BFF-37, 38 Major Covid-19 vaccine trial resumes in UK after safety review





Major Covid-19 vaccine trial resumes in UK after safety review

LONDON, Sept 12, 2020 (BSS/AFP) – Pharma giant AstraZeneca and
Oxford University on Saturday said they had resumed a Covid-19 vaccine
trial after getting the all-clear from British regulators, following a
pause caused by a UK volunteer falling ill.

“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 company said in a statement.

AstraZeneca announced on Wednesday it had “voluntarily paused” its
trial of the vaccine developed alongside Oxford University after the
volunteer developed an unexplained illness.

An independent committee was drafted in to review safety, in what
the company and the World Health Organization described as a routine

The committee “has concluded its investigations and recommended to
the MHRA that trials in the UK are safe to resume”, AstraZeneca said.

Oxford University confirmed the resumption and said: “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.”

After the pause, AstraZeneca had said it remained hopeful that the
vaccine could still be available “by the end of this year, early next

But pharma companies including AstraZeneca and scientists have
expressed concern about political pressure to rush a vaccine out, not
least from US President Donald Trump.

Joe Biden, the Democratic candidate for president, has accused
Trump of “undermining public confidence” by regularly raising the
possibility a vaccine will be ready before the election on November 3.

Charlotte Summers, lecturer in intensive care medicine at Cambridge
University, welcomed the resumption of the Oxford trial and said the
researchers had shown their commitment “to putting safety at the heart
of their development programme.”





“To tackle the global Covid-19 pandemic, we need to develop
vaccines and therapies that people feel comfortable using, therefore
it is vital to maintaining public trust that we stick to the evidence
and do not draw conclusions before information is available,” she

– ‘Losing control’ –

AstraZeneca’s vaccine candidate is one of nine around the world
currently in late-stage Phase 3 human trials.

In the United States, the company began enrolling 30,000 volunteers
across dozens of sites on August 31, and the inoculation is being
tested on smaller groups in Britain, Brazil and South Africa. Trials
are also planned in Japan and Russia.

The AZD1222 vaccine uses a weakened version of a common
cold-causing adenovirus engineered to code for the spike protein that
the Covid-19 coronavirus uses to invade cells.

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

“AstraZeneca is committed to the safety of trial participants and
the highest standards of conduct in clinical trials,” Saturday’s
statement read.

“The company will continue to work with health authorities across
the world and be guided as to when other clinical trials can resume to
provide the vaccine broadly, equitably and at no profit during this

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

In Britain, infection rates are again surging in line with the
rising trend seen of late in the rest of Europe, forcing the
government to tighten public restrictions from Monday and impose local

“I think one would have to say that we’re on the edge of losing
control,” Mark Walport, the British government’s former chief
scientific adviser, told BBC radio.