COVID-19 vaccine : In case you missed GO... - Lung Cancer Support

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COVID-19 vaccine

Miranda_GO2 profile image
Miranda_GO2Partner
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In case you missed GO2 Foundation's weekly update last week about COVID-19, I will copy the text here and include the link to our webpage that is full of additional information to keep you informed.

Webpage: go2foundation.org/blog/upda...

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 the website link above and follow the links.

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?

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.

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 the links on the webpage noted at the top of this post.

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

IASLC’s Guide to COVID-19 and Lung Cancer

The National Cancer Institute website for COVID-19 and emergency preparedness COVID-19: What People with Cancer Should Know

Updates from the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)

Johns Hopkins COVID-19 Resource Center

Interactive map of US COVID-19 cases by state

COVID-19 in patients with cancer: managing a pandemic within a pandemic

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

American Medical Association resources for healthcare providers.

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Miranda_GO2 profile image
Miranda_GO2
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5 Replies
Denzie profile image
DenzieModeratorVolunteer

Wow! Lots of good information. Thank you, Miranda.

Ncpoet profile image
Ncpoet

Thanks for this info, Miranda! Happy Holidays!Judy

etpd2226 profile image
etpd2226

Thank you Miranda. Great info. Happy New Year!!!

Miranda, this is terrific info! As many on this forum, I receive immunotherapy. Do we know whether or not it is safe for patients on immunotherapy to receive the vaccine? My oncology nurse practitioner today said we would have to ask my oncologist... Given the risks of over-response of the immune system, I am concerned as well as desperately hopeful to receive the vaccine!

Miranda_GO2 profile image
Miranda_GO2Partner in reply to Jenniferroseolson

Hi Jennifer,

Yes, the balance of hope and concern is felt by many patients and the answer is that it really is a risk/ benefit discussion with your doctor about your personal situation.

From the weekly COVID-19 and lung cancer updates we have been sending you may have seen notes through out that we are still learning a lot about the vaccine and it's effects. BUT, we also know the risk of COVID19 with lung cancer patients (see our COVID-19 updates on our website)

With that being said , there were about 700 people (out of the 44,000) in the Pfizer trial that were cancer patients. We don’t have any breakdown of what type of cancer or stage or whatever yet. But within the review of that limited data, there was no reason to not give the cancer patients the vaccine or the FDA would have flagged it. We are going to talk more about the vaccine and indication at our living room 1/19/21, hope you can tune it for it as we talk more about this careful balance of what we know and what we don't know.

In the meantime, here is a statement from the Society for Immunotherapy of Cancer.

:

SITC Statement on SARS-CoV-2 Vaccination

and Cancer Immunotherapy

The Society for Immunotherapy of Cancer (SITC) commends the global biomedical community for coming together to develop and authorize safe and effective SARS-CoV-2 vaccines at unprecedented speeds. SITC stands with the world in hoping that rapid vaccine deployment will help to end the global pandemic.

Representing leaders in the field of cancer immunotherapy, SITC recognizes that optimal patient care and clinical trials must both continue and coexist with the dire need for global SARS-CoV-2 vaccination. Based on the demonstrated efficacy and safety of the BNT162b2 (Pfizer Inc./BioNTech SE) and mRNA-1273 (Moderna Inc.) vaccines in healthy individuals across study demographics, and subsequent Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA), SITC recommends the following actions for all relevant stakeholders and patients concerning SARS-CoV-2 vaccination and cancer immunotherapy:

1.All cancer patients receiving approved or investigational immunotherapy as part of their treatment regimen, either as standard of care or as part of clinical trials and without a general contraindication to vaccination, should/could receive an FDA approved and/or authorized SARS-CoV-2 vaccination when made available to them;

2.At this point in time, the only known relevant contraindications based on available data are patient age as described within EUAs and/or history of anaphylaxis to similar/comparable vaccine components;

3.SITC does not recommend experimental and/or non-approved SARS-CoV-2 vaccination for patients being treated with immunotherapy outside of dedicated clinical trial settings at this time;

4.Immunosuppressed patients, e.g., those receiving corticosteroids or TNF blockers to manage immune-related side effects, patients with hematologic malignancies, or patients with B cell deficiency, may not mount a robust immune response against vaccines and/or may need additional booster vaccinations. SITC recognizes that this aspect has not yet been studied in clinical trials;

5.Given limited data, SITC acknowledges that possible interactions between cancer immunotherapies and SARS-CoV-2 vaccines are unknown at this time. As always, SITC believes the best medical judgment of risk/benefit of SARS-CoV-2 vaccination should be considered for each patient individually.

SITC’s current recommendations regarding SARS-COV-2 vaccination in patients being treated with immunotherapy are subject to change as more data are collected in real-world scenarios and in clinical trials. In addition, SITC may provide further recommendations as additional vaccine candidates gain approval and/or authorization.

Given the paucity of data concerning the interactions between immunotherapy treatment and SARS-CoV-2 vaccination, SITC encourages healthcare professionals, industry sponsors, regulators, and academics to rapidly collect and report novel data relevant to unique aspects of cancer immunotherapy treatment.

SITC recognizes that human immune responses are highly regulated and that immune-modifying therapies could positively or negatively impact SARS-CoV-2 vaccination efficacy and safety. As such, SITC believes continued data collection and research will help to address vital knowledge gaps that could clarify optimal protocols for SARS-CoV-2 vaccination in patients with cancer receiving immunotherapy. Critical aspects that must be further characterized include but are not limited to:

1.Optimal sequence of SARS-CoV-2 vaccination and immunotherapy treatment, to preserve the efficacy and safety of both modalities;

2.Determining effective dosage of SARS-CoV-2 vaccine for patients receiving immunotherapy;

3.Monitoring of SARS-CoV-2 antibody and cellular immune response in patients receiving immunotherapy treatments following receipt of SARS-CoV-2 vaccines

4.Impact and reporting of SARS-CoV-2 vaccination upon immune-related adverse events, and regulatory considerations for adverse event attribution in immunotherapy clinical trials;

5.Development of standards for establishing theoretical risk factors that would support a delay in SARS-CoV-2 vaccination while administering cancer immunotherapy

In conclusion, SITC supports SARS-CoV-2 vaccination in cancer patients receiving immunotherapy, and looks forward to collaborating with the global community to address the above scientific questions while simultaneously working to end the COVID-19 pandemic.

"

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