Reuters, Feb. 8 – Novavax Inc (NVAX.O) has only delivered a portion of the 2 billion COVID-19 injections it promises to distribute throughout the globe in 2022 and has delayed shipments in Europe and lower-income nations like the Philippines, according to public officials engaged in their governments’ vaccine rollouts.
Novavax said it has only delivered around 10 million vaccine doses so far, but it is working to send its contractual supply for this quarter as rapidly as possible.
Some shipments have been delayed by regulatory procedures and are now awaiting delivery to healthcare professionals, according to Novavax spokeswoman Amy Speak.
Novavax, situated in Gaithersburg, Maryland, has aspirations to give a vaccine for the whole globe, pledging to deliver its doses by mid-2021.
Buyers went to competitors such as Pfizer Inc (PFE.N)/BioNTech SE, Moderna Inc (MRNA.O), and Chinese drugmakers after the little business failed its 2021 objectives.
According to officials in those regions, delays in shipments to the European Union, Indonesia, and the Philippines were caused by a late regulatory approval from the World Health Organization (WHO), export restrictions imposed by its manufacturing 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.
As a result of the supply delays, at least one government is rethinking its Novavax purchase.
According to corporate data and analytics firm GlobalData Plc, the company has failed to deliver vaccines on its biggest contract for 1.1 billion doses to COVAX, a worldwide vaccination distribution program for impoverished nations, which would make Novavax its third-largest supplier.
Novavax did not specify a schedule but told Reuters that in the current quarter, it intends to deliver roughly 80 million doses to COVAX, which is less than 10% of the total.
Novavax doses are scheduled to be given shortly, according to a representative for the GAVI vaccination partnership, which co-runs COVAX with the WHO.
“It’s troubling when they claim they’re ready to send millions of doses but the figures you’re hearing are different,” Mayank Mamtani, a healthcare analyst at B. Riley Securities, said.
According to Refinitiv statistics, Novavax is estimated to earn roughly $5 billion in 2022 from COVID-19 vaccine sales.
WHO and European Union officials, as well as India, Indonesia, and the Philippines have given their approval to the two-dose vaccination.
According to trial results, the vaccine is more than 90% effective in avoiding serious disease and death.
Low- and middle-income nations would be the worst hit if Novavax fails to deliver on time, according to Stephen Morrison, director of global health policy at the Center for Strategic and International Studies in Washington, D.C. “It’ll be an unpleasant experience for COVAX and its bilateral partners.”
Late this year, Novavax started exporting Serum Institute-produced dosages to Indonesia.
Despite India’s claim that Serum Institute sent over 10 million injections to Indonesia in November and December, an Indonesian official who did not want to be identified stated the nation only got around 200,000 doses. According to Novavax, the Indian government has approved the shipment of 20 million Serum injections to Indonesia.
RENEGOTIATING THEIR AGREEMENT
The Philippines has not received any of the 30 million shots it requested, according to a government official.
According to Vaccination Secretary Carlito Galvez, director of COVID-19 vaccine procurement for the Philippines, the Philippines is renegotiating its contract with Novavax and contemplating decreasing its purchase, in part because it has 96 million vaccine doses in its national stockpile. Nine COVID vaccines have been approved in the nation.
Novavax declined to comment on the deliveries or the new contract in the Philippines.
Novavax had said that injections will be available in Europe by January, but this has been postponed, according to a company representative. The first shipments from Serum Institute were sent to the company’s distribution center in the Netherlands, where they are awaiting final regulatory approval before being released, she added.
As a consequence, at least two EU nations have pushed back their timeframes for providing Novavax doses, according to a source familiar with the situation.
Novavax has had trouble securing the final regulatory approval because it hasn’t provided enough information regarding batches manufactured in India, according to a source familiar with the company’s talks with EU regulators. Initial supplies to the EU would come from India, according to the agreement.
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The Dutch health authority RIVM, which is in charge of approving the batches, has refused to comment on the cause for the delay but has said that the vaccine would be available in early March.
“We anticipate to ship as soon as testing and release are completed, and we are trying to make that happen as soon as possible,” stated a Novavax spokeswoman.
Novavax’s injection was licensed in the United Kingdom on February 3, but the company has not said when it would begin delivering dosages there.
Novavax applied for FDA approval in the United States late last month, about a year after it had expected to do so.
“The question is whether these products and logistical challenges will get better with time,” said Peter Shapiro, a pharmaceutical industry analyst at GlobalData.