Main Covid-19 vaccine trial resumes in UK after security evaluate

Pregnant women with COVID-19 may more likely need intensive care and give birth early

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Pharmaceutical company AstraZeneca and Oxford University announced on Saturday that they have resumed a COVID-19 vaccine study after receiving the all-clear from UK regulators after a hiatus caused by a sick UK volunteer.

"Clinical trials for the AstraZeneca Oxford coronavirus vaccine AZD1222 have resumed in the UK after the Medicines Health Regulatory Authority (MHRA) confirmed it was safe," the company said in a statement.

AstraZeneca announced Wednesday that it "voluntarily stopped" its trial of the vaccine, which was jointly developed with Oxford University, after the volunteer developed an unexplained disease.

An independent committee was set up to review safety, which the company and the World Health Organization identified as a routine move.

The committee "has completed its investigation and recommended the MHRA to restart the UK trials," said AstraZeneca.

Oxford University confirmed the readmission, saying: "In large studies like this one, some participants are expected to feel uncomfortable and each case must be carefully assessed to ensure a thorough safety assessment."

After the break, AstraZeneca had said it was still hopeful that the vaccine could still be available "late this year, early next year".

However, pharmaceutical companies like AstraZeneca and scientists have voiced concerns about political pressure to scrap a vaccine, not least from US President Donald Trump.

Joe Biden, the Democratic presidential candidate, has accused Trump of "undermining public confidence" by regularly raising the possibility of a vaccine being ready before the November 3rd election.

Charlotte Summers, professor of intensive care medicine at Cambridge University, welcomed the resumption of the Oxford study, saying the researchers have shown their commitment to "putting safety at the heart of their development program".

"To fight the global COVID-19 pandemic, we need to develop vaccines and therapies that people are comfortable with. So it is important to maintain public confidence that we are sticking to the evidence and not drawing conclusions before information is available, "she said.

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AstraZeneca's vaccine candidate is one of nine worldwide currently in late-stage phase 3 human trials.

In the United States, the company began enrolling 30,000 volunteers in dozen of locations on August 31. The vaccination is being tested on smaller groups in the UK, Brazil and South Africa. Trials are also planned in Japan and Russia.

The AZD1222 vaccine uses a weakened version of a common cold adenovirus, which encodes the spike protein that the COVID-19 coronavirus uses to enter cells.

After vaccination, this protein is produced in the human body, which causes the immune system to attack the coronavirus if the person later becomes infected.

"AstraZeneca is committed to the safety of study participants and the highest standards of behavior in clinical trials," said Saturday's statement.

"The company will continue to work with health authorities around the world to seek advice on when to resume other clinical trials to deliver the vaccine broadly, equitably, and without profit during this pandemic."

According to an AFP census, the disease has killed more than 900,000 people worldwide since first surfacing in China late last year. More than 28.5 million cases have been confirmed, and the United States has the most deaths with more than 193,000.

In the UK, infection rates are rising again in line with the rising trend in the rest of Europe, forcing the government to tighten public restrictions and impose local bans from Monday.

"I think it has to be said that we are on the verge of losing control," Mark Walport, former chief scientific advisor to the UK government, told BBC Radio.

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The main study on the Covid-19 vaccine will resume in the UK after a safety review (2020, September 12, 2020).
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