⁍ The FDA is expected to ask vaccine manufacturers seeking an emergency authorization to follow trial participants for a median of at least two months after they receive a second vaccine shot.
⁍ Few vaccine developers were expected to have definitive trial results before the presidential election.
⁍ Pfizer said on Tuesday that based on current infection rates it still expects to know whether or not their vaccine works as early as the end of October.
– The US Food and Drug Administration is expected to soon announce new, more stringent standards for an emergency authorization of a COVID-19 vaccine, lowering the chances that one might be cleared for use before the Nov. 3 election, the Washington Post reports. The FDA is expected to ask vaccine manufacturers seeking an emergency authorization to follow trial participants for a median of at least two months after they receive a second vaccine shot. It also says the agency is asking trials identify a specific number of severe cases of COVID-19 in patients who received a placebo in the trials. Few vaccine developers were expected to have definitive trial results before the presidential election. Pfizer Inc had been the exception, although its timetable could slip with the new guidance. Moderna Inc has said it is unlikely to have data in October. AstraZeneca Plc’s trial in the United States is halted while investigators try to determine whether a serious neurological problem suffered by one participant in the company’s UK trial was caused by the vaccine. Two months of follow-up would make it unlikely the companies would have enough data before mid-November. Pfizer said on Tuesday that based on current infection rates it still expects to know whether or not their vaccine works as early as the end of October.
Source: https://www.reuters.com/article/us-health-coronavirus-fda-vaccine/us-fda-to-tighten-coronavirus-vaccine-authorization-standards-ahead-of-election-paper-idUSKCN26D2X7