Pfizer and BioNTech began late-stage human trial for coronavirus vaccine Monday

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Source: CNBC

U.S. drugmaker Pfizer and German biotech BioNTech said they began their late-stage human trial for a potential coronavirus vaccine on Monday as pharmaceutical companies race to win regulatory approval before the end of the year.

Shares of Pfizer rose more than 3% in after-hours trading Monday. BioNTech was up more than 2%.

The trial will include up to 30,000 participants between the ages of 18 and 85 across 120 sites globally, including 39 U.S. states, the companies announced. If successful, they expect to submit it for final regulatory review as early as October. They plan to supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

The decision to start the trial reflects “our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio,” BioNTech CEO Ugur Sahin said in a release. “Many steps have been taken towards this important milestone and we would like to thank all those involved for their extraordinary commitment.”

The companies’ experimental vaccine, uses messenger ribonucleic acid, or mRNA molecules, to provoke an immune response to fight the virus. Scientists hope mRNA, which relays genetic instructions from DNA, can be used to train the immune system to recognize and destroy the virus.

Earlier this month, the companies said one of its four coronavirus vaccine candidates produced neutralizing antibodies, which researchers believe is necessary to build immunity to the virus, in all participants who received two of the 10 or 30 microgram doses.

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Categories: The Muslim Times, Vaccine

3 replies

  1. Pfizer Inc. is preparing for the novel coronavirus to endure, leading to long-term demand for a seasonal shot to protect against Covid-19.

    The New York pharmaceutical giant and its German partner BioNTech SE are front-runners in the race to develop a Covid-19 vaccine, employing a technology known as messenger RNA that can quickly advance through clinical studies. The companies dosed their first U.S. patient in a late-stage trial Monday, and they could be ready to seek approval from regulators as early as October.

    There has been a growing sense that a one-time vaccine regimen may not be enough to ward off Covid-19 forever. It isn’t clear how long coronavirus antibodies can protect people from the disease, and early trials haven’t yet yielded proof that a shot could prevent infection for an extended period of time.

    Pfizer said it expects that a Covid-19 vaccine could, like the flu shot, be an inoculation that is needed regularly to be effective.

    https://www.bloomberg.com/news/articles/2020-07-28/pfizer-says-covid-could-endure-sees-long-term-need-for-shot?srnd=premium&sref=eGA8az79

  2. Pfizer anticipates it will be able to enroll the majority of its 30,000-person late-stage trial before the end of August, according to Bourla. “At the end of September it’s very likely we’ll have enough events to say if the product works, he said. “This is when we can say we have an effective vaccine and only then.”

    https://www.bloomberg.com/news/articles/2020-07-28/pfizer-says-covid-could-endure-sees-long-term-need-for-shot?sref=eGA8az79

  3. Pfizer and BioNTech were over a month behind Moderna in beginning clinical testing of four COVID-19 vaccine candidates, with the first participants in a phase 1/2 study conducted in Germany dosed on April 29. A phase 1/2 study in the U.S. began the following week.

    But Pfizer has now nearly caught up with Moderna. The big drugmaker and its smaller German partner announced on Tuesday of this week that COVID-19 vaccine candidate BNT162b2 is being advanced into pivotal phase 2/3 clinical testing.

    More importantly, Pfizer and BioNTech could have late-stage results roughly around the same time as Moderna. The two companies stated that they “expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October 2020.” That’s in line with public statements made by Moderna CEO Stephane Bancel, who recently said that late-stage results for mRNA-1273 could be released in October or November.

    https://www.fool.com/investing/2020/07/31/why-pfizer-could-be-a-bigger-coronavirus-winner-th.aspx

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