Virus World

The French company said its vaccine generated a stronger immune response than the Oxford/AstraZeneca vaccine.  Based on a U.K. trial of 4,012 participants, Valneva said that its vaccine stimulated the creation of protective antibodies at around a 40 percent higher rate compared with AstraZeneca’s vaccine and was better tolerated. The vaccine also prevented coronavirus infections at a similar rate to the Oxford/AstraZeneca shot, and there were no serious cases across both groups, the company said. A placebo-controlled trial was not possible on ethical grounds, given the arrival of authorized vaccines.  Chief Medical Officer Juan Carlos Jaramillo told journalists in a briefing that Valneva is positioning the jab as a first-vaccination course for people in the U.K., Europe, North America and around the world. “I think there's very much a role for this vaccine, even in places where the programs are well advanced,” added Adam Finn, chief investigator. The biotech began a rolling review in August with the U.K.’s Medicines and Healthcare products Regulatory Authority (MHRA) and plans to finalize its submission in November. It expects an initial approval, “hopefully by the year-end,” Jaramillo said. A European decision is anticipated early next year. This will initially be for those aged 18 to 55, based on the trial participants. The company anticipates expanding its use to older and younger people based on ongoing trials. Valneva is also carrying out a booster study with its inactivated virus vaccine. Investors reacted positively to Valneva's announcement, sending its shares 36% higher in European trading.

Bittersweet pill

While it’s positive news for the French company, which chose the U.K. for its clinical development as well as for manufacturing its vaccine, it’s tainted by a lack of buyers.  Britain last month terminated its contract to buy 190 million doses; the first 60 million doses were expected in the first quarter of 2022. The U.K. alleged that Valneva was in breach of its obligations under the supply agreement, which the company said it strenuously denied. A Department of Health and Social Care spokesperson said on Monday in an emailed statement that they had "received the latest interim clinical trial data,” but did not address whether the contract was still salvageable. Meanwhile, the company has been in prolonged talks with the European Commission but has not completed an agreement due to issues over agreeing to a supply schedule. Jaramillo said he was unable to comment on the U.K.’s contract but said EU discussions “are happening as we speak.” Meanwhile, MHRA approval could pave the way for World Health Organization pre-qualification, Finn pointed out. Valneva is preparing to submit a rolling review with the European Medicines Agency and anticipates a decision in the first quarter of 2022.

Promising data

The Valneva shot is the only vaccine in clinical development in Europe based on a whole inactivated, adjuvanted virus — a more traditional form of vaccine than mRNA or adenoviral-vector shots. Similar technology is used in the Chinese vaccines from Sinopharm and Sinovac. In terms of safety, Valneva said that participants who received its vaccine reported “significantly fewer” adverse side-effects when compared with Oxford/AstraZeneca. In addition, analysis shows that the shot provoked the creation of a broad spectrum of T-cells, which, along with antibodies, give protection against the coronavirus and are understood to be linked with long-term immunity. Given that the vaccine contains the whole inactivated virus, T-cell immune responses were detected not only against the S (spike) protein but also against other parts of the virus known as M and N proteins. To date, all EU authorized vaccines only target the spike protein. This broader approach “theoretically provide[s] you with some security if you like against viral evolution,” said Finn.

Valneva's Press Release (Oct. 18, 2021):

https://valneva.com/press-release/valneva-reports-positive-phase-3-results-for-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001/ 

The French vaccine developer Valneva has received a €21M ($23.4M) grant to catch up with the competition in commercializing the first potential vaccine for the chikungunya virus. Coming from the nonprofit Coalition for Epidemic Preparedness Innovations (CEPI), the grant will boost the manufacturing and development of Valneva’s vaccine for the tropical disease chikungunya, which causes fever and can trigger chronic pain in the joints. Chikungunya has long been a problem in developing countries with endemic tropical diseases, but has received less attention from developed countries until recently. However, climate change could increase the range of disease-carrying mosquitoes, and chikungunga outbreaks in Europe could become more common. Companies developing vaccines for the disease could deliver an important weapon in the fight against the disease. 

In May, the vaccine showed the potential to protect against the virus in a phase I trial. As the company has already calculated an optimal dose, Valneva’s one-shot vaccine could skip phase II and head directly to phase III.

The Austrian biotech Themis Bioscience is also developing a vaccine for chikungunya, which is expected to enter phase III later this year. With a phase III trial expected to begin in early 2020, Valneva might narrow Themis’ lead in the race to get the first chikungunya vaccine to the market. 

The CEPI allocates grants to fund the development of vaccines against infections causing humanitarian crises. CEPI also recently provided a 19M euros grant to Themis, with the aim of accelerating vaccines for chikungunya and other diseases to the market.

French biotech Valneva has revealed additional phase I results concerning its experimental chikungunya vaccine; all 68 patients that were given a single injection of the vaccine showed sustained protection after 12 months. The company is currently running a phase II study and plans to launch a pivotal phase III trial next year.

Valneva's vaccine for the chikungunya virus has proved effective and safe for up to six months after injection in an ongoing phase I trial. By six months after injection, the trial's 120 enrolled volunteers showed no adverse events related to the vaccine, and continued to have antibodies against the virus in their blood. A group of the volunteers was injected with the vaccine for a second time, and showed robust immune protection. The trial will continue to follow the volunteers for up to 13 months after the initial injection. The company expects to announce a plan later this year for how it will work with the FDA to get market approval for the vaccine, which has an FDA Fast Track designation.