Scientists race to find a cure or vaccine for the coronavirus. Here are the top drugs in development

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The Muslim Times has the best collection of articles for the war against Covid 19, especially the vaccine. Suggested reading by the Muslim Times: FDA authorizes the drug remdesivir for emergency use in COVID-19 patients 

Source: CNBC

By Berkeley Lovelace Jr.; @BERKELEYJR

Health officials and scientists across the world are racing to develop vaccines and discover effective treatments against the coronavirus, which has infected more than 4.2 million people worldwide in as little as four months, according to data compiled by Johns Hopkins University.

There are no proven, knockout treatments and U.S. health officials say a vaccine could take at least a year to 18 months.

On May 1, the Food and Drug Administration granted emergency use authorization for Gilead Sciences’ antiviral drug remdesivir. This after a government-run clinical trial found Covid-19 patients who took remdesivir usually recovered after 11 days. That is four days faster than those who didn’t take the drug. The EUA means doctors in the U.S. will be allowed to use remdesivir on patients hospitalized with Covid-19 even though it has not been formally approved by the agency.

Even if the drug wins final approval, infectious disease specialists and scientists say researchers will need an arsenal of medications to fight this respiratory virus, which can also attack the cardiovascular, nervous, digestive and other major systems of the body.

Below is a list of the leading vaccines and drugs in development to battle Covid-19.

Vaccines
Moderna

Vaccine: mRNA
Development: Phase 1 trial near complete, phase 2 trial set to start
The National Institutes of Health, an agency within the Department of Health and Human Services, has been fast-tracking work with biotech company Moderna to develop a vaccine to prevent Covid-19. The company began the first phase 1 human trial on 45 volunteers testing a vaccine to prevent the disease in March and has been approved to soon start its phase 2, which would expand the testing to 600 people, by late May or June. If all goes well, its vaccine could be in production as early as July.

Moderna has developed the first experimental coronavirus medicine, but an approved treatment is more than a year away.

Moderna’s potential vaccine contains genetic material called messenger RNA, or mRNA, that was produced in a lab. The mRNA is a genetic code that tells cells how to make a protein and was found in the outer coat of the new coronavirus, according to researchers at the Kaiser Permanente Washington Health Research Institute. The mRNA instructs the body’s own cellular mechanisms for making proteins to create those that mimic the virus proteins, thereby producing an immune response.

Johnson & Johnson

Vaccine: Modified adenovirus
Development: Preclinical
Johnson & Johnson began Covid-19 vaccine development in January. J&J’s lead vaccine candidate will enter a phase 1 human clinical study by September, the company announced in March, and clinical data on the trial is expected before the end of the year. If the vaccine works well, the company said it could produce 600 million to 900 million doses by April 2021.

The company said it is using the same technologies it used to make its experimental Ebola vaccine, which was provided to people in the Democratic Republic of Congo in late 2019. It involves combing genetic material from the coronavirus with a modified adenovirus that is known to cause common colds in humans.

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Zia H Shah MD, In charge of health section for the Muslim Times

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Categories: The Muslim Times, Vaccine

4 replies

  1. The coronavirus vaccine trial that started out in Seattle is progressing well enough to get onto Food and Drug Administration’s fast track for development, with planning well underway for the next two phases of testing.

    Seattle’s Kaiser Permanente Washington Health Research Institute kicked off the Phase I clinical trial, which focuses on ensuring that the vaccine is safe for humans.

    The first participants got their shots in mid-March, and last month, the trial was expanded to Emory University in Atlanta and the National Institute of Allergy and Infectious Diseases’ Vaccine Research Clinic in Bethesda, Md. NIAID is funding the trial, and the vaccine was developed by Moderna Therapeutics.

    Last week, Moderna said the Phase I results were so encouraging that the FDA gave the go-ahead for Phase II trials, which involve administering the vaccine to 600 volunteers and finding out whether it sparks the desired immune response.

    Today, Moderna said the FDA issued fast-track authorization, and NIAID director Anthony Fauci gave the vaccine his vote of confidence during a Senate hearing. “If we are successful, we hope to know that in the late fall or early winter,” Fauci said.

    Plans are already being made for Phase III trials. “My team is actually spending most of the time now preparing for Phase III that they say could start in early summer,” Moderna CEO Stephane Bancel said during a CNBC interview.

    Bancel marveled at how the timetable for Phase II and Phase III is being sped up.

    “In normal times, we would have waited for antibody levels, looked at total data, asked experts, and only then start to make the Phase II material,” he said. “So here we say, look, lives are at stake. Let’s make the Phase II material at risk during the Phase I. Let’s not wait … let’s just go into Phase II as soon as we know the safety of Phase I is positive.”

    https://www.geekwire.com/2020/positive-results-seattle-covid-19-vaccine-will-face-key-trials-summer-moderna-ceo-says/

  2. The company announced that the Food and Drug Administration had cleared its application to proceed to a clinical trial involving about 600 people.

    On Thursday, May 7, Moderna announced that the Food and Drug Administration had cleared its application to proceed to a clinical trial involving about 600 people.

    “The imminent Phase 2 study start is a crucial step forward,” Stéphane Bancel, Moderna’s chief executive, said in a statement.

    The main goal of this set of tests is to find out if the vaccine is safe and if positive results from the first few dozen volunteers in the first phase can be replicated in a much larger group. If it is successful, later studies, known as Phase 3 trials, will determine exactly how well the vaccine works.

  3. Governments and drugmakers are weighing how to roll out coronavirus vaccines, including reserving the first batches for health-care workers, as several shots race to early leads.

    Of more than 100 vaccines in development globally, at least eight have started testing in humans, including candidates from Moderna Inc. and Pfizer Inc. At the same time, pharmaceutical giants like Johnson & Johnson, AstraZeneca PLC and Sanofi SA are building capacity to make hundreds of millions of doses of their own or their partners’ vaccines.

    The efforts are part of a larger rush, including at the White House, to line up funding for accelerated testing and expanded manufacturing capacity, all to make doses available in the U.S. starting as soon as this fall.

    A safe and effective vaccine is the best way to prevent Covid-19, the respiratory disease caused by the new coronavirus, and to curb its transmission, public-health officials say. Drugmakers say they are developing potential coronavirus vaccines at remarkably fast speeds.

    Yet there isn’t a guarantee that any of the most advanced vaccine candidates will prove to work safely on such a short timetable. Some, like vaccines from Pfizer and Moderna, are based on relatively new technologies that haven’t been approved previously.

    https://www.wsj.com/articles/coronavirus-vaccine-frontrunners-emerge-rollouts-weighed-11589707803?mod=hp_lead_pos1

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