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

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

 

Washington Post
Business
Trump’s Operation Warp Speed promised a flood of covid vaccines. Instead, states are expecting a trickle.
The administration pledged several hundred million doses in 2020. Companies will actually ship about 10 percent of that.
Christopher Rowland, Lena H. Sun, Isaac Stanley-Becker and Carolyn Y. Johnson
Dec 5, 2020
Federal officials have slashed the amount of coronavirus vaccine they plan to ship to states in December because of constraints on supply, sending local officials into a scramble to adjust vaccination plans and highlighting how early promises of a vast stockpile before the end of 2020 have fallen short.

 

Instead of the delivery of 300 million or so doses of vaccine immediately after emergency-use approval and before the end of 2020 as the Trump administration had originally promised, current plans call for availability of around a tenth of that, or 35 to 40 million doses…

As planning accelerated for distributing supplies, the government began to further lower expectations. To make sure supplies don’t run out and leave some people only partially immunized, the government said it would stagger deliveries to ensure that states have enough supply for the second shot, required 21 days later for the Pfizer vaccine, which is expected to be first to gain approval.

Lower-than-anticipated allocations have caused widespread confusion and concern in states, which are beginning to grasp the level of vaccine scarcity they will confront in the early going of the massive vaccination campaign.

The gap reflects the disconnect between Trump’s campaign promises, as well as the optimistic estimates from some drug companies, and scientific and manufacturing realities.

The drop-off is a product of manufacturing problems, bottlenecks in the supply of raw materials and other hurdles in ramping up clinical-trial production of 5 liters of protein-based vaccine at a time to commercial-scale fermentation of 2,000-liter batches, the companies and the Trump administration said.

“There were a couple of our vaccine candidates that took significantly longer, in terms of failed batches, in terms of not having the purity we sought,” Paul Mango, deputy chief of staff for policy at the Department of Health and Human Services, said in an interview. He declined to say which company experienced batch failures…

 

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Moderna Announces Amendment to Supply Agreement with the Ministry of Health of Israel to Supply Additional Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
December 04, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced an expanded supply agreement with the Ministry of Health of Israel for an additional 4 million doses of mRNA-1273..

Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate
December 03, 2020

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization
November 30, 2020

Moderna Announces Amendment to Current Supply Agreement with United Kingdom Government for an Additional 2 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
November 29, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a supply agreement with the UK government for an additional 2 million doses of mRNA-1273,

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Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19
December 01, 2020
:: U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA vaccine for emergency supply under Regulation 174; Companies are ready to deliver the first doses to the U.K. immediately
:: First authorization for a COVID-19 vaccine represents a breakthrough scientific achievement to help combat this devastating pandemic
:: The companies previously signed an agreement to supply a total of 40 million doses to the U.K. with delivery in 2020 and 2021
:: U.S. FDA and EU EMA decisions on authorization are expected in December

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Dr. Reddy’s and RDIF commence clinical trials for Sputnik V vaccine in India
December 01, 2020
HYDERABAD, India–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), and Russian Direct Investment Fund (RDIF) announced today that they have commenced adaptive phase 2/3 clinical trials for Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli, India. This will be a multicenter and randomized controlled study, which will include safety and immunogenicity study.
The clinical trials are being conducted by JSS Medical Research as the clinical research partner. Further, Dr. Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support and to use BIRAC’s clinical trial centres for the vaccine…

 

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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].

Sputnik V – “the first registered COVID-19 vaccine” [to 05 Dec 2020]
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
RDIF and Ministry of Health of Kazakhstan announce cooperation on the registration, production and distribution of the Sputnik V vaccine
04.12.2020
…Upon obtaining the regulatory approval, the production technology and the materials required for the production of 2 million doses of the vaccine will be transferred to Kazakhstan.
Currently, Phase III clinical trials have approval and are ongoing in Belarus, the UAE, Venezuela and a number of other countries, as well as Phase II-III being underway in India. Requests for more than 1.2 billion doses of the Sputnik V vaccine have come from more than 50 countries. Vaccine production for the global market will be undertaken by RDIF’s international partners in India, Brazil, China, South Korea and four other countries…