COVID-19 Vaccines :: Development/Procurement/Distribution/Logistics

Milestones :: Perspectives :: Research

 

COVID-19 Vaccines :: Development/Procurement/Distribution/Logistics

Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine programme to improve immune response in the elderly
11 December 2020 Issued: London and Paris
:: Phase 1/2 interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years
:: Insufficient response in older adults demonstrates the need to refine the concentration of antigen in order to provide high-level immune response across all age groups
:: Companies plan a Phase 2b study with an improved antigen formulation
:: With support from BARDA as part of Operation Warp Speed, study to start in February 2021, including a proposed comparison with an authorised COVID-19 vaccine
:: Product availability now expected in Q4 2021 pending successful completion of the development plan

AstraZeneca will test using component of Russia’s Sputnik V in clinical trials of its own vaccine against coronavirus
Press release, 11.12.2020
[See Sputnik below for detail]

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19 [FDA]
December 11, 2020

U.S. Government Exercises 1st Option for Additional 100 Million Doses of Moderna’s COVID-19 Vaccine Candidate
December 11, 2020

Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S.
December 10, 2020

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine
December 10, 2020

Moderna Announces First Participants Dosed in Phase 2/3 Study of COVID-19 Vaccine Candidate in Adolescents
December 10, 2020

Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
December 08, 2020

Canada Exercises Increased Option for Total of 40 Million Doses of mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)
December 07, 2020

 

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Editor’s Note:
To better present a global view of COVID-19 vaccine development, regulatory review, procurement and deployment, we will present headlines from this site – which provides as its contact point the Russian Direct Investment Fund [RDIF – “Russia’s sovereign wealth fund”].

Sputnik V – “the first registered COVID-19 vaccine” [to 12 Dec 2020]
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
AstraZeneca will test using component of Russia’s Sputnik V in clinical trials of its own vaccine against coronavirus
Press release, 11.12.2020
:: Sputnik V is one of the most effective vaccines globally with over 90% efficacy against coronavirus. The unique feature of the Russian vaccine is the use of two different components based on human adenovirus in two separate inoculations in order to deliver genetic material from the spike of the coronavirus into the human body. This approach provides for a stronger and longer-term immune response compared with vaccines using the same component for both inoculations.
:: On November 23, 2020, following results which showed high efficacy for the Sputnik V vaccine, RDIF and the Gamaleya Center offered AstraZeneca the use of one of the two components of the Sputnik V vaccine.
:: AstraZeneca accepted the proposal by RDIF and the Gamaleya Center to use one of the two vectors of the Sputnik V vaccine in additional clinical trials of its own vaccine, which will commence before the end of this year.

RDIF and Government of Argentina have signed a contract to supply 10 million doses of the Sputnik V vaccine
Press release, 10.12.2020
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and the Government of Argentina have agreed to supply to the country 10 million doses of Sputnik V, the world’s first registered vaccine against coronavirus.
The vaccine will enable Argentina to secure a diversified portfolio of vaccines against coronavirus. Supplies of the vaccine will be facilitated by international partners of RDIF in India, China, South Korea and other countries…

 

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WHO, national regulators and vaccine manufacturers in South-East Asia Region discuss COVID-19 vaccines
11 December 2020
New Delhi: The World Health Organization, national regulatory authorities and vaccine manufacturers in WHO South-East Asia Region discussed fast tracking of COVID-19 vaccine rollout in Member countries.

“The vaccine manufacturing and regulatory sectors have a critical role to play in equitable and efficient deployment of vaccines,” said Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region, at the two-day virtual meeting that ended today.

The meeting deliberated processes and timelines to fast-track registration of COVID-19 vaccines in countries using the Emergency Use Listing procedures while comprehending the landscape of COVID-19 vaccine production in the Region.

Aimed at strengthening collaboration between national programmes, vaccine producers and regulators in the region for COVID-19 vaccine deployment, the meeting provided a platform for interaction and experience sharing for vaccine registration, deployment and regulation.

The Regional Director said all countries in the Region are now developing and finalizing national deployment and vaccination plans for COVID-19, of which regulatory preparedness is a core component.

 

Establishing expedited regulatory pathways for vaccine approval and adjusting regulatory pathways to the type of vaccine that is developed and filed for approval remains critical as emergency use authorization will precede full licensure, Dr Khetrapal Singh said.

While vaccine licensure systems may need to be modified, having standard operating procedures and stipulated timelines for emergency use authorization would be vital, she said.

The Regional Director emphasized on effective coordination, collaboration and information-sharing. From R&D to production, and from information on country readiness to post-marketing surveillance, manufacturers, regulators, policy-makers and planners must continue to work together to optimize and refine vaccine deployment.

“Countries in our Region are among the world’s largest vaccine manufacturers, and the vaccines produced here are likely to be administered to billions of people globally. I am certain that together, in solidarity with all people of the Region and world, you will effectively contribute to health and well-being of all,” Dr Khetrapal Singh said.

Key global and regional partners such as GAVI and UNICEF participated in the meeting. Among the vaccine manufacturers, from India Bharat Biotech International Ltd, Biological E Ltd, Cadila Healthcare Ltd, Serum Institute of India Pvt. Ltd,  Dr Reddy’s Laboratories and  Wockhardt Limited; from Indonesia Bio Farma Limited, and from Thailand  Government Pharmaceutical Organization (GPO), Bionet Asia Co.Ltd and Siam Bioscience, participated in the meeting.

This was the second such meeting with vaccine manufacturers and regulators organized in WHO South East Asia Region, with the first held in April…