A vaccine trial for a front-runner Covid-19 shot from AstraZeneca Plc and the University of Oxford restarted in Japan after studies were halted globally last month when a U.K. participant became ill.
The phase I-II trials resumed after the Japanese regulator gave the go-ahead, according to a statement from AstraZeneca Friday. Studies in the U.K., Brazil, South Africa and India have also restarted in recent weeks.
The news follows the European regulator’s decision this week to begin an accelerated review of the potential shot, a move that could pave the way for the vaccine to become the first in the region to win approval. The “rolling review” allows regulators to see clinical data in real-time so that a vaccine or drug can be brought to the market more quickly if successful.
The British pharmaceutical company and university are still waiting for trials to resume in the U.S.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.
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.
Back at home, speaking at India Today Healthgiri Awards 2020, Guleria said it is really difficult to say when the vaccine will be available in the country. Also Read - Sputnik V: Trials For Russian Coronavirus Vaccine May Begin in India in Upcoming Weeks
He said from the ongoing trials to the effectiveness of the vaccine — developing a vaccine depends on a lot of factors. Also Read - DCGI Issues Notice to Serum Institute Over Suspension of COVID Vaccine Trial by AstraZeneca Abroad
Talking about the challenges of developing the vaccine, the AIIMS chief said that the big challenge after the vaccine is developed will be its production and distribution on such a large scale.
Responding to a question on Covid-19 peak, Guleria said cases have stabilised marginally over the past few days. He further added that if the current trend continues for the next two weeks, it could clear that India is past its peak.
The development comes at a time when India’s COVID-19 caseload inched closer to 64 lakh-mark with 81,484 infections reported in a day, while the number of people who recuperated from the disease crossed 53 lakh pushing the recovery rate to 83.70 per cent, the Union health ministry said on Friday.
Inputs from - www.Bloomberg.com