Hyderabad-based Biological E has entered into two agreements for development of novel Coronavirus vaccines, one with drug giant Johnson & Johnson, and the other with Houston-based Baylor College of Medicine.
Biological E is the second major pharmaceutical player in India to announce agreements with vaccine developers for the manufacture of these candidate vaccines. It could facilitate the deployment of these vaccines in India after they are approved for use. Earlier, Pune-based Serum Institute of India, the world’s largest manufacturer of vaccines by volume, has entered into similar agreements with AstraZeneca, which is developing a vaccine with Oxford University, and with US-based Novavax. The candidate vaccines of AstraZeneca and Novavax are both in phase-3 human trials.
With Johnson & Johnson, the agreement is about creating new or upgrading existing infrastructure at Biological E for manufacturing ingredients (“drug substance”) as well as the final vaccine (“drug product”). The Johnson & Johnson candidate vaccine is in combined phase-1 and phase-2 human trials. It expects to enter into phase-3 trials in September and is aiming to be ready with the vaccine early next year. The J&J vaccine has already received a US$ 1 billion backing from the United States government which has secured 100 million doses of the vaccine whenever it is ready.
In the second agreement, the Hyderabad company has licensed the recombinant protein based vaccine being developed by the Baylor College of Medicine. This vaccine is in pre-clinical trials right now. The agreement will enable Biological E to manufacture the vaccine, and also collaborate on its further development. The production of the vaccine at Biological E could facilitate its deployment in India and other middle and low-income countries, the company said in a statement.
US backing vaccine trials in other countries
In order to test the leading vaccine candidates on diverse populations, the United States has been roping in scientists in South Africa and Latin America to conduct human trials in those countries, according to a Reuters report.
The level of immune response triggered by a vaccine can differ in different population groups. As such, tests on diverse populations can provide a better assessment of the safety and efficacy of a vaccine being tried.
The countries which the United States is roping in stand to benefit through promises of assured supplies of vaccines when they are developed and approved, the report said.
The report said researchers in South Africa, Mexico, Brazil, Peru and Argentina were in discussions to join their US counterparts in conducting large scale human trials of a candidate vaccine being developed by Johnson & Johnson from next month. The J&J candidate is just one of the several vaccines that the US has been backing. It has already entered into advance bilateral agreement with several leading vaccine developers for assured supplies of hundreds of millions of doses of the vacccines when they are developed and approved for use.
Also in Explained | The US has pre-ordered 800 million doses for its 330 million population
WHO-backed platform books production capacity at South Korean facility
A World Health Organisation backed platform that seeks to make Coronavirus vaccines affordable and accessible to all has reserved production capacities at a South Korean facility to for exclusive manufacture of the vaccines that it is backing.
The WHO has launched COVAX platform, in partnership with CEPI, or the Coalition for Epidemic Preparedness Innovations, GAVI (previously called Global Alliance for Vaccines and Immunisation, now just GAVI), and Bill and Melinda Gates Foundation, that is aimed at accelerating the development and manufacturing of Coronavirus vaccines and ensuring equitable access of these vaccines to everyone.
CEPI on Thursday announced that it had secured the manufacturing capacity of SK Bioscience’s facilities in South Korea for the production of vaccines being supported through the COVAX platform.
“Under the terms of the agreement, SK Bioscience will reserve manufacturing capacity in 2020 and 2021 exclusively for the development and production of COVID19 vaccines designated by CEPI. CEPI has an option to extend the reservation of manufacturing capacity beyond 2021,” CEPI said in a statement.
One or more CEPI-supported vaccine candidates are expected to be manufactured at the South Korean facility, and the appropriate vaccines will be selected on the basis of technical characteristics of the vaccines and their suitability for production at that facility, it said.
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Hunt for Coronavirus vaccine: The story so far
- More than 160 vaccine candidates in pre-clinical or clinical trials
- 29 of them in clinical trials
- Six in final stages, phase-III of human trials
- At least eight candidate vaccines being developed in India. Two of these have entered phase -II trials after completing phase-I.
(As on August 13; Source: WHO Coronavirus vaccine landscape of August 13, 2020)
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