Novavax underdelivers due to COVID-19 vaccine promise


Novavax Inc. will deliver a small portion of the 2 billion COVID-19 shots it plans to send worldwide in 2022, the first in low-income countries such as Europe and the Philippines, a government-affiliated civil servant. Postponed quarterly shipments. The development of the vaccine told Reuters.

Novavax said the vaccine dose to Indonesia reached about 10 million doses and millions of vaccines arrived in Australia and New Zealand on Monday. The company declined to comment on the exact number of deliveries it has made so far, but said it is moving as quickly as possible to ship contract supplies this quarter.

Some shipments have been suspended by a regulatory process and are waiting to be sent to healthcare providers in distribution warehouses, according to Novavax spokeswoman Amy Speak.

Novavax shares fell nearly 10% in early trading.

Based in Gaithersburg, Maryland, Novavax has never launched a product, promised to provide the vaccine by mid-2021, and had the ambition to provide the vaccine to the world.

When the small company failed to meet its 2021 target, buyers turned to rivals such as Pfizer / BioNTech SE, Moderna and Chinese pharmaceutical companies.

Shipments to the European Union, Indonesia and the Philippines have been delayed by regulatory approval from the World Health Organization (WHO), export restrictions from our production partner, the Indian Serum Institute, and approval of individual vaccine batches by European regulators. Was suppressed by the delay of. According to officials in these areas, the shots need to be scrutinized before distribution.

Due to delivery delays, at least one country has revisited Nuvavax’s orders.

According to business data and analytics company Global Data Plc, the company has not yet provided COVAX with 1.1 billion doses of vaccine under its largest contract. This is a global vaccine distribution program for poor countries, making Novavax the third largest supplier.

Novavax did not provide a timeline, but told Reuters that it plans to provide COVAX with doses of less than 10% about 80 million times this quarter.

A spokesperson for the GAVI Vaccine Alliance, which co-operates COVAX with WHO, said he expects a dose of Novavax to be delivered soon.

B. Mayankuma Mutani, Healthcare Analyst at Riley Securities, said:

According to Refinitiv data, Novavax is expected to make about $ 5 billion from the sale of the COVID-19 vaccine in 2022.

The double dose vaccine has been approved by WHO and European Union regulators, as well as countries such as India, Indonesia and the Philippines.

Test data have shown that the vaccine is more than 90 percent effective in preventing severe illness and death.

Stephen Morrison, director of global health policy at the Center for Strategic and International Studies in Washington, DC, said low- and middle-income countries would be most in a pinch if Nuvaxovid missed a planned shipment. “It’s a pain for the COVAX, and it will be a pain for its bilateral partner.”

Novavax began providing Indonesia with doses manufactured by the Serum Institute at the end of last year.

India said the Serum Institute shipped about 10 million shots to Indonesia in November and December, but unnamed Indonesian officials said the country received only about 200,000 doses. Said. According to Novavax, the Indian government has cleared 20 million serum shots shipped to Indonesia.

Contract renegotiation

Filipino officials said they had not received any of the 30 million shots the country ordered.

The Philippines is renegotiating the deal and is considering reducing orders from Novavax. This is partly due to the fact that the country’s stockpile has 96 million vaccinations, said Vaccine Secretary Carlito Galvez, COVID-19 Vaccine Procurement Officer in the Philippines. The country has approved nine COVID vaccines.

Novavax has not commented on Filipino shipping or new contracts, but said it is working with the government to meet regulatory requirements for dose release.

Novavax said it would roll out shots in Europe by January, but that was delayed, a spokeswoman for the company said. She said the first cargo from the Serum Institute was delivered to a Dutch delivery facility, awaiting final regulatory approval for release.

As a result, at least two EU member states have postponed the planned schedule for managing Novavax shots, a person familiar with the matter said.

According to someone familiar with the discussions between Novavax and EU officials, Novavax had a hard time getting final regulatory approval because it has not yet provided enough information about batches produced in India. Under the EU Agreement, the first supply to the block will come from India.

The Dutch health authority RIVM, whose mission is to clear the batch, declined to comment on the timing reasons, but said the vaccine would be available from early March.

“We plan to ship as soon as testing and release are complete, and we’re working to make it happen as quickly as possible,” said a Nuvavax spokeswoman.

The UK approved a shot of Nuvavax on February 3, but the drug company hasn’t announced when to start distributing doses there.

Novavax applied for US approval at the end of last month, almost a year after the original plan.

Peter Shapiro, a pharmaceutical industry analyst at Global Data, said: “The question is whether these manufacturing and logistics issues will improve over time.”

Karl O’Donnell, Francesco Guaracio, Neil Jerome Morales

Reuters

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