AstraZeneca has resumed the U.S. trial of its experimental COVID-19 vaccine after approval by regulators, and Johnson & Johnson is preparing to resume its trial on Monday or Tuesday, the companies said on Friday.
The news signaled progress against the novel coronavirus that has infected more than 41 million globally, including 8 million Americans and comes 10 days before a U.S. presidential election that may hinge on plans to fight the pandemic.
AstraZeneca, one of the leading vaccine developers, paused its U.S. trial on Sept. 6 after a report of a serious neurological illness, believed to be transverse myelitis, in a participant in the company’s UK trial.
J&J paused its large, late-stage trial last week after a study participant became ill.
Both companies have contracts to provide vaccine to the United States and other governments if they are cleared by regulators.
Officials and experts have expressed concern that the regulatory approval process overseen by the Food and Drug Administration (FDA) will be undermined by political pressure, and around a quarter of Americans say they are hesitant to take a COVID-19 vaccine.
nfections are rising in 80 countries here as people in the northern hemisphere spend more time indoors with winter approaching.
J&J said on Friday that the safety panel, called a Data and Safety Monitoring Board, has recommended that the drugmaker resume trial recruitment after finding no evidence that the vaccine caused the volunteer to fall ill.
J&J expects to resume its trial in the United States on Monday or Tuesday and remains on track to produce data from the trial on the vaccines’ effectiveness by the end of 2020 or early 2021, J&J’s chief scientific officer Paul Stoffels said.
J&J is also in discussions with other regulators to resume a trial outside of the United States, the company said.
So far, the medical board has not identified a clear cause for the patients’ illness. J&J cannot reveal any details about the patient’s sickness because of patient privacy rules, Stoffels said.
AstraZeneca said that it is not unusual for some trial participants to fall ill during large scale vaccine trials but that the U.S. Food and Drug Administration has reviewed all safety data from the trials globally and deemed it safe to continue testing the vaccine.
AstraZeneca trials in the United Kingdom, Brazil and South Africa resumed last month even as the U.S. Food and Drug Administration continued its investigation into the case.
Reuters earlier this week reported that the FDA had completed its review and that the AstraZeneca U.S. trial was set to resume as early as this week, citing four sources familiar with the situation.
AstraZeneca’s vaccine is being developed along with researchers at Oxford University.
In Switzerland a 2,000-square-metre space in the new Lonza factory is still a construction site. But Torsten Schmidt, who heads the company’s Visp facility in canton Valais, southwestern Switzerland, is confident.
“Everything will be ready to produce the first doses in December,” he told reporters on Tuesday.
The Swiss pharma company is building three vaccine production lines in Visp at a cost of $210 million (CHF191 million) to supply 300 million doses annually for the rest of the world. In parallel, new production lines at Lonza’s site in Portsmouth, New Hampshire, aim to start making vaccine ingredients exclusively for the US in November.
Meanwhile Health officials reviewing Gilead Science Inc’s remdesivir against COVID-19 should consider all evidence, including a trial in which the medicine failed, before giving it the green light, the top WHO scientist said on Friday.
U.S. regulators appeared not to have done so when approving the drug this week, Soumya Swaminathan told a news conference.
The U.S. Food and Drug Administration on Thursday approved Gilead’s antiviral drug for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.
The FDA decision came a week after the release of the results of the World Health Organization’s Solidarity trial, which concluded remdesivir has little or no impact on a patient’s chances of surviving COVID-19.
The FDA said its approval was based on three trials, including a 1,062-patient study by the National Institute of Allergy and Infectious Disease, which found that remdesivir reduced hospital stays to 10 days from 15 days, and helped reduce the risk of death in some patients who were receiving oxygen. The drug did not improve overall survival.