Clinical trials resume on AstraZeneca-Oxford Covid-19 vaccine candidate


The Oxford University AstraZeneca trial was paused earlier this week after a person who received the vaccine in the United Kingdom was hospitalised with neurological complications.

Egypt is carrying out phase 3 trials of two Chinese coronavirus vaccines starting Saturday, Egypt's health minister Hala Zayed said. "We are reviewing the situation and pausing India trials till AstraZeneca restarts them".

A national committee was formed to oversee this clinical research, she added, and confirmed that the Holding Company for Biological Products and Vaccines (VACSERA) is ready to produce the vaccine as soon as its effectiveness is proven.

This last Tuesday morning, AstraZeneca was among 9 pharmaceutical companies to sign a letter pledging the continued assurance and monitoring for safety and tolerability in the first COVID-19 vaccine candidates, in response to reports that a vaccine may be regulated and distributed in alignment with the upcoming US Presidential Election in November.

The statement said the UK Medicines Health Regulatory Authority approved trials to resume after an independent review of data "triggered a voluntary pause" on September 6.

At the start of next year, phase three trials of Russia's "Sputnik-V" COVID-19 vaccine will also be conducted on 10,000 volunteers in Brazil in partnership with the state of Parana's Technology Institute, known as Tecpar.

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Earlier, Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate, had announced that it is pausing clinical trials of the vaccine, and said that it is "reviewing the situation" and will keep the trials paused until AstraZeneca resumes them.

But the New York Times has previously reported the patient had been diagnosed with transverse myelitis, an inflammatory syndrome which affects the spinal cord and is often sparked by viral infections.

This is one of the nine vaccines in advanced stage of phase III human trials.

Ideally, scientists do not expect side effects except for minor nasal obstruction or rhinorrhea, Yuen said.

Temporary holds of large medical studies aren't unusual, and investigating any serious or unexpected reaction is a mandatory part of safety testing. Sauerit said the whole world is considering trying this vaccine, so it's so much discussed.

AstraZeneca has already said it would work with health authorities around the world to supply around three billion doses of the vaccine "equitably", to countries including Russia, China, the USA and Brazil.