COVID Vaccine Developer/Manufacturer Announcements

COVID Vaccine Developer/Manufacturer Announcements
[relevant press releases/announcement from organizations from WHO EUL/PQ listing above]

 

AstraZeneca
Press Releases
Evusheld long-acting antibody combination retains neutralising activity against Omicron variant in independent FDA study
PUBLISHED 16 December 2021
Only antibody authorised in the US for pre-exposure prophylaxis of COVID-19 

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination for the prevention of COVID-19, retained  neutralising activity against the Omicron SARS-CoV-2 variant (B.1.1.529), according to new preclinical data.
In this study, Evusheld’s Inhibitory Concentration 50 (IC50), a measure of neutralising potency of an antibody, was 171 ng/ml and 277 ng/ml in two confirmatory tests, which is within the range of neutralising titres found in someone who has been previously infected with COVID-19. Evusheld’s IC50 for the original strain of SARS-CoV-2, previously referred to as the Wuhan strain, was approximately 1.3 ng/ml and 1.5 ng/ml, respectively…

 

Bharat Biotech
Press Releases – No new digest announcements identified

BioCubaFarma – Cuba
Últimas Noticias – – No new digest announcements identified

 

CanSinoBIO
News – [Website not responding at inquiry]

Clover Biopharmaceuticals – China
News – No new digest announcements identified

 

Curevac [Bayer Ag – Germany]
News – No new digest announcements identified

 

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
Dec 17, 2021
Johnson & Johnson Statement on its COVID-19 Vaccine Following CDC ACIP
Johnson & Johnson remains confident in the overall positive benefit-risk profile of its COVID-19 vaccine. Studies have shown that the Johnson & Johnson COVID-19 vaccine generates strong antibody and cellular immune responses[i] and long-lasting immune memory[ii] and breadth of protection across variants. In addition, a growing body of evidence is revealing the strength of protection of our vaccine as a booster to either the Janssen COVID-19 vaccine or a different authorized or approved COVID-19 vaccine, both in terms of its efficacy and durability.[iii], [iv], [v], [vi],[vii],[viii], [ix]
“The safety and well-being of those who use the Johnson & Johnson vaccine continues to be our number one priority,” says Mathai Mammen M.D., Ph.D., Global Head, Janssen Research & Development, LLC, Johnson & Johnson. “We appreciate today’s discussion and look forward to working with the CDC on next steps. In addition, we strongly support education and generating awareness of rare events, such as Thrombosis with Thrombocytopenia Syndrome (TTS) and how to effectively manage it.”
Given its strong durability, the Johnson & Johnson COVID-19 vaccine remains an important choice in the U.S. for people who can’t or won’t return for multiple vaccinations or who would remain unvaccinated without an alternative to the mRNA vaccines…

Dec 15, 2021
United States
Johnson & Johnson Announces Positive CHMP Opinion for a Booster Shot of its COVID-19 Vaccine
CHMP recommendation based on data showing a booster (second shot) of the Johnson & Johnson COVID-19 vaccine increased protection to 75 percent against symptomatic COVID-19 infection globally
Data also demonstrated 100 percent protection against severe COVID-19, at least 14 days post-booster vaccination
The Johnson & Johnson COVID-19 vaccine, when given as a booster or primary shot,
was generally well-tolerated

 

Moderna
Press Releases
December 13, 2021
Moderna and Australia Announce Collaboration to Bring mRNA Manufacturing to Australia
:: Up to 100 million mRNA vaccine doses could be produced in Australia each year
:: Manufacturing facility to provide access to domestically manufactured vaccines against respiratory viruses
:: Collaboration will support Australia with direct access to rapid pandemic response capabilities

 

Novavax
Press Releases
Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine
Dec 17, 2021
:: First EUL granted by WHO for a protein-based COVID-19 vaccine
:: EUL vaccine manufactured and marketed by SII as COVOVAX™
:: WHO EUL for Nuvaxovid™ currently under assessment; will be completed following European Medicines Agency (EMA) review

Novavax Announces Submission of New Drug Application in Japan for Approval of COVID-19 Vaccine
Dec 15, 2021

Novavax Statement on PREVENT-19 Phase 3 Clinical Trial Results Publication in the New England Journal of Medicine
Dec 15, 2021

Novavax Files for Emergency Use of COVID-19 Vaccine in the United Arab Emirates
Dec 13, 2021

 

Pfizer
Recent Press Releases
12.17.2021
PFIZER AND BIONTECH PROVIDE UPDATE ON ONGOING STUDIES OF COVID-19 VACCINE
NEW YORK and MAINZ, GERMANY, DECEMBER 17, 2021 — Pfizer Inc. (NYSE: PFE) and
BioNTech SE (Nasdaq: BNTX) today shared that following a routine review by the external independent Data Monitoring Committee (DMC), the companies will amend the clinical study evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age. The study will now include evaluating a third dose of 3 µg at least two months after the second dose of the two-dose series to provide high levels of protection in this young age group.
While the study is ongoing and remains blinded, a pre-specified immunogenicity analysis was conducted on a subset of the study population one month following the second dose. Compared to the 16- to 25-year-old population in which high efficacy was demonstrated, non-inferiority was met for the 6- to 24-month-old population but not for the 2- to under 5-year-old population in this analysis. No safety concerns were identified and the 3 µg dose demonstrated a favorable safety profile in children 6 months to under 5 years of age.
The decision to evaluate a third dose of 3 µg for children 6 months to under 5 years of age reflects the companies’ commitment to carefully select the right dose to maximize the risk-
benefit profile. If the three-dose study is successful, Pfizer and BioNTech expect to submit data to regulators to support an Emergency Use Authorization (EUA) for children 6 months to under 5 years of age in the first half of 2022.
Pfizer and BioNTech also plan to evaluate a third dose of the 10 µg formulation in children 5 to under 12 years of age…

12.17.2021
CHMP Issues Positive Opinion for Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Vaccine-Type Pneumococcal Pneumonia in Adults

12.16.2021
Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of COMIRNATY® in Adolescents 12 Through 15 Years of Age

12.17.2021
EMA Issues Advice for Potential Early Use of Pfizer’s Novel COVID-19 Oral Antiviral Candidate

 

Sanofi Pasteur
Press Releases
December 15 2021 Press releases
Sanofi and GSK announce positive preliminary booster data for their COVID-19 vaccine candidate and continuation of Phase 3 trial per independent Monitoring Board recommendation

 

Serum Institute of India
NEWS & ANNOUNCEMENTS
Friday, December 17, 2021
World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine ‘COVOVAX™‘ .

 

Sinopharm/WIBPBIBP
News – No new digest announcements identified

 

Sinovac
Press Releases – No new digest announcements identified

 

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]

 

::::::

GSK
Press releases for media
17 December 2021 Xevudy (sotrovimab) granted marketing authorisation by the European Commission for the early treatment of COVID-19

15 December 2021 GSK and Sanofi announce positive preliminary booster data for their COVID-19 vaccine candidate and continuation of phase III trial per independent Monitoring Board recommendation

 

Merck
News releases
Merck and Ridgeback Announce Publication of Phase 3 Study of Molnupiravir, an Investigational Oral Antiviral COVID-19 Treatment, in the New England Journal of Medicine
December 16, 2021

European Commission Approves Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for Individuals 18 Years of Age and Older
December 15, 2021

 

Novartis
News – No new digest announcements identified

 

SK Biosciences
Press releases – No new digest announcements identified

 

Valneva
Press Releases
December 16, 2021
Valneva Announces Positive Homologous Booster Data for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001