British-Swedish pharmaceutical company AstraZeneca’s large-scale human COVID-19 vaccine trial has been paused after one of the participants developed an unexplained illness. A spokesperson for AstraZeneca said the pause is “routine” and occurred when the firm’s standard review process was triggered. An independent committee will now review safety data pertaining to the trial. AstraZeneca stressed that an adverse reaction was only witnessed in one study participant, and that pausing trials was a common part of the vaccine development process. No details have been released about the nature of the participant’s illness, but it has been reported that the individual is expected to recover. Right now, all trials of the joint AstraZeneca-University of Oxford developed vaccine, AZD1222, have been halted worldwide, including in the United States, UK, Brazil, South Africa, and India. AZD1222 is one of three COVID-19 vaccines in late-stage Phase 3 trials in the United States. AstraZeneca and eight other drug makers have said they will not seek approval from US government regulators for any vaccine until all data showed it was safe and effective. All of the companies, which include Johnson & Johnson, Merck & Co, GlaxoSmithKline, Novavax Inc, Sanofi and BioNTech, said “the safety and well-being of vaccinated individuals” was their top priority.
With the number of confirmed COVID-19 cases worldwide now at more than 25 million, any news involving potential vaccines is important, which is why a recent announcement from AstraZeneca Plc is exciting. The British multinational pharmaceutical and biopharmaceutical company, which has its headquarters in Cambridge, England, says it has begun to enroll 30,000 participants aged above 18 in the United States for a large-scale human trial of its COVID-19 vaccine candidate, AZD1222. The US trial will evaluate whether the vaccine can prevent COVID-19 infection or keep the illness from becoming severe, the National Institutes of Health said in a statement. It also will assess if the vaccine can reduce incidence of emergency department visits due to COVID-19. AstraZeneca says the study is being funded by the US Government and that participants will either receive two doses of either AZD1222 or a saline control (a placebo), four weeks apart. The AstraZeneca shot, which has been developed by researchers from the University of Oxford, is one of the farthest along of numerous COVID-19 vaccines in development. As well as the US trial, a final-stage test of the vaccine is underway in the United Kingdom. Preliminary results from this test could be yielded as soon as next month. Other companies that have COVID-19 vaccines in phase 3 trials include Moderna Inc. and Pfizer Inc.
A coronavirus vaccine developed by the Universality of Oxford and AstraZeneca appears safe and triggers an immune response that should protect people against infection. According to a trial of the vaccine involving 1,077 participants, the findings of which are published in The Lancet, the vaccine led to individuals making antibodies and T-cells that fight SARS-CoV-2, the new coronavirus. Within just 14 days of receiving the vaccine, participants’ T-cell levels peaked. After 28 days participants’ antibody levels peaked. Both T-cells and antibodies are crucial in the body’s immune defence of viruses, which is why any effective vaccine needs to induce both in the people who receive it. But while the findings are immensely promising, more research is needed to determine exactly how safe the vaccine is, whether it can indeed provide protection against SARS-CoV-2 and how long any protection would last. Nevertheless, the UK has already ordered 100m doses of the vaccine. Prof Andrew Pollard, from the Oxford research group, told the BBC: “We're really pleased with the results published today as we're seeing both neutralising antibodies and T-cells. “They're extremely promising and we believe the type of response that may be associated with protection. “But the key question everyone wants to know is does the vaccine work, does it offer protection... and we're in a waiting game.” The next step is for more than 10,000 people to take part in the next stage of the trial to further determine how safe the vaccine is. [Related reading: World leaders pledge billions to help develop coronavirus vaccine]