Moderna to begin trial of new COVID vaccine to address virus variant first found in South Africa

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Source: USA Today

CAMBRIDGE, Mass. — Moderna, which makes one of the two authorized COVID-19 vaccines, is set to launch a clinical trial of a new vaccine designed to combat a variant of the virus, the company announced Wednesday. 

The company says it has produced enough of its variant-specific candidate vaccine, called mRNA-1273.351 to begin testing it in people.

Any change to address variants, which other vaccine makers also are working on, would need to be approved by the U.S. Food and Drug Administration. 

In a study published last week, Moderna showed that blood from people who received the current vaccine includes neutralizing antibodies against the major known variants. But only one-sixth of their antibodies were protective against the B.1.351 variant of the virus, which originated in South Africa, and which is the target of its new vaccine. 

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Categories: Vaccine

6 replies

  1. Moderna, which produces one of two coronavirus vaccines authorized for use in the U.S., announced on Wednesday that it has shipped a vaccine modified to fight the variant first discovered in South Africa to the National Institutes of Health for testing in humans.

    The company said the National Institute of Allergy and Infectious Diseases, part of the NIH, will conduct a phase one trial to determine if the modified vaccine boosts immunity against the variant, which has caused concerns due to being more resistant to the current vaccines.

    “We look forward to beginning the clinical study of our variant booster and are grateful for the NIH’s continued collaboration to combat this pandemic,” Stéphane Bancel, Moderna’s chief executive officer, said in a statement. “As we seek to defeat COVID-19, we must be vigilant and proactive as new variants of SARS-CoV-2 emerge. Leveraging the flexibility of our mRNA platform, we are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic.”

    https://abcnews.go.com/Health/moderna-sends-vaccine-modified-south-african-variant-nih/story?id=76094914

  2. CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announces that it has completed manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 variant known as B.1.351 first identified in the Republic of South Africa, and has shipped doses to the National Institutes of Health (NIH) for a Phase 1 clinical trial that will be led and funded by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The Company also is providing an update on its strategy for addressing SARS-CoV-2 variants of concern.

    “We look forward to beginning the clinical study of our variant booster and are grateful for the NIH’s continued collaboration to combat this pandemic”

    While initial data confirms that the Moderna COVID-19 Vaccine (mRNA-1273) provides neutralizing activity against variants of concern, out of an abundance of caution, Moderna is pursuing two strategies against these variants, subject to U.S. Food and Drug Administration (FDA) review. First, the Company is evaluating booster doses of vaccine to increase neutralizing immunity against the variants of concern. Moderna plans to evaluate three approaches to boosting, including:

    A variant-specific booster candidate, mRNA-1273.351, based on the B.1.351 variant first identified in the Republic of South Africa, at the 50 µg dose level and lower.
    A multivalent booster candidate, mRNA-1273.211, which combines mRNA-1273, Moderna’s authorized vaccine against ancestral strains, and mRNA-1273.351 in a single vaccine at the 50 µg dose level and lower.
    A third dose of mRNA-1273, the Moderna COVID-19 Vaccine, as a booster at the 50 µg dose level. The Company has already begun dosing this cohort with the booster.
    Second, the Company plans to evaluate mRNA-1273.351 and mRNA-1273.211 as a primary vaccination series for those who are seronegative. These candidates will be evaluated in a two-dose series at the 100 µg dose level and lower.

    Consistent with the recently updated FDA Guidance for Industry, the Company plans to evaluate immunogenicity and safety in participants who have not received a COVID-19 vaccine as well as participants in clinical studies who previously received the mRNA-1273 vaccine.

    NIAID, part of the National Institutes of Health (NIH), will conduct a Phase 1 clinical trial to determine if mRNA-1273.351 can boost immunity against the variants of concern. Moderna will provide doses of mRNA-1273.351 to the NIH. NIAID will initiate this study after receiving safe-to-proceed authorization from the FDA. NIAID will provide additional information when the trial begins, and details will also be available on clinicaltrials.gov. In parallel, the Company will be conducting its own clinical studies to support regulatory filings for any booster vaccine or updated primary vaccine.

    “We look forward to beginning the clinical study of our variant booster and are grateful for the NIH’s continued collaboration to combat this pandemic,” said Stéphane Bancel, Chief Executive Officer of Moderna. “As we seek to defeat COVID-19, we must be vigilant and proactive as new variants of SARS-CoV-2 emerge. Leveraging the flexibility of our mRNA platform, we are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic. Moderna is committed to making as many updates to our vaccine as necessary until the pandemic is under control. We hope to demonstrate that booster doses, if necessary, can be done at lower dose levels, which will allow us to provide many more doses to the global community in late 2021 and 2022 if necessary.”

    https://www.businesswire.com/news/home/20210224006083/en/Moderna-Announces-it-has-Shipped-Variant-Specific-Vaccine-Candidate-mRNA-1273.351-to-NIH-for-Clinical-Study

  3. (CNN)Two separate teams of researchers said this week they have found a worrying new coronavirus variant in New York City and elsewhere in the Northeast that carries mutations that help it evade the body’s natural immune response — as well as the effects of monoclonal antibody treatments.

    Genomics researchers have named the variant B.1.526. It appears in people affected in diverse neighborhoods of New York City, they said, and is “scattered in the Northeast.”
    One of the mutations in this variant is the same concerning change found in the variant first seen in South Africa and known as B.1.351. It appears to evade, somewhat, the body’s response to vaccines, as well. And it’s becoming more common.
    “We observed a steady increase in the detection rate from late December to mid-February, with an alarming rise to 12.7% in the past two weeks,” one team, at Columbia University Medical Center, write in a report that has yet to be published, although it is scheduled to appear in pre-print version this week.

    https://www.cnn.com/2021/02/25/health/variants-coronavirus-new-york-city/index.html

  4. Pfizer Inc. and BioNTech SE’s Covid-19 vaccine was overwhelmingly effective against the virus in a study that followed nearly 1.2 million people in Israel, results that public-health experts said show that immunizations could end the pandemic.

    Two doses of the vaccine prevented 94% of Covid-19 cases in 596,618 people vaccinated between Dec. 20 and Feb. 1, about one-quarter of whom were over the age of 60, teams from the Clalit Research Institute and Harvard University reported in a study published Wednesday in the New England Journal of Medicine.

    The researchers matched each vaccinated person with someone who hadn’t gotten a shot, enabling the best analysis yet of whether extremely good results from an earlier clinical trial would hold up in the real world. The Pfizer-BioNTech shot cleared every hurdle. It was so effective, in fact, that outside experts said that with broad enough use it may be possible to halt the pandemic.

    https://www.bloomberg.com/news/articles/2021-02-24/pfizer-biontech-shot-could-help-end-pandemic-israel-study-shows?sref=eGA8az79

  5. Shares of Moderna Inc. MRNA, 5.67% gained 2.2% in premarket trading on Thursday after the company reported half a million dollars in sales of its COVID-19 vaccine in the fourth quarter of last year. The company had a loss of $272,000, or 69 cents per share, in the fourth quarter of 2020, compared with a loss of $123,000, or 37 cents per share, in the same quarter a year ago. The FactSet consensus was for a loss of 34 cents. It had revenue of $570.7 million in the fourth quarter of last year, up from $14.1 million in the same quarter ago, as its COVID-19 vaccine began to be distributed in several countries around the world, including the U.S. The FactSet consensus was $279 million in revenue for the quarter. The vaccine is the first authorized product in the company’s history. Moderna said it plans to produce at least 700 million doses of its vaccine in 2021, up from a previous low-end range estimate of 600 million, with a new goal of making 1.4 billion doses in 2022. The company said it has concluded enrollment in a clinical trial testing the COVID-19 vaccine in teens, and a Phase 2 trial for kids between the ages of 6 months and 11 year olds is also expected to begin in the “near-term.” Moderna’s stock has rallied 509.4% over the past 12 months, while the broader S&P 500 SPX, -1.18% is up 21.7%.

    https://www.marketwatch.com/story/moderna-reports-570-million-in-revenue-for-first-time-driven-by-sales-of-covid-19-vaccine-2021-02-25

  6. (CNN)The release of Johnson & Johnson’s Covid-19 vaccine and its partnership with Merck means that President Joe Biden expects the US to have enough Covid-19 vaccines delivered to cover every adult by the end of May.

    If Johnson & Johnson and fellow vaccine makers Moderna and Pfizer meet their vaccine pledges, the bigger question we may soon be facing isn’t whether we have enough doses of Covid-19 vaccines, but whether people will actually take them.
    Recent polling suggests a continued drop in the vaccine hesitant population as more and more people get vaccinated in the US.
    The past two weeks alone, there were two polls that show just how much vaccine hesitancy has declined. The Kaiser Family Foundation poll found that 55% of adults say they now want a Covid-19 vaccine as soon as possible or have already received their first dose. That’s up from 47% in January and 34% in December.
    While the percentage of hardline “get it only if required” or “definitely not” has remained fairly consistent at or just north of 20%, the hesitant population of “wait and see how it’s working” has dropped by nearly half during the last two months from 39% to 22%.

    https://www.cnn.com/2021/03/06/politics/covid-vaccine-analysis/index.html

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