Moderna CEO Says Vaccine Won't Be Ready Before Election Day

In an interview with the FT, Moderna CEO Stephane Bancel acknowledged that his company wouldn't be able to apply for emergency authorization of its vaccine candidate before election day. The news - Bancel had left open the possibility that the vaccine would be ready by the end of October - deals another blow to Trump's hopes of producing a vaccine before the election, something that was on display during last night's debate.

Bancel said the company wouldn't be ready to apply for FDA approval until Nov. 25 at the earliest. Approval to distribute the vaccine to all segments of the population, beyond just health care workers and the most vulnerable, may not arrive until the spring.

"November 25 is the time we will have enough safety data to be able to put into an EUA [emergency use authorisation] file that we would send to the FDA — assuming that the safety data is good, ie a vaccine is deemed to be safe," Bancel said at a US Pharma and Biotech conference hosted by the FT.

Here's some more on the timeline for the Moderna vaccine (which, remember, was subsidized by nearly $1 billion in federal taxpayer dollars).

Mr Bancel said Moderna would not be ready to file an application to serve the whole population until at least late January, making March the earliest he thought it could be approved. “I think a late [first quarter], early [second quarter] approval, is a reasonable timeline, based on what we know from our vaccine.” He added it would not be possible for Moderna to file for a limited emergency authorisation before November 1, due to guidelines agreed with the FDA that require at least half of trial participants to have undergone two months of screening following their final injection. Moderna injected the 15,000th participant in its 30,000-person trial last Friday, he said, making November 25 the earliest it could complete the two-month screening.

The FT noted that President Trump's best hope for a pre-election day announcement will most likely come from Pfizer. CEO Albert Bourla has said the company will have "an answer" on the vaccine it's developing with Germany's BioNTech by the end of October.

https://www.zerohedge.com/geopolitical/new-research-hints-lower-herd-immunity-threshold-eu-approves-new-rapid-covid-19-test