Greece’s hopes to get an initial batch of 600,000 COVID-19 vaccines from the British pharmaceutical company AstraZeneca were dashed when it paused a global trial of its experimental version after a participant became ill.
The company expected to have a first batch of 30 million doses of the vaccine in November for the European Union if it’s proved safe and effective during the ongoing trials in a rush to find an answer to COVID-19.
EU officials said another 100 million shots could be available in a second development with the Greek government saying a crucial issue is the terms of indemnification for vaccine manufacturers for the cost of compensating patients if there are unexpected side effects.
Charalambos Gogos, an infectious disease specialist and member of Greece’s COVID-19 Committee of Experts, said the second wave hitting the country can be held down with early diagnosis and treatment and effective tracking.
The suspension was reported by the Reuters news agency which said the vaccine, being developed in conjunction with the University of Oxford, the trial seen as the first best hope to deal with the lingering pandemic.
The British drugmaker said it voluntarily paused trials to allow an independent committee to review safety data, and it was working to expedite the review to minimize any potential impact on the trial timeline, the report said.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials,” the company said in an emailed statement but it would not reveal the illness or whether the participant had contracted the disease itself during the experiment.
The participant is expected to recover, according to Stat News, which first reported the suspension due to a “suspected serious adverse reaction,” the company refusing to disclose it.
The US Food and Drug Administration defines an adverse event as one in which evidence suggests a possible relationship to the drug being tested – essentially meaning the vaccine transmitted the virus it’s designed to stop.
A New York Times report which cited a person familiar with the situation said the participant in the UK was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections.
Whether the illness was directly linked to AstraZeneca’s vaccine remains unclear, the report said. AstraZeneca declined to comment on the report despite the whole world wanting to know what happened.
Staying mum didn’t help the company’s financial picture as its shares plummeted more than 8 percent in after-hours US trading, while shares in rival vaccine developer Moderna rose more than 4%.
Called AZD1222, the vaccine is in late-stage clinical trials in the United States, Britain, Brazil and South Africa and additional trials are planned in Japan and Russia. The trials aim to enroll up to some 50,000 participants globally.
The US National Institutes of Health, which is providing funding for AstraZeneca’s trial, declined to comment as President Donald Trump said he wants a vaccine to boost his reelection bid before the Nov. 3 polls.
Moderna said in an emailed statement it was “not aware of any impact” to its ongoing COVID-19 vaccine study at this time and nine leading US and European vaccine developers pledged to uphold scientific safety and efficacy standards for their experimental vaccines despite the urgency to contain COVID-19.
Read more at thenationalherald.com
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