Why Novavax’s Coronavirus Vaccine Might Be First to Market

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

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The key variable in this race is not the phase 3 trial, but which company has enough positive data for an Emergency Use Authorization.

In the race for a COVID-19 vaccine, Novavax (NASDAQ:NVAX) would seem to be in fourth place. (And that’s if we exclude the Russian and Chinese vaccine candidates.)

On July 14, Moderna (NASDAQ:MRNA) announced that the phase 3 trial for its vaccine candidate would start on July 27. Less than a week later, AstraZeneca (NYSE:AZN) announced positive data from its phase 1/2 trial and noted that it had already started a phase 2/3 trial for its COVID-19 vaccine candidate. And on July 27, Pfizer (NYSE:PFE) announced that it, too, had started its phase 3 trial for a coronavirus vaccine.

A month later, on Aug. 24, Novavax started vaccinating volunteers in its phase 2 trial. The company plans to initiate a phase 3 trial in September. Right now, the vaccine specialist seems to be about two months behind its larger competitors. So how can it possibly be first to market?

The first COVID-19 vaccine on the market will be under an EUA

The U.S. Food and Drug Administration (FDA) has a pathway in place to authorize the use of drugs more quickly in an emergency; this is referred to as an Emergency Use Authorization, or EUA. The agency uses this method often to get important drugs to people as fast as possible, and it’s already done so 45 times in the fight against the coronavirus, allowing various healthcare companies to sell diagnostic tests, personal protective equipment, ventilators, and drugs.

In order for a vaccine to be approved by the FDA, the company creating it typically needs positive data from a phase 3 trial, which is often a massive undertaking involving thousands of people. For instance, in the COVID-19 vaccine trials, drug companies are enrolling 30,000 volunteers or more. Johnson & Johnson, which has yet to start its phase 1 trial, has recently announced that its eventual COVID-19 phase 3 trial will recruit 60,000 volunteers around the world.

Recruitment for vaccine studies is not a rapid process. Since July, Pfizer has recruited 11,000 volunteers for its study. At that pace, Pfizer won’t finish enrollment until October. And of course, enrollment is just the beginning of a phase 3 trial. You have to wait a few months to see whether the vaccine works. You have to analyze the data and prepare a submission. Then the agency has to analyze the data. Even if everyone involved rushes things, it’s hard to see how a new drug application could be approved by the end of the year.

An EUA, on the other hand, might get a vaccine on the market by November or December. An EUA might be issued on the basis of strong phase 2 data, or on interim data from a phase 3 trial. And that’s how Novavax might sneak into the market first.

What kind of vaccine data does a biotech need for an EUA?

Phase 1 trial data gives companies a lot of information about their vaccine candidates. Specifically, Novavax now knows that its vaccine candidate (NVX-CoV2373) is safe, and that it increases antibodies in people. In fact, this data was so positive that some analysts have already opined that the candidate is best-in-class. However, the dramatic rise in antibodies created by the candidate doesn’t answer the real question about efficacy: Would the vaccine keep people from getting sick?

To answer that question, any biotech company has to do a pivotal trial. Novavax is prepping for a massive phase 3 trial to start in September with volunteers from around the world, but another important milestone is the relatively smaller 2,665-volunteer phase 2 study that is happening in South Africa right now. That country is experiencing a wintertime surge in COVID-19. In this trial, Novavax is testing for efficacy and safety, measured against placebo.

Dr. Zia H Shah, Chief Editor of the Muslim Times and in charge for the health section

The best of the Muslim Times’ collection for war against Covid 19:

In this day and age, understanding bacteria and viruses and developing vaccines are national security issues. In my view sizable part of every country’s defense budget should be spent in these pursuits rather than making tanks and other weapons.

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Categories: Vaccine

3 replies

  1. Four months after the Wistar Institute and Penn Medicine began testing its COVID-19 vaccine, all trial participants have demonstrated an overall immune response and experienced little to no side effects. Phases two and three of the study are expected to commence in September with more participants.

    The phase one trial, taking place at Penn Medicine and Center for Pharmaceutical Research in Kansas City, has 40 participants between 18 and 50 years old. The trial began on April 3 to test the safety and initial immunogenicity of the vaccine. Immunogenicity is the vaccine’s ability to induce an immune response in the body.

    The vaccine was the second of its kind to enter a phase one clinical study in the United States. Four U.S. vaccines have already reached at least phase two of clinical trials, according to The New York Times.

    Phase two will test the vaccine’s safety and immunogenicity in a larger population, while phase three will simultaneously evaluate its efficacy and readiness for distribution. Penn Med professor and principal clinical investigator of the study Pablo Tebas will continue to oversee the next phases with greater numbers of participants at more universities nationwide, Weiner said.

    https://www.thedp.com/article/2020/08/inovio-coronavirus-vaccine-wistar-penn-medicine-trials

  2. By
    Carolyn Y. Johnson
    August 27, 2020 at 3:25 p.m. EDT
    Add to list
    Moderna and Pfizer, the companies leading the U.S. race for a coronavirus vaccine, disclosed this week they have enrolled more than half the people needed for the 30,000-person trials that represent the final phase of testing. But only about a fifth of participants are from Black and Hispanic communities, which have been hit hardest by the virus — lagging what several experts said should be the bare minimum of diversity.

    An online registry that people can use to express interest in the vaccine trials — a list of about 350,000 volunteers — had only about 10 to 11 percent Black and Hispanic people as of late last week, according to James Kublin, executive director of the federal HIV Vaccine Trials Network, based at the Fred Hutchinson Cancer Research Center in Seattle. The HIV trials network is being repurposed to test coronavirus vaccines.

    “We are working a bit uphill, in the Sisyphean task to get the studies representing the diversity [of the U.S.] — and that goes into the historical legacy of not just discrimination, but of outright unethical medical practices” on minority communities, Kublin said.

    https://www.washingtonpost.com/health/2020/08/27/large-us-covid-19-vaccine-trials-are-halfway-enrolled-lag-participant-diversity/

  3. Hahn also noted that the vaccine advisory committee would meet on October 22. The comments were noteworthy, given that the FDA’s website does not list that committee meeting on its calendar.

    Mizuho Securities analyst Vamil Divan figures that vaccine timeline can only benefit Pfizer. If the company is already halfway to its goal of recruiting 30,000 patients in the mRNA vaccine trial, he figured, the company should “reach full enrollment by end of next month,” Divan wrote in a note sent to investors Thursday. That means the first dataset should be released in mid-September, potentially at an investor event the company has scheduled for that time.

    All of the data from the trial could be ready by mid-October, Divan added, just in time for the FDA committee meeting. “While difficult to predict, this does set the stage for potential … review and FDA Emergency Use Authorization in that same time period,” he wrote.

    Pfizer did not immediately respond to a request for comment.

    https://www.fiercepharma.com/pharma/pfizer-could-score-fast-covid-vaccine-approval-as-fda-s-hahn-promises-october-review-analyst

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