FDA approves the world's first cancer vaccine within months
The US Food and Drug Administration (FDA) has granted the world's first cancer vaccine, which is produced by Moderna, the title of "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 skin cancer recurrence or death by 44%, noting that Moderna is communicating with the US Food and Drug Administration to review priority data.
The newspaper said that the cancer vaccine, produced by Moderna, was awarded "advanced treatment" status by health chiefs, paving the way for rapid approval, as the vaccine, which is given along with an immunotherapy drug produced by Merck, is used to treat patients recovering from cancer. Advanced melanoma and those 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 after surgery by 44%, compared to the immunotherapy drug alone.
The newspaper pointed out that more than a million Americans suffer from melanoma skin cancer, which is the most dangerous form of skin cancer, and about 4% of them have advanced forms of the disease. The experimental treatment consists of the Moderna vaccine and the immunotherapy drug from Merck.
The new word “breakthrough” means that the US Food and Drug Administration believes that the vaccine may “meet unmet medical needs in treating serious or life-threatening conditions.” In practice, this means that the agency will hold frequent meetings with Moderna about the progress of the vaccine. The move 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 the experiments, it can be approved before conducting the third phase of the experiments.
The newspaper said, the new vaccine uses mRNA technology that uses parts of the genetic code from patients' tumors to teach the body to fight cancer.
Merck and Moderna said they plan to start a Phase 3 study in the treatment this year, when it will be tested on thousands of patients, and that they will also "expand quickly" to look at other cancers, including non-small cell lung cancer.
In a phase II study, 157 patients were given personalized vaccines along with Merck's immunotherapy. They are compared to a control group who also had high-risk melanoma but were only given immunotherapy. The trial last year continued. If the vaccine works, it will be tried in a cohort. Much larger, with thousands of patients.
Moderna was able to develop its trial and approve its coronavirus vaccine 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 inside the body, The mRNA delivers this piece of code to human cells, telling them to recognize and attack cancer cells if they return.
The newspaper said that 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 about 99,780 new melanomas (about 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 (about 5,080 men and 2,570 women). You're more than 20 times more likely to develop skin cancer if you're white than if you're African-American.
She explained, the lifetime risk of developing melanoma is about 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.