After days of uncertainty following a safety alert triggered in the global trials for one of the frontrunners in the Covid-19 vaccine race, AstraZeneca Saturday said that it was resuming human testing in the UK of the candidate it developed jointly with the Oxford University. The company said it will continue to work with health authorities “across the world” and “be guided” as to when other clinical trials can resume.
The development may offer relief to Pune-headquartered Serum Institute of India (SII), which had to pause testing of the vaccine here after a notice by India’s top drug regulator about the global issue. The development may help SII resume vaccination here, as the Pune firm on September 10 told Drug Controller General of India (DCGI) Dr VG Somani that the Data Safety and Monitoring Board (DSMB) looking into follow up data from the first set of volunteers vaccinated in India “noted no safety concerns”.
According to a statement by AstraZeneca on Saturday, an independent expert committee in the UK set up to review the issue had concluded investigations and recommended to the Medicines Health Regulatory Authority (MHRA) that the trials are “safe to resume”. MHRA, in turn, confirmed that the trials could resume, the Swedish-British drug giant added.
“As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events are a clear example why we should not bias the process and should respect the process till the end,” said SII CEO Adar Poonawalla in a tweet on Saturday night after the announcement.
SII has said that it would resume trials “once DCGI will give us the permission to restart the trials in India”.
On September 6, AstraZeneca announced that the standard review process in its ongoing trials of the vaccine candidate triggered a “voluntary pause to vaccination” across “all” global sites so that independent committees and international regulators could review safety data related to the vaccine. This was reportedly flagged because of a volunteer in the UK who had developed a potentially serious adverse reaction.
“The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume,” stated AstraZeneca.
“In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety,” stated the University of Oxford in a statement, adding that, globally, some 18,000 individuals have received study vaccines as part of the trial.
“AstraZeneca and the University of Oxford, as the trial sponsor, cannot disclose further medical information. All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards,” said AstraZeneca.
According to instructions issued by the DCGI following up SII’s response on September 10, the Pune firm will only be able to resume vaccination in the Indian trials of this vaccine candidate once it submits safety clearances from the DSMB in India as well as the UK board that reviewed the global safety issue. The firm will also have to “increase safety monitoring” of the volunteers who have already been vaccinated with this candidate here and report to the regulator on these follow ups.
Around 100 participants in the trials in India had been vaccinated prior to the Indian DSMB review, before which the voluntary pause on global vaccinations was called.
Somani first issued a show cause notice to SII on September 9 for failing to alert the regulator about AstraZeneca’s decision to pause global trials while it reviewed the safety concern. At that time, SII had said this move would not impact the trials in India.
Investigations of SAE (serious adverse event) reported in the UK study is completed” and the sponsor of the global trials as well as the UK DSMB are “satisfied” that the vaccine does not pose any safety concerns.
Queries to SII about whether it had already received and submitted the UK committee’s findings to the Indian regulator remained unanswered by press time Saturday.
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