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

If successful, Valneva
0OB3,
+0.34%
will carry out a larger study in April 2021, with more than 4,000 volunteers testing two doses of the vaccine in two groups: those aged between 18-65 years and over 65s.

The vaccine candidate 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
INRLF,
-2.29%
Chief Executive Thomas Lingelbach.

The experimental shot is being manufactured at a plant in West Lothian, 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.

Valneva’s vaccine is the fifth to enter clinical trials in the U.K., alongside AstraZeneca
AZN,
+2.24%
and the University of Oxford, Imperial College London, Novavax
NVAX,
-2.68%
and Johnson & Johnson
JNJ,
+1.01%
division Janssen Pharmaceuticals, whose studies are currently ongoing.

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
PFE,
-1.28%
and its German partner BioNTech
BNTX,
+2.71%,
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

On Wednesday, the government said that more than 137,000 people in the U.K. have received the first dose of the Pfizer–BioNTech vaccine in the first week. The majority of the vaccines have been administered to the over-80s, care-home workers and National Health Service staff through more than 70 sites across the country.

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
22UA,
+1.79%
and Pfizer
0Q1N,
-3.87%,
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.