PORTAGE, Mich. Pfizer, one of the worlds largest drug makers, is also one of a few companies closing in on a vaccine for COVID-19.
Recently, Pfizers vaccine candidate entered Phase 3 of the Food and Drug Administrations testing. The late-stage testing includes human trials, and Pfizer told FOX17 Thursday they hope to have the drug ready by the end of the year.
Were just going as fast as we can, said Chaz Calitri, the site leader at Pfizers Portage facility. We have a commitment this year up to 100-million doses, and then next year around a billion doses.
Pfizer couldnt say exactly when a vaccine would be ready to hit the market, only noting it would depend heavily on the trials. Last week, Pfizer reached a deal with the U.S. government worth $1.95 billion for those first 100-million doses by the years end.
Pfizers candidate differs from a traditional vaccine in that it uses the cells you already have in your body to fight the invading virus.
So its giving the cells instructions to make the antigens, versus a traditional vaccine which is an inactivated virus typically, said Calitri. The fact that this is a vaccine which is going to actually utilize your own cells to make an antigen could prove it very safe as well.
Pfizer would not say how much doses of the vaccine would cost once it hits the market, though reports have indicated different amounts.
Pfizer says its less about the money than the result. Theyve diverted almost 200 workers to the vaccine program, and say theyve invested almost a billion dollars at-risk to produce results at a rapidly faster pace than a traditional timeline for a vaccine.
Were throwing everything we have at this to get it done as soon as we can, said Calitri. Everyone would say that all of our lives have changedand a vaccine is really going to be the only solution.
Fake news about the coronavirus can do real harm. Polygraph.info is spotlighting fact-checks from other reliable sources here.
Claim:The West loses the race to develop a coronavirus vaccine. Russias vaccine against COVID-19 is ready.
Verdict:False
Read the full story at:EUvsDisinfo
"US social media users still mischaracterize Canadas COVID-19 aid,"Agence France-Presse, July 29.
Covid-19 infections leave an impact on the heart, raising concerns about lasting damageTwo new studies from Germany paint a sobering picture of the toll that Covid-19 takes on the heart.-- Stat, July 27
The world's biggest COVID-19 vaccine test got underway Monday with the first of 30,000 planned volunteers. The experimental vaccine is made by the National Institutes of Health and Moderna Inc. It's one of several candidates in the vaccine race. (July 27) AP Domestic
Enrollment expected to begin in early August of patient referrals from local physicians.
Hattiesburg Clinic is packing a double punch in the fight againstthe coronavirus, which causes the disease COVID-19.
The clinic, with Forrest General Hospital, has joined two nationwide clinical trial programs one for treating seriously ill patientsthrough Mayo Clinic and the other for preventing infection through vaccination with Moderna and the National Institutes of Health.
Leading the treatment program for Hattiesburg Clinic is Dr. John "Bo" Hrom,clinical trial director for oncology for Hattiesburg Clinic and Forrest General.
"This is kind of my wheelhouse," he said. "Since I set up and help run clinical trials, I basically have the experience to do it."
Mississippi: Health experts, governor debunk 7 common COVID-19 myths
The other clinical trial, conducted by Dr. Rambod Rouhbakhsh, principal investigator for Hattiesburg Clinic's MediSync Clinical Research, will focus on testing patients who meet certain criteria as part of a larger study by Moderna and the NIHs National Institute of Allergy and Infectious Diseases.
Bonnie Hill, a nurse at a southwest Florida hospital, transfers convalescent plasma from a patient in this Tuesday, April 21, 2020, file photo. The plasma is used to treat seriously ill COVID-19 patients who are participating in the Mayo Clinic's study of convalescent plasma. Hattiesburg Clinic joined the Mayo Clinic program and is treating similar patients in Mississippi.(Photo: Andrew West, The News-Press)
The study is in its third stage, which meansthere has been positive results in the earlier stages and it is time toopen the trial to a larger group of participants who will randomly be given either the vaccine or a placebo to accurately measure the effects of the vaccine and make sure it is safe.
Rouhbakhsh said Hattiesburg Clinic is one of 89 sites in the country taking part in this phase of the vaccine study. He said Hattiesburg Clinic is expected to begin the trial soon.
Hromsaid Mississippi south Mississippi in particular saw an influx of cases early in the pandemic, with many people requiring hospitalization. Medical professionals knew something needed to be done quickly to help patients, but there was no known treatment at the time.
"When the pandemic first started in March, we didn't have any available therapies," Hrom said. "We still have very limited therapies as far as treatment for COVID-19."
Dr. John "Bo" Hrom(Photo: Courtesy of Hattiesburg Clinic)
One of the first programs Hattiesburg Clinic and Forrest General consideredwas Mayo Clinic's convalescent plasma treatment. While the treatment is not FDA approved, the protocol for the program met FDA approval.
"Hattiesburg Clinic was one of the early adopters of the treatment," Hrom said. "When (the pandemic) first started, the hospital and Hattiesburg Clinic administrationtalked about we needed to do something so that we would have a treatment that was available in the hospital.
"This basically came out of the need for treatment. We wanted to do something to have treatment available."
Motherhood: Caring for COVID-19 positive moms presents unique challenges at Mississippi hospital
They joined Mayo Clinic's Expanded Access Program, which allows Hattiesburg Clinic and Forrest General to treat seriously ill COVID-19 patients with convalescent plasma collected from those who have recovered from the coronavirus.
Plasma is the liquid part of blood, Hrom said. A recovered person's plasma contains coronavirus antibodies, which could help neutralize and kill the virus when given to a person who is fighting COVID-19.
So far, Hrom said, more than 100 patients have been treated, with encouraging results. Nationwide there are nearly 2,700 sites participating in the trial with more than 40,000 people treated.
Hrom said the clinic and hospital hope to treat many more patients, but needs plasma donations from those who have recovered from COVID-19 and meet certain criteria.
"It's slow going," he said. "There's not enough recovered patients who have donated."
While Hattiesburg physicians, educators and others worked quickly on creating personal protection equipment, rapid-response testing and other innovations since the onset of the pandemic, treatment and prevention have been slowly evolving but are now gaining steam.
We are very pleased to be involved in the latest phase 3 trial (for the Moderna vaccine), which means our community will have access to this as early as any other community in the world,Rouhbakhsh said.
He said enrollment is expected to begin in early August from patient referrals by Hattiesburg Clinic physicians who know the inclusion and exclusion criteria. A website also will be available for those interested in learning more ormay want to volunteer for the trial.
"But we are going to rely on our doctors to help refer patients,"Rouhbakhsh said.
Mississippi: Hundreds sick with COVID-19 at George County correctional facility
Those being considered for the study are people who are at high risk, such as older patients and those who haveco-morbid illnesses, he said.
If it proves to be efficacious with lower side effects, production could be ramped up quickly "to get billions of doses out in the world."
Rouhbakhsh said other doctors at Hattiesburg Clinic will be called on to help him and sub-investigator Dr. Elizabeth Danfordwith the trial on a volunteer basis
"This is such a large trial that is going to rapidly enroll patients, so we are essentially asking doctors to volunteer their off time to participate in this,"Rouhbakhsh said. "Many faculty colleagues have volunteered to be sub-investigators."
He said the goal is to vaccinate around 420, but could getclose to 500 people locally in the next six to seven weeks. Moderna is hoping to have around 30,000 participants nationwide.
In this March 16, 2020, file photo, a person at a Seattle hospital receives a shot in the first-stage safety study clinical trial of a potential vaccine by Moderna for COVID-19, the disease caused by the new coronavirus. Hattiesburg Clinic is joining the study, now in its third stage. According to results released on Tuesday, July 14, 2020, early-stage testing showed the first COVID-19 vaccine tested in the U.S. revved up peoples immune systems the way scientists had hoped. The vaccine is made by the National Institutes of Health and Moderna Inc.(Photo: Ted S. Warren, AP)
Participants would not know if they are receiving theinvestigational medication or a placebo.
The doctors won't either.
Rouhbakhsh said the doctors will follow the patients during length of trial and send the responses to Moderna, along with the other participating sites, so results won't be skewed. A review board also will examine the findings.
If that data is so compelling and it shows that it is so effective, we could potentially end this trial early because it would be unethical to continue with it and deny the placebo group of patients the access to this investigational trial,"Rouhbakhsh said.
That likely wont happen until the early part of 2021 at best,Rouhbakhsh said.
Dr. Rambod Rouhbakhsh(Photo: Courtesy of Hattiesburg Clinic)
Participants who are given the vaccine or placebo will be asked to conduct their lives as usual using the same coronavirus precautions they did before the trial, such as wearing a mask, social distancing and regular hand washing.
"Participants will still need to continue using the same protocols,"Rouhbakhsh said. "Dont go out and be careless and reckless. As scientists,we presume the trial is not going to work and treat participants accordingly."
While the vaccine has already been proven to work, seeing its effectiveness in a larger group of people is another matter. And anumber of participants with the placebo could get COVID-19 during the trial.
"In the United States there are a lot of cases, so the likelihood of getting the illness is quite high,"Rouhbakhsh said.
He said most research is done in bigger cities and in academic settings. The vaccination trial will focus on different size communities
Rouhbakhsh said it is important for the trial to be conducted in communities of all sizes, so Hattiesburg is a prime location since it has qualified experts to conduct the trials.
"We punch above our weight," he said. "We have resources here that are far beyond a city of our size."
To donate, a person must have had a formal COVID-19 diagnosis,be recovered and have no symptoms for 14 days and have a negative COVID-19 RNA swab.
If the person meets the criteria, he or she may go to a blood donation center, such as Vitalant or American Red Cross, where they are hooked up to a machine similar to ones used in traditional blood donations. Donors can give once per week.
"We can get anywhere from two to six units of convalescent plasma at a time," Hrom said."One unit of convalescent plasma is used to treat one patient, so potentially, two to six patients can be treated from one persons donation.
LSUHS will be using serology testing to support the convalescent plasma therapy clinical trial and help identify ideal plasma donors. Shreveport Times
The goal of the trial is to determine if the antibodies developed in a patient who has recovered from the virus will effectively treat those who are currently affected by the disease, Hrom said in a news release.
Only patients in serious, critical condition currently are able to receive convalescent plasma treatment.
While the study is in its infancy, risks associated with receiving treatment are the same as any other blood transfusion. Since plasma is takenat a blood donation center, it meets FDA requirements. Every unit that is donated undergoes various system checks to ensure it is safe.
We needed access to something that would help critically ill patients," Hrom said."If this treatment proves to be beneficial, I want to be able to offer patients the same treatment as those services provided by the Mayo Clinic or Mount Sinai Hospital in New York.
"We want to be able to provide the same level of care as some of these major medical institutions.
Anyone interested in participating in the Convalescent Plasma Clinic Trial may visit hattiesburgclinic.com/convalescent-plasma-trial and fill out the information form provided.
For more information on the COVID-19 Expanded Access Program, visit uscovidplasma.org.
To learn more about the enrollment process for the Coronavirus EfficacyStudy, visit hattiesburgclinic.com/medisync-study-opportunitiesor call 601-544-1866.
To learn more about Moderna and the COVE study, visitinvestors.modernatx.com/news-releases/news-release-details/moderna-announces-phase-3-cove-study-mrna-vaccine-against-covid.
Contact Lici Beveridgeat 601-584-3104 orlbeveridge@gannett.com. Follow her onTwitter@licibevor Facebook atfacebook.com/licibeveridge.
Read or Share this story: https://www.clarionledger.com/story/news/local/2020/07/31/covid-19-vaccine-clinical-trial-hattiesburg-clinic-mississippi/5442834002/
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Ever since the new coronavirus emerged as a global threat, public health officials have repeated the same warning: Shutdowns, masks, and social distancing can help to contain the virusbut the pandemic won't truly end until we get a vaccine.
Moderna's coronavirus vaccine shows promise. Here's what happens next.
But what does it mean to "get a vaccine"?
It's not enough, after all, to devise a single dose of vaccine in a hermetically sealed laboratory. We must also conduct clinical trials to prove that vaccine is effective, manufacture it in mind-boggling quantities under impeccably sanitary conditions, dispense it into hundreds of millions of vials, ship it (perhaps under refrigeration) to every city and village in the country, and inject it into the arms of nearly every single American.
And if the vaccine requires multiple doses? Well, we'll have to do much of that work all over again.
A slip-up at any of these stages could delay the end of the epidemic, potentially costing tens of thousands of livesand further postponing the day when America returns to "normal."
So which obstacles are most likely to delay a Covid-19 vaccine, and how can we prepare to overcome them? That's the focus of an extensive new report authored by Ezekiel Emanuel, the prominent bioethicist and former adviser to President Barack Obama, and Topher Spiro of the left-leaning Center for American Progress.
It's a sobering read, one that makes clear just how daunting a task it will be to bring this epidemic to a close.
Emanuel and Spiro identified no fewer than 22 roadblocks to a vaccine, surfacing seemingly esoteric issues such as limits in "the capacity of manufacturers of brewing equipment" and "assess[ing] alternatives to glass vials."
But upon deeper review, six potential problems stand out to us as especially critical:
How Covid-19 is disrupting your supply chain (and what to do about it)
For those of us feeling encouraged by the recent progress of vaccine candidates, Emanuel and Spiro's report is a sobering read. It makes clear that vaccine approval is just the "tip of the iceberg," and that the real work will come next: manufacturing, distributing, publicizing, and monitoring the vaccinethat is, taking it from a few isolated laboratories into the arms of 330 million Americans.
And let's not forget, even a universally administered vaccine may not be universally effective. The FDA has said it will approve a vaccine that shows 50% efficacy relative to a placebo. While manufacturers and public health experts are aiming for higher effectiveness (Peter Marks of the Center for Biologics Evaluation and Research has proposed 70% as a goal), it's clear that early vaccines may still leave some patients vulnerable.
And all of this is unfolding against a backdrop that has revealed just how poorly prepared the health care industry is to manufacture and distribute needed suppliesfrom tests to drugs to personal protective equipmentat a massive scale on short notice.
Let's hope that plans such as this one can galvanize enough investment, coordination, and planning to resolve these problems and smooth our path to the "new normal."
What can you expect if you volunteer? News 8's Steve Price spoke with a man in Seattle, who already has the vaccine in his system.
SAN DIEGO COUNTY, Calif. San Diegans are being asked to participate in a Phase 3 trial that's taking place at UC San Diego to test the effectiveness of a COVID-19 vaccine. So what can you expect if you volunteer? News 8's Steve Price spoke with a man in Seattle who already has the vaccine in his system.
The pain I had the next morning was less than I've had for a flu shot and vaccinations in the past, said Neal Browning.
He got his first dose of the Moderna vaccine back in March, followed by a second dose 28 days later.
There is no live or weakened or dead virus in this vaccine so you can't contract COVID from it first and foremost - which is an important aspect," Browning said.
Besides a little arm soreness, he didn't have any side effects. Others in his trial who received bigger doses of the vaccine did experience fatigue and sore muscles, but nothing alarming to doctors.
So far there's no evidence that there are any serious safety concerns with this vaccine, said Dr. John Dunn, a researcher running the Phase 1 trial that Browning is participating in.
Researchers gave the vaccine, in varying amounts, to 45 volunteers. All of them developed antibodies. Lessons learned in that trial led researchers to discover what they say is the perfect dosage amount and it confirmed the vaccine is safe for humans.
The UC San Diego study is the start of Phase 3 testing.
By the time you reach Phase 3, it's pretty much ready for primetime, Browning said. It's locked in as far as what's the safe dosage, how will people react to it. You've had literally, by this time, hundreds of other people exposed to the vaccine.
Participants in the UC San Diego trial will be asked about their medical history, will be required to track their health after injections, and will be asked to come in for follow-up visits that could include blood draws. It's definitely a commitment, but Browning said he'd gladly do it again.
It's about the future and if you can lessen the amount of pain, suffering, and possible deaths, step up to the plate and we all do our part for mankind no matter how large or small it is," he said.
UC San Diego just started taking applications for its trial this week with full enrollment expected within two months.
WILMINGTON, NC (WWAY) A COVID-19 vaccine trial is about to happen right here in the Cape Fear. PMG Research of Wilmington hopes to begin the trial in about two weeks.
PMG in Wilmington has worked on a number of different vaccine trials for years, including vaccines for the flu.
Medical Director Kevin Cannon says they have several COVID vaccine trials lined up for the fall. He says theyre hoping to start the first one in two weeks, and will be enrolling patients for the trial for six weeks.
He says they overall trial will last for around a year, while they monitor patients health status. Cannon says the trials will be looking at the effectiveness of the vaccine.
You would get screened for the trial and get the vaccine on that first day, come back in three weeks, get another vaccine and then come back a few weeks later for a blood draw, Cannon said. Then we would follow you for the next six to 12 months with any signs and symptoms of COVID.
Cannon says theyre looking for patients of all ages to sign up for the trial.
He says theyre very excited to bring a trial to the Cape Fear, and play a role in fighting the pandemic.
Cannon says medical professionals around the nation are optimistic there will be a viable vaccine option by the end of this year or early next year.
For each person who enrolls in a COVID vaccine trial with PMG, Cannon says theyll make a donation to the Food Bank of Southeastern North Carolina.
If you would like to sign up for a trial, you can find more information here or call 910-799-5500.
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As a growing list of drug companies sign deals to sell their still-unproven Covid-19 vaccines, a rift is opening between those that say they plan to profit off their vaccines and those that wont.
The British drugmaker GlaxoSmithKline (ticker: GSK) and its French partner Sanofi (SNY) said Thursday they had agreed to sell 60 million doses of their Covid-19 vaccine to the U.K. government.
The companies didnt say how much the government would pay. Speaking to journalists on Wednesday, Glaxo CEO Emma Walmsley drew a sharp line between her company and those that will sell their Covid-19 vaccines for a profit.
Our position has not been the same as some others, Walmsley said. Weve been very clear from the beginning that we dont expect to profit from these partnerships during the pandemic phase. Well be reinvesting any short-term profits in pandemic preparedness.
Walmsleys comments come amid a growing focus on Covid-19 vaccine pricing. The Financial Times reported on Tuesday that Moderna (MRNA) was seeking to sell its Covid-19 vaccine for between $25 and $30 a dose. Pfizer (PFE) is charging developed countries roughly $20 a dose.
I think its very wrong, Pfizer CEO Albert Bourla said in an interview on Tuesday of the argument that drug companies shouldnt be making a profit off the drugs and vaccines they introduce to fight Covid-19. You need to be very fanatic and radical to say something like that right now.
The price of Glaxos American depository receipts fell 0.6% in premarket trading on Wednesday, while Sanofis ADRs were up 1.5%. S&P 500 futures were up 0.3%.
Both companies also reported earnings Wednesday morning. Glaxo reported earnings of 0.19 per share, or about 25 U.S. cents, just below the S&P Capital IQ Consensus estimate of 0.20. Sanofi, meanwhile, reported earnings of 1.28 per share, or about $1.50, just above the S&P Capital IQ Consensus estimate of 1.22.
Glaxo and Sanofi said they aim to have their vaccine approved by regulators in the first half of next year. Though the program is progressing less rapidly than competing vaccines from Pfizer, Moderna, and others, it is based on a far more proven technology. While Pfizer and Moderna are developing messenger RNA-based vaccines, which have never received regulatory approval, the GlaxoSmithKline and Sanofi vaccine is based on a well-established technology that Sanofi uses in a flu vaccine already on the market.
Just over a week ago, Pfizer and its partner BioNTech (BNTX) announced a deal to provide 30 million doses of the Covid-19 to the U.K. government. The financial terms werent disclosed, though on an earnings call on Tuesday the president of Pfizers biopharmaceuticals group, Angela Hwang, said no developed country would pay less than the U.S. for similar volume commitments. The U.S. committed to pay $1.95 billion for 100 million doses, or around $19.50 a dose. At the same rate, the U.K. would have committed $585 million.
Sanofis U.S. traded shares are up 3.3% this year, while Glaxos are down 12.1%. The Dow Jones Industrial Average has fallen 7.6%
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
The United States will pay up to $2.1 billion for 100 million experimental COVID-19 vaccines from pharma giants GlaxoSmithKline and Sanofi Pasteur.
LONDON, UK Pharma giants GlaxoSmithKline and Sanofi Pasteur have announced they will supply 100 million doses of its experimental COVID-19 vaccine to the United States as governments buy up supplies in hopes something will work.
The United States will pay up to $2.1 billion for development including clinical trials, manufacturing, scale-up and delivery of its vaccine,'' the companies said in a statement. Sanofi will get the bulk of the funds.
The U.S. government has a further option for the supply of an additional 500 million doses longer term as part of its Operation Warp Speed program.
The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year, U.S. Health and Human Services Secretary Alex Azar said in a statement. Todays investment supports the Sanofi and GSK adjuvanted product all the way through clinical trials and manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.
Earlier this week the British government signed a deal for 60 million doses of a potential coronavirus vaccine that could start to be rolled out in the first half of next year.
Britains GSK and Frances Sanofis vaccine prospect is based on the existing DNA-based technology that is used to produce Sanofis seasonal flu vaccine. It is one of several vaccines in development.
The global need for a vaccine to help prevent COVID-19 is massive, and no single vaccine or company will be able to meet the global demand alone, said Thomas Triomphe, executive vice president of Sanofi Pasteur.
The companies said discussions are ongoing with the European Commission.
Coronavirus Nomenclature
On February 11, 2020 the World Health Organizationannouncedan official name for the disease that is caused by the 2019 novel coronavirus outbreak, COVID-19. The virus itself has been designated SARS-CoV-2 by the International Committee on Taxonomy of Viruses.
What is Coronavirus
According to the World Health Organization[i], Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).
What is 2019 Novel Coronavirus
The 2019 Novel Coronavirus, formerly known as 2019-nCoV and now known as SARS-COV-2, is a new strain of coronavirus that was first identified during an investigation into an outbreak in Wuhan, China. Its important to note that how easily a virus spreads person-to-person can vary. Some viruses are highly contagious, while other viruses are less so. Investigations are ongoing tobetterunderstandthetransmissibility,severity,andotherfeaturesassociated with the Novel Coronavirus, but person-to-person spread is occurring[i].
Know the Novel Coronavirus Symptoms
According to the CDC, patients with confirmed infections have reported mild to severe respiratory illnesses with symptoms including:
CDC believes at this time that symptoms of COVID-19 may appear in as few as 2 days or as long as 14 days after exposure. This is based on what has been seen previously as the incubation period ofMERSviruses.[iv]
How Coronavirus is Spread
The CDC states[iv] that the viruses is thought to spread mainly from person-to-person from:
These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled in the lungs.
It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose or possibly their eyes, but this not thought to be the main way the virus spreads.
The virus that causes COVID-19 seems to be spreading easily and sustainably in the community (community spread) in some affectedgeographic areas. There is much more to learn about the transmissibility, severity, and other features associated with the Novel Coronavirus and investigations are ongoing.
How to help protect from the Coronavirus
The best way to protect yourself is avoid being exposed to the virus. The CDC always recommends[i] simple everyday preventative steps to help prevent the spread of respiratory virus, including:
Aswithall infectious diseases, good hygiene can play a role in controlling its spread. However, the most important publichealth recommendation isthat people report to the nearest health facility if they develop any symptoms indicative of Coronavirus. Call the office of your health care provider before you go and tell them about your travel and your symptoms. They will give you instructions on how to get care without exposing other people to your illness. Visit the CDC website to learn more on What To Do if You Are Sick.
Improper use of Disinfectants
Due to recent speculation and social media activity, RB (the makers of Lysol and Dettol) has been asked whether internal administration of disinfectants may be appropriate for investigation or use as a treatment for coronavirus (SARS-CoV-2).
As a global leader in health and hygiene products, we must be clear that under no circumstance should our disinfectant products be administered into the human body (through injection, ingestion, or any other route). As with all products, our disinfectant and hygiene products should only be used as intended and in linewith usage guidelines. Please read the label and safety information.
We have a responsibility in providing consumers with access to accurate, up-to-date information as advised by leading public health experts. For this and other myth-busting facts, please visit Covid-19facts.com.
