Oxford vaccine trial is back with a bang - UK regulator gives safety
clearance |

AstraZeneca pharma giant has resumed clinical trials of the Oxford
coronavirus vaccine, AZD1222, after a pause clamped last week
over development of an illness, transverse myelitis, in a
participant. The final trials were going on in several countries like
the UK, US and India. The trials resumed after safety clearance
from the UK Medicines and Healthcare products Regulatory Agency (MHRA).
The adverse episode of transverse myelitis, a neurological disorder
of the spinal cord, could be caused by a coincidental viral infection
or an autoimmune attack on the myelin in the spinal column on the
lines of MS or just like in bowel dysfunction (IBS) or could be even
a minor cytokine storm, not linked to the vaccine.
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NEW DELHI, Sept 13: The Oxford vaccine for coronavirus on Saturday resumed
final clinical trials halted across several countries due to the development of
an illness in one of the tens of thousands of participants in its UK leg last
week. The clearance has come in lightning speed considering the emergency situation,
even as predictions from various quarters did not see any chance of resumption
of the trials untill next year.
The sanction from the UK regulator, Medicines and Healthcare products Regulatory
Agency (MHRA), followed the recommendations of an independent safety review
committee, which investigated the episode.
"Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have
resumed in the UK following confirmation by the Medicines Health Regulatory
Authority (MHRA) that it was safe to do so," the AstraZeneca pharma giant said
in a statement.
AstraZeneca, the British-Swedish pharma company, has been participating in
the trial and production of the AZD1222 COVID-19 vaccine with the Oxford University
Jenner Institute, which had developed the vaccine.
The illness in one participant in a UK leg that led to the pause in the final
phase of trials of the Oxford vaccine all over the world has now been revealed
as transverse myelitis, a neurological disorder, that may or may not be an isolated
case of reaction to the vaccine. AstraZeneca's chief executive, Pascal Soriot,
had told medical journal Stat News that the illness has been diagnosed as transverse
myelitis but did not disclose further details, may be because of patient's confidentiality
issue. Possibly the adverse event was not linked to the vaccine as the pause
has been lifted with immediate effect.
Eruption of various symptoms is quite common in the course of development of
a vaccine. And temporary pauses in trials are also not uncommon in medical research.
Besides, a stray episode could be coincidental as its possibility is higher
when thousands of volunteers are participating, said AstraZeneca. It may not
have anything to do with the vaccine at all.
What is transverse myelitis
Transverse myelitis could be viral infection. It could also be an autoimmune
attack on the myelin in the spinal column on the lines of MS or just like in bowel
dysfunction (IBS) etc or a minor cytokine storm occurring as a blind response
to the introduction of the vector or even a RNA simulator in the vaccine. The
vaccine candidate had already passed all the stages of safety trials so far.
Transverse myelitis can give pain in the neck or back or numbness in the legs
etc. It can progressively lead to sensorimotor myelopathy as well. Administration
of steroids is the common treatment.
The Oxford vaccine Phase 3 final clinical trials on around 30,000 participants
have been going on in the US, the UK, Brazil, South Africa and India.
Nearly 180 vaccine candidates are being developed around the world but none
has yet completed all the clinical trials, according to WHO statistics. The
Oxford vaccine was considered as number one to hit the market.
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SELECTIONS FROM OUR ARCHIVES |
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