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Recent data releases from Novavax and Johnson & Johnson on 2019 coronavirus disease (COVID-19) vaccines show efficacy, but concerns remain about new variants that have recently become more prevalent.
The 2019 coronavirus (COVID-19) protein-based NVX-CoV2373 vaccine candidate, from Novavax, reported phase 3 results showing 89.3% efficacy in preventing COVID-19 in participants in the Kingdom -United.
The results of the trials – conducted at a time of significant transmission in the country and an emerging more transmissible variant spreading globally – coincide with the results of phase 2b which show less prevention of the variant initially seen in South Africa. South.
The vaccine
NVX-CoV2373 is a vaccine composed of an advanced full-length pre-fusion protein composed of patented recombinant nanoparticle technology and the adjuvant Matrix-M based on saponin.
Produced in insect cells, the purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike protein.
With the emergence of new mutated strains of SARS-CoV-2 in regions such as South East England and South Africa, Novavax began the development of new vaccine constructs specified in the strain genetic codes. , in the hope that ideal candidates will be provided via a booster or in combination as a bivalent vaccine will become apparent in the coming days.
Testing for these new vaccines would start in the second quarter of 2021.
“One of the main advantages of our adjuvanted platform is that it uses a very small amount of antigen, which enables the rapid creation and large-scale production of combination vaccine candidates that could potentially treat multiple strains in circulation. COVID-19, ”said Gregory M. Glenn, MD, president of research and development at Novavax, in a statement.
UK trial
Researchers recruited more than 15,000 adult participants, aged 18 to 84, to assess the vaccine for a primary endpoint of symptomatic COVID-19 occurrence confirmed by PCR, appearing at least 7 days after the booster dose of the vaccine. in participants serologically negative for SARS -CoV-2 at baseline.
More than a quarter (27%) of the trial participants were over 65 years old.
In the first interim analysis of 62 cases of COVID-19, 56 (89.2%) were seen in the placebo arm, compared to only 6 in the vaccine group (95% CI, 75.2 – 95.4). Of the 62 cases, only one was serious – in a patient on placebo.
The highly transmissible British variant strain has been detected in more than half of all observed cases, investigators noted (n = 32). In a post hoc evaluation, researchers reported that NVX-CoV2373 was 95.6% effective against the original COVID-19 strain and 85.6% effective against the British variant strain.
In an interim analysis of the safety database, investigators observed low and balanced rates of serious and medically assisted adverse events in both treatment arms.
Clive Dix, chairman of the UK Vaccine Taskforce, hailed the results as “spectacular” and expressed encouragement for the slightly less effective effect seen against the UK variant with the vaccine.
“It is an incredible achievement which will ensure that we can protect individuals in the UK and the rest of the world from this virus,” Dix said in a statement. “Novavax plans to share more details on UK trial results as more data becomes available.”
Trial in South Africa
In the Phase 2b clinical trial evaluating the vaccine versus placebo in more than 4,400 adult participants from August 2020 to mid-January 2021, researchers reported an efficacy of 60% (95% CI, 19.9 – 80.1) in preventing COVID-19 in participants who were HIV negative.
Overall, they observed 29 cases in the placebo group and 15 in the NVX-CoV2373 group. Again, only one serious case was reported in the placebo group.
In the overall trial population, made up of both HIV-positive and HIV-negative participants, the researchers reported an efficacy of 49.4% (95% CI, 6.1 – 72.8).
Preliminary sequencing data shows that for 27 of the 44 total COVID-19 diagnoses observed, 92.6% of the cases were the South African variant.
Researchers pointed out, however, that a third of enrolled participants were HIV-positive, demonstrating a previous infection with COVID-19 to begin with. Pre-test infections, based on temporal epidemiology data for the region assessed, indicate that these cases would be the original COVID-19 strain.
It is questionable whether the current Novavax product could completely protect against the South African variant that is prevalent around the world, but researchers are emphasizing its value in reducing the severity of COVID-19.
“The 60% reduced risk of COVID-19 disease in people vaccinated in South Africa underscores the value of this vaccine in preventing the disease of the very disturbing variant that is currently circulating in South Africa, and which is spreading in the world, ”Professor Shabir Maddi, senior researcher and executive director of the Vaccine and Infectious Disease Analysis (VIDA) Research Unit at Wits, said in a statement. “This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the dominant variant in South Africa.”
American essay
According to Novavax, the PREVENT-19 clinical trial for recruitment in the United States and Mexico has already randomized more than 16,000 participants, with a expectation of 30,000 targeted registrations in early February.
Conducted in support of federal agencies, including Operation Warp Speed (OWS), the phase 3, randomized, placebo-controlled, blinded evaluation will assess the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in adults compared to placebo.
Johnson & johnson
Johnson & Johnson (J&J) today announced that its JNJ-78436735 COVID-19 vaccine was 85% effective in preventing serious illness in all regions studied, 28 days after vaccination.
These regions included the United States, Latin America and South Africa. Efficacy against serious illness increased over time, with no cases in vaccinated participants reported after day 49 in all adults 18 years and older.
Additionally, the vaccine’s level of protection against moderate to severe infection with COVID-19 was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days after vaccination.
The investigational single-dose vaccine, which is developed by the Janssen pharmaceutical companies of Johnson & Johnson, is more commonly referred to as the Ad26.COV2.S vaccine and is a replication-incompetent recombinant adenovirus vector of serotype 26 (Ad26) encoding a full length, stabilized SARS-CoV-2 spike (S) protein.
“These first results with a single injection COVID-19 vaccine candidate represent a promising moment. The potential to dramatically reduce the burden of serious disease, by providing an effective and well-tolerated vaccine with a single vaccination, is a critical part of the global public health response, ”Johnson & Johnson Vice Chairman of the Executive Committee and Scientific Director Paul Stoffels, MD, said. “A single-dose vaccine is viewed by the World Health Organization as the best option in pandemic situations, improving access, distribution and compliance. 85% effectiveness in preventing severe COVID-19 illness and preventing COVID-19-related medical interventions will potentially protect hundreds of millions of people from severe and fatal COVID-19 outcomes. It also offers hope to help alleviate the enormous burden placed on health systems and communities.
These results come from the Whole Society study conducted in eight countries and three regions.
“The J&J vaccine gives a fantastic result,” said former FDA commissioner Scott Gottlieb, MD. tweeted this morning. “We now have 3 highly effective vaccines. This vaccine has shown sustained (and increasing!) Immune protection over time, possibly through robust early induction of immune memory cells (CD4 and CD8). The protection was strong and durable. “
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