Environmental News for a Healthier Planet and Life

COVID-19 Vaccine Trial Put on Hold Over Safety Concerns

Health + Wellness
COVID-19 Vaccine Trial Put on Hold Over Safety Concerns
The offices of British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca PLC in Macclesfield, Cheshire on July 21, 2020. PAUL ELLIS / AFP via Getty Images
One of the leading candidates for a COVID-19 vaccine has been stopped after a study participant had a serious adverse reaction that is suspected to have been caused by the vaccine, as STAT News reported. The vaccine from the pharmaceutical giant AstraZeneca and the University of Oxford was in the late stages of a phase 3 trial, meaning it was being tested for safety at several sites around the country and in Europe.

After a study participant in the United Kingdom fell ill, AstraZeneca said in a statement that it would review safety and efficacy data. Then the company released a second statement, saying it initiated the pause even though the study participant is expected to make a full recovery, according to STAT News.

Despite the pause, adverse reactions are very common in clinical trials as is pausing for a safety and efficacy review. It also does not mean the vaccine candidate is a failure. However, it does make it increasingly unlikely that the vaccine will be approved and ready for distribution by Election Day, as President Trump has often said a vaccine would be.

In a statement, according to The New York Times, AstraZeneca described the pause as a "routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."

AstraZeneca was not clear about how long the pause in the vaccine trial will last. The late-stage vaccine trial so far has included 17,000 people in Europe, the U.S., Brazil and South Africa, according to The Guardian. Phase 3 trials include a large number of study participants for exactly this reason; only by testing a large number of people do rare side-effects emerge.

"This is the whole point of doing these Phase 2, Phase 3 trials," said Dr. Phyllis Tien, an infectious disease physician at the University of California, San Francisco, as The New York Times reported. "We need to assess safety, and we won't know the efficacy part until much later. I think halting the trial until the safety board can figure out whether or not this was directly related to the vaccine is a good idea."

While the exact condition that the study participant suffered has not been released, The New York Times is reporting that sources are saying the person received a diagnosis of transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. It's unclear if the diagnosis is directly related to the vaccine candidate or not.

Robert Booy, a University of Sydney professor of vaccinology, told The Guardian that if the sickness is unrelated to the vaccine candidate then the trial might be paused for just one week, but it may extend to one month. He said that the pause "is more likely the product of being super careful" rather than a problem with the vaccine.

"This could have just been a high fever and it turns out they've got appendicitis," he said. "My bet would be that they find something in this participant that is not causal [from the vaccine]. It'll take them about one to two weeks to ascertain this, and then they will probably restart the trial in a month."

AstraZeneca said in a statement that it was "working to expedite the review of the single event to minimize any potential impact on the trial timeline," and did not waver from its commitment "to the safety of our participants and the highest standards of conduct in our trials," as The New York Times reported.

AstraZeneca was one of nine companies that signed a pledge Tuesday to assure the public that a vaccine would not be rushed due to politics. In a rare move, nine companies working on a vaccine made a joint pledge to "stand with science" and insisted that they would not be rolled out prematurely without proving beyond a doubt that they are safe and effective, according to The New York Times.

A group of climate activists that have been cycling from the North of the country in stages to draw attention to the climate case are arriving to the Court of Justice on the day that the climate lawsuit against Shell starts in The Hague, on December 1st, 2020. Romy Arroyo Fernandez / NurPhoto / Getty Images

By Julia Conley

Representing more than 17,000 claimants who support climate action, the international organization Friends of the Earth on Tuesday opened its case against fossil fuel giant Shell at The Hague by demanding that a judge order the corporation to significantly reduce its carbon emissions in the next decade.

Read More Show Less

EcoWatch Daily Newsletter

Eat Just, Inc. announced that its cultured chicken has been approved for sale in Singapore as an ingredient in chicken bites. The company has developed other cultured chicken formats as well. Eat Just

As concern mounts over the environmental impacts of animal agriculture, Singapore has issued the world's first regulatory approval for lab-grown meat.

Read More Show Less


Wildfires are seen burning out of control on November 30, 2020 on Fraser Island, Australia. Queensland Fire and Emergency Services / Getty Images

The world's largest sand island has been on fire for the past six weeks due to a campfire, and Australia's firefighters have yet to prevent flames from destroying the fragile ecosystem.

Read More Show Less
A plane sprays pesticide over the Wynwood neighborhood in the hope of controlling and reducing the number of mosquitos, some of which may be capable of spreading the Zika virus on Aug. 6, 2016 in Miami, Florida. Joe Raedle / Getty Images

By Jessica Corbett

A national nonprofit revealed Tuesday that testing commissioned by the group as well as separate analysis conducted by Massachusetts officials show samples of an aerially sprayed pesticide used by the commonwealth and at least 25 other states to control mosquito-borne illnesses contain toxic substances that critics call "forever chemicals."

Read More Show Less
Prime Minister Jacinda Ardern plants a tree as part of Trees That Count, a project to help New Zealand make a positive impact on climate change, on June 30, 2019 in Wellington, New Zealand. Hagen Hopkins / Getty Images

The government of New Zealand declared a climate emergency on Wednesday, a symbolic step recognizing the Intergovernmental Panel on Climate Change (IPCC) predictions of substantial global warming if emissions do not fall.

Read More Show Less