RIO DE JANEIRO, BRAZIL – On Saturday, September 12th, Oxford University announced the resumption of clinical trials of its experimental vaccine against Covid-19 after a brief interruption due to the detection of a suspected spinal cord inflammation in a woman vaccinated with the formula in the United Kingdom.
[UPDATE: Late Saturday, September 12th, Brazil’s Federal Health Regulatory Agency ANVISA, after examining the data received from the UK, announced that it had authorized AstraZeneca to resume the phase 3 testing in Brazil, starting Monday, September 14th.]
The institution explained that in a trial like this, currently involving 18,000 volunteers, “it is expected that some will fall ill and each case needs to be thoroughly analyzed to ensure safety.”
On September 6th, the institution and its partner, the British pharmaceutical laboratory AstraZeneca, decreed a halt in clinical trials in all countries where they are taking place – UK, Brazil, South Africa and USA – so that an independent committee could review the vaccinated volunteer’s case. Both this group and the British regulatory agency, MHRA, recommended the resumption of trials in the UK on Friday.
Brazil’s regulatory agency ANVISA followed suit on Saturday, authorizing resumption of trials in Brazil beginning Monday, September 14th.
Claiming “confidentiality grounds” for medical information, Oxford University provided no details about the woman’s condition. It is the second time that clinical trials of this vaccine are halted and later resumed. In July, this occurred after a subject was diagnosed with multiple sclerosis. At the time, it was found to be a coincidence.
Interruptions in such trials, involving thousands of subjects, are not uncommon. “This could be normal in principle and would prove that the trials are being conducted correctly and that decisions are prudent to ensure safety,” said virologist Isabel Sola, co-director of a group that is developing an experimental vaccine against Covid at the National Center of Biotechnology (CSIC) in Madrid.
There are currently 35 experimental vaccines in the world in human trials, nine of them in the third and final phase. The Oxford vaccine is one of the most advanced. It has already shown promising results in a first trial with over a thousand healthy volunteers in the UK. The experimental vaccine produced a strong immunological reaction without causing serious adverse effects, according to data published in July in The Lancet medical journal.
Source: El Pais