Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 19 August 2021

Milestones :: Perspectives :: Research

 

Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 19 August 2021
For 22 vaccine candidates, presents Manufacturer, Name of Vaccine, NRA of Record, Platform, EOI Accepted Status, Pre-submission Meeting Held Status, Dossier Accepted for Review, Status of Assessment; Anticipated/Completed Decision Date
[No updates since 19 Aug 2021]
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COVID Vaccine Developer/Manufacturer Announcements
[relevant press releases/announcement from organizations from WHO EUL/PQ listing above]

 

AstraZeneca
Press Releases – No new digest announcements identified

BioCubaFarma – Cuba
Últimas Noticias – [Website not responding at inquiry; receiving 403-Forbidden]

 

CanSinoBIO
News – [Website not responding at inquiry]

Clover Biopharmaceuticals – China
News – No new digest announcements identified

 

Curevac [Bayer Ag – Germany]
News
September 14, 2021
CureVac Streamlines European Network for mRNA Product Manufacturing
:: CureVac right-sizes manufacturing network to adapt to changes in vaccine peak demands
:: Demand reassessed for first-generation COVID-19 vaccine candidate, CVnCoV, currently under regulatory review with EMA
:: Contracts with manufacturing partners WACKER and Celonic terminated; Rentschler Biopharma and Novartis contracts unaffected

 

Gamaleya National Center
Latest News and Events – No new digest announcements identified [See Russia/RFID below]

IMBCAMS, China
Home – No new digest announcements identified

 

Janssen/JNJ
Press Releases – No new digest announcements identified

 

Moderna
Press Releases
September 16, 2021
Moderna Announces Health Canada Approves its COVID-19 Vaccine

September 15, 2021
Moderna Highlights New Clinical Data on its COVID-19 Vaccine
:: mRNA-1273 remains highly effective against COVID-19 in real-world effectiveness study during surge in Delta cases
:: New analysis of open-label portion of Phase 3 COVE study shows lower risk of breakthrough infection in participants vaccinated more recently (median 8 months after first dose) than participants vaccinated last year (median 13 months after first dose)
:: Company believes data support benefit of an mRNA-1273 booster dose

 

Novavax
Press Releases
Novavax Statement on Proof of COVID-19 Vaccine Requirements for PREVENT-19 Clinical Trial Participants in the U.S.
Sep 17, 2021
The U.S. Centers for Disease Control and Prevention (CDC) recently provided updated guidance stating that participants in the Novavax PREVENT-19 Phase 3 clinical trial meet the criteria to be considered fully vaccinated two weeks after they have completed the active vaccine series. With this validation from the United States’ leading public health authority, Novavax expects our PREVENT-19 Phase 3 clinical trial participants will be considered fully vaccinated and in compliance with mandated vaccination policies, including those of employers and any other organizations or entities requiring proof of vaccination. Novavax is grateful to our clinical trial participants for helping to ensure a safer future for all, and we continue to advocate for them at the highest levels.

Novavax to Participate in University of Oxford Com-COV3 Study Comparing Mixed COVID-19 Vaccine Schedule in Adolescents
Sep 16, 2021
– Study to explore heterologous regimen of COVID-19 vaccines from different manufacturers in adolescents 12-16 years of age
– Will assess potential for flexibility in the delivery of COVID-19 vaccines

 

Pfizer
Recent Press Releases
FDA Advisory Committee Votes Unanimously in Favor Of COMIRNATY® Booster for Emergency Use in People 65 and Older and Certain High-risk Populations
09.17.2021
:: Committee reviewed clinical data showing a booster dose of COMIRNATY® elicits high neutralization titers against SARS-CoV-2 and all currently tested variants
:: Reactogenicity profile within seven days of the booster dose was typically mild to moderate, with frequency of reactions similar to or lower than after the primary vaccination series
:: Real-world data presented by Israel Ministry of Health show additional protection after receiving a booster translated to vaccine effectiveness comparable to levels seen early in the country’s vaccine rollout
:: FDA expected to make its decision in the coming days

 

Sanofi Pasteur
Press Releases
September 14 2021 Press releases
Sanofi completes acquisition of Translate Bio, accelerating the application of mRNA in new vaccines and therapeutics
Sanofi announced today the completion of its acquisition of Translate Bio, further accelerating the company’s efforts to develop transformative vaccines and therapies using mRNA technology. The acquisition adds a critical pillar to the company’s mRNA Center of Excellence which aims to unlock the potential of next-generation mRNA vaccines and other strategic areas such as immunology, oncology, and rare diseases…

 

Serum Institute of India
NEWS & ANNOUNCEMENTS
Biocon Biologics and Serum Institute Life Sciences Announce Strategic Alliance
:: BBL will have access to 100 million doses of vaccines annually and commercialization rights of the SILS vaccine portfolio for global markets
:: SILS to receive ~15% stake in BBL at a post-money valuation of ~$4.9 billion
Bengaluru, Karnataka, India – September 16, 2021 Biocon Biologics Limited (BBL), a subsidiary of Biocon Ltd. and Serum Institute Life Sciences Private Limited (SILS), a subsidiary of Serum Institute of India Pvt. Ltd. today announced a strategic alliance.
Under the terms of the agreement, BBL will offer approximately 15% stake to SILS, at a
post-money valuation of ~$4.9 billion, for which it will get committed access to a 100
million doses of vaccines per annum for 15 years, primarily from SILS’s upcoming vaccine
facility in Pune with commercialization rights of the SILS vaccine portfolio (including
COVID-19 vaccines) for global markets…

 

Sinopharm/WIBPBIBP
News – [Website not responding at inquiry]

 

Sinovac
Press Releases
SINOVAC agrees to supply an additional 101,000 doses of COVID-19 vaccines (CoronaVac®) to meet demand for inactivated virus vaccines from Singapore residents
2021/09/15
· Doses will be available through SGX-Catalist listed Livingstone Health group at 17 clinics islandwide
· Inactivated viral vaccines offer an alternative option for those unable to take up vaccines available under the National Vaccine Programme, or prefer inactivated virus vaccines

 

Vector State Research Centre of Viralogy and Biotechnology
Home – No new digest announcements identified

Zhifei Longcom, China
[Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.]
[No website identified]

 

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GSK
Press releases for media – No new digest announcements identified

 

SK Biosciences
Press releases – No new digest announcements identified