The US FDA is hosting a listening session to gather patient perspectives on￼ oncogene-driven lung cancer. Representatives from several biomarker patient groups will speak; I will be speaking on behalf of The ROS1ders. Representatives from the FDA will share ways they are addressing the concerns raised by the patients.
TODAY! What are your bold predictions for innovations, policy changes, advocacy strategies & anything else in the prevention, detection, treatment of lung cancer & support of our community? Join moderator David Cooke, MD for #LCSM Chat on Twitter! Read more here:
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).
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.
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.
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?
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.
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.
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.
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.
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!
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.)?
While I would prefer the uncertainty about the US presidential election be resolved quickly, I’m glad to see the media is waiting for most/all votes to be counted before calling states where the count is close. We are a country that is clearly divided, with tensions running high. Accuracy in counting every vote is vital.
I am sad to hear so many Americans on both sides label their fellow citizens with derogatory names and language. It’s possible to have strong beliefs without attacking one another. We can’t make lasting change by refusing to consider the views of those who see things differently.
Politics are intended to help individuals with different beliefs, goals and abilities live together in a free country. We have strong feelings, and that’s OK. We aren’t always going to agree. Sometimes we win elections, sometimes we lose, but when we attack each other with harsh words and name calling, we weaken our country by making tensions worse, reinforcing that which divides us, and stoking the flames of hatred.
One bright spot in the elections: we had record high voter turnout. I’m thrilled so many citizens exercised their right to vote and participate in our government. That’s phenomenal, especially since this year we’re also dealing with a pandemic.
I hope every US citizen who wanted their voice to be heard was able to register easily, safely obtain a ballot or access a polling place in a timely manner, submit their ballot before the deadline in their area, and have their vote counted fairly.
Whatever the outcome of this election, the USA faces significant challenges. I hope we can move forward in healing our nation and keeping its people as safe and healthy possible using compassion, reason, access to knowledge, diplomacy, and other resources.
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.
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.
–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 distancing
Attending indoor gatherings with people from outside your householdAttending large indoor celebrations with singing or chanting
Watching a sporting event in a virtual get-together
Attending a small outdoors sports event where public health precautions are maintained
Attending a crowded sports event, even if it’s outdoors
Watching all Thanksgiving events (parade, sports) from home
Attending 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
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.