AstraZeneca resumes coronavirus vaccine trials in the UK, but it's unclear when it will restart elsewhere
The vaccine trials were paused temporarily because of unexplained illness in a participant but now the UK's MHRA has recommended that it is safe to resume
The AstraZeneca coronavirus vaccine trials, which were paused temporarily because of unexplained illness in a participant, have resumed in the UK. The company said that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has recommended that it is safe to resume the trials. The vaccine candidate was co-invented by the University of Oxford and its spin-out company, Vaccitech.
"Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the MHRA that it was safe to do so. On September 6, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees and international regulators. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume," said AstraZeneca in a statement.
While trials in the UK have received the green signal, the status of trials elsewhere remains unclear. "AstraZeneca is committed to the safety of trial participants and the highest standards of conduct in clinical trials. The company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably, and at no profit during this pandemic," said the company.
AstraZeneca's vaccine candidate is one of those in the late-stage human clinical trials — the final step before approval if it is found to be safe and effective. On September 9, a statement issued by AstraZeneca explained, "This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials. In large clinical trials, illnesses will happen by chance and must be independently reviewed."
AstraZeneca and the University of Oxford, as the trial sponsor, has not disclosed any further medical information about the participant who fell ill. "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 the University of Oxford, an estimated 18,000 individuals have received study vaccines as part of the trials globally. "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," it said.
The US has already invested billions in potential coronavirus vaccines, including AZD122. The US Department of Health and Human Service (HHS) has announced up to $1.2B in support of AstraZeneca’s candidate vaccine. The agreement is to make available at least 300M doses of the vaccine for the US, with the first doses delivered as early as October 2020 and phase 3 clinical studies beginning this summer with approximately 30,000 volunteers in the US.
There are currently over 169 Covid-19 vaccine candidates under development, with 26 of these in the human trial phase, according to the World Health Organization (WHO). "WHO is working in collaboration with scientists, business, and global health organizations through the ACT (access to Covid-19 tools) Accelerator to speed up the pandemic response. When a safe and effective vaccine is found, COVAX (an initiative led by WHO, Gavi, and the Coalition for Epidemic Preparedness Innovations) will facilitate the equitable access and distribution of these vaccines to protect people in all countries. People most at risk will be prioritized," said the agency.