Valneva Archives - Medical Design Sourcing

Pfizer invests $95 million in vaccine firm Valneva

After struggling to find support for its inactivated whole-virus COVID-19 vaccine candidate VLA2001, French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has received a €90.5 ($95) million investment from Pfizer (NYSE:PFE), which amounts to 8.1% of the company’s share capital at a price of €9.49 per share.

The Saint-Herblain, France–based company plans on using the funding to support a planned Phase 3 study involving the Lyme disease vaccine candidate VLA15. Pfizer will lead the Phase 3 study, scheduling it for the third quarter of 2022.

In February, Valneva and Pfizer announced positive data from a Phase 2 study of the VLA15 vaccine. The data suggested that a three-dose primary series of the vaccine promised to offer a robust immune response.

In related news, the European Medicines Agency recently recommended authorizing Valneva’s VLA2001 COVID-19 vaccine for individuals between 18 and 50.

After the vaccine won regulatory approval …

Valneva agrees to terminate UK supply agreement for COVID-19 vaccine

French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has reached a settlement agreement with regulators in the United Kingdom related to the termination of a supply agreement for its COVID-19 vaccine candidate.

The company is attempting to salvage a COVID-19 vaccine deal with the EU after regulators announced plans to terminate an Advance Purchase Agreement (APA) related to the vaccine candidate.

VALN shares tumbled 6.87% to $15.73 in afternoon trading.

The company has developed the only whole virus, inactivated, adjuvanted vaccine candidate.

Demand for COVID-19 vaccines has faltered in recent months. The majority of the population in many European countries has been fully vaccinated.

On September 13, 2021, Valneva received a termination notice from the UK government.

The agreement between the parties included a provision giving the UK government the discretionary right to terminate for convenience.

The recent s…

Valneva aims to salvage COVID-19 vaccine deal with EU

French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) is hoping to change the European Commission’s (EC) mind after regulators notified the firm that they intend to terminate an Advance Purchase Agreement (APA) for its inactivated whole-virus COVID-19 vaccine candidate VLA2001.

VALN shares fell 15% to $20.00.

In February, Valneva announced that it expected authorization for the vaccine in the European Union in April. Regulators from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had sent the company several questions about the vaccine candidate. Valneva said then that it swiftly answered them.

EMA accepted the filing of the Marketing Authorization Application on May 19.

After the European Commission received Valneva’s remediation plan, Valneva hopes to have further discussions with regulators interested in its inactivated, adjuvanted whole-virus vaccine.

Valneva ind…

Valneva anticipates EMA nod for its COVID-19 vaccine candidate in April

French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has sent the company a “small set” of questions related to its VLA2001 COVID-19 vaccine candidate.

The firm announced on February 25 that CHMP had sent the company a series of questions as part of its initial assessment, to which it responded within two working days.

It anticipates that it can swiftly respond to the latest batch of questions.

Valneva anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001 for primary immunization in adults 18 to 55 years of age in April 2022.

In such a case, the company would supply European countries with the vaccine in the second quarter of the year.

Valneva has an agreement with the European Commission to provide up to 60 million doses of the vaccine over two years.

The company says t…

Valneva shares surge 30% after announcing its vaccine candidate neutralized omicron in neutralizing antibody study

Valneva vaccine vials

Valneva SE (NSDQ:VALN) announced promising preliminary lab results involving recipients of its inactivated VLA2001 COVID-19 vaccine.

In a pseudovirus neutralization assay involving sera from 30 volunteers in the Phase 1/2 trial VLA2001-201, all samples had neutralizing antibodies against the ancestral virus and the delta variant. In addition, 87% (26 samples) had neutralizing antibodies to omicron.

VALN shares jumped 30.41% to $42.74 in mid-afternoon trading.

“We continue to believe that VLA2001 could be an important component of the fight against COVID-19, and Valneva remains fully committed to bringing VLA2001 to people who need it as soon as we can,” said Dr. Juan Carlos Jaramillo, chief medical officer of Valneva, in a statement.

Valneva said it was sending data on an ongoing basis to several regulatory agencies, including the European Medicines Agency (EMA) and…