|
 However, Chief Executive Stanley Erck added that talks with the U.S.
Food and Drug Administration are ongoing and the agency may require
Novavax to submit data from its U.S. trial, which could take an
additional two months to complete, pushing back U.S. clearance to
mid-summer.
Novavax shares were off 5.6% at $226.85 in extended trading after
initially rising following release of its quarterly results. The
shares have soared about 2,400% from $9.82 on Jan. 21, 2020, when
the company announced it was developing a vaccine against the
coronavirus.
Preliminary data from its UK trial released in January showed the
vaccine to be around 96% effective against the original version of
the coronavirus and around 86% effective against the now widely
circulating variant first discovered in Britain.
Novavax can already manufacture its shots at scale and will be able
to have tens of millions of doses stockpiled and ready to ship in
the United States when it receives authorization, Erck said.
"It will be substantial - in the many tens of millions or a hundred
million," Erck said in an interview.
Novavax had promised to deliver 110 million doses to the U.S.
government by the end of the third quarter. That could happen as
early as July, Erck said.
Novavax's vaccine production plants should all be fully functional
by April, said Novavax research chief Gregory Glenn on a conference
call after the company reported quarterly results.
"In April, May, June, we should be finishing filling and finishing
product in advance of regulatory approvals," Glenn said.
[to top of second column] |
 In late January, Erck said he
expected it would take several weeks for Novavax
to file U.K. trial data with regulators in the
United Kingdom, Europe and elsewhere. Novavax
could produce up to 150 million doses per month
by May or June, he had added in January in an
interview.
The Novavax shot, if authorized, would add to
the vaccine options for millions of Americans
awaiting immunization against the coronavirus.
Johnson & Johnson's one-dose vaccine on Saturday
become the third to win U.S. emergency use
authorization (EUA). Vaccines produced by Pfizer
Inc with partner BioNTech and Moderna Inc
received EUAs in December.
Novavax's vaccine is a two-dose regimen like
Pfizer's and Moderna's, but is easier to ship as
it can be stored at refrigerator temperatures,
rather than frozen.
Novavax promised to deliver doses to the United
States after the Trump administration awarded it
$1.6 billion to help finance research,
development and production of a COVID-19
vaccine.
Novavax completed enrollment of its
30,000-subject U.S.-based trial in February.
(Reporting by Carl O'Donnell; Editing by Bill
Berkrot and Alistair Bell)
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