Shantay Brown, a proud sports mom, longs to get into a packed stadium for her boys' Ohio State football games. She will scream over the action.
Brown is not able to enjoy the simple pleasures of Covid-19. Missouri resident, 47 years old, takes immunosuppressant medication to treat lupus. Her body has shown virtually no immune response to coronavirus vaccine, leaving her in constant danger.
Brown is one of the 3% Americans who are immunosuppressed, which includes transplant recipients as well as people with cancer or autoimmune disorders like Lupus.
These millions felt a sense of springtime freedom that was fueled by vaccines, but it quickly turned into a summer filled with discontent after the Centers for Disease Control and Prevention said that the vaccine may not be able to protect them. Their families were advised to return to social distancing and masking. The Food and Drug Administration (FDA), cleared an additional vaccine for many last month.
Brown, who lost her uncle to the disease, stated that Covid is a real threat because of my immune system. She knows that immunosuppression can increase her chances of suffering severe illness or death.
Brown was intrigued when her Washington University in St Louis rheumatologist, who is also her laboratory technician, said that the FDA might soon issue emergency authorizations for immunocompromised patients to receive preventive monoclonal antibody injections.
Brown stated that he trusts the scientists and feels like he doesn't have a choice about receiving antibodies to prevent Sars-Cov-2. For me, it's a simple decision.
Alfred Kim, Browns rheumatologist said that his immunocompromised patients feel frustrated by the fact that they are seeing the world expand in some places faster than they can.
He stated that their interest in antibody PrEP was very high.
According to Dorry Segev (an epidemiologist and transplant specialist at Johns Hopkins University, who is leading a major research on extra vaccines for this population, the end result will be that there will be an overwhelming number of immunocompromised individuals who won't mount a protective immune response to vaccines.
They will likely find monoclonal antibodies such as PrEP to be their best and most reliable protection.
Alfred Kim, a rheumatologist at Washington University, St. Louis. Photograph by Katherine Bish
Regenerons dual antibody cocktail Regen-Cov is covered by federal government at $2,000. Each dose has emergency authorization to treat non-hospitalized patients within 10 day of symptom onset. These antibodies are still effective against Delta and have been proven to be very effective in reducing the likelihood of death, hospitalization, and severe Covid.
The FDA issued an additional emergency authorization for Regenerons cocktail to be used as post-exposure protection (or PEP) in August. People who are unvaccinated and immunocompromised and at high risk for severe Covid can be given a preventive injection or subcutaneous injection of RegenCov if they have been in close proximity to someone who has tested positive. This should happen within four days.
Participants were randomly assigned to either a single dose of Regen-Cov, or a placebo, within 96 hours after a household member's coronavirus diagnosis. According to the New England Journal of Medicine, 81% of 1,505 participants who had tested negative for Sars-Cov-2 infection at first were able to have their symptoms reduced by receiving an antibody injection over four weeks.
Regeneron is currently in discussions with the FDA to secure emergency authorization for RegenCov as PrEP. It would likely require monthly injections. The cocktails half-life is about the same. Under the FDAs PEP authorization, individuals who are not vaccinated or immunocompromised can already follow this protocol if they reside or work in an institution such as a prison or nursing home where coronavirus exposure may be expected.
AstraZeneca will apply for authorization in the fall to create its own prophylactic anti-body cocktail that could provide protection for as much as 12 months. The US government has agreed to contingent agreements that will allow the company to supply up to 700,000.
AstraZeneca released preliminary results of a PrEP trial it had conducted among 5,172 coronavirus-negative and initially unvaccinated participants on 20 August. The European and American versions of the study are ongoing. It randomized one third of participants to receive placebo. A single intramuscular injection with antibodies has reduced the risk of developing symptomatic Covid syndrome by 77%, compared to the placebo over the first five months of a planned fifteen-month follow-up.
None of the people who received the antibody cocktail (called AZD7442) have suffered from severe Covid or died. This compares with the three severe cases and two deaths that were reported in the placebo group.
Howard J Huang, a Houston Methodist Hospital transplant pulmonologist, stated that for people with weak, suppressed, or no immunity to vaccination prophylactic antibodies injections are a realistic alternative to permanent isolation and the risk of serious illness or death due to Covid-19.
Huang calls PrEP a ray for immunocompromised patients and maintains such a positive outlook despite the fact that they have made up 1.5% to 4.4% of the study population in key prevention and treatment trials of these antibodies.
Myron Cohen is the director of the Institute of Global Health and Infectious Diseases of the University of North Carolina. He speaks in Paris. Photograph: Benjamin Ryan
Myron Cohen, a leading coronavirus antibody researcher at North Carolina University Chapel Hill, and leader of the prophylactic RegenCov study, stated that he didn't see any reason to believe that immunosuppression would decrease the antibodies preventive power.
Cohen stated that they have been very safe and that he expected the FDA to approve at least one cocktail as PrEP. He also said that there is a strong pipeline of coronavirus anti-prophylactics. These drugs have no known side effects.
Cohen stressed that PrEP was meant to complement and not replace vaccination.
This was a huge relief for me.
PrEP, a public-health strategy, has been a major contributor to HIV prevention in the United States over the past decade. Currently, 300,000 HIV-negative Americans take antiretroviral medication that almost eliminates their chance of contracting the virus.
Sheila Portington is a rare early bird to the eagerly awaited prophylactic revolution on Covid. Sheila Portington is a British expat living in Bolton Landing and a kidney transplantee. After learning that her immune system was not responding to the coronavirus vaccine, she experienced severe anxiety.
Portington, 68, stated that suddenly realizing these vaccines aren't working for your body can change your entire life. It is terrifying.
Her nephrologist spent many hours making sure that her Regen-Cov was PrEP under compassionate usage. In August, she received her first monthly dose.
Portington said that the mental change it made was amazing and she is now able to plan a long-awaited visit to her family in England. This was the biggest relief I felt when I got out of the doctor's office.
Janet Handal (70), a transplant recipient, is a New York City consultant, who created a Facebook group of immunocompromised people with 540 members and associated advocacy organization.
She stated that people want to be able resume their normal lives and go out to concerts and eat indoors.
Shantay Brown stated that PrEP would enable her to attend the all-important Ohio State football games with more confidence and ease. She acknowledged, however, that she would not be immune to the effects of antibody injections. She said that she would be vigilant and keep her mask on.
This will stop me screaming as loudly as I want.