COVID News: Pfizer, Sanofi, Roche, Novavax & More

The latest on COVID-19 vaccines/drugs and manufacturing from Pfizer/BioNTech, Sanofi, Roche, Novavax, the European Medicines Agency, Humanigen, PCI Pharma Services, and Valneva. Highlights below. 

Manufacturing and supply of COVID-19 vaccines and drugs 
* EMA Issues List of Critical COVID Medicines, Vaccines 
* Valneva Provides Update on Supply Pacts for COVID-19 Vaccine 
* Humanigen, PCI in Pact for COVID-19 Drug 
Updates on COVID-19 therapeutics and vaccines 
* EMA Initiates Review of Pfizer’s/BioNTech’s COVID-19 Variant Vaccine 
* Sanofi, on COVID-19 Booster Against Omicron 
* Novavax’s COVID-19 Vaccine Gets OK as Booster in Australia 
COVID-19 testing 
* Roche Gets US OK for New COVID-19 PCR Test 

Manufacturing and supply of COVID-19 vaccines and drugs 

EMA Issues List of Critical COVID Medicines, Vaccines 
The European Medicines Agency (EMA)’s Medicines Shortages Steering Group has issued a list of critical medicines and vaccines authorized for COVID-19 as part of an EMA process for monitoring supply and demand to identify and manage potential or actual shortages. The full list of critical medicines can be found here

The list contains all the approved vaccines and therapeutics in the European Union (EU) to prevent or treat COVID-19. The EMA says it will update the list to reflect changes in the pandemic situation that may give rise to an increased risk of shortages of particular medicines or following the authorization of new medicines. The list does not replace national guidance on vaccination and the clinical management of COVID-19. 

Marketing authorization holders of medicines included in the list are required to regularly update the EMA with relevant information, including data on potential or actual shortages and available stocks and forecasts of supply and demand. In addition, EU member states will provide regular reports on estimated demand for critical medicines at national levels.  

Source: European Medicines Agency 

Valneva Provides Update on Supply Pacts for COVID-19 Vaccine 
Valneva, a Saint-Herblain, France-based vaccine company, has proposed a plan to the European Commission (EC) following the EC’s notification that it intends to terminate its advanced purchase agreement for Valneva’s COVID-19 vaccine candidate, VLA2001. Separately, the company has reached a settlement agreement with the UK in its supply pact for its COVID-19 vaccine. 

Last November (November 2021), Valneva signed an advanced purchase agreement with the EC supply up to 60 million doses of its COVID vaccine, over two years. Last month (May 2022), the EC notified the company that it intended to terminate its supply pact and provided the company with 30 days to provide an alternate plan.  

Valneva proposed a remediation plan, which is now subject to further discussion within the EC and participating European Union (EU) member states. Although some member states have confirmed their interest in Valneva’s vaccine, preliminary, unofficial volume indications received from the EC would not be sufficient to ensure the sustainability of Valneva’s COVID-19 vaccine program. If such indications are confirmed, Valneva will not be able to enter into an amendment to the advance purchase agreement that would allow for a reduced order, and the EC is likely to terminate the agreement.  

VLA2001 is a whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. The company says that the regulatory process with the European Medicines Agency (EMA) is continuing as planned. The EMA accepted the filing of marketing authorization application in May (May 2022), and the EMA’s Committee for Medicinal Products for Human Use is expected to take a final vote during the week of June 21, 2022. Valneva says it also continues to work with agencies outside of the EU for potential future approvals and additional purchase agreements. 

Valneva also reported this week (June 15, 2022) that it had reached a settlement with the UK government over the UK’s termination of its supply pact for the company’s COVID-19 vaccine. The UK government terminated the supply pact last September (September 2021). The company signed a multi-year supply pact with the UK government in September 2020, worth up to $1.6 billion.   

Source: Valneva (EU supply pact) and Valneva (UK settlement) 

Humanigen, PCI Pharma in Pact for COVID-19 Drug 
Humanigen, a Short Hill, New Jersey-based bio/pharmaceutical company, has entered into an agreement with PCI Pharma Services, a CDMO of drug products and contract packaging, under which PCI will provide importation, release, and commercialization services in the UK for Humanigen’s COVID-19 drug, lenzilumab, for treating hospitalized patients with COVID-19.  

Under the agreement, PCI will purchase lenzilumab for resale and distribution if the drug receives conditional marketing authorization the UK. 

Lenzilumab is an investigational product and is not approved or authorized in any country. 

Source: Humanigen 

Updates on COVID-19 therapeutics and vaccines 

EMA Initiates Review of Pfizer’s/BioNTech’s COVID-19 Variant Vaccine 
The European Medicines Agency (EMA) has initiated a rolling review for a variant-adapted version of the Pfizer’s/BioNTech’s COVID-19 vaccine. The review is initially based on chemistry, manufacturing, and controls (CMC) data shared with the EMA earlier this month (June 2022). Additional clinical data, including data on immunogenicity against Omicron and its subvariants, will be added to the rolling submission as it becomes available.  

The companies also plan to begin the submission of data supporting a potential variant-adapted vaccine to the US Food and Drug Administration (FDA) in the coming weeks (June 15th, 2022). 

The composition of the variant-adapted vaccine will be discussed with global regulatory bodies to determine a potential vaccine booster approach for the fall 2022 season.  

Source: Pfizer and BioNTech 

Sanofi Provides Update on COVID-19 Booster Against Omicron 
Sanofi reports its COVID-19 vaccine booster candidate, made in partnership with GlaxoSmithKline (GSK), demonstrated potential to protect against COVID-19 variants of concern, including Omicron BA.1 and BA.2, with a favorable safety and tolerability profile. The booster vaccine candidate is modelled on the Beta variant antigen and includes a GSK adjuvant. 

In a Phase III study, the Sanofi–GSK vaccine booster candidate induced (at day 15 post-immunization) a boost in antibody titers above baseline against multiple variants of concern:  a 15-fold increase against the D614 parent virus and a 30-fold increase against the Beta strain in adults previously primed with mRNA COVID-19 vaccines. In particular against Omicron, preliminary data show a 40-fold increase against BA.1. 

In a separate study evaluating immune response, following primary vaccination with two doses of Pfizer’s/BioNTech’s COVID-19 vaccine, Comirnaty, Sanofi reported that the Sanofii–GSK booster candidate generated a higher immune response (as measured by neutralizing antibody titers) than the Pfizer-BioNTech’s booster or the Sanofi–GSK first-generation booster. 

Sanofi and GSK have developed their next-generation booster candidate in parallel to ongoing regulatory reviews of their first-generation vaccine candidate. The totality of data supporting this next-generation booster vaccine will be submitted to regulatory authorities in the upcoming weeks (as reported on June 13, 2022) with the aim of making it available later this year (2022). 

Source: Sanofi 

Novavax’s COVID-19 Vaccine Gets OK as Booster in Australia 
Novavax, a Gaithersburg, Maryland-based vaccine company, reports that the Australian Therapeutic Goods Administration (TGA), Australia’s national pharmaceutical regulatory agency, has granted provisional registration of Nuvaxovid, the company’s COVID-19 vaccine, as a booster in individuals aged 18 and over as a heterologous third booster dose. 

The TGA granted provisional registration in January 2022 for use of Nuvaxovid in individuals aged 18 and over. Novavax filed for expanded provisional registration in Australia for use in adolescents aged 12 through 17 in May 2022. 

Nuvaxovid has received conditional authorization from the European Commission and the World Health Organization. The vaccine has not yet been authorized for use in the US.  

Source: Novavax 

COVID-19 Testing 

Roche Gets US OK for new COVID-19 PCR Test 
The US Food and Drug Administration has issued emergency use authorization for Roche’s COVID-19 test, cobas SARS-CoV-2 duo, which combines the standard qualitative result of a traditional SARS-CoV-2 PCR test with a quantitative result, which measures the viral load of a patient suspected of COVID-19.  

The test is an automated, real-time reverse transcription-polymerase chain reaction assay for in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens. 

Roche reports that the test will be available in the United States by the second quarter of 2022. 

Source: Roche