EMA kicks off rolling review of AstraZeneca COVID vaccine candidate

Regulatory NewsRegulatory News | 01 October 2020 |  By 

The European Medicines Agency (EMA) has begun a rolling review of the COVID-19 vaccine being developed by AstraZeneca and the University of Oxford. This is the agency’s first review of a vaccine against SARS-CoV-2, the virus that causes COVID-19.
EMA’s human medicines committee (CHMP) has begun with an evaluation of non-clinical data, announced EMA on 1 October. The rolling review is meant to hasten the time to a decision on the safety and effectiveness of a therapeutic or vaccine during a public health emergency; CHMP decided to begin the process with the Astra Zeneca vaccine candidate because of “preliminary results from non-clinical and early clinical studies suggesting that the vaccine triggers the production of antibodies and T cells…that target the virus,” said EMA.
The AstraZeneca/Oxford vaccine candidate is based on an engineered chimpanzee adenovirus vector platform called ChAdOx1 that has previously been studied for several other infectious diseases.
During the public health emergency of the COVID-19 pandemic, CHMP previously used a rolling review in its evaluation of remdesivir to treat COVID-19. (RELATED: EMA kicks off rolling review of Gilead’s remdesivir, Regulatory Focus  01 May 2020)
CHMP will continue to evaluate clinical data on safety and effectiveness as they become available; the committee will also assess quality data addressing such areas as ingredients and production as part of the rolling review. “EMA will complete its assessment according to its usual standards for quality, safety and effectiveness,” according to the announcement.
The day before EMA’s announcement of the commencement of the vaccine candidate’s rolling review, Reuters reported that the US Food and Drug Administration (FDA) was expanding an investigation into the AstraZeneca/Oxford candidate to look at earlier vaccine trials that investigated the ChAdOx1 vector for other disease indications. Vaccine trials are currently halted in the US after a study participant in the United Kingdom was reported to have sustained a severe adverse event, thought at the time to be transverse myelitis. Trials have recommenced in the United Kingtom, as well as in South Africa, India and Brazil.


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