Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine

 

Paul T. Heath, F.R.C.P.C.H., 

Eva P. Galiza, M.B., B.S., 

David N. Baxter, M.D., Ph.D., 

Marta Boffito, M.D., Ph.D., 

Duncan Browne, M.D., 

Fiona Burns, Ph.D., 

David R. Chadwick, Ph.D., 

Rebecca Clark, M.B., Ch.B., 

Catherine Cosgrove, Ph.D., 

James Galloway, Ph.D., 

Anna L. Goodman, D.Phil., 

Amardeep Heer, M.B., Ch.B., 

 for the 2019nCoV-302 Study Group*

DOI: 10.1056/NEJMoa2107659

PDF: 

https://www.nejm.org/doi/pdf/10.1056/NEJMoa2107659?articleTools=true

Abstract

BACKGROUND

Early clinical data from studies of the NVX-CoV2373 vaccine (Novavax), a recombinant nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that contains the full-length spike glycoprotein of the prototype strain plus Matrix-M adjuvant, showed that the vaccine was safe and associated with a robust immune response in healthy adult participants. Additional data were needed regarding the efficacy, immunogenicity, and safety of this vaccine in a larger population.

METHODS

In this phase 3, randomized, observer-blinded, placebo-controlled trial conducted at 33 sites in the United Kingdom, we assigned adults between the ages of 18 and 84 years in a 1:1 ratio to receive two intramuscular 5-μg doses of NVX-CoV2373 or placebo administered 21 days apart. The primary efficacy end point was virologically confirmed mild, moderate, or severe SARS-CoV-2 infection with an onset at least 7 days after the second injection in participants who were serologically negative at baseline.

RESULTS

A total of 15,187 participants underwent randomization, and 14,039 were included in the per-protocol efficacy population. Of the participants, 27.9% were 65 years of age or older, and 44.6% had coexisting illnesses. Infections were reported in 10 participants in the vaccine group and in 96 in the placebo group, with a symptom onset of at least 7 days after the second injection, for a vaccine efficacy of 89.7% (95% confidence interval [CI], 80.2 to 94.6). No hospitalizations or deaths were reported among the 10 cases in the vaccine group. Five cases of severe infection were reported, all of which were in the placebo group. A post hoc analysis showed an efficacy of 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 (or alpha) variant and 96.4% (95% CI, 73.8 to 99.5) against non-B.1.1.7 variants. Reactogenicity was generally mild and transient. The incidence of serious adverse events was low and similar in the two groups.

CONCLUSIONS

A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant. (Funded by Novavax; EudraCT number, 2020-004123-16. opens in new tab.)

https://www.nejm.org/doi/full/10.1056/NEJMoa2107659

Regeneron, GlaxoSmithKline and Eli Lilly COVID-19 drugs prioritized for expedited review in Europe

 Amid the global war on pandemic variants, the European Union has identified five COVID-19 therapeutics it will prioritize with the hope to authorize three by October.

Europe has selected four monoclonal antibody regimens—Eli Lilly's bamlanivimab/etesevimab combo, Celltrion’s regdanvimab, Regeneron and Roche’s casirivimab/ imdevimab cocktail and GlaxoSmithKline and Vir Biotechnology’s sotrovimab.

Also on the list is Eli Lilly’s baricitinib, a treatment already approved as Olumiant to treat rheumatoid arthritis and atopic dermatitis. The drug reduces the activity of the immune system and has been repurposed for COVID-19 patients on oxygen.

The effort is aimed at providing more regulatory flexibility with rolling reviews, conditional marketing authorizations and flexible labelling and packaging requirements. It also will allow for more scientific support from the European Medicines Agency and for the bloc to facilitate partnerships within the industry.

To that end, the EU will hold an industry "matchmaking event” on July 12 and 13. Officials aim to identify and address supply chain bottlenecks and make plans to immediately boost production for the drugs upon their potential approvals.

An apparent frontrunner is the antibody treatment from Regeneron. In February, the EMA issued a positive opinion on the cocktail for patients at risk of progressing to severe COVID-19. Earlier this month, the EU purchased 55,000 doses of the drug.

Lilly’s bamlanivimab and etesevimab combo was the first to win approval in the United States for COVID-19 patients at risk for progressing to a severe form of the disease. But with the cocktail showing weakness against COVID variants from Brazil and South Africa, the U.S. halted its use last week.

The sotrovimab antibody from GSK/Vir scored authorization for use in America last month, but the companies have yet to cut a deal with the U.S. to supply it.

Last October, Europe purchased 500,000 doses of Gilead's remdesivir for $1.2 billion. But a month later, the bloc suspended its use after the World Health Organization declared the drug ineffective for patients hospitalized with COViD-19.

The EU hopes to add more promising treatments to the portfolio, targeting 10 by the end of the year “subject to R&D outcomes,” it explained in a release.

https://www.fiercepharma.com/pharma/covid-19-treatments-from-regeneron-lilly-gsk-vir-among-5-prioritized-for-expedited-review

India's Zydus Cadila seeks approval for its 3-dose COVID vaccine

 Indian drugmaker Zydus Cadila said on Thursday it has applied for emergency use approval of its three-dose COVID-19 vaccine that showed efficacy of 66.6% in an interim study and could become the second home-grown shot if regulators consent.

Although coronavirus infections have dropped from a devastating peak in April and May that strained healthcare facilities, experts have warned of a third wave, saying widespread vaccination is one of the best pandemic defences.

Zydus' vaccine "will certainly help in ramping up India's overall vaccination drive as it would be the fifth approved," Prashant Khadayate, a pharmaceutical industry analyst at GlobalData said.

Zydus said https://archives.nseindia.com/corporate/CADILAHC_01072021072201_PressRelease01072021.pdf the efficacy result is based on an interim analysis of a late-stage trial of more than 28,000 volunteers nationwide, including nearly 1,000 subjects in the age group of 12 to 18.

The drugmaker said it was evaluating a two-dose regimen for the shot.

If approved, ZyCoV-D will be the world's first DNA vaccine, Zydus said, as it makes use of a portion of the genetic code - DNA or RNA - in the SARS-CoV-2 virus to stimulate an immune response against its spike protein.

DNA vaccines differ from other approved COVID-19 shots, which are based on new mRNA technology such as in those from Pfizer and Moderna, and established technology like viral vectors, as with AstraZeneca.

Zydus, which aims to produce up to 120 million doses annually, said its study coincided with the peak of India's second wave of infections and affirmed its efficacy against new mutants, especially the Delta variant.

It did not, however, disclose its efficacy against those variants. 

https://www.marketscreener.com/quote/stock/CADILA-HEALTHCARE-LIMITED-34067618/news/India-s-Zydus-Cadila-seeks-approval-for-its-3-dose-COVID-vaccine-35761612/

Novartis weighs entry into mRNA technology - chairman

 Swiss drugmaker Novartis could get into the hot field of messenger ribonucleic acid (mRNA) technology, which has come to the fore during the coronavirus pandemic, Chairman Joerg Reinhardt said in a newspaper interview.

"The mRNA technology has proven to be an attractive option in this situation and of course every research company is questioning whether they should invest more in this area," he told the Swiss paper Aargauer Zeitung.

"Novartis is doing the same and we are having the discussion this week in the executive committee and then in August in the board of directors," he added without being more specific.

Many companies, including Novartis, had withdrawn from antiviral and antibacterial research, figuring the probability of success was relatively low. "We are now reassessing that," he said.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Novartis-nbsp-weighs-entry-into-mRNA-technology-chairman-tells-paper-35762215/

Elliott Calls for Board Changes at GlaxoSmithKline Ahead of Separation

 Activist investor Elliott Management Corp. has called on U.K. pharmaceutical giant GlaxoSmithKline PLC to assess its board and management ahead of a long-planned separation of its consumer-healthcare business.

The investor criticized GlaxoSmithKline's "poor record of execution and value creation" in a letter published Thursday, its first public intervention over the FTSE 100 company since it built a significant stake. It said the company's combined businesses should be worth around 45% more than GlaxoSmithKline's current valuation.

Elliott urged the company's board to appoint nonexecutive directors with biopharma and consumer-health expertise prior to the separation and to run robust processes for selecting the best executive leadership for the two businesses, considering both internal and external candidates.

GlaxoSmithKline Chief Executive Emma Walmsley, who became CEO in 2017, has driven more investment into research as well as the separation of the consumer-healthcare business.

"Elliott is not advocating a specific outcome but is arguing for a robust process, because it is critical that the board assure current and future shareholders that the new leadership of both companies was selected through a credible process that conforms to corporate governance best practices," the investor said. It said existing management should remain in place until a decision is made on new leadership.

The investor also said GlaxoSmithKline should incentivize a stronger performance and greater ambition, improve profitability while investing more in research-and-development, display openness to value-maximizing pathways and preserve the nimbleness of its vaccines and pharma operations.

https://www.marketscreener.com/quote/stock/GLAXOSMITHKLINE-PLC-9590199/news/Elliott-Calls-for-Board-Changes-at-GlaxoSmithKline-Ahead-of-Separation-35763446/

Jazz gets FDA OK for recombinant lymphoma/leukemia med

 Approval under U.S. FDA's Real-Time Oncology Review program represents an important therapeutic advance for pediatric and adult patients who develop hypersensitivity to E. coli-derived asparaginase treatments

Rylaze is expected to become commercially available in the U.S. in mid-July

Company to host investor webcast in July; details to follow

https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-us-fda-approval-of-rylaze-asparaginase-erwinia-chrysanthemi-recombinant-rywn-for-the-treatment-of-acute-lymphoblastic-leukemia-or-lymphoblastic-lymphoma-301323782.html

Acumen Pharma Prices Upsized IPO

 Acumen Pharmaceuticals, Inc. (“Acumen” or “Acumen Pharmaceuticals”) (Nasdaq: ABOS), a clinical-stage biopharmaceutical company developing a novel disease-modifying approach to target what Acumen believes to be a key underlying cause of Alzheimer’s disease, today announced the pricing of its upsized initial public offering of 9,999,999 shares of common stock at a public offering price of $16.00 per share. The gross proceeds to Acumen, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $160 million. All of the shares of common stock are being offered by Acumen. In addition, Acumen has granted the underwriters a 30-day option to purchase up to an additional 1,499,999 shares of common stock at the initial public offering price, less the underwriting discounts and commissions.

Acumen’s shares are expected to begin trading on the Nasdaq Global Select Market on Thursday, July 1, 2021 under the ticker symbol “ABOS.” The offering is expected to close on July 6, 2021, subject to customary closing conditions.

BofA Securities, Credit Suisse and Stifel are acting as joint lead book-running managers for the offering. UBS Investment Bank is also acting as a book-running manager.

https://finance.yahoo.com/news/acumen-pharmaceuticals-announces-pricing-upsized-024400697.html