Tag Archives: COVID-19

Congressman calls for FDA to continue vaccine trials

D’Andre Henderson, ABC News: December 29, 2020.


WASHINGTON, D.C. (WRIC) — Americans are hopeful that the COVID-19 vaccines will make 2021 a better year than 2020. However, there are concerns that Pfizer and Moderna will stop their clinical trials and immediately treat everyone in their placebo group.

Some scientists, doctors and now a Congressman argues that can be dangerous because they said there is still so much unknown about the vaccines.

Rep. Llyod Doggett of Texas wrote a letter to the Food and Drug Administration (FDA) urging for the clinical trials to continue.

“the continuation of clinical trials is critical to our understanding of the efficacy and length of immunity the vaccines offer,” Doggett wrote.

In the letter, Doggett said while the initial results received from Pfizer and Moderna are showing positive results, it’s not definitive given the limited data.

[…]

“Clinical trials have suffered from a lack of diverse participant enrollment and evaluation of subpopulations,” Doggett said. “Including individuals with comorbidities, children, pregnant and breastfeeding patients, long-term care residents and individuals with diverse racial and ethnic backgrounds.”

Diana Zuckerman, President of the National Center for Health Research, a non-partisan think tank in Washington D.C., agrees that the clinical trials should continue. She said healthcare workers who volunteered for the clinical trials should have immediate access to the vaccine if they want it.

“Like most public health experts, I’ve been very concerned that Pfizer and Moderna told the FDA that they want to stop their clinical trials of the COVID vaccine and instead immediately inoculate everyone in their placebo groups,” Zuckerman said. “While I understand the desire to reward the clinical trial volunteers for their service, it would be a huge loss of information from a public health point of view. Losing the placebo group means we’d have no way to scientifically determine which of the vaccines – if any — have 95% efficacy rates that last more than 2 or 3 months. Or how long the vaccine works on people over 75.”

Zuckerman added the people who volunteer for the clinical trials shouldn’t be vaccinated before those in priority groups such as teachers, essential workers, etc.

“Since many of the study volunteers are young and healthy, it also seems unfair for them to “cut in line” for a vaccine while healthcare workers and others at high risk are still waiting their turn,” she said.

[…]

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Covid-19: Should vaccine trials be unblinded?

Jeanne Lenzer, BMJ: December 29, 2020.


The lack of planning for how to treat participants in covid-19 vaccine trials is a bad precedent, with the loss of potentially valuable safety and efficacy data, say research experts. Jeanne Lenzer reports:

 

In October the US Food and Drug Administration issued non-binding guidance to manufacturers of covid-19 vaccines urging them to devise a method to allow volunteers in their studies’ placebo arms to receive the vaccine while also maintaining the integrity of ongoing scientific data collection.1 Emergency use authorisation was not “grounds for stopping blinded follow-up,” said the agency.23

The companies say they have an ethical obligation to unblind volunteers so they can receive the vaccine. But some experts are concerned about a “disastrous” loss of critical information if volunteers on a trial’s placebo arm are unblinded.45

To try to tackle the problem the FDA invited Steven Goodman, associate dean of clinical and translational research at Stanford University, for a recommendation that could balance the right of volunteers to find out whether they were in the placebo arm and the simultaneous need to preserve scientific data.

Goodman recommended a study design endorsed by Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases: a blinded crossover study in which placebo recipients would be given the vaccine, and vice versa.235 That would ensure that all volunteers receive the vaccine but would be unaware of which shot they received at which time. This would allow ongoing surveillance of safety issues and more time to observe any waning effects of the vaccine and the possible need for booster doses.

But the companies said that the demands of a blinded crossover design were “onerous” and might not be feasible.6 And even before the FDA advisory committee meeting on Moderna’s vaccine on 17 December, the company notified volunteers that they could learn their status if they chose to receive the vaccine.

Pfizer also sent a letter to its trial participants one week after its vaccine was authorised on 10 December.7 It told them that, on request, they could learn whether they were in the placebo arm so they could receive the vaccine as it became available and according to recommendations of the US Centers for Disease Control and Prevention.

Asked by The BMJ whether the FDA had set any baseline requirements for the companies regarding the removal of blinding, the agency declined to answer, referring the journal to the respective companies for their plans.

Pfizer told The BMJ that the “move from the placebo group to the vaccine group would be completely optional, and participants would be encouraged to remain blinded throughout the full study duration.” Moderna failed to respond to several requests for comment.

Loss of data

Diana Zuckerman, president of the National Center for Health Research, told The BMJ that the FDA could have demanded that companies use the blinded crossover design for them to win full approval for their vaccines. She said that failure to do that meant the loss of future reliable data, which is especially concerning given that preliminary data are insufficient to determine efficacy.

“I’m especially concerned that Pfizer’s vaccine trials included only five people aged 75 and older who were diagnosed with covid-19, with an unspecified number of those defined by Pfizer as severe cases,” she said. “That makes it impossible to determine how effective the vaccine is for frail elderly patients.”

Although the FDA has granted the vaccines emergency use authorisation, to get full licence approval two years of follow-up data are needed. The data are now likely to be scanty and less reliable given that the trials are effectively being unblinded.

Consumer representative Sheldon Toubman, a lawyer and FDA advisory panel member, said that Pfizer and BioNTech had not proved that their vaccine prevents severe covid-19. “The FDA says all we can do is suggest protection from severe covid disease; we need to know that it does that,” he said.

He countered claims, based on experience with other vaccines, six weeks of follow-up was long enough to detect safety signals. Six weeks may not be long enough for this entirely new type of “untested” [mRNA] vaccine, Toubman said.

Goodman wants all companies to be held to the same standard and says they should not be allowed to make up their own rules about unblinding. He told The BMJ that, while he was “very optimistic” about the vaccines, “blowing up the trials” by allowing unblinding “will set a de facto standard for all vaccine trials to come.” And that, he said, “is dangerous.”

Footnotes

  • Correction: On 30 December we amended the final paragraph to clarify Steven Goodman’s comment.

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

References

  1. ? Food and Drug Administration. Emergency use authorization for vaccines to prevent covid-19: guidance for industry. 2020. https://www.fda.gov/media/142749/download.
  2. ? Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee meeting December 10, 2020. 2020. https://www.fda.gov/media/144245/download.
  3. ? Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee December 17, 2020 meeting briefing document. 2020 https://www.fda.gov/media/144434/download.
  4. ? WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation. Placebo-controlled trials of covid-19 vaccines—why we still need them. N Engl J Med2020. doi:10.1056/NEJMp2033538.
  5. ? Weiland CZ. Noah. Many trial volunteers got placebo vaccines. Do they now deserve the real ones? New York Times. 2 Dec 2020. https://www.nytimes.com/2020/12/02/health/covid-vaccine-placebo-group.html.
  6. ? Karlin-Smith S. Covid-19 vaccine sponsors want US FDA to find alternatives for control-arm data after first EUA. Pink Sheet. 2020. https://pink.pharmaintelligence.informa.com/PS143143/COVID-19-Vaccine-Sponsors-Want-US-FDA-To-Find-Alternatives-For-Control-Arm-Data-After-First-EUA.
  7. ? Tanne JHCovid-19: FDA panel votes to approve Pfizer BioNTech vaccine. BMJ2020;371:m4799.  doi:10.1136/bmj.m4799 pmid:33310748 FREE Full TextGoogle Scholar 

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HEALTH CARE BRIEFING: FDA Vaccine Rules Challenged as Weak

Brandon Lee and Alex Ruoff, Bloomberg Government: October 23, 2020


U.S. vaccine advisers questioned whether safety and efficacy standards set by Food and Drug Administration officials were high enough to warrant emergency authorization of a shot.

About two dozen outside advisers to the FDA with expertise in infectious diseases met yesterday to weigh in on agency standards that require a vaccine to work in at least 50% of people and for drugmakers to collect two months of safety data on at least half of clinical trial volunteers.

“They haven’t gone far enough” in terms of safety, said Hayley Altman-Gans, a panel member and pediatrics professor at Stanford University Medical Center.

Many panel members and outside researchers who commented during the hearing worried that if a vaccine is rushed out that later turns out to have safety problems or to be less effective than promised, it could backfire in a big way, undermining public confidence in Covid-19 vaccines for years to come.

Several panel members expressed concern that the two-month safety follow-up the FDA is calling for before a vaccine gets an emergency authorization is simply not enough. In addition to safety, it means that doctors won’t know whether a vaccine’s efficacy could fade after just a few months.

Diana Zuckerman of the National Center for Health Research told the committee the vaccine trials “have serious design flaws.”

The trials are too geared to preventing mild infections, and may not show whether they prevent severe infections and hospitalizations, she said. Longer follow up may be especially important because some of the first vaccines, including messenger RNA vaccines from Pfizer and Moderna, are based on new technologies that have never been used in an approved product. 

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FDA Panel To Lay Regulatory Groundwork For COVID-19 Vaccine


Noel King and Sydney Lupkin, NPR: October 22, 2020


NOEL KING, HOST:

There are several COVID-19 vaccines in development. But before they are approved, they have to be safe. It’s the FDA’s job to ensure that. Today an FDA advisory panel is meeting for the first time about the coronavirus vaccine. It’ll be making recommendations based not on politically motivated timetables, but on data.

Sydney Lupkin covers the pharmaceutical industry for NPR. Good morning, Sydney.

SYDNEY LUPKIN, BYLINE: Good morning.

KING: So what is the deal with this FDA panel? Who’s on it? What are they going to be doing?

LUPKIN: Well, the FDA regularly turns to committees of outside advisers for guidance. Most often, these panels are asked to evaluate specific drugs or health products, and that helps the agency to decide whether to approve these products. Today’s meeting of the committee that looks at vaccines is going to be a little different.

KING: How?

LUPKIN: Like everything else in this pandemic, it’s a bit unusual. The big difference is that the committee isn’t going to be sifting through data for a specific coronavirus vaccine like it normally would. The meeting will be a broader discussion of how the agency should think about safety and effectiveness of these new kinds of vaccines, particularly safety. Dr. Paul Offit is a committee member who works at the Children’s Hospital of Philadelphia.

PAUL OFFIT: How robust should safety data be? How long, for example, after the first or second dose should patients be followed or participants be followed for any possible safety issue?

LUPKIN: They’ll be discussing FDA’s existing guidance to companies, which includes some of that information. They’ll also discuss how studies should continue after the first vaccine is given the green light. What do you do for patients who got a placebo once a vaccine is widely available? Of course, the FDA usually heeds the advice of these committees, but it doesn’t have to.

KING: So since there’s no vaccine to review, I would think that in ordinary times, we would not know about this meeting. It would not be news at all. It’s very clear that the FDA wants to make public that this is happening. Why do they want to do that?

LUPKIN: Well, I mean, it gives the American public a window into the process. There’s been so much discussion around whether the FDA will put politics ahead of science. So it’s important to see what’s going on. And the FDA has questions that it wants answers to. Here’s Dr. Miles Braun, a former FDA epidemiologist.

MILES BRAUN: There is a level of humility that the FDA is coming to its advisers with. And I think that’s a good thing. And if they find out they’ve missed some important things, they’ll address those.

LUPKIN: Committee members will hear presentations from scientists at the FDA, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority. The public will also have an opportunity to weigh in. Diana Zuckerman is the president of the National Center for Health Research, an advocacy group slated to speak.

DIANA ZUCKERMAN: We’ve seen the guidance of what they’re telling companies they’re supposed to be studying. Frankly, they’re not very stringent, so we are concerned about them.

LUPKIN: She hopes the meeting will delve into making sure the clinical trials are diverse, for example. She also questions whether the study approach the FDA suggested to manufacturers is long enough to assess vaccine safety.

[…]

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FDA Promises Strong Safety Standards for Covid-19 Vaccines as It Convenes Advisory Panel

Thomas M. Burton, Wall Street Journal: October 23, 2020


SILVER SPRING, Md.—Food and Drug Administration officials gave fresh assurances Thursday that Covid-19 vaccines will undergo rigorous testing before being made widely available—a message they underscored in a meeting with outside medical experts aimed at bolstering the agency’s credibility.

“Only those vaccines that are demonstrated to be safe and effective” will be licensed by the FDA, said Marion F. Gruber, director of the FDA’s Office of Vaccines Research and Review. But some speakers and panel members raised concerns about whether the FDA’s vaccine guidelines for Covid-19 clinical trials are sufficiently rigorous.

These comments came at the first meeting of a 25-member panel of medical experts, including specialists in fields like virology, infectious diseases and biostatistics. The group, which met remotely via video-conferencing, was  established to make recommendations to the FDA on how best to assess the safety and effectiveness of vaccines.

“The FDA frequently convenes outside panels of medical experts for their advice on products,” said Peter Marks, director of the FDA’s center for biological products. “But normally panels about vaccines are watched by dozens of people. In this case, it’s watched by many thousands.”

[….]

President Trump has pushed to get a vaccine approved quickly, which has drawn concern from some public health experts and political opponents that the FDA would be under pressure to bypass usual precautions to rush a vaccine to market quickly.

FDA officials have vowed not to do so. In addition to convening the advisory panel, they have issued a set of guidelines to govern how vaccine clinical trials will be conducted and evaluated.

They also formulated a set of rigorous standards for the FDA to employ before granting what is known as an emergency-use authorization (EUA) for a vaccine. The EUA is the faster equivalent during the Covid-19 pandemic of a conventional approval by the agency.

[….]

Various speakers questioned whether the shorter EUA test period was sufficient.

“The vaccine trials have serious design flaws,” said Diana Zuckerman, president of the National Center for Health Research in Washington. In addition to the two-month period, she said FDA guidelines focus on measuring milder cases of the disease, and not the most serious cases.  

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FDA Vaccine Rules Challenged as Weak at Advisory Panel Meeting

Anna Edney and Robert Langreth, Bloomberg Business: October 22, 2020


About two dozen outside advisers to the FDA with expertise in infectious diseases met Thursday to weigh in on agency standards that require a vaccine to work in at least 50% of people and for drugmakers to collect two months of safety data on at least half of clinical trial volunteers.

“They haven’t gone far enough” in terms of safety, said Hayley Altman-Gans, a panel member and pediatrics professor at Stanford University Medical Center.

Many panel members and outside researchers who commented during the hearing worried that if a vaccine is rushed out that later turns out to have safety problems or to be less effective than promised, it could backfire in a big way, undermining public confidence in Covid-19 vaccines for years to come.

Archana Chatterjee, advisory panel member and dean of Chicago Medical School, said the public has a lot of concern about safety. Meanwhile, she added, “What we’re being asked to do is to build this plane as we fly it.”

Several panel members expressed concern that the two-month safety follow-up the FDA is calling for before a vaccine gets an emergency authorization is simply not enough. In addition to safety, it means that doctors won’t know whether a vaccine’s efficacy could fade after just a few months.

Panel member Amanda Cohn, who is chief medical officer at the National Center for Immunization and Respiratory Diseases, worried that the efficacy of vaccines that just meet the 50% threshold after two months may see reduced effectiveness a few months later if the shot doesn’t offer a long period of protection.

“Very rarely do we look at [vaccine efficacy] so shortly after completing a series,” according to Cohn, whose organization is part of the Centers for Disease Control and Prevention.

Design Flaws

The advisers weren’t alone in questioning the standards. Diana Zuckerman of the National Center for Health Research told the committee the vaccine trials “have serious design flaws.”

The two-month follow up the FDA has asked for is too short to establish how long a vaccine will work, and the trials are too geared to preventing mild infections, and may not show whether they prevent severe infections and hospitalizations, she said.

Longer follow-up may be especially important because some of the first vaccines, including messenger RNA vaccines from Pfizer Inc. and Moderna Inc., are based on new technologies that have never been used in an approved product.

The debate over the rigor of the FDA guidelines was one of two main issues debated before the committee, which heard comments from regulators, drugmakers and the public. The second questioned whether trial participants on a placebo should be advised when a vaccine is deemed to be safe and effective.

[…]

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“We Can’t Ever Go to the Doctor with Our Guard Down”: Why Black Women Are 40% More Likely to Die of Breast Cancer

Maria Aspan: Fortune Magazine June 30, 2020


Racism kills Black Americans, and has long before COVID-19. But its toxic combination with sexism has particularly vast and disastrous consequences for the health of Black women.

While Black people in the U.S. are dying from the COVID-19 pandemic at a disproportionately high rate, this national health crisis underlines an even grimmer status quo: Black Americans are also much more likely to die from far more common and longstanding health problems every day. Black women are at particularly high risk of heart disease and strokes, and are at least three times as likely to die as a result of childbirth as white women, contributing to the overall alarmingly high maternal mortality rate in the United States.

Then there are the shocking statistics around breast cancer, which affects one in every eight women and is the most common non-skin cancer affecting women. Black women are less likely to develop it—but 40% more likely to die from it than white women, according to the U.S. Centers for Disease Control and Prevention.

The reasons behind this awful disparity are wide-ranging, and include systemic problems both within healthcare and far beyond it. Now the disproportionately high toll of COVID-19 on the Black population in the U.S. and the simultaneous national reckoning over racism are drawing new attention to the racial inequities hurting Black women—and amplifying the voices of doctors, scientists, and public health experts who have long sounded the alarm.

[…]

Women of all races could be legally omitted from government-funded clinical trials before 1993, and are still often under-represented in most research studies of conditions that affect them. Pregnancy and menstrual cycles are thought to “complicate” the results of trials that are mostly conducted on white men, who are seen as the “norm.”

This can obviously backfire. In 2013, the U.S. Food and Drug Administration sharply cut its recommended dosages of Ambien for women, after years of complaints about grogginess and falling asleep while driving, when followup tests showed that women metabolized the active ingredient in sleeping aids much more slowly than men.

When it comes to clinical trials funded by pharmaceutical companies, “the FDA encourages but does not require diversity in clinical trials,” says Diana Zuckerman, a scientist and president of the National Center for Health Research. “Worse, the agency frequently approves drugs and devices for all adults, even if they were primarily studied on white adults.”

One treatment that the FDA approved in April, for the “triple-negative” type of breast cancer that disproportionately affects Black women, was approved after being tested on 108 patients. Eight of them, or 7%, were Black. Another breast-cancer treatment was approved last year after being tested on 234 patients; seven of them, or 3%, were Black.

[…]

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What People With Cancer or Compromised Immune Systems Need to Know about Coronavirus (COVID-19)

National Center for Health Research: April 1, 2020


The coronavirus can infect anyone, young or old, healthy or frail. People with cancer and other serious health conditions, and their loved ones, need to be especially careful. Here’s what you need to know.

Some cancer treatments, such as chemotherapy, targeted therapies, immunotherapy, and radiation, can weaken the immune system and possibly cause lung problems. People who have weakened immune systems or lung problems are more likely to have serious symptoms if they become infected with this virus. Anyone with cancer in the lungs (whether lung cancer or cancer that has spread to the lungs) is especially at risk if they develop COVID-19.

If you had scheduled surgery, screening, or other procedures that were considered not urgent or not immediately life-threatening, those might have been postponed. This is for everyone’s protection. Many hospital staff,  including doctors, nurses, receptionists, and cleaning staff, have been exposed to the virus and don’t know whether they can infect others.  If you are battling cancer or doing follow-up after successful treatment, you don’t want to be exposed to the coronavirus when you go in for surgery or testing procedures.  And, you don’t want your medical center to be less able to fight the coronavirus at a time when it is spreading throughout your community.

The coronavirus is spreading in all 50 states, in urban, suburban, and rural areas, so it is important to listen to health experts (and governors or mayors) who tell you to stay home, limit contact with others, and keep a distance of 6 feet away when you or your family members or caregivers go grocery shopping or other essential activities.

What is coronavirus?

Coronaviruses are a large group of viruses that can cause respiratory illness. The new (novel) coronavirus is called SARS-CoV-2 and the illness it causes is called coronavirus disease 2019, which is why it’s abbreviated as COVID-19.  Since it is new, nobody has immunity from it.

How does COVID-19 spread between people?

The virus usually spreads through close contact with other people, especially through droplets when a person coughs or sneezes – or even when they breathe normally. These droplets can travel through the air and can be inhaled or get into the noses, mouths, or eyes of people nearby.

It is most contagious when the person has symptoms, but it is possible to catch the virus from infected people who have no symptoms at all. In addition, these droplets (as well as fecal matter containing the virus) can end up on surfaces where it can survive for hours or even days. When you touch these surfaces and then touch your face, you can be exposed to the virus. That’s why it’s important to wash your hands regularly.  If you don’t have antiseptic wipes, you can wipe down surfaces in your bathroom, kitchen, and other rooms with bleach of rubbing alcohol to help prevent exposure.  However, most of the time the virus is spreading through close contact with people who have it.

What about food or food packaging?  The risk of catching the virus from packaging is very low, but since the virus can survive for up to 24 hours on cardboard and up to 3 days on plastic and stainless steel, it’s a good idea to wash your hands for at least 20 seconds after handling mail, takeout containers, and packaging from groceries. You can also disinfect food packages using a cleaning product that kills viruses, but don’t use disinfectants on food.

What are the symptoms of COVID-19?

Symptoms tend to start between 2 and 14 days after coming into contact with the virus.  Although some people have compared the symptoms to a cold or flu, there are some differences.

The most common symptoms are:

  • Fever (this can come and go)
  • dry cough
  • tiredness

Other symptoms include:

  • shortness of breath
  • aches and pains
  • sore throat
  • trouble breathing
  • chest pain or pressure
  • pink eye (conjunctivitis)
  • loss of sense of smell (and sense of taste)

These symptoms are less common but can be signs of COVID-19:

  • runny nose
  • diarrhea
  • nausea or vomiting
  • abdominal discomfort

Most people who are infected with this coronavirus have mild symptoms and can recover at home in about 2 weeks. However, symptoms can become severe.  These are the ones that require immediate medical attention:

  • difficulty breathing or shortness of breath
  • persistent chest pain or pressure
  • confusion or inability to awaken
  • blueish color in the lips or face

People who are older than 60, and people who have existing serious health conditions, such as heart disease, lung disease, and diabetes, are more likely to develop severe illness and complications from COVID-19. This includes people who are receiving cancer treatments that can weaken the immune system.  The most serious complications include pneumonia, organ failure, and death.

How can I protect myself and others?

The best way for anyone to protect themselves is to avoid being exposed to it. There are no proven medications or vaccines, so don’t be fooled by false claims (especially those made by telemarketers).

“Social distancing” or “physical distancing” refers to staying away from other people because it is impossible to know who has the virus.  The safest people in your life are the ones you are living with who are not exposed to others who might have the virus (in other words, they are not going to work or spending time close to other people). Staying at home and not seeing your loved ones is not fun, but it is essential for your own safety and for everyone else’s.  If everyone does that now, the spread of this virus will be reduced sooner, and some of these restrictions will no longer be necessary in a few weeks.

  • stay at home
  • avoid public spaces
  • avoid public transportation and unnecessary travel
  • avoid social gatherings
  • work from home
  • stay at least 6 feet away from people when out in public
  • avoid physical contact in social situations, such as shaking hands, hugging or kissing

AND

  • wash your hands using soap and water for at least 20 seconds, especially after being out in public
  • use alcohol-based hand sanitizer when soap and water aren’t available (or wash your hands as soon as you get home)
  • avoid touching your face when your hands aren’t clean or you are out in public
  • avoid contact with people you don’t know very well
  • clean and disinfect surfaces you touch daily, including things you might not think of like doorknobs, light switches, faucet handles, and phones. Make sure you use a cleaning agent that is effective for killing viruses.

What about a face mask?  Experts say that you only need to wear a face mask if you have the virus, to avoid infecting other people you must come in contact with.  It is not clear that it protects you unless you are in close contact with someone with the virus.  If you want to be extra cautious, since the masks that doctors and nurses use are in short supply, you can use homemade masks or scarves to cover your face when you are out in public.  But you should NOT be out in public except when absolutely essential.

If you are undergoing cancer treatment that can weaken your immune system or cause lung problems, here are extra steps to protect yourself:

  • Make a plan with your doctor to monitor for symptoms
  • Avoid friends and family except those you live with or depend on for essentials.  Otherwise, rely on your phone to maintain contact.
  • Have a plan with your loved ones or caregiver if you or they get sick
  • Have the medications you rely on and order any you need in advance (to be delivered, if possible)
  • Ask a friend or family member to shop for groceries for you
  • Wash your hands (20 seconds with soap and water) even more often if you are exposed to others

What should I do if I develop symptoms?

If you develop a fever, cough, or shortness of breath, call your doctor. If you are currently receiving chemo, a fever is a medical emergency.  Other severe symptoms, such as difficulty breathing, persistent chest pain or pressure, confusion or inability to awaken, or blueish color in the lips or face, means you need to call 911. Tell the 911 operator that you think you have COVID-19 so the responders can take the necessary precautions to protect themselves.

People who experience mild symptoms can usually stay home and will recover in about 2 weeks. But, if you are receiving treatment for cancer, be sure to tell your doctor.  Do not just show up at the doctor’s office with symptoms:  Call them first so you have tell them about your symptoms and they can help decide what to do.  If you do become sick, you can take the following steps to protect others:

  • Stay home, unless you need essential medical care
  • Wear a facemask when you are near others.  (People caring for you should also wear a facemask).
  • Stay away from others in your home as much as possible
  • Cover your mouth and nose when you cough or sneeze, properly dispose of tissues, and wash your hands
  • Monitor your symptoms and temperature

If you were not tested for COVID-19, you should follow those steps until at least one week has passed since you first noticed symptoms or your fever goes away for 3 full days without fever-reducing medicine.  If you have been diagnosed with COVID-19 based on test results, you should follow these steps until you have 2 negative test results taken 24-hours apart, your fever goes away without fever-reducing medicine, and your symptoms improve.

What if my cancer treatment is delayed?

When a person is diagnosed with cancer, they are likely to want treatment as soon as possible.  Treatment or testing may seem more urgent than it really is, especially with cancers that often grow slowly, such as prostate cancer or breast cancer. And, if you don’t have COVID-19, you don’t want to be exposed to it during cancer surgery, testing, or follow-up appointments.  Talk to your doctor about what is the best strategy to get the treatment you need when it is safe to do so.

Questions?

We are here to help by answering your questions.  We do not provide medical care.  If you have questions contact info@center4research.org and we’ll get back to you as soon as possible.