US biotech firm Moderna will not seek an emergency use authorisation for its coronavirus vaccine before November 25, its CEO told the Financial Times on Wednesday. The news deals a blow to President Donald Trump’s hopes of having an injection ready before the election to give his campaign a much-needed boost. Stephane Bancel told the newspaper: “November 25 is the time we will have enough safety data to be able to put into an EUA file that we would send to the FDA (Food and Drug Administration) – assuming that the safety data is good, i.e. a vaccine is deemed to be safe.” Trump, whose approval has taken a hit over his handling of the Covid-19 crisis, has frequently hinted a vaccine could be ready before the November 3 vote. This has raised concern among experts that his administration may attempt to interfere with the regulatory process for political reasons. The Republican repeated his claim on Tuesday night, during a debate with his Democratic rival, former vice-president Joe Biden. “It’s a possibility that we’ll have the answer before November 1,” he said. Moderna’s vaccine is one of 11 experimental vaccines in final stage trials. Another is being developed by Pfizer, whose CEO Albert Bourla has taken the position that his company may have a clear answer about whether their shot works by October. Most experts are sceptical of the claim, believing that the ongoing trials will not have sufficient statistical data to prove the drug’s safety and effectiveness by that time. Speaking to The Washington Post on Tuesday, Bourla denied he was attempting to curry favour with the president by making his October claim. Vaccines alone won’t be enough to fight Covid-19, Novartis CEO says “For me, the election day is an artificial day. The end of October is an artificial day. This is how we operate. If we can bring it earlier, we will,” he said. Meanwhile, the FDA has broadened its investigation of a serious illness in AstraZeneca Covid-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters. AstraZeneca’s large, late-stage US trial has remained on hold since September 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis. The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced Covid-19 vaccine candidates in development. The requested data was expected to arrive this week, after which the FDA would need time to analyse it, two of the sources said. Effective vaccines are seen as essential to help end a pandemic that has killed more than one million people worldwide. Regulators in Britain, Brazil, India and South Africa have allowed AstraZeneca to resume its clinical trials there. The FDA, however, wants to determine whether similar side effects emerged in trials of other vaccines designed by AstraZeneca’s coronavirus vaccine partner, researchers at Oxford University, the sources said. That does not mean the agency believes there were safety issues associated with any of these vaccines, they added. “It just shows that the FDA is being thorough,” said one of the sources. Additional reporting by Reuters