The pause in late-stage trials of a coronavirus vaccine being developed by Oxford University and AstraZeneca have triggered global concern over the development of the vaccine. 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.
The pharma giant had on September 6 temporarily put on hold the late-stage trials of its vaccine candidate- AZD1222 after a study participant reportedly suffered a serious adverse reaction. The inoculation's human tests have been paused, not stopped, in the United States (US) and other countries, as the company had confirmed.
However, following the halt, there has been a lot of confusion regarding the countries that have temporarily discontinued the vaccine trials.
What's the current status of AstraZeneca's coronavirus vaccine trials in several countries, including India:-
United Kingdom: Where the UK has resumed the clinical tests following a review by the country's drug regulator MHRA (Medicines and Healthcare products Regulatory Agency), and an independent safety review committee, trials paused in India, US, and South Africa are yet to resume. AstraZeneca announced last Saturday that it had resumed trials in Britain after regulators completed their review of a serious side effect in one trial participant there.
United States: AstraZeneca's COVID-19 vaccine trial remains on hold in the US pending an investigation into the serious side effect in Britain even as other trials of the vaccine resume, sources told Reuters. 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. Sources told the news agency that enrollment of new patients and other trial procedures for the pivotal US trial was being rescheduled until at least midweek and that it was not clear how long it would take for the FDA to complete its probe.
India: The Serum Institute of India (SII), which has partnered with AstraZeneca and is conducting phase 2/3 human clinical trials in the country, has not given any clarification on how it would resume the trials in the country. The Pune-based company, which is the world's largest vaccine manufacturer by volume, has inked a deal with AstraZeneca to produce and market the inoculation in low and middle-income countries including India. The Serum Institute had initially said that the vaccine trials in India would not be affected because of the incident in Britain. But after being pulled by the drug regulator, DGCI (Drugs Controller General of India), it paused the tests. Meanwhile, the decision regarding when to resume the clinical trials rests with the DGCI.
Brazil: Clinical trials for the coronavirus vaccine being developed by AstraZeneca and Oxford University resumed in Brazil on Monday, September 14 after the country's health regulator received confirmation over the weekend that its British equivalent MHRA had approved the resumption of clinical tests, a company representative said. The Federal University of Sao Paulo, which is running the trials, said in a statement that 4,600 of the planned 5,000 volunteers have been vaccinated in Brazil without any of them reporting any serious health issues. 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.
South Africa: The country is yet to resume the clinical tests of AstraZeneca's COVID-19 vaccine. There has been no confirmation from the concerned authorities in South Africa yet on when the trials will recommence. Meanwhile, the Bhekisisa Centre for Health Journalism, a Johannesburg-based independent media organisation, reported on Tuesday, September 15, that results of the South African arm of AstraZeneca's coronavirus vaccine trial are expected to be delayed until early next year.