AstraZeneca and Johnson & Johnson have resumed clinical trials of COVID19 vaccines after the review of the security and safety of the trials by the US Food and Drug Administration (FDA).
AstraZeneca and Johnson & Johnson resumed the clinical trials for experimental COVID19 vaccines in the US on October 23.
The pharmaceutical companies said the independent Data Safety and Monitoring Board (DSMB) approved the resumption of the clinical trial recruitments.
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FDA has allowed the phase III trials of AstraZeneca’s COVID19 AZD1222 while it has authorized Johnson & Johnson to restart its phase 3 ENSEMBLE trial of the Janssen COVID19 vaccine.
The trials of the two pharmaceutical firms were halted after serious adverse reactions (SAE) were detected in the volunteers.
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“Today, we are preparing to resume recruitment in the pivotal Phase 3 trial of our investigational Janssen #COVID19 vaccine in the U.S. after a temporary pause,” Johnson & Johnson said on its Twitter handle on Saturday.
“There is no greater priority than the health & safety of the people we serve around the world,” it said.
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“We will develop and test our investigational COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles,” said Paul Stoffels, vice chairman of the executive committee and chief scientific officer of Johnson & Johnson.
“Our primary goal is to ensure the safety, well-being and privacy of the participants and all those involved in our trials,” Stoffels added.
“After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified,” Johnson & Johnson said in a statement issued on Friday.
There are many possible factors that could have caused the event, it said.
Based on the information gathered to date and the input of independent experts, the company has found no evidence that the vaccine candidate caused the event, it claimed.
“At Johnson & Johnson, there is no greater priority than the health and safety of the people we serve every day around the world. Our primary goal is to ensure the safety, well-being and privacy of the participants and all those involved in our trials,” the company said.
AstraZeneca in a statement said clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators in the US, UK, Brazil, South Africa and Japan confirming that it was safe to do so.
“The Food and Drug Administration (FDA) today authorised the restart in the US, following the resumption of trials in other countries in recent weeks,” AstraZeneca said in the statement issued on Friday.
“The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial,” it added.
Pascal Soriot, chief executive officer, AstraZeneca, said, “The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic.”
“We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use,” Soriot added.
