Moderna CEO Says Vaccine Won't Be Ready Until Next Spring
Moderna CEO Stéphane Bancel said on Wednesday that the company's potential COVID-19 vaccine will not be ready for public distribution until spring of next year.
In addition, Moderna will not seek emergency authorization for the vaccine for frontline medical workers and other at-risk individuals until Nov. 25 at the earliest.
Bancel also said that Moderna would not be ready to seek Food and Drug Administration approval for the vaccine use in the general population until at least late January.
Approval is unlikely until late March or early April if vaccine is proven to be safe and effective.
"I think a late [first quarter], early [second quarter] approval is a reasonable timeline, based on what we know from our vaccine," Bancel was quoted in a report.
A Moderna spokesperson confirmed Bancel's comment at the conference noting that the company expects to have enough vaccine testing data to ask for FDA emergency use authorization.
The spokesperson said this could be done by Nov. 25.
The timeline is a setback for Moderna as it earlier said this month that it could seek emergency authorization for a vaccine as early as Nov. 1.
It also deals a blow to claims by President Donalt Trump.
Trump earlier claimed in his debate with Democratic presidential candidate Joe Biden that a vaccine could be ready in week or before the Nov. 3 election.
"I've spoken to Pfizer, I've spoken to all of the people that you have to speak to - Moderna, Johnson & Johnson and others," Trump was quoted.
Meanwhile, Moderna shares plummeted $4 to just over $70 a share on the news of its revised timeline.
Moderna did not respond to a request for a comment.
Other potential coronavirus vaccines are now doing late-stage testing.
More than 170 potential treatments are under development.
Deutsche Bank analysts said that about a third of vaccine candidates typically make it through all phases of testing.
Meanwhile, Pfizer CEO Albert Bourla and vaccine partner BioNtTech have said the companies expect phase 3 data by the end of October, adding that an FDA application could soon follow.
But more than 60 researchers and bioethicist urged the partners to wait for more safety data before submitting their shot for distribution.
Experts called on Pfizer to wait until late Novmber at least to submit its vaccine to the FDA.
The experts said that to be successful, the public needs to have the utmost trust in the vaccine and science behind it.
Submission of an application for an EUA before this standard is met would severely erode public trust and set back efforts to achieve widespread vaccination," the experts were quoted.
Pfizer's phase three trial had enrolled more than 35,000 participants as of Monday.
More than 24,000 had received their second doses.
The company aims to include around 44,000 people for the trial.
A Pfizer spokesperson said the company is very appreciative of the experts' input.
The spokesperson added that the company is committed to giving sufficient efficacy and safety data to help FDA.
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