Oxford and AstraZeneca resume coronavirus vaccine trial

Sunday, 13 Sep, 2020

AstraZeneca PLC said Saturday clinical trials for its experimental coronavirus vaccine have resumed in the United Kingdom after regulators concluded it was safe to do so, following a pause in studies globally after a person who received the vaccine had an unexplained illness.

AstraZeneca previously also received permission to conduct the third stage of clinical trials of the AZD1222 vaccine in Russian Federation, follows from the state register of clinical trials. "In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety", the university had said in a statement earlier, according to CNN.

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.

"AstraZeneca, the biopharmaceutical giant in tie-up with the university to produce the vaccine, had described the pause as a "routine" one following what was an unexplained illness".

During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research.

Serum Institute of India, one of AstraZeneca's development and production partners, said on Thursday it was joining the suspension, backtracking on remarks that it did not face any issues. It has also authorised emergency usage of COVID-19 vaccines developed by some select domestic companies.

Brazil's health regulator ANVISA said it was awaiting notice from the British MHRA confirming that resumption of trials has been authorized before resuming in Brazil.

The World Health Organization (WHO) has flagged the AstraZeneca vaccine, which is being developed with the University of Oxford, as the most promising for coronavirus.

Why it matters: AstraZeneca is running late-stage clinical trials - which determine whether the vaccine candidate is safe and effective - in the U.S., U.K., Brazil and South Africa.

Shares in AstraZeneca fell on Wednesday after the trial halt raised doubts about the timeline for the vaccine's rollout.

The nasal spray vaccine uses live attenuated influenza vaccine; the other four technical routes China is using to develop the coronavirus vaccines are inactivated vaccines, adenoviral vector-based vaccines, and DNA and mRNA vaccines.