One time, Glatt used monoclonal antibodies to help a patient. During the first year of the Pandemic, Glatt, an infectious disease physician at Mount Sinai South Nassau in Oceanside, N.Y., was able to treat his patient with drugs. Glatt says that she had an amazing turn around after the beginning of the injection. Her breathing got better and she perked up. I talked to her the next day and she was doing great.
It couldn't happen today. Although millions of people with COVID have been successfully treated with these antibodies over the past two years, the evolution of the virus has rendered them useless because they don't block new subvariants. Drug companies are updating their products. Whether these drugs will be available in a few months, rather than years, depends on whether the FDA will accept fact-track data gathered during laboratory studies.
Millions of people with immune system problems are at high risk of infections because their body doesn't respond well to vaccines. Myron Cohen is an infectious disease specialist at the University of North Carolina. The mAbs are important for people who can't take Paxlovid because the pills can interact with other drugs.
Scientists take patients' immune cells and clone them for the purpose of developing mAbs. The spikeprotein of the virus that causes COVID is the reason why the antibodies work. Large clinical trials involving thousands of people have tested this binding ability.
Many scientists argued in favor of a quicker testing strategy during a December workshop hosted by the FDA. The idea is to show that newer mAbs can be used in the lab to destroy older ones. At a point in time, we can say that the ability to protect against COVID disease in the real world is related to the ability to protect against SARS-CoV-2. If a new mAb is effective, large human studies are no longer necessary. It needs to be shown that it has anti-viral activity. You can do that in a tube. Within three to five months, industry experts say, these expedited processes could generate new mAbs for public use.
There is an established history of immunotherapy in the vaccine industry. New versions of the annual flu shot are assessed by the FDA frequently. Primary immunizations against the disease in younger age groups were authorized by the approach. It is the first time it will be used to evaluate a drug. The method hasn't been used for drugs like Paxlovid because they don't act on immune responses but attack the virus directly.
Preexposure defense in people with a compromised immune system is possible with one mAb therapy. It initially provided long- lasting protection, but it has waned. Glatt says that we don't have a replacement for exposure prophylactics. This is what I'm most worried about.
The FDA will work with drug companies on expedited development of preventive therapies for patients with suppressed immune systems, according to an e-mail from the agency. The FDA has not said when it will make a decision. They are waiting for an answer. The head of infectious disease research at the company says that they are working to get new mAbs available as quickly as possible. I wish we were interacting with regulators more quickly. He thinks we can get there.
All Rights Reserved © 2024
