Moderna is preparing to test a third dosage in 120 transplant recipients. Pfizer, which makes immunosuppressant medication, is also planning to study 180 adults and 180 children who have an immune condition. (Representative Image)
Esther Jones, a rural Oregon dialysis nurse, decided that the third time was the charm when it came to coronavirus vaccine. After receiving two doses from the Pfizer BioNTech vaccine, which failed to produce antibodies in her body, Esther Jones sought out the Moderna shot.
It worked. Although the antibody level was lower than in healthy individuals, blood tests showed that there was a reasonable response. In the hope of increasing her levels, she received a fourth dose of the drug last month.
Jones, 45, received a kidney transplant in 2010. She has been taking drugs to suppress her immune response since 2010 in order to prevent rejection. She was concerned that she would have difficulty responding to the coronavirus vaccine and so she enrolled in one the few studies to examine the effectiveness of a third dose for people with weak immune systems.
France's health care professionals have been routinely giving a third dose to patients with immune disorders since April. One team of French researchers recently found that organ transplant recipients with antibodies rose to 68% after receiving the third dose of the vaccine, up from 40% four weeks earlier.
Jones was a part of a study that found similar results for 30 recipients of organ transplants who received third doses by themselves.
COVID-19 Vaccine Commonly Asked Questions View More How does a vaccine function? The vaccine mimics a natural infection. A vaccine induces an immune response that protects people against future COVID-19 infections. It also builds herd immunity quickly to end the pandemic. A vaccine induces immunity in a sufficient number of people to prevent the spread of a disease from person-to-person. Good news is that the SARS-CoV-2 virus was relatively stable which makes it more likely that a vaccine will be developed. There are many vaccines. There are four main types of vaccines. One is a vaccine that is based on the entire virus. Two is a vaccine that is based on a virus vector. Three are nucleic-acid vaccines with genetic material such as DNA and RNA of the antigens. Four are protein subunit vaccines. These vaccines contain the recombinant SARS-COV-2 proteins along an adjuvant (booster). How long does it take for a vaccine to be developed? The process of developing a vaccine is complex and long. Vaccines are not given to patients with a specific disease, but are administered to healthy people as well as to vulnerable groups such children and pregnant women. It is mandatory to undergo rigorous testing. Although five years is the fastest time to develop a vaccine, it often takes twice as long or more. See more
According to Dr. Dorry Segev of Johns Hopkins University, who was the lead in this study, being vulnerable to infection after vaccination is very frightening and frustrating for immunocompromised patients. They must continue to be unvaccinated until better immunity is achieved.
The United States does not have a coordinated effort from federal agencies or vaccine makers to test this approach. This leaves people with low immunity with more questions and less answers. The Centers for Disease Control and Prevention (FDA), the Food and Drug Administration and National Institutes of Health recommend against testing to determine who is protected. Academic scientists are also hindered by restrictions on vaccine access.
According to Dr. Balazs Halmos (an oncologist at Montefiore Medical Center, Bronx), there should already be a national study about post-transplant patients receiving booster shots. He led a study that showed some patients with cancer did not respond well to vaccines. This shouldn't be a Bronx team trying to figure it out.
An estimated 5% are immunocompromised. There are many causes, including some cancers, organ transplants and chronic liver disease, kidney failure, dialysis, kidney failure, and drugs such as Rituxan, steroids, and methotrexate. These medications are used by approximately 5 million people to treat a variety of conditions, from rheumatoid and psoriasis, to certain types of cancer.
These are the people being overlooked, according to Dr. Jose U. Scher of NYU Langone Health, who conducted a study on methotrexates' effect on vaccines.
These risk factors may not be present in everyone. Without more research, it is impossible to determine who may need additional doses of vaccines and how many. There is evidence that the virus may continue to reproduce in the body for longer periods of time, possibly leading to new variants.
Monoclonal antibodies can be infused to help people who don't produce them, but this idea is still being explored by John Moore, a virologist at Weill Cornell Medicine, New York.
Monoclonal antibodies make a lot of sense for these people. He said that he would like to see more companies get involved in this area. It would be a good idea to pressurize the government.
Because there is a clear precedent, the third-dose approach is popular among researchers. For example, immunocompromised patients are given booster doses for vaccines against hepatitis B or influenza. Methotrexate discontinuation after receiving a flu vaccine has been shown to increase vaccine potency. This is why the American College of Rheumatology recommended that methotrexate be stopped for a week before getting immunized against coronavirus.
Numerous studies have shown that patients who have not had antibodies detected after the second or first dose of coronavirus vaccine might be able to receive a third dose. However, research has been slow.
Moderna is preparing to test a third dosage in 120 transplant recipients. Pfizer, which makes immunosuppressant medication, is also planning to study 180 adults and 180 children who have an immune condition.
At least two independent research teams from outside the company were turned down by the companies, who wanted to examine the effects of a third dosage.
The NIH is currently recruiting 400 people with immunocompromised to participate in a trial that would monitor their immune cells and antibodies for up to 24 month. However, there are no trials for a third dose.
It can take time, especially for a government agency like the National Institute of Allergy and Infectious Diseases. Emily Ricotta, an epidemiologist, stated that it takes time. To do these types of projects, we have to go through many regulatory and approval processes.
However, this explanation is not satisfactory to some researchers. Scher pointed out that many medical centers already have patients who are not responding to vaccines. Federal agencies could easily organize a clinical study. He said that it is a simple study. This is not rocket science.
Previous studies had suggested that vaccines would not work for many cancer patients. However, these analyses were performed after the patient had received one dose. Halmos and his coworkers published a new study this month that dispelled some of these fears. According to large analyses, the vaccines work well in patients with many types of solid and soft tumors.
15% of patients with blood cancers had antibodies that were not detectable after the second dose, and 30% of those who received drugs to suppress their immune system had antibodies. Halmos stated that he and his colleagues wanted to see if a third dose of vaccines could be beneficial for those patients, but they have not been able access to them.
Segev's team discovered in an earlier study, that less than half the 658 recipients of organ transplants had antibodies after receiving both Pfizer-BioNTech and Moderna mRNA vaccines. To confirm the finding, they had no choice but to recruit volunteers such as Jones, who had received third doses of mRNA vaccines.
Researchers found that all 30 recipients of organ transplants had elevated antibody levels after receiving a third dose.
Jones stated that many people felt like Jones, especially when there was the possibility of contagious variants spreading in the United States.
She said that some members of an immunocompromised group who are desperate for protection have received a third dose at mass vaccine sites, where providers don't check records or have crossed state lines. Many continue to wear masks to keep themselves safe and are sometimes subject to harassment.
She said that it is really disappointing to me that so many people have made masking, such a super-political thing, when it shouldn't have been. This makes it harder to take care ourselves.
By Apoorva Mandavilli
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