This article contains:
AstraZeneca's COVID-19 Vaccine Trials On Pause
AstraZeneca's COVID-19 Vaccine Trials On Pause
Written By: Paphapin Pairojtanachai
On September 8, AstraZeneca, along with eight other COVID-19 vaccine developers, reassured the public concerning the safety of vaccines by signing a pledge “to uphold scientific and ethical standards” and to apply for approval only after their vaccines have gone through three phases of clinical study. The British-Swedish biopharmaceutical company did not fail to keep its promise.
A day later, after a woman in the United Kingdom who was injected with the company’s COVID-19 vaccine exhibited neurological symptoms of transverse myelitis, a rare but serious inflammatory syndrome that affects the spinal cord, the company immediately announced to temporarily halt the randomized, controlled clinical trials of the vaccine known as AZD1222, which was co-invented by the University of Oxford and Vaccitech. This was to allow an independent committee to begin a standard review process due to the unexplained illness that the participant experienced during the phase III trial.
AstraZeneca’s vaccine trial has only recently moved to phase III, involving 30,000 participants in the US as well as around 20,000 in the UK, India, Brazil, and South Africa. The standard review is being done by the Medicines and Healthcare products Regulatory Agency (MHRA), and they could arrive at a final decision on whether or not to restart the trial within a few days.
Although this is the first phase III COVID-19 vaccine known to have been put on hold, such a hold is “not uncommon at all,” as Anthony Fauci, MD, head of the National Institute of Allergy and Infectious Diseases, has said. Dr. Francis Collins, the director of the National Institutes of Health, also informed that the purpose of the clinical hold is to try to figure out whether the unprecedented illness is due to the vaccine or to coincidence and the trial volunteer was going to get that illness anyway. “You investigate carefully to see if anybody else who received that vaccine or any of the other vaccines might have had a similar finding of a spinal cord problem,” he explained. This is why phase II and phase III trials are extremely crucial when it comes to testing vaccines, because these rare but serious side effects only show up in large trials in which thousands of people receive the vaccine.
It is very rare for the FDA to approve vaccines that are associated with this type of event in late-stage trials, so this will definitely factor into the agency’s decision to greenlight the vaccine. Even so, many medical experts agree that it is encouraging to see AstraZeneca put the vaccine’s clinical study on pause. Members of the public need to understand that clinical trials often do not run smoothly, and temporary holds are usually considered normal if the study is rigorous enough. In fact, a bioethicist at Lurie Children’s Hospital in Chicago, Seema K, even mentions that “If nothing goes wrong while you’re testing it, maybe you didn’t test it well enough.” This is how clinical trials are supposed to be carried out.
Pascal Soriot, the CEO of AstraZeneca, said: “At AstraZeneca we put science, safety and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts. We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”
As of yesterday, September 12, the University of Oxford has reported that the trial will proceed in the UK — although it did not say when — and that health authorities are discussing when the trials in other parts of the world will be able to resume.
Comments