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Drug companies agree not to release COVID-19 vaccine until it’s ready

[Photo by Fusion Medical Animation on Unsplash]

Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine.

The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as they pursue regulatory approvals of the first vaccines for the novel coronavirus.

“FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US,” the pledge states. “FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly dem…

MedTech 100 roundup: Industry hits another mid-pandemic high

Despite a minor regression week-over-week, the medtech industry’s stocks hit another milestone as the COVID-19 rebound remains in progress.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.01 points at the end of last week (July 31). Overall, medtech stocks saw a -0.3% increase from the 89.29-point total at the same time a week prior (July 24).

On July 30, the index reached 90.37 points, marking its highest point since that pre-pandemic high, with the previous mid-pandemic high (90.11) coming last week.

The most recent high mark represents just a -2.1% dip from the Feb. 19 high point of 92.32, marking the smallest margin of decline over the past five months.

Meanwhile, the S&P 500 Index saw a 1.7% increase from July 24 to July 31, and the Dow Jones Index posted a -0.2% drop over the same period of time.

Medtech’s lowest point during the COVID-19 pandemic remains at …

Moderna touts preclinical study results for COVID-19 vaccine candidate

Moderna (NSDQ:MRNA) announced today that the preclinical study of its COVID-19 vaccine candidate observed immune response and protection against the virus in non-human primates.

Cambridge, Mass.-based Moderna’s study, published in The New England Journal of Medicine, showed that a two-dose vaccination schedule of the mRNA-1273 vaccine candidate led to a “robust immune response and protection” against SARS-CoV-2 infection in the upper and lower airways in non-human primates.

Additionally, there was no evidence of vaccine-associated enhanced respiratory disease (VAERD) in the primates, according to a news release.

The study assessed immunogenicity and protective efficacy after a two-dose vaccination schedule of 10 µg or 100 µg doses of mRNA-1273 or control given four weeks apart. Then, four weeks after the second vaccination, animals were challenged with high doses of SARS-CoV-2 through intranasal and intratracheal routes.

Moderna …

Moderna launches Phase 3 study of its COVID-19 vaccine candidate

Moderna (NSDQ:MRNA) announced today that it began dosing participants in the Phase 3 clinical study of its mRNA-1273 COVID-19 vaccine candidate.

Cambridge, Mass.-based Moderna’s COVE (coronavirus efficacy) study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Dept. of Health and Human Services.

Get the full story at our sister site, Drug Discovery & Development.

Moderna launches Phase 3 study of its COVID-19 vaccine candidate

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) announced today that it began dosing participants in the Phase 3 clinical study of its mRNA-1273 COVID-19 vaccine candidate.

Cambridge, Mass.-based Moderna’s COVE (coronavirus efficacy) study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Dept. of Health and Human Services.

The company had previously announced on June 11 that it expected to begin the Phase 3 trial at some point this month. At that point, it had already fully enrolled the first cohort of healthy adults between ages 18-53 in the Phase 2 study, 13 days after the first participant was dosed, having prev…

MedTech 100 roundup: Markets dip again

Medtech stocks continue to fluctuate amid the COVID-19 pandemic, with a significant dip in the shares belonging to the industry’s biggest names.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 81.88 points at the end of last week (June 26). That total represents a -3.7% decrease from the 85.00-point total at the same time a week prior (June 19), demonstrating another downturn after a 3.5% bump just one week before.

Meanwhile, the S&P 500 Index experienced a -2.9% drop from June 19 to June 26, and the Dow Jones Index fared slightly worse with a -3.3% decrease over the same period of time. Both indexes mirrored the medtech industry’s changes, having each posted marginal increases the week before.

Medtech’s lowest point during the COVID-19 pandemic remains at 62.13 on March 23. Since then, the industry’s stocks have experienced 31.8% growth in total. Stocks in the industry remai…

Moderna, Catalent partner on COVID-19 vaccine candidate manufacturing

Moderna (NSDQ:MRNA) and Catalent (NYSE:CTLT) today announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at Catalent’s biologics facility in Bloomington, Ind.

Catalent will provide vial filling and packaging capacity, as well as additional staffing required for 24×7 manufacturing operations at the site to support production of an initial 100 million doses intended to supply the U.S. market starting in the third quarter of 2020. The companies said they are in discussions to secure fill-finish capacity for continued production of hundreds of millions of additional doses. Somerset, N.J.-based Catalent will also provide clinical supply services from its facilities in Philadelphia, including packaging and labeling, as well as storage and distribution to support Moderna’s Phase 3 clinical study for this candidate.

Get the full story on our sister site, Pharmaceutical Processing W…

Moderna, Catalent partner on COVID-19 vaccine candidate manufacturing

Moderna (NSDQ:MRNA) and Catalent (NYSE:CTLT) today announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at Catalent’s biologics facility in Bloomington, Ind.

Catalent will provide vial filling and packaging capacity, as well as additional staffing required for 24×7 manufacturing operations at the site to support production of an initial 100 million doses intended to supply the U.S. market starting in the third quarter of 2020. The companies said they are in discussions to secure fill-finish capacity for continued production of hundreds of millions of additional doses. Somerset, N.J.-based Catalent will also provide clinical supply services from its facilities in Philadelphia, including packaging and labeling, as well as storage and distribution to support Moderna’s Phase 3 clinical study for this candidate.

The randomized, 1:1 placebo-controlled trial is expected to b…

MedTech 100 roundup: Markets skid after strong stretch

Following a strong performance over the last couple of weeks, the medtech market experienced one of its most significant drop-offs in recent months amid investor worries over a rise in COVID-19 cases in some states.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 82.12 points at the end of last week (June 12). That total represents a -6% decrease from the 87.37-point total at the same time a week prior (June 5), highlighting a significant drop from one of the strongest stretches the medtech market had seen since the COVID-19 pandemic hit.

Meanwhile, the S&P 500 Index experienced a -4.8% decrease from June 5 to June 12, and the Dow Jones Index fared even worse with a -5.6% increase over the same period of time. The drop-off is stark compared to this time a week ago, when both indexes saw sizeable growth — rising 3.14% and 6.81%, respectively.

The earlier market surge came on the back of t…

Moderna to begin Phase 3 of COVID-19 vaccine study in July

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) announced today that it expects to begin dosing in Phase 3 of the clinical trial for its COVID-19 vaccine candidate in July.

The Cambridge, Mass.-based biotech company said in a news release that it finalized the Phase 3 study protocol for the mRNA-1273 COVID-19 vaccine candidate based on feedback from the FDA. The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 enrolled U.S. participants in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Get the full story at our sister site, MassDevice.

Moderna to begin Phase 3 of COVID-19 vaccine study in July

Moderna (NSDQ:MRNA) announced today that it expects to begin dosing in Phase 3 of the clinical trial for its COVID-19 vaccine candidate in July.

The Cambridge, Mass.-based biotech company said in a news release that it finalized the Phase 3 study protocol for the mRNA-1273 COVID-19 vaccine candidate based on feedback from the FDA. The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 enrolled U.S. participants in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Moderna’s trial will have a primary endpoint of the prevention of the symptomatic COVID-19 disease, with key secondary endpoints including prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2, the virus causing COVID-19.

Primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic COVID-19, with …

Moderna prices $1.3 public offering following positive COVID-19 vaccine results

Shortly after touting positive results from its COVID-19 vaccine candidate, Moderna announced the pricing of an offering of 17.6 million shares of its common stock.

The Cambridge, Mass.-based clinical-stage biotechnology company announced yesterday that it received positive interim clinical data from trials for its mRNA-1273 vaccine candidate against coronavirus (SARS-CoV-2).

Get the full story at our sister site, MassDevice.