US widens safety inquiry into AstraZeneca's coronavirus vaccine

FILE PHOTO: Small bottles labeled with a "Vaccine COVID-19" sticker and a medical syringe are seen in this illustration

Reuters

• AstraZeneca’s vaccine study is being investigated further by the Food & Drug Administration (FDA) after a participant experienced a suspected adverse reaction to the drug. This could put additional delays on the British drugmaker’s late-stage trial.
• Meanwhile, European regulators are set to announce the start of AstraZeneca’s review in Europe as soon as this week - the first vaccine to undergo EU approval.
• AstraZeneca’s CEO said on September 10 the vaccine would be ready by the end of the year or early next year, despite the COVID-19 trial halting due to the illness.
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The US Food and Drug Administration (FDA) has broadened its investigation into the suspected adverse reaction of a participant in AstraZeneca's COVID-19 vaccine trial, whilst European regulators are set to announce its review as soon as this week.

The FDA also wants to examine results from earlier studies of other vaccines produced by the same scientists of the AstraZeneca vaccine to see if similar side effects have emerged, three sources with knowledge of the trial told Reuters on Wednesday. But these checks don't mean the agency suspects safety concerns with any of the vaccines, the people said.

"It just shows that the FDA is being thorough," one of the sources told Reuters.

AstraZeneca's vaccine study, which is said to be one of the most advanced COVID-19 vaccines in the world, could be delayed even further due to the wider probe into safety issues carried out by the FDA.

The drugmaker's phase three coronavirus vaccine trial was put on hold on September 6 following a serious illness of a participant in the UK who has reportedly come down with a rare spinal inflammatory disorder called transverse myelitis.

Trials have now resumed in the UK, South Africa, India and Brazil, but US authorities are yet to give AstraZeneca the all-clear to restart trials.

The US government has pledged up to $1.2 billion to support AstraZeneca's vaccine development and has secured 300 million doses for the whole country.

AstraZeneca's CEO Pascal Soriot said an interview on September 10 it is normal for vaccine trials to be paused due to unexpected events, but that "the difference is with other vaccine trials is that the whole world is not watching them."

Vaccine review kicks off in Europe

Meanwhile, European regulators are set to announce a review of AstraZeneca's vaccine as soon as this week, according to a source familiar with the matter, per Bloomberg.

The head of the European Medicines Agency, Marco Cavaleri, said in July the agency would announce "rolling reviews" of potential coronavirus vaccines after the summer, adding that the EU could approve the first effective vaccine by the end of this year. A rolling review avoids delays, allowing a quick approval of a drug from the European Commission, which is necessary in emergencies like a pandemic.

Shares in AstraZeneca rose 1% in early London trading on Wednesday.

The British drugmaker's vaccine could be the first COVID-19 candidate to undergo EU process and seek approval in the continent. With the global coronavirus death toll exceeding one million on Tuesday, and the infection rate steadily increasing in Europe, the need for a vaccine is becoming more essential day by day.

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