|
 The Pennsylvania-based biopharmaceutical firm is partnering with
India's Bharat Biotech, a developer of the vaccine, to commercialize
the shot in the United States. COVAXIN was shown to be 81% effective
in an interim analysis of late-stage trial data on some 26,000
people in India.
Musunuri said Ocugen aimed to launch the two-dose vaccine in the
United States in the second quarter of 2021, initially with imported
shots before beginning production there.
It is unclear whether the U.S. government is seeking additional
vaccine suppliers. The U.S. Department of Health and Human Services,
which runs Operation Warp Speed, declined to comment on potential
interest in COVAXIN.
Musunuri said Ocugen had held initial talks with the U.S. Food and
Drug Administration and planned to seek emergency use authorization
in April. The FDA declined to comment.
The U.S. government's Operation Warp Speed program to bring COVID-19
vaccines to market quickly has ordered over 800 million doses from
Pfizer/BioNTech, Moderna and Johnson & Johnson <JNJ.N>, the first
three shots to be authorized for emergency use in the country.
Additional supply has been ordered from at least two other
drugmakers.
Pfizer, Moderna and J&J are expected to deliver more than enough
shots for all adult Americans by the end of May.
Bharat Biotech says as many as 40 countries are interested in
COVAXIN and it has sought emergency approvals in Brazil and the
Philippines. Cracking the U.S. market would be a significant
milestone for the company and India's vaccine industry, the world's
largest.
"They're fine with the way the interim analysis is being done,"
Musunuri said of the FDA, adding that Ocugen had "a regulatory path"
to take the process forward.
The FDA has so far required that COVID-19 vaccine makers test their
shots in the United States, and the agency must sign off on the
manufacturing at each facility that makes the vaccine.
Musunuri said COVAXIN had the potential to work against COVID-19
variants and Ocugen could initially focus on children as it was
likely to be safe for those over the age of 12, while shots produced
by other drugmakers targeted adults.
[to top of second column] |
 Pfizer's vaccine has been
authorised for emergency use in the United
States for individuals 16 years and older, with
the other two given authorisation for emergency
use in people 18 years and above.
Pfizer and Moderna are testing their vaccines in
trials involving thousands of children. Johnson
& Johnson plans to start their trial in children
soon. "Like a polio virus given
to babies, this could be safe for all children, high-risk groups,
pregnant women and people with comorbidities," Musunuri said of
COVAXIN.
BOOSTER SHOT
He said Ocugen was expecting more data from Bharat Biotech on
COVAXIN after a study by the Indian company in January which showed
the shot was likely to be effective against the British strain of
the coronavirus.
India's drug regulator approved COVAXIN for emergency use in January
for people above 12, saying it could act against the whole body of a
virus instead of just its "spike-protein" tip, potentially making it
more effective in case of mutations.
Musunuri said this could mean it could be used as a booster for
people already vaccinated with a first dose of other shots.
He said Bharat Biotech would export "tens of millions of doses" to
Ocugen, which is also finalising U.S. contract- manufacturers for
the product.
Shares in Ocugen have nearly tripled this year, taking it close to a
$2 billion market capitalisation, helped by a spike when Bharat
Biotech announced its late-stage trial results.
COVAXIN has been given to more than 2 million prioritised adults in
India since the country's vaccination drive began in mid-January.
Bharat Biotech says it wants to produce about 700 million doses a
year domestically.
(Reporting by Krishna N. Das; Editing by Alexander Smith and Howard
Goller)
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