|
 Novavax said it has completed delivery of only around 10 million
vaccine doses so far, but is moving as quickly as possible to ship
its contracted supplies for this quarter.
Some shipments have been held up by regulatory processes and are
waiting in a distribution warehouse to go to healthcare providers,
Novavax spokesperson Amy Speak said.
Gaithersburg, Maryland-based Novavax, which had never launched a
product, had ambitions to provide a vaccine for the world, promising
to deliver its shots by mid-2021.
When the tiny company missed 2021 targets, buyers turned to rivals
including Pfizer Inc/BioNTech SE, Moderna Inc, and Chinese
drugmakers.
Shipments to the European Union, Indonesia and the Philippines were
held back by a late regulatory approval from the World Health
Organization (WHO), export limitations of its production partner the
Serum Institute of India, and delayed approval of individual vaccine
batches by European regulators, who must vet the shots before they
can be distributed, according to officials in those regions.
The delivery delays have left at least one country reconsidering its
Novavax order.
The company has yet to deliver vaccine on its largest contract for
1.1 billion doses to COVAX - a global vaccine distribution program
for poorer countries - which would make Novavax its third largest
supplier, according to business data and analytics firm GlobalData
Plc.
Novavax did not provide a timeline but told Reuters it expects to
deliver around 80 million doses in the current quarter to COVAX,
less than 10%.
A spokesperson for the GAVI vaccine alliance that co-runs COVAX with
the WHO said it expected Novavax doses to be delivered soon.
"It's concerning when they have been saying they have been ready to
ship millions of doses but the numbers you’re hearing are
different," said Mayank Mamtani, a healthcare analyst at B. Riley
Securities.
Novavax is expected to earn around $5 billion in 2022 from COVID-19
vaccine sales, according to Refinitiv data.
Its two-dose vaccine has been authorized by WHO and European Union
regulators, as well as countries including India, Indonesia and the
Philippines.
Trial data has shown the vaccine is more than 90% effective in
preventing severe illness and death.
Low- and middle-income countries will feel the pinch the most if
Novavax is missing planned shipments, said Stephen Morrison, the
director of the global health policy at Washington D.C. research
group Center for Strategic and International Studies. "It's going to
be painful for COVAX and painful for its bilateral partners."
Novavax began delivering Serum Institute-produced doses to Indonesia
late last year.
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 Although India has said Serum Institute shipped
around 10 million shots to Indonesia in November
and December, an Indonesian official who
declined to be named said the country has
received only around 200,000 doses. The Indian
government has cleared 20 million Serum shots to
be shipped to Indonesia, Novavax said.
RENEGOTIATING ITS CONTRACT
A Philippines official said the country has not received any of the
30 million shots it ordered.
The Philippines is renegotiating its contract and considering
reducing its order from Novavax, in part because it has 96 million
vaccine doses in its national stockpile, said Vaccination Secretary
Carlito Galvez, head of COVID-19 vaccine procurement for
Philippines. The country has authorized nine COVID vaccines.
Novavax did not comment on the Philippines deliveries or new
contract.
Novavax had said it would roll out shots in Europe by January but
that has been delayed, the company spokesperson said. The initial
shipments from Serum Institute were delivered to its distribution
facility in the Netherlands and are awaiting final regulatory
clearance for release, she said. At least two EU
countries have pushed back their planned timelines for administering
Novavax shots as a result, a person familiar with the matter said.
Novavax has had difficulty getting the final regulatory nod because
it has yet to provide sufficient information about batches produced
in India, a person familiar with discussions between Novavax and EU
officials said. Under the EU deal, initial supplies to the bloc
would come from India.
Dutch health authority RIVM, which is tasked with clearing the
batches, declined to comment on the reason for the timing but said
the vaccine will be available from early March.
“We expect to ship as soon as the testing and release is complete
and we are working to make that happen as quickly as possible,” the
Novavax spokesperson said.
The UK approved Novavax’s shot on Feb. 3, but the drugmaker has not
said when it will begin distributing doses there.
Novavax filed for U.S. authorization late last month, almost a year
after it had originally planned to do so.
Peter Shapiro, a pharmaceutical industry analyst at GlobalData,
said: “The question is whether these manufacturing and logistics
issues are going to get better with time.”
(Reporting by Carl O'Donnell in New York, Francesco Guarascio in
Brussels, and Neil Jerome Morales in the Phillippines; additional
reporting by Stanley Widianto in Jakarta, Krishna Das and Neha
Aurora in New Delhi; Editing by Caroline Humer and Bill Berkrot)
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