Novavax Vaccine Phase I / II Trial Published in the New England Journal of Medicine

The Muslim Times has the best collection of articles for the war against Covid 19, especially the vaccines.

Abstract

BACKGROUND

NVX-CoV2373 is a recombinant severe acute respiratory syndrome coronavirus 2 (rSARS-CoV-2) nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins and Matrix-M1 adjuvant.

METHODS

We initiated a randomized, placebo-controlled, phase 1–2 trial to evaluate the safety and immunogenicity of the rSARS-CoV-2 vaccine (in 5-μg and 25-μg doses, with or without Matrix-M1 adjuvant, and with observers unaware of trial-group assignments) in 131 healthy adults. In phase 1, vaccination comprised two intramuscular injections, 21 days apart. The primary outcomes were reactogenicity; laboratory values (serum chemistry and hematology), according to Food and Drug Administration toxicity scoring, to assess safety; and IgG anti–spike protein response (in enzyme-linked immunosorbent assay [ELISA] units). Secondary outcomes included unsolicited adverse events, wild-type virus neutralization (microneutralization assay), and T-cell responses (cytokine staining). IgG and microneutralization assay results were compared with 32 (IgG) and 29 (neutralization) convalescent serum samples from patients with Covid-19, most of whom were symptomatic. We performed a primary analysis at day 35.

RESULTS

After randomization, 83 participants were assigned to receive the vaccine with adjuvant and 25 without adjuvant, and 23 participants were assigned to receive placebo. No serious adverse events were noted. Reactogenicity was absent or mild in the majority of participants, more common with adjuvant, and of short duration (mean, ≤2 days). One participant had mild fever that lasted 1 day. Unsolicited adverse events were mild in most participants; there were no severe adverse events. The addition of adjuvant resulted in enhanced immune responses, was antigen dose–sparing, and induced a T helper 1 (Th1) response. The two-dose 5-μg adjuvanted regimen induced geometric mean anti-spike IgG (63,160 ELISA units) and neutralization (3906) responses that exceeded geometric mean responses in convalescent serum from mostly symptomatic Covid-19 patients (8344 and 983, respectively).

CONCLUSIONS

At 35 days, NVX-CoV2373 appeared to be safe, and it elicited immune responses that exceeded levels in Covid-19 convalescent serum. The Matrix-M1 adjuvant induced CD4+ T-cell responses that were biased toward a Th1 phenotype. (Funded by the Coalition for Epidemic Preparedness Innovations; ClinicalTrials.gov number, NCT04368988. opens in new tab).

Read further

Read the whole article in a PDF file:

Categories: Vaccine

2 replies

  1. The U.S. Centers for Disease Control has just told states to prepare for a possible vaccine as early as November, putting the issue of vaccine approval front and center. So consider this column an open letter to scientists, researchers and other experts in public health. I have some news for you: In the debate over how quickly the Food and Drug Administration should approve a vaccine for Covid-19, and over concern about premature approval, you are losing to President Donald Trump.

    Right now your arguments are simply not good enough. To be clear, I am inclined to agree with you, as I am not myself flying around the world, trying to get the “early vaccines” from Russia and China. Yet the all-important question of the optimal speed of vaccine approval deserves far more attention. The Federal Reserve puts hundreds of economists on the task of figuring out the best monetary policy. There should be an equal number of you in the field of public health studying vaccine policy.

    https://www.bloomberg.com/opinion/articles/2020-09-02/early-vaccine-trump-is-winning-debate-with-public-health-experts?sref=eGA8az79

  2. Amid the frenzied race for a COVID-19 vaccine, Pfizer may have early efficacy results in just a matter of weeks.

    During a digital event Thursday, Pfizer CEO Albert Bourla said the company has enrolled about 23,000 people for its phase 3 coronavirus vaccine trial so far. The company expects initial results in late October. If the results are positive, the company would be ready to ask the FDA to authorize vaccinations as soon as possible.

    In fact, the company is already preparing its application to submit quickly if the vaccine shows promise, he added. The FDA has set an advisory panel meeting for October 22 to discuss COVID-19 vaccine progress.

    In October, “the truth will be revealed,” Bourla said in a Washington Post interview.

    Bourla’s timeline would have been unthinkable at the beginning of the year, when the novel coronavirus started spreading and researchers got to work on the first vaccine candidates. Moderna entered the clinic in record time, while partners Pfizer and BioNTech started U.S. human testing in early May.

    At the start of the R&D process, experts predicted a vaccine could be available in 12 to 18 months if all went smoothly. Now, experts are still skeptical that a vaccine could be ready in late October.

    As the programs raced ahead, Americans grew wary about getting a shot developed and approved in short time. In a recent survey conducted by Stat and Harris Poll, more than 80% of people responded that they’d worry about safety for a hastily approved vaccine. Nearly 80% see politics driving the approval process rather than science.

    https://www.fiercepharma.com/vaccines/pfizer-could-see-early-efficacy-data-for-coronavirus-vaccine-late-october-ceo

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.