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while unconfirmed, astrazeneca had told investors a female trial participant from the u.k. had developed neurological symptoms consistent with transverse myelitis , a rare, but serious, spinal inflammatory disorder. her status has not been officially disclosed but last week, it was reported she was recovering and would soon be discharged from the hospital this week.
“astrazeneca and the university of oxford, as the trial sponsor, cannot disclose further medical information. all trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards,” according to the statement .
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all phase 3 trials of the vaccine, developed by the university of oxford and british-swedish pharma company astra-zeneca, were put on hold. t he trial had intended to enrol about 30,000 participants across the u.s. .
in the phase 1 and 2 trial of the same vaccine , approximately 60 per cent of people experienced mild to moderate side effects such as headaches, fever, or some discomfort at the site of injection. however, there were no serious adverse events, and all side effects subsided.
news of the halted trials comes on the same day that nine vaccine companies pledged to only seek approval of the vaccine once it was proven safe and effective, instead of bowing to political pressure. the companies were responding to u.s. president donald trump’s attempts to bully the food and drug administration into approving a vaccine before the november election.
“out of an abundance of caution, they decided to pause things, investigate, and then move forward,” says dr. barry pakes , assistant professor at the dalla lana school of public health and program director of the public health and preventive medicine specialty training program. “i think it helps communicate to the public what kind of systems are in place and the processes in place to ensure the highest standards of safety are working.”
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genetic vaccines use the virus’ genes to stimulate the body’s immune response. the body never actually has to encounter the whole virus, just some viral proteins. the vaccines in the moderna and pfizer trials are using these methods.
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viral vector vaccines are similar to genetic vaccines in using the novel coronavirus’s genes to provoke an immune response, but uses live viruses to carry dna into the human cells to elicit an immune response.. this is the method used in the cansinobio and gamaleya vaccines as well as the oxford/astrazeneca vaccine currently on hold.
protein-based vaccines use the coronavirus proteins (the crown of protein spikes around sars-cov-2 which give it the “corona” name) to provoke an immune response. this method is currently used in vaxine , sanofi pasteur , and novavax vaccines.
dduong@postmedia.com | @dianaduo
