The logo of Valneva SE Group is pictured at the company's headquarters in Saint-Herblain, near Nantes, western France, on July 30, 2020. (JEAN-FRANCOIS MONIER / AFP)

PARIS/LONDON - Valneva's shares dived about 20 percent on Monday after the French drugmaker warned that the future of its COVID-19 vaccine was in jeopardy.

Valneva's vaccine program was hit by delays in its marketing application after the European Medicines Agency sought more information

Valneva has been trying to salvage a deal with the European Commission which had said it would terminate an advance purchase agreement for 60 million doses. But Valneva said on Monday that initial signs from the Commission suggested volumes would not be enough to sustain the firm's vaccine program. 

It said that if this reduced order was confirmed, it would not be able to enter into an amended agreement.

"This is clearly a disappointing development," Rx Securities said in a note, after previously forecasting more than 400 million euros ($419 million) in COVID-19 vaccine sales, mostly relating to the contract with the Commission.

"Our forecasts no longer assume any vaccine revenues from sales to the EC," it said in a note.

ALSO READ: US FDA: Moderna COVID-19 shots effective, safe for kids

Valneva's vaccine program was hit by delays in its marketing application after the European Medicines Agency sought more information. EMA has since then accepted the application but Valneva missed the Commission's April deadline for European approval. An EMA recommendation on whether the vaccine should be approved is now expected on June 21.

Britain's cancelled its Valneva contract in 2021, although the company has secured approvals in Bahrain and the United Arab Emirates.

Valneva's vaccine uses technology already employed for decades in shots against polio, influenza and hepatitis. The company had bet it would entice people who had refused COVID-19 vaccines that used mRNA and other newer technology.

But demand for a new crop of COVID-19 vaccines is uncertain. US-based Novavax's  shot uses traditional technology like Valneva's but has had limited take up in Europe, with only about 220,000 doses administered out of 12.6 million distributed in the region.

Some vaccine makers, such as AstraZeneca and Johnson & Johnson, have warned of a global COVID-19 vaccine glut.

A Sanofi logo sits on the company's headquarters in Paris, France, on Feb 6, 2020. (MARLENE AWAAD / BLOOMBERG)

Sanofi

French drugmaker Sanofi on Monday said the COVID-19 vaccine candidate it has developed jointly with GSK in two trials showed a potential to protect against the virus's main variants of concern, including the Omicron BA.1 and BA.2 strains, when used as a booster jab.

"Across both studies, the Sanofi-GSK next-generation vaccine candidate was well-tolerated, with a favourable safety profile," Sanofi said in a statement, adding that it would publish the complete findings of the studies later this year.

A health worker prepares a dose of the Pfizer-BioNTech vaccine against COVID-19 at a vaccination center in Santiago on Jan 20, 2022. (JAVIER TORRES / AFP)

US Food and Drug Administration staff reviewers on Sunday said Pfizer-BioNTech's COVID-19 vaccines were effective and safe for use in children aged 6 months to 4 years.

US President Joe Biden's administration expects vaccinations for young children to begin in earnest as early as June 21 if the FDA and the Centers for Disease Control and Prevention approve the vaccines

The FDA reviewers said in briefing documents published on Sunday evening that their evaluation did not reveal any new safety concerns related to the use of the vaccine in young children.

The FDA analysis of data from Pfizer's trial was published ahead of a June 15 meeting of its outside advisers. Recommendations from the external advisers will determine the FDA's decision on the vaccines.

"Available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series in preventing COVID-19 in the age group of 6 months through 4 years," FDA staff said in the review.

An early analysis of data from Pfizer-BioNTech's vaccine based on 10 symptomatic COVID-19 cases identified when the Omicron coronavirus variant was dominant suggested a vaccine efficacy of 80.3 percent in the under-5 age group.

COVID-19 shots for children under the age of 6 are yet not approved in most parts of the world. It remains unclear how many parents will get their young ones vaccinated as demand has been low for kids aged 5 to 11.

US President Joe Biden's administration expects vaccinations for young children to begin in earnest as early as June 21 if the FDA and the Centers for Disease Control and Prevention approve the vaccines. 

Government officials say pre-orders for use in the under-6 age group has been low but demand is expected to pick up once the vaccines gain authorization.

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The FDA on Friday released a staff review of Moderna Inc's COVID-19 vaccine which said the doses were safe and effective for use in children aged 6 months to 17 years old.