Per a New York Times report, the Trump administration has identified five companies, which are most likely to be successful in making vaccines to prevent COVID-19.
As part of the Operation Warp Speed (OWS) initiative to rapidly develop a vaccine for SARS-CoV-2, the virus that causes COVID-19, the administration narrowed down on the five promising candidates from an extensive list of probable candidates, which are being developed by around a dozen companies. The White House aims to begin widespread vaccination of its citizens by the end of this year even though health experts have time and again said that development of a vaccine would take a year to 18 months.
The five companies that have been shortlisted are Moderna MRNA, the partnership between Oxford University and AstraZeneca AZN, J&J JNJ, Merck MRK and Pfizer PFE.
The report mentioned that the five companies will get extra federal funds, help to run their clinical studies and manufacturing assistance. Moderna, AstraZeneca, and J&J already have funding support from the Biomedical Advanced Research and Development Authority (BARDA) for their COVID-19 vaccine development program. Other than BARDA, the National Institute of Allergy and Infectious Diseases (NIAID) is also providing funding to companies involved in making drugs/vaccines. The Coalition for Epidemic Preparedness Innovations (CEPI), a global organization based in Oslo, has also provided funding of millions of dollars to biotechs including Moderna, Novavax, CureVac and Inovio and several universities to accelerate the development of vaccines against COVID-19.
The report said that the White House will officially announce the names of the five companies in the next few weeks. Here we discuss how the five companies are progressing in their coronavirus vaccine development program.
This week, Moderna initiated phase II studies on its mRNA-based coronavirus vaccine candidate, mRNA-1273. Phase I data on the vaccine was announced last month. It demonstrated that patients vaccinated with mRNA-1273 achieved levels of antibodies similar or higher than those typically found in a patient who recovered from COVID-19 naturally. Moreover, the company is finalizing the design for a phase III study on mRNA-1273 and anticipates to initiate the study in July. Meanwhile, Moderna has a $483 million funding support from BARDA to accelerate the development of mRNA-1273. It has also signed a strategic collaboration agreement with Lonza for manufacturing of mRNA-1273.
AstraZeneca & Oxford University
British drugmaker, AstraZeneca has an agreement with Oxford University for the global development and distribution of the University’s potential recombinant adenovirus vaccine, also known as AZD1222, to prevent COVID-19. AZD1222 is currently being evaluated in a phase I/II study, which began last month. Data from the study is expected to be released shortly. If the data is successful, late-stage studies with 30,000 participants are expected to begin in a number of countries.
Last month, AstraZeneca received more than $1billion in funding from BARDA to help produce the vaccine. AstraZeneca secured the first agreements to supply at least 400 million doses and plans to begin the first deliveries of the vaccine from September 2020. AstraZeneca has also agreed to provide the United States with up to 300 million doses. Meanwhile, AstraZeneca also said that it has the capacity to produce one billion doses if the vaccine is approved and continues to increase capacity further.
J&J has identified a lead vaccine candidate for COVID-19 and expects to begin phase I human clinical studies on the same in the United States and Europe by September. J&J’s goal is to supply more than 1 billion doses of the vaccine globally. J&J looks confident of having the first batch of COVID-19 vaccine available for emergency use authorization, on a not-for-profit basis, by early 2021. It has established a new U.S. vaccine manufacturing facility and is in discussions with other potential partners to expand manufacturing capacity in Europe and Asia.
J&J is committed to invest more than $1 billion in partnership with BARDA to co-fund vaccine research, development, and clinical testing.
Last month, Pfizer and its German partner BioNTech dosed the first patients in the United States in the phase I/II clinical study for BioNTech’s mRNA-based vaccine program, BNT162 to prevent COVID-19. Pfizer and BioNTech announced plans to co-develop a COVID-19 vaccine in March. Four vaccine candidates, each representing different mRNA formats and target antigens, will be evaluated in a single, continuous study in the United States. The companies also initiated a phase I/II clinical study in Germany in April.
Pfizer earlier said that it has the potential to supply millions of vaccine doses by the end of 2020 if it receives the necessary regulatory approvals. Thereafter, it can rapidly scale up capacity to produce hundreds of millions of doses in 2021.
Last month, Merck announced a deal to acquire Austrian private biotech Themis, which has a COVID-19 vaccine candidate in preclinical development with clinical studies expected to start later this year. Themis developed the candidate using its measles virus vector platform. Themis is part of a consortium which includes the Institute Pasteur and The Center for Vaccine Research at the University of Pittsburgh to make the vaccine. The consortium has funding support from CEPI.
Merck also signed a collaboration with a nonprofit research organization, IAVI to co-develop a vaccine, designed by IAVI scientists, to prevent COVID-19. The vaccine candidate will leverage the recombinant vesicular stomatitis virus (rVSV) technology, which has also been the basis of development of Merck’s rVSV-based vaccine for Ebola Zaire, Ervebo.
Other than these five, companies like Novavax and Inovio Pharmaceuticals have initiated human/clinical studies on a coronavirus vaccine. However, both have been left out of the list. Several other vaccine candidates are in pre-clinical stage of development.
All eyes are on these pharma/biotech companies to find a vaccine for COVID-19 as they are being considered the key to bring stalled global economies back on track.
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