Tag Archives: Novavax

Novavax combined influenza/COVID-19 vaccine shows promise in animal study

(Reuters) -Novavax Inc said on Monday its combined flu and COVID-19 vaccine produced functional antibodies against influenza and the coronavirus in a preclinical study.

The company said the NanoFlu/NVX-CoV2373 vaccine elicited robust responses to both influenza A and B and protected against the SARS-CoV-2 virus.

“Seasonal influenza and COVID-19 combination vaccines will likely be critical to combating emerging COVID-19 variants,” said Russell Wilson, the executive vice president and NanoFlu general manager of Novavax.

Hamsters that received the combined vaccine had heightened levels of COVID-19 antibodies two weeks after the first immunization, which increased significantly after a second dose, compared to animals that received the COVID-19 vaccine, NVX-CoV2373, alone, the company said.

Novavax said it expects to start clinical studies of the combined vaccine by the end of 2021.

(Reporting by Mrinalika Roy and Amruta Khandekar in Bengaluru; Editing by Amy Caren Daniel)

Exclusive: New global lab network will compare COVID-19 vaccines head-to-head

By Kate Kelland

LONDON (Reuters) – A major non-profit health emergencies group has set up a global laboratory network to assess data from potential COVID-19 vaccines, allowing scientists and drugmakers to compare them and speed up selection of the most effective shots.

Speaking to Reuters ahead of announcing the labs involved, Melanie Saville, director of vaccine R&D at the Coalition for Epidemic Preparedness Innovations (CEPI), said the idea was to “compare apples with apples” as drugmakers race to develop an effective shot to help control the COVID-19 pandemic.

The centralized network is the first of its kind to be set up in response to a pandemic.

In a network spanning Europe, Asia and North America, the labs will centralize analysis of samples from trials of COVID-19 candidates “as though vaccines are all being tested under one roof”, Saville said, aiming to minimize the risk of variation in results.

“When you start off (with developing potential new vaccines) especially with a new disease, everyone develops their own assays, they all use different protocols and different reagents – so while you get a readout, the ability to compare between different candidates is very difficult,” she told Reuters.

“By taking the centralized lab approach … it will give us a chance to really make sure we are comparing apples with apples.”

The CEPI network will initially involve six labs, one each in Canada, Britain, Italy, the Netherlands, Bangladesh and India, Saville said.

Hundreds of potential COVID-19 vaccines are in various stages of development around the world, with shots developed in Russia and China already being deployed before full efficacy trials have been done, and front-runners from Pfizer, Moderna and AstraZeneca likely to have final-stage trial results before year-end.

Typically, the immunogenicity of potential vaccines is assessed in individual lab analyses, which aim to see whether biomarkers of immune response – such as antibodies and T-cell responses – are produced after clinical trial volunteers receive a dose, or doses, of the vaccine candidate.

But with more than 320 COVID-19 vaccine candidates in the works, Saville said, the many differences in data collection and evaluation methods are an issue.

As well as potential variations in markers of immunity, there are differences in how and where samples are collected, transported and stored – all of which can impact the quality and usefulness of the data produced, and make comparisons tricky.

And with a range of different vaccine technologies being explored – from viral vector vaccines to ones based on messenger RNA – standard evaluation of their true potential “becomes very complex”, she said.

“With hundreds of COVID-19 vaccines in development … it’s essential that we have a system that can reliably evaluate and compare the immune response of candidates currently undergoing testing,” she said.

By centralizing the analysis in a lab network, much of what Saville called the “inter-laboratory variability” can be removed, allowing for head-to-head comparisons.

CEPI says all developers of potential COVID-19 vaccines can use the centralized lab network for free to assess their candidates against a common protocol. For now, the network will assess samples from early-stage vaccine candidate testing and first and second stage human trials, but CEPI said it hoped to expand its capacity to late stage (Phase III) trial data in the coming months.

Results produced by the network will be sent back to the developer, with neither CEPI nor the network owning the data.

CEPI itself is co-funding nine of the potential COVID-19 vaccines in development, including candidates from Moderna, AstraZeneca, Novavax and CureVac.

(Reporting by Kate Kelland, editing by Mark Potter)

Novavax starts enrollment for phase two of COVID-19 vaccine trial

(Reuters) – Novavax Inc said on Monday it has begun enrolling volunteers for the second phase of an ongoing clinical trial of its COVID-19 vaccine candidate, with interim data expected in the fourth quarter of 2020.

In the new phase, the age range has been expanded, with adults between 60 and 84 years accounting for nearly 50% of the trial’s population.

Early-stage data from a small clinical trial of the vaccine has shown it produced high levels of virus-fighting antibodies, and the company aims to begin larger studies to obtain regulatory approvals as early as December.

The vaccine candidate is one of nearly 30 being tested in human clinical trials globally and lags candidates from AstraZeneca, Pfizer and Moderna that are in late-stage studies.

The U.S. government in July awarded Novavax $1.6 billion to test and manufacture its vaccine in the United States, with the aim of delivering a 100 million doses by January.

Britain has also tied-up with the company to buy 60 million doses of its vaccine candidate, some of which will be made using Fujifilm Diosynth Biotechnologies facilities in Stockton-on-Tees, northern England.

The study is targeting enrollment of up to 1,500 healthy volunteers at up to 40 sites in the United States and Australia, Novavax said.

Last week, the drug developer began a mid-stage study of its COVID-19 vaccine in South Africa.

(Reporting by Ankur Banerjee and Vishwadha Chander in Bengaluru; Editing by Arun Koyyur)

Novavax begins mid-stage study of COVID-19 vaccine in South Africa

(Reuters) – U.S. drug developer Novavax Inc said on Monday it started a mid-stage study of its experimental COVID-19 vaccine in South Africa, as the country experiences a surge in coronavirus cases.

South Africa is the fifth worst affected country with 583,653 coronavirus cases and 11,677 deaths, according to a Reuters tally.

“Because South Africa is experiencing a winter surge of COVID-19 disease, this important Phase 2b clinical trial has the potential to provide an early indication of efficacy,” Novavax research chief Gregory Glenn said.

The trial of Novavax’s NVX-CoV2373, backed by a $15 million grant from Bill & Melinda Gates Foundation, was being conducted in two separate groups, one comprising 2,665 healthy volunteers and the other, 240 HIV-positive adults.

Novavax expects its vaccine, once approved, would be supplied to South Africa through a deal signed earlier this year with the Serum Institute of India to develop and commercialize NVX-CoV2373.

The vaccine candidate is one of nearly 30 globally being tested in human clinical trials.

Early-stage data from a small clinical trial of the vaccine has shown that it produced high levels of virus-fighting antibodies, and the company aims to begin larger studies to obtain regulatory approvals as early as December.

Novavax intends to begin Phase 2 of the small clinical trial in the United States and Australia in the near future and said it would include about 1,500 candidates. It also aims to begin Phase III as soon as late September.

The U.S. government in July awarded Novavax $1.6 billion to cover testing its potential coronavirus vaccine in the United States and manufacturing with the aim of delivering a 100 million doses by January.

(Reporting by Sabahatjahan Contractor and Manas Mishra in Bengaluru; Editing by Amy Caren Daniel and Shinjini Ganguli)