AstraZeneca’s U.S. trial remains on hold pending review by FDA

Vaccine concept

Governments and citizens across the world were pinning big hopes on the inoculation seen as a viable shot against SARS-CoV-2, the virus that causes COVID-19.

Some volunteers have quit Johnson & Johnson's JNJ.N COVID-19 vaccine trial in Spain after news of side effects in a participant in AstraZeneca's AZN.L trial, the Spanish programme's lead investigator told Reuters on Tuesday.

Phase two trials are created to test which dose and schedule of a vaccine generates the most antibodies while phase three tests the vaccine's efficacy.

Also Read: Oxford coronavirus vaccine trials halted: What are other COVID-19 vaccines to watch out? A prolonged delay in the US trial could slow access to the vaccine in the United States. AstraZeneca announced that the centres were recruiting up to 30,000 participants for the third phase trials in the United States.

The comments follow rival AstraZeneca's COVID-19 vaccine trials being put on hold worldwide on September 6 after a serious side effect was reported in a volunteer in Britain. The clinical tests are likely to remain on hold until midweek pending the US Food and Drug Administration's investigation in the case along with a safety panel.

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Oxford University, AstraZeneca's partner on the vaccine, has already resumed its clinical trial in Britain, saying in a statement that adverse reactions were an "expected" part of a large trial, the BBC reported.

South Korea's SK Bioscience in July agreed to manufacture AstraZeneca's experimental vaccine, which has shown promise, to help the British company build global supplies. This came after a notice issued by the central drug regulator. Meanwhile, the decision regarding when to resume the clinical trials rests with the DGCI.

Johnson & Johnson's Belgian Janssen unit began phase two trials of its COVID-19 vaccine on 190 people in Spain on Monday with those tests due to conclude on September 22. Volunteers have been recruited in Sao Paulo, Rio de Janeiro, and Salvador in the northeastern state of Bahia where a hospital is conducting the tests.

About one in seven volunteers who received a groundbreaking Russian coronavirus vaccine have complained of side effects such as muscle pain, weakness, and fever, according to the country's Minister for Health Mikhail Murashko.

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