Novavax

New Delhi- The Subject Expert Committee of India's central drug regulatory authority has given a go-ahead to the Serum Institute of India to conduct Phase 2 and 3 clinical trials for Novavax's Covid vaccine candidate in the country. According to the minutes of meetings accessed by IANS, the Pune-based vaccine manufacturing giant will be conducting bridging trials of American vaccine manufacturer's Covid vaccine in India. The SII had applied for the trails earlier but the SEC was not satisfied with the trial protocols and recommended the firm to re-submit the revised protocols. "In light of recommendations of SEC committee dated 18.12.2020 and 13.01.2021, the firm presented its proposal along with a revised protocol for conducting Phase II/III clinical trial of SARS-CoV-2 rS Protein Nanoparticle Vaccine with Matrix-M1 Adjuvant before the committee," the SEC's observation in the minutes' document said. The revised protocol was found satisfactory by the experts' committee after which it recommended to grant permission to conduct late trials bridging studies for the Novavax vaccine. "After detailed deliberation, the committee recommended for grant of permission to conduct Phase II/III clinical trial," the SEC said. However, the recommendation was given to a condition that the participants randomised in the trial for the placebo arm may be unblinded 60 days after the second dose upon request of the clinical trial participant only. "Such participant may be offered investigational vaccine as per the dose and schedule prescribed in the protocol," the committee said. A week ago, Novavax said that its Covid vaccine was 89.3 per cent effective in preventing the Covid-19 in a trial conducted in the UK. Meanwhile, its preliminary analysis and was nearly as effective in protecting against the variant found in the UK. In September last year, Novavax had announced its deal with the SII to produce 2 billion doses of coronavirus vaccines. (IANS)

New York, Jan 29 (IANS) US-based biotechnology company Novavax on Friday announced that its Covid-19 vaccine was 89.3 per cent effective in preventing Covid-19 in a trial conducted in the UK.The study assessed efficacy of the vaccine -- NVX-CoV2373 -- during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely."NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible," Stanley C. Erck, President and Chief Executive Officer, Novavax, said in a statement.The biotech company also announced results of its Phase 2b study conducted in South Africa. In the South Africa Phase 2b clinical trial, 60 per cent efficacy for the prevention of mild, moderate and severe Covid-19 disease was observed in the 94 per cent of the study population that was HIV-negative."The 60 per cent reduced risk against Covid-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally," said Shabir Maddi, principal investigator in the Novavax COVID-19 vaccine trial in South Africa.In 2020, Novavax had announced its deal with Pune-based vaccine manufacturing company Serum Institute of India (SII) in order to produce 2 billion doses of Covid-19 vaccines.The UK study enrolled more than 15,000 participants between 18-84 years of age, including 27 per cent over the age of 65. The primary endpoint of the UK Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) Covid-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.The first interim analysis is based on 62 cases, of which 56 cases of Covid-19 were observed in the placebo group versus 6 cases observed in the NVX-CoV2373 group, resulting in a point estimate of vaccine efficacy of 89.3 per cent. Of the 62 cases, 61 were mild or moderate, and 1 was severe (in placebo group).Preliminary analysis indicates that the UK variant strain that was increasingly prevalent was detected in over 50 per cent of the PCR-confirmed symptomatic cases (32 UK variant, 24 non-variant, 6 unknown). Based on PCR performed on strains from 56 of the 62 cases, efficacy by strain was calculated to be 95.6 per cent against the original Covid-19 strain and 85.6 per cent against the UK variant strain.The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.--IANSvc/pgh

New York, Aug 5 (IANS) A Covid-19 vaccine developed by US-based Novavax elicited robust antibody responses and appeared to be safe in a Phase-I human trial, the company has said.No serious adverse events were reported and safety follow-up continues, Novavax said on Tuesday, while releasing the results of the study about its Covid-19 vaccine, NVX-CoV2373.The trial evaluated two doses of the vaccine across two dose levels -- 5 and 25 microgram -- in 131 healthy adults ages 18-59 years.The trial was supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and was conducted at two sites in Australia."The Phase 1 data demonstrate that NVX-CoV2373 with our Matrix-M adjuvant is a well-tolerated COVID-19 vaccine with a robust immunogenicity profile," Gregory Glenn, President, Research and Development at Novavax, said in a statement."Using a stringent wild-type virus assay performed by investigators at the University of Maryland School of Medicine, NVX-CoV2373 elicited neutralising antibody titers greater than those observed in a pool of COVID-19 patients with clinically significant disease."NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes Covid-19 disease.It was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.The company said the data of the Phase-1 trial have been submitted for peer-review to a scientific journal and to an online preprint server at medRxiv.org.Novavax has become the third US company to release Phase-1 data of Covid-19 vaccines after Moderna and Pfizer.Novavax was awarded $1.6 billion by the US government as part of Operation Warp Speed (OWS), a program to deliver millions of doses of a safe, effective vaccine for Covid-19 to the US population.The funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial, establish large-scale manufacturing, and deliver 100 million doses of NVX-CoV2373 beginning as early as late 2020, the company said.--IANSgb/in