Written by Amal Allam
Saturday, February 25, 2023 11:29 AM
Awarded by the US Food and Drug AdministrationFDAThe world’s first cancer vaccine, which Moderna produces, is called a “breakthrough” for the prevention of skin cancer, which means that it can be approved within months, bringing the vaccine one step closer to reality.
According to the British Daily Mail, the vaccine reduces the risk of recurrence skin cancer or death by 44%, indicating that Moderna Modern It is contacting the US Food and Drug Administration to review priority data.
The newspaper said that the cancer vaccine produced by Moderna has been granted “advanced treatment” status by health chiefs, paving the way for rapid approval, as the vaccine, which is given alongside an immunotherapy drug produced by the company, is used. Merck For the treatment of patients recovering from advanced melanoma who are at risk of recurrence.
And the newspaper said, The phase II trial showed that the combination reduces the chance of relapse or death in patients following surgery by 44%, compared to the immunotherapy drug alone.
The newspaper stated that more than a million Americans suffer from melanoma skin cancer, which is the most dangerous form of skin cancer, and regarding 4% of them have advanced forms of the disease. The experimental treatment consists of the Moderna vaccine and a drug.Immunotherapy from company Merck.
The new “breakthrough” means that the FDA believes the vaccine may “fulfill unmet medical needs in treating serious or life-threatening conditions.”“In practice, this means that the agency will hold frequent meetings with Moderna Modern It also makes the vaccine eligible for urgent approval and priority review by the US Food and Drug Administration.
Moderna plans to start a Phase 3 trial later this year. Most drugs or vaccines need to pass Phase 3 trials before they can be approved for widespread use, but only in special circumstances if the vaccine appears to be safe and effective in Phase 1 and 2. From experiments, it can be approved before conducting .The third stage of experiments.
The newspaper said, the new vaccine uses technology mRNA Which uses parts of the genetic code from patients’ tumors to teach the body to fight cancer. The vaccine is given to people following surgery to prevent a tumor from returning. It is tailored to each patient, meaning no two vaccines will be the same.
firm said Merck And Modern They plan to start a phase 3 study in the treatment this year, when it will be tested on thousands of patients, and they will also “expand rapidly” to look at other cancers, including non-small cell lung cancer..
In the second phase of the study, 157 patients were given personalized vaccines along with immunotherapy MerckThey are compared to a control group that also has high-risk melanoma but are only given immunotherapy. The trial last year continued, and if the vaccine works, it will be tried in a much larger cohort of thousands of patients..
Moderna managed Modern From developing its trial and having its coronavirus vaccine approved within a year, the vaccine uses DNA taken from each patient’s tumor. This genetic snippet is then inserted into messenger RNA — the molecule that carries the cell’s instructions for making proteins. Once in the body, it delivers mRNA This part of the code is transmitted to human cells, and teaches them to recognize and attack cancer cells if they return.
The newspaper said, the hope is that the body can recognize and destroy them before they begin to multiply and form tumors. The vaccine is given in 9 doses every 3 weeks, in addition to one dose of immunotherapy every 3 weeks..
The American Cancer Society said that skin cancer rates have increased significantly over the past years, and it is estimated that regarding 99,780 new melanomas (regarding 57,180 in men and 42,600 in women) will be diagnosed in the United States in 2022. 7,650 people died of skin cancer (regarding 5,080 men and 2,570 women), more than 20 times more likely to develop skin cancer if you were white than if you were African American.
She explained, the lifetime risk of developing melanoma is regarding 2.6% (one in 38) for whites, 0.1% (one in 1,000) for blacks, and 0.6% (one in 167) for Hispanics. The type of cancer is more common in men. However, before the age of 50 it is more common in women.
