Biological E will conduct a bridging trial for the vaccine in India and also manufacture the vaccine.
Hyderabad-based Biological E Limited has signed a deal with Canadian biotechnology company Providence Therapeutics Holdings Inc for its COVID-19 vaccine. Biological E will conduct a bridging trial for the vaccine in India. If successful, it will also manufacture the vaccine after getting emergency use approvals (EUA) from the health bodies in India. This announcement was made on Tuesday, 1 June but the financial terms were not disclosed. Providence focuses on mRNA therapeutics and vaccines and has created an mRNA vaccine to fight COVID-19 .
A bridging trial is a supplementary clinical trial that is conducted in a new region, country to provide clinical data on efficacy, safety, dosage and dose regimen in that region. This will allow the new region that will allow extrapolating of the foreign clinical data to the new region.
According to the new rules announced by the Ministry of Health and Family Welfare, last month, a company that has recieved approval for their vaccine, in their country can get EUA in India, without conducting a bridging trial first. However, the trials can be conducted parallelly while the vaccine is being administered to the masses.
Providence’s PTX-COVID19-B vaccine is an mRNA vaccine. A messenger RNA vaccine is a new type of vaccine that is found to be effective against infectious diseases. According to the CDC, it teaches our cells how to make a protein that triggers an immune response, against the virus, inside our bodies. This type of vaccine does not use a life or mRNA vaccines do not use the live virus, either weakened or inactivated germ. Hence there is no way that a person can accidentally get the virus via the vaccine.
“The mRNA platform has emerged as the front runner in delivering the first vaccines for emergency use to combat the COVID-19 pandemic. Biological E. is very pleased to be able to work with Providence on its promising mRNA vaccine candidate. We hope to provide India and other countries yet another option to ramp up their efforts towards achieving herd immunity against COVID-19 ,” said Mahima Datla, Managing Director of Biological E in a statement.
Providence will provide Biological E with the necessary technology transfer needed to manufacture the vaccines in India. It will have a minimum production capacity of 600 million doses in 2022, with a target capacity of one billion doses.
According to the statement, the terms for sale by Providence decrees that up to 30 million doses of the vaccine will be given to Biological E and other buyers. These are all the doses that remain from 2021 that Providence produced and also includes a portion of the early 2022 production. However, first prefernace will be given to accomodating the orders from the Province of Manitoba, Canada.
Biological E is also working on its own subunit vaccine candidate. It has finished Phase I/II clinical trials and has got approvals to conduct Phase III clinical trial from the Central Drugs Standard Control Organization (CDSCO) – Subject Expert Committee (SEC). In Phase I/II, the vaccine was tested in about 360 healthy individuals between the ages of 18 to 65 years. The two-dose vaccines were given 28 days apart and were found to be safe. Phase III will be conducted in 15 sites across India, in about 1268 people within the age group of 18 to 80 years.