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Novavax falls short of their COVID vaccination promises

FILE PHOTO: A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in front of displayed Novavax logo in this illustration taken, October 30, 2020. REUTERS/Dado Ruvic

Novavax Inc has only delivered a small portion of the 2 billion COVID-19 shots it wants to send around the world in 2022, and has delayed first-quarter shipments in Europe and lower-income nations such as the Philippines.

The news: Novavax said it has only delivered about 10 million vaccine doses so far, but it is working to ship its contracted supplies for this quarter as rapidly as possible.

  • Some shipments have been delayed by regulatory processes and are currently awaiting delivery to healthcare professionals, according to Novavax spokesperson Amy Speak.
  • Novavax, situated in Gaithersburg, Maryland, has aspirations to give a vaccine for the entire world, pledging to deliver its doses by mid-2021.
  • Buyers moved to rivals such as Pfizer Inc/BioNTech SE, Moderna Inc, and Chinese drugmakers after the little business missed its 2021 targets.
  • 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 reconsidering its Novavax order.

What’s going on: According to corporate data and analytics firm GlobalData Plc, the company has failed to deliver on its largest contract for 1.1 billion doses to COVAX, a global vaccination distribution programme for impoverished countries, which would make Novavax its third largest supplier.

  • Novavax did not specify a schedule, but said that in the current quarter, it intends to deliver roughly 80 million doses to COVAX, which is less than 10 per cent of the total.
  • Novavax doses are scheduled to be given soon, according to a representative for the GAVI vaccination partnership, which co-runs COVAX with the WHO.
  • According to Refinitiv data, Novavax is estimated to earn roughly $5 billion in 2022 from COVID-19 vaccine sales.

What’s important: WHO and European Union officials, as well as India, Indonesia, and the Philippines, have given their approval to the two-dose vaccine.

  • According to trial results, the vaccine is more than 90 per cent effective in preventing serious disease and death.
  • Low- and middle-income countries will be the hardest 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’s going to be painful for COVAX and painful for its bilateral partners.”

What happened: Late last year, Novavax began exporting Serum Institute-produced dosages to Indonesia.

  • Despite India’s claim that Serum Institute sent over 10 million shots to Indonesia in November and December, an Indonesian official who did not want to be identified said the country only received about 200,000 doses. According to Novavax, the Indian government has approved the shipment of 20 million Serum shots to Indonesia.

What they’re saying: The Philippines has not received any of the 30 million shots it requested, according to a government official.

  • According to Vaccination Secretary Carlito Galvez, head of COVID-19 vaccine procurement for the Philippines, the Philippines is renegotiating its contract with Novavax and considering decreasing its purchase, in part because it has 96 million vaccine doses in its national stockpile. Nine COVID vaccines have been approved in the country.
  • Novavax declined to comment on the deliveries or the new contract in the Philippines.
  • Novavax had stated that shots will be available in Europe by January, but this has been postponed, according to a company representative. Serum Institute’s initial shipments were transferred to its distribution centre in the Netherlands, where they are awaiting final regulatory approval before being released.
  • As a result, at least two EU countries 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 produced in India, according to a source familiar with the company’s discussions with EU officials. Initial supplies to the EU would come from India, according to the agreement.
  • The Dutch health authority RIVM, which is in charge of clearing the batches, has refused to comment on the cause for the delay, but has stated that the vaccine will be available in 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.
  • Novavax’s shot was licenced in the United Kingdom on February 3, but the company has not stated when it will begin distributing dosages there. Novavax applied for FDA approval in the United States late last month, about a year after it had expected 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.”
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