AstraZeneca, Johnson & Johnson’s COVID-19 Vaccine Trials Are Underway in the U.S.



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WASHINGTON: Two major clinical trials for COVID-19 experimental vaccines got back on track in the United States on Friday (October 23), providing a glimmer of hope as the number of cases skyrockets across the country.

COVID-19 has now killed more than 223,000 Americans, and the health crisis is a major issue in the presidential elections pitting incumbent Donald Trump against Joe Biden.

AstraZeneca announced that the trial of its candidate vaccine, developed with Britain’s Oxford University, has been resumed in the US, the only country where it remained suspended following a participant’s illness six weeks ago.

“The Food and Drug Administration (FDA) authorized the restart in the US today, following the resumption of trials in other countries in recent weeks,” the drugmaker said.

READ: COVID-19 Vaccine Trials Evaluating Mostly Mild Cases, Not Designed to Show They Can Save Lives – Expert

The trial was suspended worldwide on September 6, but resumed shortly thereafter in Britain and in the following weeks in South Africa, Brazil and Japan, with authorities determining that the disease was apparently not related to the vaccine.

“The FDA reviewed all the safety data from the trials globally and concluded that it was safe to resume the trial,” AstraZeneca said.

The company added that it expected to have results later this year, “depending on the infection rate within the communities where clinical trials are being conducted.”

The AstraZeneca vaccine project is one of the most promising and advanced in the world to combat the global pandemic, which has now claimed the lives of 1.1 million people.

It is one of 10 candidate vaccines that are being tested in tens of thousands of people in so-called phase 3 trials.

In the United States, the top two contenders for the FDA green light are Pfizer and Moderna. They both hope to apply for approval next month.

Many countries have the use of the AstraZeneca vaccine to inoculate their populations.

The drugmaker sold hundreds of millions of doses on several continents and signed partnership agreements with other producers to ensure the doses could be made locally.

READ: Scientists raise alarm over COVID-19 vaccine ‘hesitation’ signs

“NO EVIDENCE” VACCINE CAUSED ILLNESS

Shortly after the AstraZeneca announcement, Johnson & Johnson said it was preparing to resume recruiting for its side trial, which was suspended last week after a volunteer fell ill.

“After a thorough evaluation of a serious medical event experienced by a study participant, no clear cause has been identified,” the group said in a statement.

“The company has found no evidence that the candidate vaccine caused the event.”

Just before Friday’s announcements, a senior US official involved in Operation Warp Speed, the government’s vaccine initiative, said he expected the J&J trial to resume quickly.

READ: COVID-19 vaccine could be ready by the end of the year: WHO’s Tedros

Paul Mango of the US Department of Health and Human Services also said he hoped the country would have enough doses available to vaccinate the “most vulnerable” Americans before the end of the year.

“By the end of January, we believe that we will be able to vaccinate all older people,” Mango said, adding that by March or April, “we believe we will be able to vaccinate any American who wants a vaccine.”

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