Clinical trials start for new COVID-19 vaccine candidate from Valneva

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Clinical trials start for new COVID-19 vaccine candidate from Valneva


French biotech company Valneva
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will start the first clinical trials of its COVID-19 vaccine candidate in sites across the U.K., the country’s business ministry said on Wednesday.

The Phase 1 and Phase 2 study will involve 150 volunteers in sites across Bristol, Birmingham, Southampton and Newcastle, to evaluate the safety of the experimental shot, and whether it produced an immune response is healthy adults.

Data from the trials, which will be supported by the National Institute for Health Research, is expected in the early second quarter of 2021.

If successful, Valneva
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will carry out a larger study in April 2021, with more than 4,000 volunteers being given two doses each of the vaccine candidate, which could then become available by the fourth quarter of 2021.

“While conducting our first clinical trials, we are already ramping-up our manufacturing capacities and commencing production at full-scale so that we can make the vaccine widely available across the world assuming the vaccine is safe and effective,” said Valneva
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Chief Executive Thomas Lingelbach.

The experimental shot is being manufactured at a plant in Livingston, Scotland.

The U.K. government has ordered 60 million doses of Valneva’s experimental shot which will be delivered in the second half of 2021, with an option to acquire a further 130 million from 2022-2025.

The start of Valneva’s trial comes just days after the U.K. rolled out its large-scale vaccination program of the shot developed by U.S. drug company Pfizer
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and its German partner BioNTech
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after it became the first country in the world to approve it on Dec. 2.

Read: World watches as first person receives Pfizer–BioNTech COVID shot

Some scientists have warned that it could take at least a year to inoculate the entire U.K. population.

On Monday, writing in the journal Anaesthesia, Jeremy Farrar, director of the Wellcome Trust and a member of the Scientific Advisory Group for Emergencies, and Prof. Tim Cook, a consultant in anesthesia and intensive-care medicine from the University of Bristol, said the scale of the vaccination program “should not be underestimated.”

“1,000 vaccination centres each vaccinating 500 people a day for five days a week, without interruptions of supply or delivery, would take almost a year to provide two doses to the U.K. population,” the scientists wrote.

“No country has mounted a whole-population vaccination campaign in living memory and it will need to be undertaken with local leadership and cultural sensitivity,” they added.

Read: Boris Johnson warns of ‘immense logistical challenge,’ as U.K. becomes first to authorize use of Pfizer–BioNTech COVID-19 vaccine

Valneva is developing an inactivated, whole-virus vaccine, a more traditional approach than the one being used by BioNTech
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and Pfizer
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which uses the so-called messenger RNA, or mRNA, approach, which sends a message to cells telling them to create proteins that can generate an immune response. 

Adam Finn, chief investigator of the Valneva trial and professor of pediatrics at the University of Bristol, said the effort to produce vaccines to prevent COVID-19 has included several “very new” approaches, but that there were also tried and tested approaches to developing highly effective and safe vaccines that can be used.

“Growing the whole virus and then inactivating it to make a vaccine is an approach first developed in the 1950s and has contributed to disease prevention over many decades. We expect this inactivated vaccine containing two adjuvants could generate a broader immune response,” said Finn.

The government has signed deals for five vaccines, providing up to £267 million doses at an expected cost of £2.9 billion, according to a report published on Wednesday by public-spending watchdog the National Audit Office.

The total cost to the taxpayer of the government’s efforts to purchase and deploy vaccines is currently estimated at up to £11.7 billion ($16 billion), said the NAO. The figure doesn’t cover the costs of any future potential multiyear vaccination programs.

By contrast, Operation Warp Speed — the U.S. government program to support companies in making, delivering and distributing 300 million doses of safe and effective vaccines by January 2021 — has invested more than $10 billion in vaccine development.

Read: More Americans now say they’ll get a COVID-19 vaccine once it’s available

The NAO report also noted that several drug companies have requested immunity in the event of liabilities or legal action relating to their vaccines, meaning the taxpayer may have to pay the costs of claims against them.

In four out of the five contracts agreed so far, no cap has been applied to the amount that the government could pay in the event of a successful claim against the pharmaceutical companies.

Gareth Davies, head of the NAO, said that with one vaccine now approved for use and its rollout started, significant challenges remain. “Efficient delivery to the U.K. population presents complex logistical challenges and requires excellent communication with the public,” said Davies.



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