COVID-19 Q&A: August 2021

In December of 2019, the World became familiar with a newly discovered Coronavirus- SARS-CoV-2. The disease this virus can cause in humans is known as COVID-19.

As the news continues to evolve on the COVID-19 Pandemic, it - and its impact - is felt within immunocompromised communities. Know that IDF hears your questions. We are doing our best to provide answers and advocate for your needs in every way we know how. Below are some questions and information related specifically to protections against the virus and its variants. For access to all IDF COVID-19 resources, visit primaryimmune.org/coronavirus.  

Many of the inquiries that we receive are related to individual situations about medications or medical care. These inquiries should always be directed to a physician. The IDF team is following the situation very closely and will continue to provide updates as needed.

As a PI patient dependent on immunoglobulin replacement therapy, do Ig infusions protect me against COVID-19 and its increasingly contagious variants?

As time goes on, the level of neutralizing antibodies to the SARS-CoV-2 virus will continue to increase. Based on existing research, it is believed that plasma collected today may be approaching protective levels against the virus.

Due to the nature of the collection, manufacturing, and distribution of Ig therapy, the products will almost always be behind the latest variants of concern-an estimated 9-12 months.

That being the case, it is likely that there will still be some protection, despite “being behind” the latest variants. It is currently not known exactly what level of protection is needed, and it is not known how this may vary from individual to individual and from strain to strain. Researchers are currently working on these issues, and we hope to have more information and better answers soon.

The good news is that the current vaccines seem to offer protection against the latest variants and even most of those who are immunocompromised seem to mount a decent, protective T-cell response. We encourage those who are immune-compromised and who are not currently vaccinated to have a conversation with their immunologist about whether or not the vaccines are right for them.

Will IDF advise pharmaceutical manufacturers to disseminate plasma information on the quantity of neutralizing SARS-CoV-2 antibodies to COVID-19 and its variant types?

IDF is already engaged with the pharmaceutical industry in these conversations and we are expanding these questions to the government as well. It is important to note that all labeling and package inserts (including any proposed changes) must be reviewed and receive approval from the FDA. Additionally, the level of neutralizing antibodies to SARS-Cov-2 will vary from lot to lot, even within the same product.

What is the status of SARS-CoV-2 antibodies in current Ig products for the treatment of PI?

Some antibodies to SARS-CoV-2 already exist in current plasma donations. These antibodies have made it into the supply either through natural infection or vaccination and are increasing rapidly. It is not explicitly known how much is in any given lot. IDF will be having conversations with manufacturers and the FDA around this issue.

Plasma Suppliers have reported rapidly rising levels of SARS-CoV-2 antibodies in collected plasma and it may already be close to similar levels of protection against the virus as found in current monoclonal antibody therapies (mAbs). IDF will continue to monitor the situation and report findings to the community.

Individuals with PI will not have full protection until the immunoglobulin therapy includes COVID-19 antibodies. Is access to regular monoclonal antibody therapy prophylactically a viable solution to protect the PI community against developing COVID-19?

Even the monoclonal antibody therapies (mAbs) are going to lag behind the latest variants of concern. These products were initially developed early in the pandemic by collecting antibodies from people who recovered from COVID-19 and then testing those antibodies against the SARS-Cov-2 variants circulating at that time. They selected a few of the most effective antibodies out of those tested and then cloned them to be infused to treat COVID-19. As with plasma, as new variants arise, the ability of existing mAbs to effectively counter new strains is unknown. We do know that some already approved mAbs have been withdrawn as they are no longer effective against current circulating strains.

Although mAbs can be an effective treatment, they are an imperfect tool that is not a single solution to the issues and concerns of those immunocompromised. As of July 30, 2021, the FDA issued an Emergency Use Authorization (EUA) for post-exposure prophylaxis REGEN-COV monoclonal antibody therapy. The revised EUA specifically notes, REGEN-COV should only be used as post-exposure prophylaxis for individuals who are:

• not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2* vaccination (for example, people with immunocompromising conditions, including those taking immunosuppressive medications), and 
  • have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC), or 
  • who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes or prisons) 

Will the trials being conducted on monoclonal antibody therapies allow for expedited access to such therapies for individuals with PI?

New trials for prophylactic use for immunocompromised people may have to be conducted separately; because these trials are lengthy, they need to take place promptly. Clinical trials are typically multi-million dollar and multi-year endeavors fraught with fits, starts, and delays. Trials specifically aimed at rare diseases are even more challenging. IDF will continue to advocate with industry and the government to include the immunocompromised in existing and future trials. It is possible these therapies may be approved for Emergency Use Authorization(EUA)for prophylactic use based on data from other populations and could be available in the future for those with PI, even without a clinical trial.

Will IDF connect with the medical advisors of the vaccine manufacturers to begin controlled trials of prophylactic neutralizing synthetic SARS-Co-V2 antibodies for the PI community?

IDF is currently working on an engagement strategy with these actors. As mentioned above, the ability to get these trials completed successfully, particularly as they relate to PI, will be exceedingly difficult. However, we will impress upon all pharmaceutical and government entities the particular importance of these trials to the immunocompromised community. 

Who should PI community members contact if they have specific questions regarding COVID antibodies in their product?

IDF encourages people to reach out directly to the manufacturer of their product for these answers. Below are manufacturer names, their products, and their phone numbers.

Immunoglobulin Replacement Manufacturer Contact Numbers:

• ADMA Biologics: 1-833-ADMA-BIO (ASCENIV, Bivigam) 
• BPL: 844-4BPLUSA (844-427-5872) (Gammaplex) 
• CSL Behring: 877-355-IgIQ (877-355-4447) (Hizentra, Privigen) 
• Grifols: 888.GRIFOLS (888-474-3657) (Flebogamma DIF, Gammunex-C, Xembify) 
• Kedrion: 1-855-353-7466 (Gammaked) 
• Octapharma: 800-554-4440 (Cutaquig, Octagam, Panzyga) 
• Takeda Pharmaceutical Company Limited - 855-250-5111 (Cuvitru, Gammagard, HYQVIA 3) 

Should people with PI get COVID-19 vaccine “booster shots” to increase their antibody response? 

While booster shots have not yet been authorized, IDF is currently engaging with federal agency representatives on this critical issue. We anticipate that the FDA and CDC will soon be making recommendations regarding the use of COVID-19 vaccine booster shots. When these authorizations and guidelines are released, we recommend that you immediately consult with your physician about whether a booster shot is appropriate for your condition.

What other recommendations does IDF have for the PI community as they continue to navigate the COVID-19 pandemic?

Here are some important actions for you to take:

• Maintain precautions. Remember to take the same precautions you have always taken during other outbreaks and throughout the pandemic. The costs and benefits of potential exposure forgoing appointments and procedures should always be a consideration. Most facilities now primarily have vaccinated staff, proper isolation, and infection control procedures in place. The risk of canceling needed healthcare may be greater than the risk of infection. These are individual decisions and there is no single answer or solution.
• Encourage everyone around you to get vaccinated and, after consulting with your physician, get vaccinated yourself (if not contra-indicated).
• Volunteer to participate in trials. Be part of the solution.
  • https://www.niaid.nih.gov/clinical-trials/study-immune-response-and-safety-profile-covid-19-vaccines-individuals-and-without
  • https://combatcovid.hhs.gov/joinaclinicaltrial 
• Mask up with K/N95s. There are no longer mask shortages, so there should be plenty of them to access.
• If exposed to COVID-19, make a plan for access to prophylaxis mAbs. Talk to your doctor and make sure that you know how this can be quickly accessed if needed. IDF will be reaching out to professional associations to make sure they understand this option and how to access this for their patients.
• We encourage you to seek opportunities to get PI included in clinical trials on oral antivirals and other therapies to protect immunocompromised individuals from COVID-19. https://combatcovid.hhs.gov/joinaclinicaltrial/activ-6