One of the most promising coronavirus vaccines ran into a problem, which has raised awareness of the probabilities of clinical development and the safety risks involved.
The news that AstraZeneca Plc suspended testing of its experimental vaccine after a patient fell ill is a routine event for the pharmaceutical industry. It could be a harbinger of something concerning or totally unrelated to the vaccine.
But in a world paralyzed by the pandemic, the reverse is a reminder that vaccines can fail, or worse, that they can sometimes cause more harm than good: a disclaimer for politicians and governments who promise that a solution against COVID-19 is very close. This week, the drug companies involved pledged to make safety a priority and to take time for science to prevail.
The suspension “shows the dangers of rushing to market,” he said. Sam Fazeli, analyst de Bloomberg Intelligence, adding that no experimental vaccine is immune from such setbacks, especially now that the experimental products are being administered to tens of thousands of people in the last crucial phase of clinical testing.
Astra’s situation reinforces the need for the discipline involved in following the traditional testing process. Yet that is not an easy message for people hoping for breakthroughs after months of confinement and economic uncertainty.
Researchers are carefully studying a patient’s unexplained illness, Astra said. If the problem turns out to be related to the adenoviral vector used, the delay in the work of the British pharmaceutical company could also affect others that depend on similar technology, such as Johnson & Johnson and China’s CanSino Biologics Inc., according to Fazeli.
“Many trials are temporarily halted to investigate potential safety issues and are never discussed, but this is clearly a very high-profile study and therefore every step of it undergoes very in-depth analysis,” he wrote. Adam Barker, analyst Shore Capital, in a report to clients. The suspension will likely delay the study results that were due in November, he said.
Drug makers have condensed their vaccine development timeline, which typically takes years, to months. Some of the test results that are about to be released could offer more surprises. Typically, only 6% of experimental vaccines are successful. Scientists have spent decades trying to develop a vaccine against HIV.
News about the vaccine Astra is developing with the University of Oxford should not affect the development of rival products based on other technologies, such as the experimental vaccine from Pfizer Inc. and its partner BioNTech SE, which could return test results in October. . Other pharmaceutical companies working on vaccines include Moderna Inc., Sanofi, and China’s SinoVac Biotech Ltd.
“Any vaccine trial has to go through strict ethical approval,” said Liu Peicheng, a spokesman for SinoVac, adding that Astra’s setback would not affect the company’s plans or schedule.
Politicians have helped fuel expectations about a vaccine. US health authorities and President Donald Trump have said a vaccine is possible before the end of the year and possibly next month.
But ensuring a safe product may take longer, especially since the vaccine could end up being administered to millions of people who are healthy and would only develop mild symptoms of covid-19.
Need for a break
“The vaccine would be given to many people to prevent them from contracting a disease that probably would not harm them, in order to prevent spread in the community to more vulnerable people,” said Barker of Shore. “In that scenario, safety becomes the top priority. Any major safety issue would end up being conclusive for a vaccine candidate. “
Russia has tried to skip stages of the process in the race to be the first to launch a vaccine against COVID-19, approving its Sputnik V product before it underwent the full testing process and generating widespread skepticism. A group of international scientists have questioned the results of a vaccine study, saying that some of the findings seem unlikely.
“The world is completely focused on having a vaccine,” he said. Kristine Macartney, Director of the Australian National Center for Immunization Research and Surveillance. “But we just have to pause and see what the next few days hold.”