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Oxford and AstraZeneca Resume UK Testing of Potential COVID-19 Vaccine Following Temporary Hiatus
The pharmaceutical company AstraZeneca and the University of Oxford have obtained the free route to resume in the United Kingdom the tests of a possible vaccine against the coronavirus that they develop jointly after pausing them temporarily in several countries when appearing « a potentially inexplicable disease » in one of the volunteers.
According to a statement released by AstraZeneca, the trials were resumed after the authority that regulates drugs in that European country determined « it was safe to do so ».
“On September 6, the standard review process resulted in a voluntary pause in vaccination in all global trials to allow review of safety data. by independent committees and international regulators”Says the note from the pharmacist.[La pausa en la vacuna de Oxford es ejemplo de por qué no se puede acelerar el proceso, según esta autoridad sanitaria]
The problem detected in a volunteer, who underwent vaccination in the United Kingdom, was an inflammation of the spinal cord or transverse myelitis, according to the Stat News.
“The UK committee concluded its investigations and recommended to the MHRA [sigla en inglés del agente regulador de los fármacos en ese país] that it is safe to resume the trials « in that nation, adds the text of the pharmaceutical company.
Decisions from regulators are still awaited in the United States, Brazil and South Africa, where tests of this experimental vaccine are also being developed. In total, 18,000 people have been vaccinated so far, according to the University of Oxford.
Temporary pauses are not unusual in large clinical studies, and investigation of any serious or unexpected reactions is a mandatory part of safety testing.
AstraZeneca noted that the problem may be a coincidence, as diseases of all kinds could arise in studies with thousands of people and announced the temporary stop on Tuesday as a “routine procedure” that is carried out to ensure the safety of the process. .
« At AstraZeneca we put science, safety and the interest of society at the center of our work, » said the chief executive of the pharmaceutical company, Pascal Soriot, in a press release. « This temporary hiatus while a panel of independent experts evaluates a single event to minimize any potential impact on the testing schedule is living proof that we follow those principles. »
Following the announcement, America’s infectious disease expert Anthony Fauci said the rehearsal interruption is an « unfortunate » event. although he clarified that it can happen frequently.
News of the hiatus came on the same day that AstraZeneca and eight other drug makers pledged to uphold the highest ethical and scientific standards in the development of their coronavirus vaccines.
With information from Stat News.