Covid Vaccine, Oxford and AstraZeneca Resume Testing After Temporary Stoppage of Volunteer Enrollment

The University of Oxford resumes the clinical trial of the vaccine developed together with the company AstraZeneca, was arrested in recent days for the occurrence of a serious adverse reaction in a trial participant. In one of the volunteers a spinal inflammation was found and it was necessary to verify if there was a connection with the administration of the compound. The investigation of the independent committee, which was tasked with determining whether it was the vaccine that triggered transverse myelitis, was concluded and, therefore, following the recommendations of the experts and the Medicines Health Regulatory Authority (Mhra), the British regulatory body that gave the go-ahead and found no security issues, will resume volunteer enrollment. The committee’s response was much faster than expected. The times “can vary from one week to three months”, explained the president of Irbm di Pomezia, Piero di Lorenzo, who participates in experimentation.

Yesterday the CEO, Pascal Soriot, said he was confident in the possibility of having the vaccine available “by the end of 2020 or early 2021.” Soriot had specified that he could not say exactly when the trials will resume, but was nevertheless convinced that the project is still “underway to have a date for this year” in the request for approval from the health authorities. “A vaccine could be available by the end of the year or early next,” depending on how quickly regulators get approval, the AstraZeneca chief executive said. Regarding the episode of the patient subject to an abnormal reaction, Soriot noted that “Adverse events” are common in the trial phases, but that normally “they are not watched by the whole world”. He then added that the diagnosis of spinal inflammation in the volunteer affected by the possible side effect is not yet confirmed.

The suspension of registration had occurred only “temporarily” and as a “precaution”. But a very difficult position had come from theWorld Health Organization: “Countries cannot take shortcuts. Just because we’re talking about the speed and scale of the operation doesn’t mean we’ll start to compromise on safety or take shortcuts. Medications and vaccines to be distributed to the general public must be tested for their safety. This is the first and most important rule ”. But the stoppage and related communication, the scientific community noted, was and is the sign that the study is serious and the results transparent and that such setbacks occur in all trials anyway. Data from initial trials looked very promising, with the vaccine capable of producing a robust immune response and only weak side effects. There had already been a break before the summer, “resolved in the end without problems.” In fact, a first volunteer had already shown a suspicious reaction, which later turned out to be unrelated to the vaccine. At the time of communication, the trial was ongoing. Great Britain, the United States, Brazil and South Africa.

The vaccine scientists are working on Jenner Institute from the University of Oxford, in collaboration with the Oxford Vaccine Group, and with the Italian contribution of Irbm of Pomezia it opened a window on the possibilities of defeating the virus that triggered the pandemic. In the global race for the anti-Covid vaccine, those who take most of it are the richest countries, according to the magazine. Nature: Great Britain in the lead, which has already bought 340 million doses. Follow the U.S, which by mid-August had already secured 800 million doses of at least six vaccines, with the option to buy another one billion doses. Immediately behind, the countries of the European Union and the Japan. Vaccines in human clinical trials compete for the podium in the market. According to data provided by the World Health Organization, the most advanced work platforms are 31, including AstraZeneca and Oxford, and the Italian Reithera with the experimentation began at the Spallanzani in Rome. From Moscow, after Putin’s announcements, the first scientific data on the Sputnik vaccine arrived on September 4: published in the Lancet magazine, it shows that 100% of the test participants developed antibodies against the virus without serious side effects. The University of Hong Kong (HKU) has announced in recent days the approval of the clinical trial of a vaccine for administration in the form of a nasal spray. “The resumption of the Astrazeneca vaccine trial is good news. But much caution is still needed. Science – says the Minister of Health, Roberto Speranza, is working to provide the world with effective and safe treatments and vaccines. Meanwhile, the real key remains the behavior of each one of us. “

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