The U.S. Drug Administration to Investigate AstraZeneca's New Coronavirus Vaccine Trial

The Director of the U.S. Food and Drug Administration Stephen Hahn said on the 15th that the investigation was triggered by a British volunteer who was vaccinated with the new coronavirus vaccine developed by AstraZeneca Pharmaceuticals. It is very important for the FDA to start with AstraZeneca to determine whether (vaccine) has safety issues.


Hahn confirmed in a video connection with Senator Tim Scott, South Carolina, that the clinical trial of the new coronavirus vaccine developed by AstraZeneca and Oxford University has been suspended in the United States.

Hahn said, 'We do not have all the facts, we do not know the causality of the incident itself, but we do need to investigate. Our primary responsibility is to (ensure) the safety of the American people.'

The Phase III clinical trial of AstraZeneca vaccine was suspended on the 6th of this month. The reason was that a British volunteer had a serious adverse reaction after being vaccinated, and was suspected of suffering from transverse myelitis.

Regulators in countries such as the United Kingdom and Brazil have restarted vaccine trials. Reuters reported on the 14th that the U.S. Drug Administration and the safety review expert team have not yet completed the investigation and therefore have not released the test.

AstraZeneca’s trials in Brazil restarted on the 14th. So far, about 4,600 people in Sao Paulo, Rio de Janeiro and Salvador in the northeastern state of Bahia have received the first dose of the vaccine, each requiring two doses in total. The Federal University of Sao Paulo, which is responsible for coordinating trials in Brazil, said on the 15th that the Brazilian Health Supervision Agency approved AstraZeneca to recruit 5,000 additional volunteers on the same day.

The Federal University of Sao Paulo issued a statement stating that these 5,000 volunteers will work with the 5,000 recruited volunteers to provide more reliable test results for the safety and effectiveness of the vaccine. It is hoped that Rio Grande do Norte and Rio Grande do Sul will reach the age of An 18-year-old volunteer participated. The Brazilian Health Inspection Agency previously required volunteers to be no more than 69 years old, and now this restriction is lifted.

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson in the United States, launched a phase II trial of the new crown vaccine in Spain on the 14th, but the negative news of the AstraZeneca trial 'scared' some volunteers.

The lead investigator of the trial, Alberto Borovia, did not disclose the number of withdrawals to Reuters, only stressing that there are still enough volunteers to participate in the trial.

Johnson & Johnson plans to recruit 190 volunteers in Spain, and at the same time carry out Phase II trials in the Netherlands and Germany. A total of 550 volunteers from the three countries are expected to participate. Josue Bakalchuk, Vice President of medical affairs in Latin America at Janssen Pharmaceuticals, said that the Phase III trial of Johnson & Johnson plans to recruit 60,000 volunteers worldwide, of which one-third are from Latin America.

Phase II trials of vaccines usually determine how many doses and time intervals can produce the most antibodies, while Phase III trials determine the effectiveness of the vaccine. Nine pharmaceutical companies including AstraZeneca and Johnson & Johnson issued a joint open letter on the 8th, promising not to seek regulatory approval of the vaccine until the safety and effectiveness of the vaccine have not been fully verified.