Novavax Vaccine Shows Great Promise in Phase I Trial

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Scientists Are Optimistic About New Vaccine Studies From Novavax

Source: NY Times

By Carl Zimmer and Katie Thomas

The company has received a $1.6 billion grant from the government’s Operation Warp Speed to have 100 million doses ready by early 2021.

Novavax, the little-known Maryland company that received a $1.6 billion deal from the federal government for its experimental coronavirus vaccine, announced encouraging results in two preliminary studies on Tuesday.

In one study, 56 volunteers produced a high level of antibodies against the virus without any dangerous side effects. In the other, researchers found that the vaccine strongly protected monkeys from coronavirus infections.

Although it’s not possible to directly compare the data from clinical trials of different coronavirus vaccines, John Moore, a virologist at Weill Cornell Medicine who was not involved in the studies, said the Novavax results were the most impressive he had seen so far.

“This is the first one I’m looking at and saying, ‘Yeah, I’d take that,’” Dr. Moore said.

Angela Rasmussen, a virologist at Columbia University who was not involved in the studies, called them “encouraging preliminary results,” but cautioned that it won’t be possible to say whether the vaccine is safe and effective until Novavax conducts a large-scale study — known as Phase 3 — comparing people who get vaccinated to people who get a placebo.

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Categories: The Muslim Times, Vaccine

7 replies

  1. “That’s pretty remarkable,” said Akiko Iwasaki, an immunologist at Yale University. She noted that the Novavax vaccine provided stronger protection for monkeys than have other coronavirus vaccines, such as Moderna’s messenger RNA vaccine.

    In May, Novavax started a Phase 1 human trial on 134 volunteers. Some of the people who received the vaccine experienced tenderness at the spot where they got injected. But the researchers found no serious side effects.

  2. Novavax enrolled about 130 healthy volunteers in its trial and gave them either a placebo or one of four escalating doses of its vaccine. Everyone who received the vaccine developed neutralizing antibodies against SARS-CoV-2, which may help prevent infection.

    The best responses came from volunteers who received two injections of Novavax’s vaccine three weeks apart, plus an adjuvant meant to boost its effects. After 35 days, those participants had neutralizing antibody levels that, on average, were roughly four times higher than what was seen in a group of 32 patients who had recovered from the disease.

    About 80% of those volunteers had side effects at the site of injection, including pain and tenderness. More than 60% had other side effects, mostly headaches, muscle pain, and fatigue. Most reactions were mild or moderate, but eight patients had side effects that required hospitalization. All of the reactions resolved after a few days, and none was life-threatening.

    https://www.statnews.com/2020/08/04/novavaxs-covid-19-vaccine-shows-promising-immune-response-early-data-show/

  3. Aug 4 – Novavax Inc said on Tuesday its experimental COVID-19 vaccine produced antibodies against the novel coronavirus and appears to be safe, according to initial data from a small, early-stage clinical trial.

    The Maryland-based biotechnology company said its vaccine candidate, NVX-CoV2373, produced higher levels of the antibodies in healthy volunteers after two doses than those found in recovered COVID-19 patients, raising hopes for its eventual success.

    The addition of its Matrix-M adjuvant, a substance designed to boost the body’s immune response, did enhance the effect of the vaccine in the study, the company said.

    The Novavax vaccine is among the first of a handful of programs singled out for U.S. funding under Operation Warp Speed, the White House program to accelerate access to vaccines and treatments that can fight the virus.

    Effective vaccines and treatments are considered essential to halting a pandemic that has claimed more than 695,000 lives worldwide.

    Novavax research chief Gregory Glenn told Reuters the company will start much larger late-stage clinical trials soon and could potentially glean enough data to obtain regulatory approvals as early as December.

    The U.S. government in July agreed to pay Novavax $1.6 billion to help cover costs related to testing and manufacturing the vaccine, with the aim of procuring 100 million doses by January 2021.

    The trial, which started in late May, tested the vaccine in 106 subjects aged 18 to 59 versus a placebo. Phase I of the study looked at the vaccine’s safety and ability to induce immune responses.

    It tested 5 microgram and 25 microgram doses of the vaccine, with and without the adjuvant.

    https://finance.yahoo.com/news/novavax-coronavirus-vaccine-induces-immune-200500304.html

  4. CNN) A third US company has released study results showing its coronavirus vaccine is safe and elicits an immune response.

    Novavax, Inc. released Phase 1 data Tuesday from 131 volunteers showing that after two doses of the vaccine, participants developed neutralizing antibodies at levels more than four times higher on average than the antibodies developed by people who had recovered from Covid-19. Neutralizing antibodies fight off the virus that causes Covid-19.

    “That’s good. That’s really encouraging,” said Novavax president Dr. Gregory Glenn.
    The vaccine also induced a response from T-cells, a type of immune cell, according to an analysis of 16 randomly selected volunteers, the report stated.

    https://www.cnn.com/2020/08/04/health/novavax-phase-1-vaccine/index.html

  5. Novavax also released animal data on Tuesday. In the study, 12 monkeys received two doses of the vaccine and were then exposed to the virus that causes Covid-19. Eleven of the 12 monkeys showed no signs of infection in their noses or lungs. One monkey, which received a low dose of the vaccine, briefly showed signs of infection in the lungs, but all signs of infection were gone two days later.

    Slaoui said he expects a vaccine to be available in December or January with enough doses for high-risk Americans, such as the elderly and those with underlying health problems. He said he expects there to be enough vaccine for every American by the end of 2021.

    https://www.cnn.com/2020/08/04/health/novavax-phase-1-vaccine/index.html

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