed 179,000, according to a Times tally.
According to the same tally, the top five states in coronavirus cases as of Thursday were: California with more than 687,000; Texas with more than 619,800; Florida with more than 608,700; New York with over 436,000; and Georgia with more than 244,000.
Nations grapple with pandemic
Elsewhere in the world, the situation remains challenging.
India has passed Britain to have the fourth-highest death toll in the world from the coronavirus, after the United States, Brazil and Mexico, the Post reported.
By Thursday, India had more than 3.3 million confirmed cases of the infection and over 60,000 deaths, a John Hopkins tally shows. Britain remains the worst-hit country in Europe, the Post reported.
Brazil is also a hotspot in the coronavirus pandemic, with over 3.7 million confirmed infections by Thursday, according to the Hopkins tally. It has the second-highest number of cases, behind only the United States.
Cases are also spiking in Russia: As of Wednesday, that country reported the world’s fourth-highest number of COVID-19 cases, at over 972,700, the Hopkins tally showed.
Even New Zealand, a country that hadn’t seen a new coronavirus case in 100 days, hasn’t been spared.
Prime Minister Jacinda Ardern has extended a lockdown in Auckland until Sunday night, the Times reported. The restrictions had been set to expire Wednesday, but Ardern said the extra time was necessary to ensure that a virus cluster of more than 100 cases in Auckland had been brought under control. Arden also said masks were now mandatory on public transportation nationwide.
Worldwide, the number of reported infections passed 24.2 million on Thursday, with more than 826,000 deaths, according to the Hopkins tally.
More information
The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.
SOURCES: Associated Press; The New York Times; Washington Post
Copyright © 2020 HealthDay. All rights reserved.
2020 APWU Health Plan Virtual Open Season Health Fairs!
As the coronavirus continues to impact families nationwide, the Health Plan wants to be sensitive to the COVID-19 risks related to work, travel, and social distancing. While in person health fairs are being canceled, we wanted to give your employees an opportunity to meet with APWU Health Plan staff virtually. Postal, Federal, and Retirees who are eligible for the Federal Employee Health Benefits Program can access and attend our virtual health fairs safely online.
During Open Season, every Tuesday and Thursday, from 12-2pm EST a Health Plan staff employee will be online to answer questions and discuss plan features. Please forward this email to your employees so that they can participate.
Once registered you will get an email confirmation with a GoToMeeting link and dial-in information. On the Monday before the virtual health fair date you selected, we will email you a reminder and include the dial-in information with instructions.
Register Now! for any of our Virtual Health Fairs.
- Tuesday, November 10, 12 pm-2pm EST
- Thursday, November 12, 12pm-2pm EST
- Tuesday, November 17, 12 pm-2pm EST
- Thursday, November 19, 12pm-2pm EST
- Tuesday, November 24, 12 pm-2pm EST
- Tuesday, December 0, 12 pm-2pm EST
- Thursday, December 03, 12pm-2pm EST
- Tuesday, December 08, 12 pm-2pm EST
- Thursday, December 10, 12pm-2pm EST
Expert Tips to Help You Beat the Heat
THURSDAY, July 23, 2020 (HealthDay News) — With much of the United States blanketed by a heat wave this week, the American Red Cross offers some survival tips.
Each year, extreme heat kills more than 600 people in the United States. And many others are at risk of heat-related illness, especially adults aged 65 and older and those with chronic medical conditions, the Red Cross noted in a news release.
Electric fans may provide some cooling, but might not provide enough protection when the temperature is in the high 90s. You should take a cool shower or bath, or go to an air-conditioned place to cool off.
The organization also suggests that you:
- Wear loose-fitting, lightweight and light-colored clothing. Drink plenty of fluids, but avoid drinks with caffeine or alcohol.
- Check on family, friends and neighbors who have no air conditioning, spend much of their time alone, or are likely to be affected by the heat.
- Never leave children or pets in your vehicle, not even for a minute. The inside temperature of the car can quickly reach 120 degrees Fahrenheit.
- Check your local news for extreme heat alerts and to find cooling shelters in your area. Slow down, stay indoors and avoid strenuous exercise during the hottest part of the day. Postpone outdoor games and activities. Check on animals frequently, and make sure they have plenty of shade and cool water.
- When working in extreme heat, take frequent breaks, monitor the condition of your co-workers, and have someone do the same for you.
- Keep tabs on those at greatest risk for heat-related illness. Besides the elderly, these include infants and young children, overweight people and those who “overexert” during work or exercise. Also at greater risk are people who are physically ill, especially if they have heart disease or high blood pressure, or take certain medications for depression, insomnia or poor circulation.
The Red Cross advises visiting at-risk adults at least twice a day. Infants and young children need much more frequent monitoring.
If you don’t have air conditioning, seek relief in public facilities that have it. And if you do go to a public facility to stay cool, follow coronavirus pandemic precautions: Wear a cloth face covering and maintain social distancing.
More information
The U.S. Centers for Disease Control and Prevention offers more hot weather safety tips.
— Robert Preidt
SOURCE: American Red Cross, news release, July 17, 2020
Copyright © 2020 HealthDay. All rights reserved.
35th Annual Open Season Seminar
The APWU Health Plan continues to monitor the developments regarding the coronavirus. As we begin to prepare for the 2020 Open Season, the coronavirus is still a priority for the Health Plan. We want to be sensitive to the COVID-19 risks related to travel and social distancing.
Out of an abundance of caution, and as part of our ongoing efforts to protect everyone’s health, the 35th Annual Open Season Seminar will be conducted virtually. Attendees can access their classes online from the safety of their homes.
We are confident that we have the tools and resources that will allow for HPR engagement and learning with Health Plan presenters facilitating live presentations in an online setting.
Registration opens July 7. To see a schedule at a glance and register for the Virtual 35th Annual Open Season Seminar here https://www.apwuhp.com/events/
Experts Optimistic in Search for COVID-19 Vaccine
By Serena Gordon
Health Day Reporter
MONDAY, June 8, 2020 (HealthDay News) — Americans are ready to rip off their face masks and just have a nice dinner in a restaurant, but the best shot at returning to normalcy — vaccines to prevent COVID-19 — will be in clinical trials for months or longer.
The good news is that there are more than 100 vaccines of varying types and in various stages of development. As of this month, eight of these vaccine candidates were already in early human trials. One research team hopes to have a vaccine available in September. Another is hoping their vaccine will be available by the start of 2021.
Because there are so many vaccine candidates of varying types, Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, told the Journal of the American Medical Association he’s “cautiously optimistic” that there will be at least one that works against the novel coronavirus.
“The majority of people make an immune response which clears the virus. If the body is capable of producing an immune response, that’s a pretty good proof of concept to say that you can get an immune response from a vaccine,” Fauci said.
But, he added, there’s no guarantee. And Fauci said he’s somewhat concerned about how long a vaccine might keep working. Natural immunity to coronaviruses that cause common colds often lasts less than a year, he noted.
Still, Fauci and other experts believe there will ultimately be several vaccines available to combat the novel coronavirus.
“I’m optimistic that we’ll have a lot of vaccines,” Dr. Paul Offit told the Journal of the American Medical Association. He’s director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
Vaccines will likely need to be given in two doses, he said. And, whether or not booster shots will be needed to ensure continued immunity against the virus remains to be seen.
The hurried pace of the research may leave some concerned about the safety of these vaccines.
Dr. Kathryn Edwards, scientific director of the Vanderbilt Vaccine Research Program in Nashville and a fellow with the Infectious Diseases Society of America, said, “We’re working very hard to generate a safe and effective vaccine. Every single vaccine that I recommend is one I would give my children and grandchildren. We may be going fast, but that doesn’t mean we aren’t being meticulous.”
Vaccine testing a rigorous process
Edwards said there are systems in place, along with numerous checks and balances to ensure safety.
Vaccines generally go through lab and animal research, and then three phases of human trials, according to the U.S. Centers for Disease Control and Prevention. Phase 1 trials are typically very small and look mostly for safety. Phase 2 trials are a bit larger and continue to evaluate safety and its effectiveness. Phase 3 trials are much larger, with a placebo group and at least one group receiving the vaccine to better measure how effective a vaccine is.
Here are some of the vaccines currently in human trials:
· Moderna. This two-dose vaccine is currently in a phase 2 trial with 600 participants, and is scheduled to move to a phase 3 trial with 30,000 participants in July. It’s a type of vaccine called a messenger RNA vaccine. Essentially, it delivers a message to the body on how to make the antibody that can prevent the infection, according to Edwards. If the clinical trials go well, the company hopes to make the vaccine available by the end of 2020 or the start of 2021.
· University of Oxford/AstraZeneca. This vaccine — a modified virus that can trigger the production of antibodies — is currently in a phase 2 trial with 500 participants. A phase 3 trial with about 30,000 is planned to begin in early summer. Edwards said this vaccine is likely going to be given in a single dose.
· Pfizer/BioNTech. This partnership is currently testing four vaccines in phase 1 or 2 trials in Germany. Their vaccines are messenger RNA vaccines. Each trial will include about 200 people.
· Inovio. This company had already been working on a vaccine for MERS (another infection caused by a coronavirus), which allowed them to quickly switch to working on a vaccine for SARS-Cov-2 (the virus that causes COVID-19). Their vaccine is a DNA vaccine (a type of vaccine that contains the DNA coding specifically for making the antibodies against a particular virus), and phase 2 and 3 trials are expected to begin this summer in the United States. Inovio believes it can have 1 million doses by the end of 2020.
There are also a number of other vaccines in upcoming or ongoing phase 1 trials, including vaccine candidates from Johnson & Johnson, Sanofi, Sinovac, CanSino Biologics and a collaboration between the Beijing Institute of Biological Products, the Wuhan Institute of Biological Products and the China National Pharmaceutical Group (Sinopharm).
So, if one or more of these vaccines works well and is safe, how can companies or governments quickly ramp up production?
Fauci explained that the government isn’t waiting.
Millions of vaccine doses will be made before testing is complete
“We’re going to start manufacturing doses of vaccine way before we even know that they work, so that by the beginning of 2021, we will have a couple of million doses,” Fauci said. That way, if testing shows a vaccine works, an initial supply will already be available.
Offit noted that producing tens of millions of doses before it’s known if a vaccine works isn’t unprecedented — it was done with the polio vaccine.
He also urged caution. “There’s a lot at stake here. If we rush it, if we put something out there into people’s arms before we know what we need to know — or as much as we can reasonably know, then I think we could do harm,” he said.
Still, Offit thinks if everyone pays attention to the science, there is “every reason to think that vaccines will be the heroes of this story.”
What remains to be seen, however, is whether Americans will embrace a new vaccine.
The most recent poll, published June 2 and conducted by the Washington Post-ABC News, found that roughly 7 in 10 Americans would get a COVID-19 vaccine if immunizations were free and available to everyone.
More information: Learn more about COVID-19 prevention from the World Health Organization.
SOURCES: Kathryn Edwards, M.D., fellow, Infectious Diseases Society of America, and professor, pediatrics, and scientific director, Vanderbilt Vaccine Research Program, Nashville, Tenn.; June 1, 2020, Journal of the American Medical Association livestream with Paul Offit, M.D.; June 2, 2020, Journal of the American Medical Association livestream with Anthony Fauci, M.D.; June 2, 2020, Washington Post
Copyright © 2020 HealthDay. All rights reserved.
