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By the end of 2020, scientists are likely to have good data on the effectiveness and safety of the first three U.S. coronavirus vaccines, according to Dr. Antonia An Kola, a Greek-American infectious disease specialist and former adviser to World Health Organization. .
Speaking to iefimerida.gr, Ms Kolokathis expressed her moderate optimism regarding the observance of the previous time frame, noting that “the scientific community, despite political pressure even publicly exerted by President Donald Trump, does not you must hurry. ”
By the end of the year, the first positive signs of US vaccines.
“With the coronavirus, everything changes and is subverted every day. There is definitely no guarantee. However, we remain moderately optimistic that by the end of the year we will have the first positive indications for the course of clinical trials that will lead to the preparation of a safe vaccine ”, said the Greek-American specialist in infectious diseases, with extensive experience in clinical research and specialist consultant. pharmaceutical companies, research centers and international organizations.
The procedure for obtaining approved coronavirus vaccines
As he explained, currently in the United States three vaccines to treat Covid-19 are in the final phase (Phase 3) of clinical trials. “In order for the US Food and Drug Administration (FDA) to approve the vaccine, it must be at least 50% effective against the new coronavirus and certainly safe for the human body.”
According to Ms Kolokathis, about 30,000 volunteers are expected to participate in each of the three studies. A team of scientists will monitor and verify the data on the safety of the volunteers during the studies, the so-called Data Safety Monitoring Board (DSMB).
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“These groups look at the data and make sure that the volunteers are not at risk of side effects or other problems related to the vaccine. The clinical evaluation and the health course of the volunteers will continue for at least one year after receiving the vaccine. “If all goes well, based on this data, we could see an ’emergency license’ or partial approval by the FDA in late 2020 and the first population groups to be vaccinated immediately after,” said Dr. Kolokathis.
It is noted that the antiviral drug Remsdenivir, which is used to fight coronavirus, has also received partial FDA approval, while the method of using plasma antibodies has been given emergency use.
Many new drugs are being studied for the coronavirus
In addition to coronavirus vaccines, as the distinguished infectious disease specialist noted, there are many new drugs under study. “These drugs offer numerous approaches to treating the new coronavirus. These are antiviral, immunomodulatory (corticosteroid) and neutralizing antibodies.” But we have to look at the evidence of their effectiveness and safety from the clinical trials that many companies are now conducting around the world. pharmaceutical companies and research centers “.
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