MILLER PLACE, N.Y. (CBSNewYork) A Sweet Sixteen party on Long Island is now considered a superspreader event as its being blamed for dozens of positive coronavirus cases.
A total of 37 people 28 students and nine adults tested positive for COVID-19, and 270 people were instructed to self-quarantine.
In Suffolk County, we have not seen an event like this before at any time throughout this pandemic. For Suffolk County, this was a superspreader event. This is the first time that the health department has taken enforcement action against a business, Suffolk County Executive Steve Bellone said.
The venue, the Miller Place Inn, has been slapped with a $10,000 fine for violating COVID restrictions.
There were 81 guests indoors at the Sept. 25 party, CBS2s Carolyn Gusoff reports. State regulations limit capacity to under 50 people.
The venue was also hit with an additional $2,000 fine for violating Suffolk Countys sanitary code.
The Suffolk County health department says it learned of the party in late September when they started seeing positive cases in the Sachem School District.
The county health department initiated a comprehensive contact tracing investigation, contacting the host of the event to obtain a copy of the guest list, which was provided voluntarily, Bellone said.
Bellone says there is no community spread but were not out of the woods yet and we need everyone to remain vigilant.
Watch Carolyn Gusoffs report
Health officials say eight schools have COVID cases tracing back to this party, including the Sachem School District, which had to go fully remote in October.
I feel bad for the kids. Theres not a lot for them to do, but I dont think theres really any excuse for that, Sachem parent Carolyn Benson told CBS2s Ali Bauman.
You think its just, oh, its just whatever, then it turns into a big thing and sooner or later a school shuts down, student Billy Curtain said.
Sachem student Samantha Brunetto says shes upset with her classmates for pausing her in-person learning.
It really just messed up school for a bunch of people that are now home, and some of them arent even going back to school, so it ruined it for a bunch of people, she said.
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The venues owner, reached by phone, said they meant no one harm but were unaware of the 50-person limit and no government agency notified them. Theyve since ceased operations.
We thought we were operating underneath the 50%, and we had no idea that we were supposed to be at 50 total occupants with kitchen and staff, Miller Place Inn co-owner Christopher Regina said.
The county executive says this venue has had prior visits and warnings. They were also cited for lack of social distancing and mask compliance, adding, We cannot have superspreading events like this. We dont want to move backwards.
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New York, NY, October 14, 2020 The International Rescue Committee (IRC) highlights encouraging signs from certain crisis-affected states of slowing COVID transmission, with several African and Asian countries reporting lower daily case counts and lower test positivity rates. The African and Asian continents writ large are both seeing a decrease in new cases, with a slowing of COVID growth with countries such as Pakistan, reporting a test positivity rate of just 1.9% in the last week compared to 22% in June. The IRC remains concerned however about low levels of testing in some places, such as Mexico, northwest Syria, Yemen, and Ethiopia, which continue to obscure the full scale of the outbreak among some of the world's most vulnerable populations.
Stacey Mearns, Senior Technical Advisor of Emergency Health at the IRC says,
"A combination of factors has contributed to the slowing down of transmission of COVID in these countries. Timely government and humanitarian responses to the disease within local communities, including the IRC's, seem to have made a dent in the prevention of further transmission and management of existing cases. On the prevention front, we have provided handwashing stations, intensified provision of water and sanitation services and engaged communities such as Bangladesh where false rumors about disease prevention and symptoms were running rife. In addition, we have trained frontline health workers on COVID-19 protocols, established isolation units as well as equipped hospitals and laboratories with beds, diagnostic kits and other vital machinery. All of this humanitarian response, supported by major donors, may be paying off: we've seen significant slowing in countries such as Pakistan and Bangladesh, saving thousands of lives and livelihoods in the process. These measures work and with redoubled financial support from the international community, we can see these gains not only last but take hold in other countries. This virus does not respect borders-- beating it in fragile states means helping defeat it altogether."
IRC has noted serious declines in COVID cases and death rates in the following countries of operation:
"These gains are significant but fragile. In countries where we see relatively little testing, such as Afghanistan and Nigeria, we are still unable to fully understand the scale of the outbreak, respond or properly understand what has worked-- even if there are encouraging signs. Having seen some of the benefits of a timely and effective response to COVID-19, more investment from the international community is needed to ensure these gains advance. Transmission is slowing in many countries and we are hopeful that the same continues. We are also looking to continue these services by engaging communities on the importance of adhering to restrictions that can support COVID-19 prevention and the use of PPE. However, in countries like Libya and northeast and northwest Syria, there is still a long way to go before the situation is brought under control. The virus is spreading quickly and the situation is deteriorating rapidly. There is an urgent need to scale up the response to prevent further loss of life."
The IRC has launched a US $30 million appeal to help us mitigate the spread of coronavirus among the world's most vulnerable populations. We are working across three key areas: to mitigate and respond to the spread of coronavirus within vulnerable communities; protect IRC staff; and ensure the continuation of our life-saving programming as much as possible across more than 40 countries worldwide.
BALTIMORE (WJZ) Patient First is offering COVID-19 testing at its Bayview Location on Eastern Avenue in Baltimore.
The location is at 5100 Eastern Ave and is by appointment only.
The test is the RT-PCR molecular diagnostic test. The test sample is collected at Patient First and sent to a reference lab for testing.
COVID-19 Virus Testing is also available at the Patient First centers in Aberdeen, Annapolis, Bel Air, Catonsville, Lutherville, Odenton, Owings Mills, Perry Hall, Towson and White Marsh.
Testing appointments can be made on-line at https://www.patientfirst.com/covid-19/covid-19-testing
For the latest information on coronavirus go to the Maryland Health Departments website or call 211. You can find all of WJZs coverage on coronavirus in Maryland here.
Dustin Johnson has withdrawn from the CJ Cup after testing positive for COVID-19 this week. Johnson has not played since the U.S. Open at Winged Foot, but came in as one of the favorites in Las Vegas to win what would be the 24th title in his PGA Tour career. Johnson had experienced symptoms of the virus, alerted PGA Tour officials and was administered a test. He is the biggest name in the sport to date to return a positive test since the sport's restart.
This is the second-straight week a top-20 player has been forced to withdraw because of COVID-19, however. Last week at the Shriners Hospitals for Children Open, it was Tony Finau. Professional golf had been sailing along pretty smoothly -- all things considered -- since a mini-outbreak at the end of June, but these are two pretty big blows to what were two great fields.
"Obviously, I am very disappointed," said Johnson in a statement. "I was really looking forward to competing this week, but will do everything I can to return as quickly as possible. I have already had a few calls with the Tour's medical team and appreciate all the support and guidance they have given me."
The second half of Johnson's 2020 has been some of the best golf of his career. In addition to wins at the Travelers Championship, The Northern Trust and Tour Championship, he has runner-up finishes at the PGA Championship and BMW Championship and a T6 at the U.S. Open nearly a month ago.
With Johnson, the bigger questions revolve around the Masters at Augusta National in four weeks. Hopefully, his recovery is swift and comprehensive, and the best player on the planet is ready to rock for the final major of 2020.
This will likely force other players to be even more cautious than they have been with a precious Masters start for many just over the horizon. Nobody wants to have to miss a major, especially one at Augusta National, because of COVID-19, and we're just one month removed from a top-40 player in Scottie Scheffler bowing out of the U.S. Open because of the virus.
JACKSONVILLE, Fla. -- There are relatively small gray and purple cartridges attached to the wall of the laundry area in the Jacksonville Jaguars equipment room. If you arent looking for them, youd probably never notice them.
Even if you did look, youd have no idea that those cartridges contain another piece of the Jaguars ongoing battle against the coronavirus.
Each cartridge contains a bag of silver ions called SilvaClean, a small dose of which is dispensed during the laundrys rinse cycle, designed to bond with fabrics to kill pathogens such as MRSA, staph and -- the company that manufactures it says -- SARS-CoV-2, the virus behind COVID-19.
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It's really all about setting a new cleanliness standard, especially giving the situation that we are in, said Priya Balachandran, the chief operations officer of Applied Silver, the company behind SilvaClean. Everyone is paying close attention to hygiene and cleanliness like never before.
Our product, when you combine that with all of the other protocols, it gives people the validity to set the new standard for cleanliness.
According to the Centers for Disease Control and Prevention, MRSA and staph have long been issues in athletic facilities, gyms, locker rooms and health clubs because people share equipment and have skin-to-skin contact. Staph, a bacteria found on skin, can cause serious skin infections, and if it gets into the blood, it can lead to sepsis or death, per the CDC.
Using ionic silver compounds to kill germs and pathogens such as MRSA and staph has already become widespread in the healthcare and hospitality industry, and it is beginning to work its way into the sports world. The Jaguars are one of six NFL teams using the SilvaClean system. San Francisco, Dallas and New Orleans are among the others. (Two other NFL teams did not give Applied Silver permission to release their names.) In addition, Cal-Poly San Luis Obispo and North Carolina State are among the colleges using the SilvaClean system.
The University of South Alabamas Laboratory of Infectious Diseases studied the product's effectiveness by treating virus samples with different concentrations of the product as well as a control solution, and LID director Dr. Jonathan Rayner said SilvaClean was found to have effectively inactivated more than 99.9% SARS-CoV-2 during the tested incubation period.
An additional benefit is that whatever it treats continuously kills the pathogens. The textiles and fabrics are not recontaminated once theyre used, and they provide ongoing protection, Balachandran said. An infection wont spread, for example, if one player touches another players T-shirt or gloves, even if the first player is sick, Balachandran said.
If someone were to touch a towel and they have germs on their skin, those germs can get on the towel, and now the SilvaClean-treated towel continuously kills it immediately, Balachandran said. You dont have to spray something on your textiles all the time. It is already there, it is gentle, it is safe for the skin, and no allergic reactions.
The Jaguars began using the system on Sept. 7, the Monday after roster cutdown. The Jaguars have a cartridge connected to each of their three 55-pound industrial washers, two 75-pound industrial washers and one high-efficiency household washer. Each cartridge contains a bag that has enough product for 200,000 pounds of laundry.
Jaguars equipment manager Jimmy Luck said he anticipates changing each bag once this season.
Theyre pretty much going from the time we get here until the time we leave, Luck said. Theres always somebody in the building making laundry. Being part of the equipment staff, were always washing somebodys stuff.
Luck learned of the SilvaClean system through his contacts with New Orleans Saints equipment manager John Baumgartner and Jim Lake, a former longtime NFL equipment manager with the Los Angeles Rams who is now the head of customer integration and success for Applied Silver. Luck also knows Daniel Fells, a strategic sports adviser for Applied Silver, from their time with the Atlanta Falcons.
I thought, If those guys are involved, let me look into this a little bit, Luck said.
One of the things Luck liked about the system is that its low-maintenance. Each unit is monitored remotely by the company using a cloud-based system, so other than clearing some space for the installation, Luck and his staff dont have to do anything.
Just walk in, make sure the lights green, and thats really about it, he said. So thats been something thats been really good for us. Its doing some things, and we dont have to do anything, which makes it nice.
Its another piece of the Jaguars battle to keep COVID-19 at bay, along with the additional sanitizing of the equipment and football facility. Per Scott Trulock, the Jaguars director of player health and performance and the teams infection control officer, three janitorial companies sanitize the facility daily and electrostatically spray Clorox 360 and cover more than 115,000 square feet. The measures seem to be working.
As of Monday, the Jaguars havent had a player placed on the reserve/COVID-19 list since running back Ryquell Armstead on Sept. 5.
Former NFL player Ian Williams used silver for several years before hooking up with Applied Silver as an ambassador. His career ended because of multiple bacterial infections after surgeries to fix a fractured left ankle, and he doesnt want anyone else to go through what he did. Williams broke his ankle in 2013 while playing defensive tackle for the San Francisco 49ers. He fought off one infection, but it returned again in 2016, and he had to have another surgery.
Things now are well, he said. ... I want people to understand that you have to pay attention to things that you cant see. You have to wash your hands, take care of your laundry and clean things now.
NORTH CAROLINA (WTVD) NCDHHS Secretary Dr. Mandy Cohen spoke Tuesday in an effort to re-energize North Carolinians and their use of personal safety measures that slow the spread of COVID-19.
Cohen warned that the states coronavirus metrics are headed in the wrong direction. She said she would get into specifics about the numbers Thursday.
Our cases are up, our hospitalizations are up, and our early surveillance data is up.
For now, she stressed that there was no one event or policy that could be blamed for the rise in COVID-19 cases. Instead, she said she thought that it was because more people were not following health guidelines such as the three Ws: wearing a mask, waiting more than 6 feet apart, washing hands thoroughly.
We need to recommit to these actions. Right now, like much of the rest country and the world, our trends are moving in the wrong direction.
Cohen was joined by Lynn Minges, President of North Carolina Restaurant and Lodging Association, and Andy Ellen, President of North Carolina Retail Merchants Association.
Minges and Ellen emphasized the hard work restaurants and other businesses have done so far to help protect employees and customers. Both said it was important for businesses to stay vigilant and for customers to continue to follow the COVID-19 safety guidelines.
We cant afford to go backward. Were counting on you, Minges said.
Cohen, Minges and Ellen all spoke aboutCountOnMeNC.org. Thats a website where businesses and patrons can pledge to do their part to keep their selves and their communities safe.
The site has a list of businesses that are going the extra mile to follow COVID-19 safety regulations.
As a major international financial institution, the International Monetary Fund (IMF) has been at the center of the emergency economic response to the COVID-19 pandemic. Although the IMF was prevented from securing the adequate resources it requested to mount a full-blown response, the Fund deserves a decent grade for the response it has managed within the confines of its current balance sheet. But as the IMF prepares to remotely convene the worlds financial authorities for its annual meetings, that progress is under threat.
In the past, the IMF infamously treated each crisis with a one-size-fits-all approach that conditioned new financing on fiscal austeritymeasures that explicitly or implicitly directed countries to engage in contractionary fiscal policies that required major reductions to health and social expenditure.
In a study of 16 Western African countries from 1995 to 2014, social scientists at Cambridge University found that IMF programs curtailed the fiscal space for health spending in those countries by 0.24 percent. In a broader study of IMF programs in 137 developing countries between 1980 and 2014, scholars found IMF programs lowered health system access, increased neonatal mortality, and accentuated inequality.
This time, thus far, is different. In a paper published in the journal COVID ECONOMICS at the Center for Economic and Policy Research in London, Franco Maldonado Carlin and I created an IMF COVID-19 Recovery Index that measures and monitors the IMFs response to the COVID-19 crisis. The IMFs response to COVID-19 has proven to be far less conditioned on fiscal austerity and has prioritized health expenditure and social spending to attack the coronavirus and protect the vulnerable.
However, despite visionary speeches by senior management, the research shows the IMF is falling far short in encouraging countries to mount a green recovery. And now, new rhetoric from IMF officials suggests a return to austerity may be around the corner.
On April 9, 2020, IMF Managing Director Kristalina Georgieva said, These are the times for which the IMF was createdwe are here to deploy the strength of the global community, so we can help shield the most vulnerable people and revitalize the economy and committed the IMF to a four-point all hands on deck approach to the crisis that would focus on supporting health systems, protecting vulnerable firms and people, containing financial panic, and mounting a recovery.
What is more, on over 10 occasions between April and July of 2020, Georgieva and senior staff made statements such as for our world to become more resilientwe must do everything in our power to promote a green recovery. IMF Deputy Managing Director Tao Zhang also emphasized that a green recovery should promote a just transition. He stated, That means assisting vulnerable households, workers, regions, and trade-exposed or fuel producing firms. And using carbon pricing revenues in broad tax reductions or public investments that boost growth and benefit all households. To back up these statements, the IMFs Fiscal Affairs Department developed and published a set of guidelines, called Special Series on COVID-19, to assist countries in their responses to the pandemic.
Three prominent guidance notes issued by the IMF centered on health expenditure, support for the vulnerable, and greening the recovery. To create our IMF COVID-19 Recovery Index, we coded the IMF programs to dateon a scale of 0 to 3, where a score of 0 means no attention and a score of 3 equals strong encouragement or conditionality on fighting the virus, protecting the vulnerable, and/or mounting a green recovery in accordance with the IMFs guidance notes.
First, we found that the IMF is not conditioning its emergency relief on draconian austerity measuresyet. As of this writing, the IMF has financed over 100 programs at upward of $88 billion. Aside from 13 of the programs, there are low to no strings attached to the liquidity provision. At least for now, the IMFs emergency programs grant the majority of countries the flexibility to get their own houses in order without onerous oversight and conditionality.
Second, the IMF deserves credit for endorsing increases in health spending and measures to protect vulnerable people and firms in the midst of the crisis. In our analysis, the IMF scores a 2.39 out of 3 for encouraging health spending and increasing the supply of medical devices in programs in Bolivia, Ghana, Gabon, Bosnia and Herzegovina, and the Dominican Republic.
Even better, the IMF earns a score of 2.65 out of 3 for encouraging the protection of the vulnerable, as indicated by programs that recommend strengthening safety nets in Cameroon, increasing spending in Bolivia, wage support in Bangladesh, and highlighting a food supply program in the Bahamas.
That said, the overall composite score for the IMFs emergency response is relatively poor at just 1.82 out of 3, largely driven by the finding that the IMF scores poorly on a green recovery, at just 0.42 out of 3. To the IMFs credit, it did recommend mandatory hurricane insurance protection in its program for the Bahamas, and supported Bangladeshs request for climate change adaptation and mitigations measures, but the overwhelming majority of IMF programs lack a green recovery component, despite the rhetoric.
Rather than building on its success, the IMF may be backtracking. In a public event last week, IMF First Managing Director and former Trump administration official Geoffrey Okamoto said developing nations should keep those receipts, hinting that a return to austerity is coming.
As the coronavirus continues to sweep through emerging market and developing countries, governments need more fiscal space, not less. That fiscal space could come in the form of new IMF resources and debt relief, and member countries must be encouraged to use that fiscal space to mount stimulus packages that promote a healthy, green, and inclusive recovery.
The IMF has taken an important step forward; the world economy and its people cannot afford for it to go backward.
The mayor of a small town in Tennessee that hosts the Bonnaroo Music and Arts Festival died Monday of Covid-19, officials said. He was 79.
"Today we share in the sorrow of a great loss to our community," the mayor's office said in a news release on Monday. "Mayor Lonnie J. Norman was a dedicated servant to the people of Manchester for several years."
Manchester Mayor Lonnie Norman was hospitalized earlier this month before dying after a valiant fight against COVID-19, the city said in a Facebook post Monday.
His family confirmed his death on Monday, saying many will remember his commitment to public service.
"It is said that when your work speaks for itself let it," Norman's family said in a statement on Monday. "Mayor Lonnie Normans eight decades on this planet were filled with work that testifies to both his accomplishments and his values."
Before entering public office in 1984, Norman worked as a technician supervisor for 40 years at the Arnold Engineer Development Complex in Tennessee, his family said. He became Manchesters first Black mayor when he started serving in 1991.
In August, Norman was elected to his third term as mayor of Manchester, a town with a population of nearly 10,000 people in Coffee County, WPLN reported.
Among Norman's proudest accomplishments were funding a new recreation complex, a soccer field and supporting the city's beloved Bonnaroo Music and Arts Festival, his family said.
The music fest, which typically brings in more than 80,000 concertgoers annually, was initially postponed this year before ultimately being cancelled altogether due to the pandemic.
"The incredible, Mayor Lonnie Norman, of our hometown Manchester, TN has been hospitalized due to COVID-19," the festival wrote on Twitter on Saturday. "The Bonnaroo family sends him all the love and hopes for a quick and speedy recovery."
Vice Mayor Marilyn Howard has taken over mayoral duties in the interim, according to WPLN.
Coffee County reported its highest seven-day average of Covid-19 cases in the past week, according to the Tennessee Department of Health. The county has logged a total of 1,557 cases and 17 deaths since the start of the pandemic.
Norman's family added: "COVID-19 is real and it took our beloved Lonnie Norman from us. To his fellow public officials, we say please remember your duty to keep the public safe."
"To our fellow citizens, we say please wear a mask, practice physical distancing, and protect public health and each other," they said. "We are all in this together."
Wilson Wong is a news associate at NBC News.
NEW BRUNSWICK, N.J. (AP) A late-stage study of Johnson & Johnsons COVID-19 vaccine candidate has been paused while the company investigates whether a study participants unexplained illness is related to the shot.
The company said in a statement Monday evening that illnesses, accidents and other so-called adverse events are an expected part of any clinical study, especially large studies, but that its physicians and a safety monitoring panel would try to determine what might have caused the illness.
The pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the U.S.
The company declined to reveal any more details about the illness, citing the participants privacy.
Temporary stoppages of large medical studies are relatively common. Few are made public in typical drug trials, but the work to make a coronavirus vaccine has raised the stakes on these kinds of complications.
Companies are required to investigate any serious or unexpected reaction that occurs during drug testing. Given that such tests are done on tens of thousands of people, some medical problems are a coincidence. In fact, one of the first steps the company said it will take is to determine if the person received the vaccine or a placebo.
The halt was first reported by the health news site STAT.
Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the U.S. as officials examine whether an illness in its trial poses a safety risk. That trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said. That companys testing has restarted elsewhere.
Johnson & Johnson was aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the U.S. require two shots.
It takes a lot of people to develop a COVID-19 vaccine. Volunteers may be one of the most important. Wochit
Recent pauses to two large-scale COVID-19 vaccine trials and a treatment study should reassure peoplenot frighten themvaccine experts said, though it is a reminder of the messiness of science.
This is an indication that the system is working as it was designed to work to protect human subjects in clinical trials, Lawrence Gostin, a public health and legal expert at Georgetown and Johns Hopkins universities, said Tuesday. It demonstrates that the ethical guard rails on vaccine trials are working.
Its not unusual for late-stage trials of drugs and vaccines to be stopped briefly to examine safety concerns, he and others said.
The discovery of an adverse event and a pause in the clinical trial is actually reassuring, said Dr. Bali Pulendran, a professor of immunology and vaccine design at Stanford University.
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
Lets say they got to the end of the clinical trial and there had not been one single report of any adverse event in the tens of thousands of people involved in the trial. That, he said, would worry me. That would be extraordinarily unusual.
Eli Lilly announced Tuesday it was pausing a trial of an experimental drug similar to one President Donald Trump recently claimed cured him of COVID-19. On Monday, Johnson & Johnson halted a large-scale trial of a candidate COVID-19 vaccine. And, in September, British regulators put a hold on another trial of a candidate vaccine by AstraZeneca. They lifted the hold a week later, but it has continued in the American arm of the study.
These occurrences should serve as a reminder that scientific research can be unpredictable, disappointing and time-consuming, specialists said.
After fourdecades in vaccines, I expect the unexpected, said Dr. Gregory Poland, director of the Mayo Vaccine Research Group and editor-in-chief of the journal Vaccine. The nature of vaccine development is there are always surprises and the unexpected. Everybodys looking for them, but time has to pass before you actually know.
According to a new poll from Informa Pharma Intelligence, a business intelligence provider, and research firm YouGov, 35% of Americans dont trust how quickly the COVID-19 vaccine clinical trials are moving and 23% dont think pharmaceutical companies have consumers' best interests in mind.
The public may have unrealistic expectationsof avaccine that's "100% effective and 150% safe," said Alan Barrett, director of the Sealy Institute for Vaccine Sciences at The University of Texas Medical Branch at Galveston.
USA TODAY Editorial Board: Don't inject politics into vaccine policy
COVID-19 vaccine trial on Aug. 5, 2020, in Detroit.(Photo: Henry Ford Health System/AFP via Getty Images)
But he thinks the companies have shown an impressive attention to safety, including the trial pauses. We cant afford to have a mistake, Barrett said. The public has to have confidence that any vaccine given to them is going to be safe and effective.
Only about 31% of all vaccine candidates make it all the way from Phase 1 clinical trials to market, according to a study published last year.
There are 49 COVID-19 candidate vaccines in clinical trials around the world, with ninein large, late-stage studies, Barrett said. Only three people out of the roughly 300,000 volunteers in all those trials have been known to have suffered serious side effects. Its not a big number, he said.
The key challenge with vaccines, compared with treatments: Vaccines are given to people who are healthy. While a patient dying of cancer may willing to take a medication with lots of side effects, a healthy person shouldnt be subjected to a risky vaccine, said Gostin, a law professorat Georgetown. Thats why we need to be super careful that our vaccines are safe and effective before we deploy them.
Late Monday, Johnson & Johnson announcedit was pausing a trial of its COVID-19 candidate vaccine, JNJ-78436735, while it investigated an unexplained illness in a trial participant. The company as well as an independent Data Safety Monitoring Board will review the participants case before deciding whether to resume the trial.
About half the 30,000 trial participants received a placebo and half the active vaccine. Only the Data Safety Monitoring Board members know which shot the volunteer received. If it was a placebo, the trial is likely to be restarted quickly; if the problem could have been caused by the vaccine, an investigation will take longer.
A similar trial by the pharmaceutical company AstraZeneca was stopped in September after a second trial participant developed an unusual neurological condition.
I volunteered for a COVID-19 vaccine trial in New Jersey: Here's what it's been like since the shot.
In the United Kingdom, where the volunteer lived, regulators examined her case and decided the trial could resume there. But the U.S. Food and Drug Administration has kept the U.S. trial on hold as it investigates her case.
Little has been revealed about her problem, though it is believed to be something called transverse myelitis, a spinal inflammation that can cause temporary paralysis. Both she and the other person who suffered a serious side effect, a woman who had a flare-up of previously undiagnosed multiple sclerosis, have apparently recovered.
(Photo: Getty Images)
If it turns out that the adverse event in the Johnson & Johnson trial was also some type of nerve issue there is a theoretical, but by no means proven, reason it could be linked to the way the vaccine delivers its immunological payload.
There are theoretical reasons it could be, said Dr. Otto Yang, a professor of medicine and associate chief of infectious diseases at UCLA's David Geffen School of Medicine.
Both the Johnson & Johnson and AstraZeneca candidate vaccines use a platform based on a harmless human virus called an adenovirus. The ones they use are uncommon in nature so most people have not developed immunity to them.
A very tiny number of people who are naturally sickened with adenovirus develop transverse myelitis, which is a neurological disorder of the spine that can cause paralysis.
Experts: Politics will have a hard time getting in the way of a safe, effective COVID-19 vaccine
Nobody knows why it happens, but it appears to be some type of immune response, perhaps the immune system is reacting to the virus and thats causing a cross-reaction, said Yang.
He cautioned that the possibility of a link is extremely theoretical and there is no data to support it at this time but said it certainly warrants a pause while the companies investigate.
Transverse myelitis does happen very rarely all by itself. So if its a 1 in 100,000 event and you see it in one person, then OK. If you see it in two people, then it starts to be suspicious.
Barrett, of the University of Texas, said he doesnt think virus delivery systemscan explain the recent problems. Theres no information to suggest they have problems, he said.
Eli Lilly released a brief statement Tuesday explaining the pause in their trial of a monoclonal antibody, which mimics the natural immune response to the virus.
Safety is of the utmost importance to Lilly, according to the statement, released by company spokeswoman Molly McCully. Lilly is supportive of the decision by the independent D.S.M.B. to cautiously ensure the safety of the patients participating in this study.
Trump last week touted the benefits of the experimental monoclonal antibody he was given a day after his diagnosis with COVID-19. That drug is made by Regeneron, a Tarrytown, New York, company.
The Lilly antibody trial, led by the National Institutes of Health, was to have enrolled about 300 volunteers with mild to moderate COVID-19 who have been sick for fewer than 13 days. Half the participants would receive the antibody via infusion and half a saline infusion. Plans are to expand the trial to another 700 participants,including more severely ill patients if the antibody performs well.
The antibody, called LY-CoV555 or bamlanivimab, was isolated from the blood of a recovered COVID-19 patient.
On Wednesday, Lilly released a second statement, saying that only the Data Safety Monitoring Board, not the company, has reviewed the data so far. This trial, called ACTIV-3, is different from others in the company's portfolio, because patients are sicker and are receiving the highest dose of the drug. The remaining trials ofbamlanivimab continue.
"Individuals in the ACTIV-3 study have been infected with the virus for a longer period of time and may have more severe symptoms than patients studied in other bamlanivimab trials," according to the statement. "Hospitalized patients receive different treatments for COVID-19 than earlier stage patients, including treatment with the antiviral medicine remdesivir."
Gostin, who also directs the ONeill Institute for National and Global Health Law at Georgetown, said hes troubled by this second hold.
The two medical interventions that are most likely to dig our way out of COVID are vaccines and monoclonal antibodies, he said. It shows us that science is miraculous, but its not foolproof and it doesnt always win over Mother Nature.
In the end, said Gostin, we just have to "be patient. Let science take its course.
Contact Elizabeth Weise at eweise@usatoday.com and Karen Weintraub at kweintraub@usatoday.com
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input
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