CLCC statement regarding COVID-19 vaccinations for cancer patients

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The COVID-Lung Cancer Consortium (CLCC) is a global forum comprised of experts in thoracic oncology, virology, immunology, and vaccines, in addition to representatives of patient advocacy, government, and professional organizations. They meet every other week to address issues and explore research at the intersection of COVID-19 and lung cancer.

CLCC has drafted a statement about the importance of prioritizing cancer patients for vaccination against COVID-19. Its language has been enthusiastically endorsed by leading clinicans and scientists. We hope it will encourage vaccine prioritization of patients with cancer–especially patients with lung cancer–so that vaccine doses will be made available for them should they CHOOSE to be vaccinated (after discussing risks and benefits for their individual case with their healthcare provider).

ASCO is also working to ensure that cancer patients receive priority designation in vaccine distribution plans.

CLCC Statement Regarding COVID-19 Vaccinations for Cancer Patients

Individuals with several clinical features and co-morbid conditions, including cancer, are at increased risk of severe COVID-19 disease. Of particular concern, patients with lung cancer have increased mortality rates of ~32% from COVID-19 infection, which calls for specific prevention measures. Currently, individual states have varying plans regarding prioritization of these high-risk patient populations for vaccination, with some states recommending cancer patients be vaccinated early while other states place these patients farther down the priority list. The COVID- Lung Cancer Consortium (CLCC) meets on a regular basis to monitor ongoing impacts of the pandemic on patients with lung cancer and is comprised of a global assembly of thought leaders in thoracic oncology, virology, immunology, vaccines and patient advocacy. CLCC recommends that state-level policies for vaccine administration should strongly consider a high priority for vaccination of all cancer patients and especially lung cancer patients. Thus, as more vaccine doses are made available, these patients will have early access should they choose to be vaccinated after discussion with their healthcare providers of the associated risks and benefits. Clearly, we still do not yet have enough information about the effectiveness and any additional side effects of such vaccines in cancer patients depending on their cancer type, stage, treatments, and other medical conditions. As such key information becomes available, like that from current NCI sponsored research, adjusted recommendations based on scientific knowledge can be made. Currently, the CLCC recommends specific attention to this vulnerable population(s) and close follow-up of these individuals to ensure the vaccine is effective and there are no unexpected adverse events.

Update for Week of December 14, 2020, to the Joint Statement on #COVID19 from #LungCancer Advocacy Groups


The first case of COVID-19 in the USA was reported on 1/20/2020—over 10 months ago. Since then, the country has reported 15,718,811cases and 294,535 deaths as of December 12 (per the Centers Disease Control and Prevention). With 80% of US counties reporting more travel than last year over Thanksgiving weekend in November 2020 despite warnings from the CDC, we are finally seeing the impact of this holiday surge.

  • The number of new cases is up more than 20 percent from 2 weeks ago
  • The number of hospitalizations has increased by 21 percent
  • The number of deaths has jumped 39 percent, with the United States surpassing 3,000 deaths in 1 day for the first time

On December 11, the United States Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the first SARS-CoV-2 mRNA vaccine, BNT162b2, manufactured by the pharmaceutical giant, Pfizer. For a description of how mRNA vaccines work, please check our last update available here. The New York times reported that large-scale manufacturing and distribution of vaccines has already begun, with the first dosing to start on December 14, 2020. This huge milestone is a positive step towards fighting the COVID-19 pandemic. However, it is important to keep in mind that it will take a considerable amount of time before the entire US population is either vaccinated or immune to COVID-19 through natural infection. With the year-end holidays around the corner and an anticipated increase in travel, the CDC has extended its travel advisory to include the winter break. We encourage our community members to weigh the risks and benefits of travel during this winter. Thanks to the vaccine, the end of the pandemic may be on the horizon. Till such time, maintaining public health measures such as masking, handwashing, social distancing, and minimizing non-essential travel are our best bets for protection.

How was the Pfizer vaccine approved?

The vaccine was approved based on a randomized, double-blind Phase 2/3 clinical trial. A total of 43,548 participants (older than 16 years) received either two doses of the vaccine or a placebo injection three weeks apart. Participants were followed for safety and for the development of symptomatic COVID-19 for approximately 2 months. Eight participants in the vaccine group developed symptomatic COVID-19, whereas 162 participants in the placebo group developed symptomatic COVID-19. The vaccine was found to be 95% effective in preventing severe COVID-19 symptoms i.e., for every 100 people who received the vaccine, 95 were protected from developing severe COVID-19.

Is the Pfizer vaccine safe?

Side effects reported by trial participants were generally mild or moderate, and reactions were less common and milder in older adults than in younger adults. Those who received the vaccine had localized reactions at the injection site (pain, redness, swelling) and systemic reactions (e.g., fever, headache, muscle ache) at higher rates than placebo recipients, with more reactions following the second dose.  Severe fatigue was observed in approximately 4% of vaccine recipients. However, this rate of severe fatigue is also lower than that observed in recipients of approved influenza vaccines for older adults. Serious side effects were similar in both the vaccine and placebo groups (0.6% and 0.5%, respectively).

It is important to keep in mind that we do not have long-term follow-up data from this clinical trial. Sometimes, side effects may show up after months of follow-up. Also, vaccination began in the United Kingdom last week. Two individuals with a history of severe allergic reactions were reported to have had a severe reaction to the vaccine. These individuals carried an EpiPen and use of the pen was sufficient to counteract the allergic reaction. It is anticipated that these reactions will be very rare given that such safety issues were not seen in the large clinical trial. The public health benefits of distributing this vaccine still far outweigh any perceived risks.

What is not known about the Pfizer vaccine?

  1. We do not know whether the vaccine will be effective for more than 2 months, because participants have only been followed for 2 months so far. However, additional data continues to be gathered.
  2. Children (less than 16 years of age), pregnant women, and immunocompromised patients (such as those who have received cell-based therapies or chemotherapy for their cancer) were not included in the study. We do not know if the virus will be safe (in children and pregnant women) or effective (in immunocompromised patients who may not mount an immune response) in the groups excluded from the clinical trial.
  3. The vaccine involves two doses given three weeks apart. The first dose “primes” the immune system to respond while the second dose “boosts” that response. If someone misses the second dose, we do not know whether the vaccine will still be effective.
  4. We don’t yet know whether the vaccine will prevent the recipient from getting infected or from spreading COVID-19. Again, we need more data. We’ll need to continue practicing public health measures such as masking and social distancing even after receiving the vaccine, at least in the near term.

When will I receive the vaccine?

The United States is adopting a phased approach to roll out large-scale vaccination. The phased approach prioritizes the most essential and the most vulnerable of our population as the first recipients of the vaccine, given the initial limited supply of vaccines. The following figure shows how the state of Massachusetts will use the phased approach for distributing vaccines.  It is anticipated that patients with lung cancer will receive vaccines in Phase 1 or 2.

As of December 2020, the Advisory Committee on Immunization Practices (ACIP) recommended that both 1) health care personnel and 2) residents of long-term care facilities be offered COVID-19 vaccine in the initial phase of the vaccination program (Phase 1a).

Each state in the United States is likely to have specific vaccination guidelines tailored to their own specific needs. For information specific to your state, please check this link.

An important population for our community is caregivers to patients with lung cancer. If you are the primary caregiver for your loved one, please check your eligibility for receiving the vaccine.

This will be our last update of the year. We wish everyone a safe and peaceful Holiday Season! Please continue to maintain social distancing, wash hands, mask, and minimize non-essential travel. See you in 2021!

Resources and websites

  1. IASLC’s Guide to COVID-19 and Lung Cancer
  2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. COVID-19: What People with Cancer Should Know
  3. Updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
  4. Johns Hopkins COVID-19 Resource Center
  5. Interactive map of US COVID-19 cases by state
  6. COVID-19 in patients with cancer: managing a pandemic within a pandemic
  7. You can find information specific to your state or city or town on your health department’s website.
    • Directory of state department of health websites
    • Directory of local health department websites
  8. American Medical Association resources for healthcare providers.

Update for Week of November 23, 2020, to the Joint Statement on #COVID19 from #LungCancer Advocacy Groups

We are at a critical moment in the ongoing COVID-19 pandemic. New cases are rapidly escalating throughout the country, and we are positioned to see explosive growth as people travel and gather to celebrate the Thanksgiving holiday with loved ones. While our understanding of how to treat COVID-19 has grown significantly since the disease first burst onto the scene, deaths continue to mount, with the US now seeing the most daily deaths since May.

The realities of the current situation are compounded by our collective national fatigue and desire to return to some sense of normalcy. When we look at website hits for these joint statements over time, we see a lot of activity in the spring when COVID-19 was “new,” but those numbers have dropped off substantially through the summer and fall. This stands in stark contrast to the growth of cases through subsequent waves of infection.

The take home message is that we must not let our guard down! Please continue to wear a mask, watch your distance and wash your hands. Our collective actions over the next few weeks CAN make a difference in helping curb the recent surge. We also recognize the importance of balance, particularly for patients with cancer who fear they may not have another Thanksgiving or Christmas. For practical guidance on how to navigate your holidays safely, please refer to this helpful discussion.

Despite the current situation, there is reason for hope. We can now see the light at the end of the tunnel with the recent announcements that both Moderna and Pfizer/BioNTech have developed highly effective COVID-19 vaccines, with others in the pipeline. You can find a comprehensive overview of how vaccine trials work and current vaccine efforts underway here.

Additionally, monoclonal antibody therapies continue to make progress. Eli Lilly recently received Emergency Use Authorization from the FDA for its antibody therapy in recently diagnosed, high-risk patients. Regeneron also received a lot of press when its antibody therapy was used to treat President Trump.

VACCINE FAQS

The development of a new class of mRNA-based vaccines has raised many questions, particularly among the lung cancer community. We have been collecting these questions and will do our best to address them here.

  1. How do mRNA vaccines work?

Messenger RNA (mRNA) is the recipe for making a protein. The mRNA gets injected into the body and is taken up by cells that “read the recipe” for making the SARS-CoV-2 spike protein. This is the protein normally expressed as a “crown” on the virus particle and is the part of the virus that binds to the receptor found on cells in the lungs and in other tissues throughout the body. Once these cells take up the mRNA and make the spike protein, they can display pieces of spike on their cell surface to signal the immune cells to become activated. B cells are a type of immune cells that make antibodies that can block virus binding. CD4 T cells support B cells to make antibodies while CD8 T cells can kill virus-infected cells. This is illustrated in the figure below for Moderna’s vaccine (though Pfizer/BioNTech’s vaccine works in the same manner).

  1. How do we know these vaccines are safe?

All new drugs and vaccines go through extensive testing as part of the clinical trials process. (summarized in the NYTimes link above). Both the Moderna and Pfizer/BioNTech vaccines are currently in Phase 3 clinical trials, reporting nearly 95% efficacy and no significant safety issues. It is important to note that these trials have been conducted in thousands of patients. However, no significant safety issues does not mean the vaccines don’t come with some unpleasant side effects which are short-lived. Those effects should not be a reason to avoid the vaccine. Educating healthcare providers on the mRNA technology and ensuring them that the vaccines are safe will be key to a successful rollout.

  1. When will the vaccines be available? Will patients with lung cancer be prioritized?

Based on the safety and efficacy profiles of both vaccines, it is expected that people will start receiving them before the end of the year, perhaps as soon as December 12 in the US.  Many national experts are developing guidance for vaccine distribution, with the National Academies issuing a framework that would see healthcare workers, frontline workers and those in high-risk categories being eligible to be vaccinated first. Given that several studies have now reported high mortality rates in patients with lung cancer who contract COVID-19 ,  it is widely expected that lung cancer patients would be among those first eligible to receive the vaccine in the early stages of rollout.

  1. Should I take the first vaccine available or wait for a later generation one?

As stated earlier, both the Moderna and Pfizer/BioNTech vaccines are highly effective with a strong safety profile. There have been fears among many that the rush to produce a vaccine would result in compromised safety or efficacy but adherence to standards established by the FDA[A1]  and other agencies assures us that these vaccines are safe.

It is important to note that before mRNA vaccines were developed in the fight against COVID-19, they were being developed to help combat cancer. Both Moderna and BioNTech (the company that partnered with Pfizer on its COVID-19 vaccine) have been developing mRNA vaccine technology for some time in the hopes of using this approach to treat various forms of cancer as well as other infectious diseases.

Given the unique threat that COVID-19 presents to the lung cancer community, we strongly encourage you to have a discussion with your doctor about getting the vaccine as soon as it is available to you. As for choosing between these two specific vaccines, the technology is essentially identical. Both require two shots over the course of a few weeks. The differences come down to logistical challenges of ensuring facilities have proper freezers for maintaining the vaccines at the appropriate subzero temperatures.

Other vaccine candidates are in development that use different technology platforms. It remains possible that some future vaccines may require only a single dose (such as Janssen’s vaccine) or be administered differently (intranasal vs injection).

Until those vaccines gain approval, the current decision will be based on availability of the two mRNA-based vaccines.

It is worth noting that a multi-institutional, NCI-funded grant has been awarded to study antibody responses to SARS-CoV-2 infection in lung cancer patients as compared to healthy people. This effort will try to answer why lung cancer patients seem to have worse outcomes from COVID-19 and will study responses in patients receiving a vaccine compared to those who do not.

UNANSWERED QUESTIONS

Several questions remain about the new mRNA vaccines:

  • Can these vaccines completely prevent infection, or will they just prevent symptoms from developing?
  • Can people who receive the vaccine still transmit the virus to others?
  • How long will any resulting immunity last? Previous results from these types of vaccines in other settings suggest that protection may wane after a year.

More data is needed before we can answer these questions.

FINAL TAKEAWAY

There is no escaping the seriousness of our current national crisis – COVID-19 cases are increasing everywhere and so we must do what we can to protect ourselves and our loved ones a little while longer.

However, hope is on the horizon. We can face 2021 knowing that, through the power of science, this pandemic will eventually come to an end.

HAPPY HOLIDAYS AND PLEASE STAY SAFE!



Resources and websites

  1. IASLC’s Guide to COVID-19 and Lung Cancer
  2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. COVID-19: What People with Cancer Should Know
  3. Updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
  4. Johns Hopkins COVID-19 Resource Center
  5. Interactive map of US COVID-19 cases by state
  6. COVID-19 in patients with cancer: managing a pandemic within a pandemic
  7. You can find information specific to your state or city or town on your health department’s website.
    • Directory of state department of health websites
    • Directory of local health department websites
  8. American Medical Association resources for healthcare providers.

Update for Week of November 9, 2020, to the Joint Statement on #COVID19 from #LungCancer Advocacy Groups

The first case of COVID-19 in the USA was reported on 1/20/2020—over 9 months ago. Since then, the country has reported 9,860,558 cases and 237,113 deaths (per Johns Hopkins). As the weather becomes cooler and we spend more time indoors, the number of cases is rapidly accelerating in almost every state.

Given this surge, holiday gatherings and activities present a serious risk for virus transmission.  On November 5, 2020, the #LCSM (Lung Cancer Social Media) Chat community on Twitter discussed ways to enjoy and celebrate the holidays safely during the pandemic. Chat participants included lung cancer patients, caregivers, advocates, physicians, and healthcare workers. The chat, which included links to many helpful resources, covered the following topics:

  • What have we learned over the past 8 months about how COVID-19 is transmitted?
  • How can people reduce the risk of COVID-19 during outdoor activities?
  • How can people reduce the risk of COVID-19 when travel is involved? What about travel to or from hot spots?
  • How safe is it to meet with family and friends who had COVID-19 and recovered?
  • How can people reduce the risk of COVID-19 for indoor activities (shopping, dining in restaurants, family gatherings, worship services, etc.)?

Read the summary of November 5 #LCSM Chat “Celebrating Safely During COVID-19 Pandemic” here:   https://wakelet.com/wake/clw31H18j2lOwCQY2MulU

We hope you find these resources useful as you plan happy and healthy holiday celebrations!


Resources and websites

  1. IASLC’s Guide to COVID-19 and Lung Cancer
  2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. COVID-19: What People with Cancer Should Know
  3. Updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
  4. Johns Hopkins COVID-19 Resource Center
  5. Interactive map of US COVID-19 cases by state
  6. COVID-19 in patients with cancer: managing a pandemic within a pandemic
  7. You can find information specific to your state or city or town on your health department’s website.
    • Directory of state department of health websites
    • Directory of local health department websites
  8. American Medical Association resources for healthcare providers.

Update for Week of October 19, 2020 to the Joint Statement on COVID-19 from Lung Cancer Advocacy Groups


The daily news reports are a stark reminder that the COVID-19 pandemic is far from over. Consistent with experts’ fears for the fall, new cases are on the rise across the US and in Europe.

Caught in the grips of this unprecedented public health crisis for almost all of 2020, Americans are growing fatigued and restless. The lockdowns in the spring and the extended period of social distancing needed to keep the virus at bay are negatively impacting people’s mental health. For many, it is the lack of touch, a simple hug, that we miss the most.

And this is the time of year when we start looking to Thanksgiving to reunite with family and loved ones, a time often celebrated with large gatherings, extended celebrations and warm embraces. But, at a time when cases are once again surging across the country, each of these activities presents a serious risk for virus transmission. This risk comes at even greater cost for the lung cancer community given the increased likelihood of severe disease and heightened mortality for lung cancer patients who contract COVID-19.

Recently, several health experts have weighed in on how best to approach the holiday to ensure maximal safety. Dr. Anthony Fauci, the nation’s leading infectious disease expert, has suggested Americans need to strongly weigh the risk-benefit of having Thanksgiving gatherings. In places or states with a high number of new cases, some experts even advise canceling (or at least postponing) this year’s celebration. You can check each state’s COVID-19 new case activity here. While we all feel the need to be close to our loved ones at this time of year especially, we want to urge all of you to do your homework and take appropriate precautions to protect yourselves and those around you. You can use a risk calculator to decide the level of risk. To assist with your planning, the CDC also provides a list of Thanksgiving activities at different risk levels. The table below offers example activities at different risk levels for virus spread.

LOW RISKMODERATE RISKHIGHER RISK
–Having a small dinner with people who live in the same household
–Having a virtual dinner with your loved ones and make it fun by sharing recipes
–Preparing special family recipes and delivering them in a safe and contact-free fashion
Having a small outdoor dinner with family and friends who live in your community while maintaining social distancingAttending indoor gatherings with people from outside your householdAttending large indoor celebrations with singing or chanting
Watching a sporting event in a virtual get-togetherAttending a small outdoors sports event where public health precautions are maintainedAttending a crowded sports event, even if it’s outdoors
Watching all Thanksgiving events (parade, sports) from homeAttending a pumpkin patch or orchard where people are following public health precautionsHaving a small group outdoor, open-air parade with social distancing  Attending or participating in crowded parades
Shopping online after Thanksgiving Going shopping in crowded stores around Thanksgiving holiday

We realize that celebrating the holidays is an important part of our tradition. We, therefore, suggest that you identify an inner circle of family and friends (your social distancing crew) who will be taking precautions with you during the holidays so you can celebrate safely! The holidays can be stressful, and with the pandemic adding a new layer of stress, do not forget to take care of your mental health.

How can you vote safely during the pandemic?

Election day is coming, and it’s important to make your voice heard. If you’re concerned about how to vote safely during a pandemic, Consumer Reports offers a Guide to Voting During a Pandemic that covers several different approaches to voting. The CDC has also issued special COVID-19 safety recommendations for voters. Many of their suggestions are familiar by now; however, the CDC also discusses additional precautions specifically for in-person voting. Some examples:

  • Avoid delays by verifying your voter info and having any necessary registration forms ready.
  • Bring your own black pen (or stylus, if used in your precinct).
  • Review a sample ballot in advance so you can vote and depart quickly.
  • Use early voting, if available in your jurisdiction.
  • Vote at off-peak times, such as mid-morning.
  • If driving to the polls and your schedule allows, monitor the voter line from your car and join it when it’s shorter.

Resources and websites

  1. IASLC’s Guide to COVID-19 and Lung Cancer
  2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. COVID-19: What People with Cancer Should Know
  3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
  4. Johns Hopkins COVID-19 Resource Center
  5. Interactive map of US COVID-19 cases by state
  6. COVID-19 in patients with cancer: managing a pandemic within a pandemic
  7. You can find information specific to your state or city or town on your health department’s website.
    • Directory of state department of health websites
    • Directory of local health department websites
  8. American Medical Association resources for healthcare providers.

Update for Week of October 5, 2020 to the Joint Statement on COVID-19 from Lung Cancer Advocacy Groups

As of October 3, 2020, the US has had close to 7.2 million cases of COVID-19, with over 200,000 deaths. Daily reported cases of COVID-19 have been on the rise. This is not surprising due to social distancing fatigue and mask fatigue.

As the weather becomes cooler and we spend more time indoors, an upward trend in COVID-19 cases is expected. Though a lot of vaccine candidates are showing promise in clinical trials, an effective anti-SARS-CoV-2 vaccine will probably not be available for large-scale community use before the middle of 2021. Even once a vaccine becomes available, we will need close to 660 million doses over the next year or so, because the vaccine candidates furthest along in trials require two doses per person. For the near and somewhat distant future, we will continue to rely on public health measures such as washing our hands, maintaining social distancing, and wearing a mask.

As the leaves turn, the holidays begin. Different holidays present different risks – Halloween typically involves large gatherings of children and young people going to door-to-door to collect candy or to party, other holidays bring loved ones together to share meals or celebrate the end of one year and the start of a new one.

Living during the pandemic does not mean we need to completely cancel our holiday celebrations. With advanced planning and maintenance of public health precautions, we can take measures to ensure a safe and COVID-19-free holiday season.

Here are some ideas for celebrating Halloween safely. Additionally, the Centers for Disease Control and Prevention have provided guidelines to ensure that we have a “COVID-free” season[A1] .

  1. Keep a track of community levels of COVID-19 in your area. You can find this information through your local department of health.
  2. If the weather permits, try to have an outdoor gathering where ventilation is not an issue. If you are planning on having an indoor celebration, it might be a good idea to keep a door or windows open – to promote air circulation.
  3. Keep the gathering as short as possible. Longer gatherings equal longer time for exposure.
  4. Smaller gatherings are of course less risky than larger gatherings. Though the CDC doesn’t have specific numbers to guide size of gatherings, they recommend that the size of the gathering be determined by ability to reduce or limit contact between guests (the event space), the risk of spread between guests, and state, local, territorial, or tribal health and safety laws, rules, and regulations.
  5. If your guests are attending from another state, check the COVID-19 caseload in that state. The same applies if you are planning to travel. It is always a good idea to check caseload at point of origin and destination. If you plan to drive to a holiday gathering and are able to, quarantine for 14 days before travel.
  6. If you are the host, remind your guests that social distancing, hand washing, and wearing a mask are a part of the celebration .
  7. The National Institutes of Health has developed a rapid COVID-19 antigen test. If you are able to access a rapid antigen test, it may be a good idea to get tested before you attend a celebration (though since these tests are less sensitive than the nasal swab PCR test and a negative test doesn’t rule out an asymptomatic or presymptomatic infection).
  8. Since patients with lung cancer are considered at high risk of developing complications from COVID-19, use your judgement and exercise caution when deciding whether you wish to attend a celebration – especially where you do not know a lot of the guests.

We wish everyone a safe and healthy Fall!


Resources and websites

  1. IASLC’s Guide to COVID-19 and Lung Cancer
  2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. COVID-19: What People with Cancer Should Know
  3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
  4. Johns Hopkins COVID-19 Resource Center
  5. Interactive map of US COVID-19 cases by state
  6. The One-Two Punch: Cancer And COVID-19 (an important perspective for cancer patients)
  7. You can find information specific to your state or city or town on your health department’s website.
    • Directory of state department of health websites
    • Directory of local health department websites
  8. American Medical Association resources for healthcare providers.

Sep 21, 2020 Update to the Joint Statement on #Coronavirus #COVID19 From #LungCancer Advocacy Groups

 The post below is shared with permission. It can also be found on the websites of the lung cancer advocacy organizations listed at the end of this blog post.

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As of September 18, 2020, the US has had 6.7 million cases of COVID-19, with just over 198,000 deaths. The Midwest is leading new cases, with 8 cities in Wisconsin appearing on The New York Times list of the 20 metro areas with fastest-growing cases.

With the run-up to the US Presidential election now less than two months away, recent weeks have seen a growing national dialog on the potential availability of a SARS-CoV-2 vaccine. In this week’s update, we want to review some basic concepts on vaccines, the clinical trials process for ensuring vaccine safety and provide an update on the current status of the various vaccine candidates currently under development.

 

What is a vaccine? How long do vaccines last?

 In the most basic terms, a vaccine is a substance that can stimulate the body’s immune response to provide protection against diseases caused by different viruses and bacteria. Some vaccines provide potentially life-long protection (measles) while others provide long-term protection but still require periodic “booster” shots (tetanus being a classic example). Still others require annual vaccination because of the nature of the virus – influenza virus (that causes “flu”) undergoes changes from year to year and so the formulation for the vaccine changes each year to accommodate these changes and offer the best protection possible.

(PSA: don’t forget to get your flu shot this year!)

 

How are vaccines tested?

Everyone feels a great sense of urgency to develop a vaccine for SARS-CoV-2 so we can think about returning to some degree of “normalcy” in our daily lives. A concerted global effort is currently underway not only to develop a safe and effective vaccine but to develop other treatments as well (including so called monoclonal antibodies as well as novel antiviral treatments). In the US, the administration has developed what it refers to as “Operation Warp Speed” to try to accelerate vaccine development.

Without getting into a political debate, we want to offer a brief overview of what goes into getting a vaccine approved. Specifically, once a candidate vaccine is identified, its safety and efficacy (how well it works) must be validated through a rigorous clinical trials process as shown in the schematic below:

 

For a great overview of how vaccines are developed, the different types of vaccines, how they are tested and the status of current efforts to develop a SARS-CoV-2 vaccine, we refer you to an excellent resource put together by The New York Times.

 

Vaccine Safety

Historically, the United States Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has been responsible for regulating vaccines in the US.  Recently, the scientific integrity of both the FDA and the Centers for Disease Control and Prevention (CDC) have come into question over fears that they may be rushing vaccine development in the interest of political expediency. Because of this concern, many of the pharmaceutical companies at the forefront of the effort to develop a SARS-CoV-2 vaccine signed an unprecedented pledge affirming their commitment to vaccine safety.

Politics aside, the scientific community must ensure any potential vaccine is both safe AND effective before it is approved and administered to the public. Past experience with the development of SARS and MERS (Middle-Eastern Respiratory Syndrome) vaccines has taught us that coronavirus vaccines need thorough testing. A recent incident that occurred during the Phase 3 clinical trial of AstraZeneca’s vaccine candidate highlights why vaccine safety is paramount. The initial lack of details about the nature of the incident raised concerns about lack of transparency by the drug companies developing these vaccines. In response to mounting pressure, several of the leading contenders have made their protocols public.

 

Hope on the Horizon

 Despite the challenges associated with developing an effective vaccine against SARS-CoV-2, there are several reasons to be hopeful:

  • The science is advancing at a historic and unprecedented pace. Previously, the fastest vaccine ever made (against mumps) took four years to develop.
  • We have access to novel vaccine development platforms and also experience with coronavirus vaccine development with SARS and MERS. Scientists are building on this pool of available knowledge to develop a vaccine against SARS-CoV-2.
  • We have gone from first identifying a novel virus (SARS-CoV-2) as the cause of COVID-19 (Dec 2019) to having the sequence of the viral genome (Jan 2020) and the pursuit of multiple, compelling vaccine efforts within the span of only six months.

 

Resources and websites:

  1. IASLC’s Guide to COVID-19 and Lung Cancer
  2. National Cancer Institute website “Coronavirus: What People with Cancer Should Know
  3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
  4. Johns Hopkins COVID-19 Resource Center
  5. Interactive map of US COVID-19 cases by state
  6. The One-Two Punch: Cancer And COVID-19 (an important perspective for cancer patients)
  7. You can find information specific to your state or city or town on your health department’s website:
    Directory of state department of health websites
    Directory of local health department websites
  8. American Medical Association resources for healthcare providers

GO2 Foundation for Lung Cancer (Amy Moore, PhD – amoore@go2foundation.org)
LUNGevity Foundation (Upal Basu Roy, PhD, MPH – ubasuroy@lungevity.org)
Lung Cancer Foundation of America (Kim Norris – KNorris@lcfamerica.org)
Lung Cancer Research Foundation (Cristina Chin, LMSW, MPH – cchin@lcrf.org)
LungCAN (Kimberly Lester – kimberly@lungcan.org)

 

Sep 8, 2020 Update to the Joint Statement on #Coronavirus #COVID19 From #LungCancer Advocacy Groups

 The post below is shared with permission. It can also be found on the websites of the lung cancer advocacy organizations listed at the end of this blog post.

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We hope that all of you had a peaceful Labor Day holiday.  This week marks the six-month anniversary of when the World Health Organization declared COVID-19 a global pandemic (March 11). As of September 7, 2020, cases in the US have surpassed the 6 million mark, with over 186,000 deaths.

Nationally, new cases appear to be on a decline but pockets of high COVID activity remain. The figure below shows which states have the most new daily cases and the relative degree of community spread versus containment of the virus:

 

 

PSA: Get your flu shots!

 With the arrival of September, we are strongly recommending that all eligible patients and caregivers get their annual flu shot this year! Public health experts are particularly concerned about the potential for patients to get infected with both influenza and SARS-CoV-2 this winter. Additionally, since the symptoms for these two viruses are similar, many patients experiencing flu-like symptoms may flood already overtaxed healthcare systems. Many doctors’ offices and pharmacies already have flu shots available. It’s also important to remember that it takes approximately two weeks from receiving the shot to have adequate protection. So please make a plan to get your shot as soon as possible.

Some patients, particularly those on checkpoint inhibitors, may be concerned about whether they can take the flu shot – we always recommend asking your doctor but previous studies suggest that it is safe for patients.

 

We want to hear from you!

We are interested in knowing what topics we should cover in future updates. Please share your thoughts with us by taking this short (1-2 minute) anonymous survey.

https://www.surveymonkey.com/r/LungAdvocacy_COVID19_needs

 

Resources and websites:

  1. IASLC’s Guide to COVID-19 and Lung Cancer
  2. National Cancer Institute website “Coronavirus: What People with Cancer Should Know
  3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
  4. Johns Hopkins COVID-19 Resource Center
  5. Interactive map of US COVID-19 cases by state
  6. The One-Two Punch: Cancer And COVID-19 (an important perspective for cancer patients)
  7. You can find information specific to your state or city or town on your health department’s website:
    Directory of state department of health websites
    Directory of local health department websites
  8. American Medical Association resources for healthcare providers

GO2 Foundation for Lung Cancer (Amy Moore, PhD – amoore@go2foundation.org)
LUNGevity Foundation (Upal Basu Roy, PhD, MPH – ubasuroy@lungevity.org)
Lung Cancer Foundation of America (Kim Norris – KNorris@lcfamerica.org)
Lung Cancer Research Foundation (Cristina Chin, LMSW, MPH – cchin@lcrf.org)
LungCAN (Kimberly Lester – kimberly@lungcan.org)

 

Aug 24, 2020 Update to the Joint Statement on #Coronavirus #COVID19 From #LungCancer Advocacy Groups

 The post below is shared with permission. It can also be found on the websites of the lung cancer advocacy organizations listed at the end of this blog post.

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It has been more than 6 months since the first cases of COVID-19 hit the United States. We issued our first update on March 3, a week before the World Health Organization declared a global pandemic on March 11. As of August 24, 2020, cases in the United States continue to rise unabated, with over 5.6 million total cases and 175,000 deaths. Countries in Western Europe that had seen a decrease in case load have recently seen small outbreaks, indicating that community spread continues to be a high possibility.

So we are left to wonder: when can we resume normal activities in our lives?

The straightforward answer to that question is when we have achieved a reasonable level of herd (or community) immunity, which occurs when a high percentage of the community is immune to a disease through vaccination and/or prior illness (natural infection). Herd immunity is critical because it not only prevents the spread of infection but also protects people who may not be able to receive a vaccine (for example, the elderly or the severely immunocompromised in whom the immune system is unable to mount a protective response against the virus).

Epidemiologists are hard at work figuring out what levels of herd immunity will protect us from SARS-CoV-2. Initial models suggested that the percentage of people who need to be immune to the virus to achieve herd immunity was around 70%. However, recent research suggests a lower threshold, on the order of only 40%. It is extremely important to keep in mind that no matter the threshold of immunity required, these estimates are based on mathematical models and not true population-based studies.

Our current level of potential immunity to SARS-CoV-2 (the virus that causes COVID-19) is measured using an antibody assay that detects past exposure to the virus whether or not a person had symptoms of COVID-19. Herd immunity through natural infection may depend on location. For example, levels of herd immunity may be lower in rural areas where people are more spread out than in cities, which are more crowded. Also, older people may be more susceptible to the virus and succumb to the disease, whereas younger people may recover from infections and add to the “pool” of herd immunity. Recent research from a COVID-19 hotspot, New York City, looking at the percentage of people who are “antibody-positive” shows a huge variation within the five boroughs of the city. It is therefore possible that the harder hit areas, such as parts of Brooklyn and Queens, may be close to achieving a herd immunity threshold whereas other parts of the city may not (assuming that the antibody tests are accurate and antibodies are long-lasting). This is especially important to keep in mind because it clearly demonstrates that achieving a high percentage of immune individuals through natural infection is not an easy task and comes with a price (please refer to our past update on seropositivity from July 13, 2020).

We are interested in knowing what topics we should cover in future updates. Please share your thoughts with us by taking this short (1-2 minute) anonymous survey.

https://www.surveymonkey.com/r/LungAdvocacy_COVID19_needs

 

Resources and websites:

  1. IASLC’s Guide to COVID-19 and Lung Cancer
  2. National Cancer Institute website “Coronavirus: What People with Cancer Should Know
  3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
  4. Johns Hopkins COVID-19 Resource Center
  5. Interactive map of US COVID-19 cases by state
  6. The One-Two Punch: Cancer And COVID-19 (an important perspective for cancer patients)
  7. You can find information specific to your state or city or town on your health department’s website:
    Directory of state department of health websites
    Directory of local health department websites
  8. American Medical Association resources for healthcare providers

GO2 Foundation for Lung Cancer (Amy Moore, PhD – amoore@go2foundation.org)
LUNGevity Foundation (Upal Basu Roy, PhD, MPH – ubasuroy@lungevity.org)
Lung Cancer Foundation of America (Kim Norris – KNorris@lcfamerica.org)
Lung Cancer Research Foundation (Cristina Chin, LMSW, MPH – cchin@lcrf.org)
LungCAN (Kimberly Lester – kimberly@lungcan.org)

 

Aug 10, 2020 Update to the Joint Statement on #Coronavirus #COVID19 From #LungCancer Advocacy Groups

 The post below is shared with permission. It can also be found on the websites of the lung cancer advocacy organizations listed at the end of this blog post.

—————————

As of August 9, 2020, we are approaching 20 million cases of COVID-19 worldwide, with almost 5 million cases and 160,000 deaths in the US alone. In this week’s update, we want to shift our attention to another looming healthcare crisis resulting from the pandemic, namely a significant decline in new cancer diagnoses. Given the importance of maintaining appointment schedules, we will also present questions that you may want to ask your healthcare provider in advance of visits to the doctor. Finally, we will highlight ongoing advances in lung cancer research, because cancer doesn’t stop and neither do we.

 

What is the impact of COVID-19 on new cancer diagnoses?

In the early days of the pandemic here in the US, many stakeholders conducted various modeling simulations to look at the short-term and long-term impacts of the pandemic, particularly related to people continuing to get their recommended cancer screenings (mammograms, colonoscopies). These studies highlighted a looming crisis, predicting a rapid decline in the number of new cancer diagnoses. Dr. Ned Sharpless, Director of the National Cancer Institute, highlighted some of this data in a recent presentation at the AACR COVID-19 and Cancer Conference and in an editorial for Science.

This past week, a new study showed an alarming overall drop (46%) in new cancer diagnoses across six different tumor types, including lung cancer, for the period from March 1 to April 18, 2020:

Additional reports from the across the country indicate an even higher drop in new cancer diagnoses. The COVID and Cancer Research Network reported a decline of 74% across 20 sites in the US for April 2020 compared to April 2019.

While people were encouraged to delay these essential screenings during the spring, we know that early detection of cancer is critical for achieving the best outcome and so we want to stress the importance of keeping up with your medical appointments and recommended screenings. To that end, we want to empower you with a set of questions to ask your doctor in advance of any visits so that you feel they are taking appropriate precautions to ensure your safety.

 

What Should I Ask My Doctor About What They’re Doing to Keep Me Safe?

It’s not unusual to be concerned about the risk of exposure to coronavirus when you go to a clinic or hospital during a pandemic. A facility that is currently experiencing a large volume of COVID-19 patients, or limiting certain procedures or services, may have limitations on which patients it can accommodate.  However, most facilities are ready to welcome patients.

Hospital and clinic facilities are taking extra precautions to keep their patients safe. Many facilities are posting videos and information on their websites explaining which precautions they’ve implemented (here is an example video).

If you can’t find information online about the facility you want to visit, call the facility and ask about their precautions.  Here are some questions you can ask your care provider or facility before an in-person appointment:

  • Can the care provider conduct the visit via telemedicine? (This option requires a patient who doesn’t need an in-person consultation or procedure, AND who is comfortable with and has the equipment for conducting video meetings on a computer or smartphone).
  • Can prescriptions be acquired through home delivery, mail order, or curbside pick-up?
  • Does the facility require everyone to wear a face covering at all times?
  • Does the facility direct patients who have COVID-19 to specific entrances or areas to minimize contact with other patients?
  • Does the facility screen all staff for typical COVID-19 symptoms before they start their shifts?
  • Does the facility have screeners at patient entrances to ask about known COVID-19 symptoms, take each visitor’s temperature, and ensure appropriate face coverings are worn (and provided, if necessary)?
  • Does the facility limit nonessential companions for each patient to no more than a single individual who is free of known COVID-19 symptoms?
  • Does the facility promote physical distancing through use of protective barriers, markers on the floor to indicate where to stand to stay 6 feet apart, and separating seats in waiting areas?
  • Is each piece of equipment and appointment area cleaned between each use by a patient?
  • Do enclosed treatment spaces (like MRI machines) have a waiting period between patients?
  • Does the facility adhere to stringent and frequent cleaning protocols, especially in high-touch areas?
  • Does the hospital allow visitors in patient rooms? If so, does it require them to check in at a nursing station or other screening area before entering patient’s room?

Additional steps YOU can take to help keep yourself safe before, during, and after a visit inside a hospital or clinic:

  • Don a clean face covering before entering the facility, avoid touching it or your face during your time in the facility, and keep it on at all times unless a healthcare provider asks you to remove it.
  • Wash your hands frequently. Bring hand sanitizer with you (just in case)
  • Before meeting your healthcare provider, wash your hands or use hand sanitizer.
  • When you get back to your car or your home, remove the mask carefully by touching only the ear loops. Use hand sanitizer after removing your mask.
  • To be extra cautious, wash your hands and face covering and change your clothes when you get home. You might even take a shower. Wash the clothes you wore to the facility.

 

And lung cancer research continues in full swing!

This year’s World Conference on Lung Cancer (WCLC 2020), hosted by the International Association for the Study of Lung Cancer, went virtual due to the COVID-19 pandemic. Originally scheduled to be held in Singapore from August 8-12, 2020, the scientific sessions will be available from January 28-31, 2021.

WCLC 2020 was officially kicked off on August 8, 2020 with the Presidential Symposium live telecast at 7 PM Singapore time. The Presidential Symposium is a platform to present practice-changing research in the early detection or treatment of lung cancer. This year’s Symposium had three fantastic Phase III trial presentations on immunotherapy for non-small cell lung cancer (NSCLC), a new targeted therapy for ALK-positive lung cancer, and immunotherapy for mesothelioma.

  1. Currently, a chemotherapy -immunotherapy (pembrolizumab) combination is prescribed as first-line treatment for NSCLC that does not have any targetable driver mutations and that does not express high levels of PD-L1 protein. This is based on the results of the KEYNOTE-189 clinical trial, and the combination is available in the United States and some Western European countries. Results from the Phase III ORIENT-11 trial conducted in China show that addition of an immunotherapy (sintilimab – a PD-1 checkpoint inhibitor) to chemotherapy shows similar benefits seen in KEYNOTE-189. This is an extremely critical finding because results of the ORIENT trial will set the stage for this combination to be available in China and other Asian countries, so that patients can continue to benefit from these advances.
  2. Ensartinib is a 2nd-generation ALK tyrosine kinase inhibitor. Results from the Phase III eXalt3 trial comparing ensartinib to crizotinib as first-line treatment for ALK-positive lung cancer show that this 2nd generation ALK inhibitor is superior to crizotinib, in terms of its effect both on the primary lung cancer and on brain metastases. These exciting results suggest that ensartinib may be another treatment option for ALK-positive lung cancer in the first-line setting.
  3. Malignant pleural mesothelioma (MPM) is an aggressive type of cancer affecting the lining of the lungs. It has been associated with exposure to asbestos. Results from the phase III CheckMate 743 trial, comparing combination immunotherapy (nivolumab-ipililumab) to chemotherapy showed that immunotherapy combo is superior to chemotherapy, in the first-line setting.

These three presentations will likely set the foundation for new drug approvals and remind us that lung cancer research will continue, no matter what COVID-19 brings!

 

Resources and websites:

  1. IASLC’s Guide to COVID-19 and Lung Cancer
  2. National Cancer Institute website “Coronavirus: What People with Cancer Should Know
  3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
  4. Johns Hopkins COVID-19 Resource Center
  5. Interactive map of US COVID-19 cases by state
  6. The One-Two Punch: Cancer And COVID-19 (an important perspective for cancer patients)
  7. You can find information specific to your state or city or town on your health department’s website:
    Directory of state department of health websites
    Directory of local health department websites
  8. American Medical Association resources for healthcare providers

GO2 Foundation for Lung Cancer (Amy Moore, PhD – amoore@go2foundation.org)
LUNGevity Foundation (Upal Basu Roy, PhD, MPH – ubasuroy@lungevity.org)
Lung Cancer Foundation of America (Kim Norris – KNorris@lcfamerica.org)
Lung Cancer Research Foundation (Cristina Chin, LMSW, MPH – cchin@lcrf.org)
LungCAN (Kimberly Lester – kimberly@lungcan.org)