Merck gives up on COVID-19 vaccine candidates

Merck (NYSE:MRK) announced today that it is discontinuing the development of its two COVID-19 vaccine candidates, with the Kenilworth, N.J.-based pharma company focusing on two therapeutic candidates instead.

Merck officials say they made the decision after Phase 1 clinical studies that showed the V590 and V591 vaccine candidates produced an immune response that was inferior to a natural infection, as well as what has been reported for other COVID-19 vaccines. The company plans to record a charge in its Q4 2020 results related to the discontinuation.

“We are grateful to our collaborators who worked with us on these vaccine candidates and to the volunteers in the trials,” said Dr. Dean Y. Li, president of Merck Research Laboratories.

“We are resolute in our commitment to contribute to the global effort to relieve the burden of this pandemic on patients, health care systems and communities,” Li said in a news release.

Merck will continue…

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MedTech 100 roundup: Another peak for the industry

Medtech has been on the rise in 2021 and the past week saw that trend continue, as the industry hit yet another all-time best mark.

MassDevice‘s MedTech 100 index reached 107.4 points on Jan. 20, topping the all-time best of 106.81 points set on Jan. 8. That mark represents a 16% jump from the pre-pandemic high of 92.32 set on Feb. 19, 2020, and a 72.9% overall leap from the lowest point of 62.13 set on March 23, 2020.

Here are some of the best-performing medtech stocks from 2020.

The high point could not be sustained, but the industry stayed strong, finishing at 106.4 to end the week on Jan. 22. Medtech’s finish to last week was enough to top the previous seven days, coming in 0.6% ahead of the 105.8-point mark set on Jan. 15.

While medtech saw slight growth from the previous week, one of the overall markets saw a larger jump, with the S&P 500 Index rising 1.9%. The Dow Jones Industrial Average fared identically to medtech, rising 0.6%.

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Johnson & Johnson vaccine trial results expected soon

Trial results for the COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) are reportedly expected to be released soon.

The Hill reported last week that former FDA Commissioner Scott Gottlieb said the single-dose vaccine from J&J appears to have a “good profile for a vaccine,” indicating the potential for a third authorized candidate, following those from Pfizer/BioNTech and Moderna.

Additionally, a report from The New York Times said that, as of Jan. 14, results from the trial could be expected in as little as two weeks, although, if approved, immediate production of doses promised to the U.S. government may be hindered by “unanticipated manufacturing delays.”

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

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Johnson & Johnson vaccine trial results expected soon

Trial results for the COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) are reportedly expected to be released soon.

The Hill reported last week that former FDA Commissioner Scott Gottlieb said the single-dose vaccine from J&J subsidiary Janssen Pharmaceutical appears to have a “good profile for a vaccine,” indicating the potential for a third authorized candidate, following those from Pfizer/BioNTech and Moderna.

Additionally, a report from The New York Times said that, as of Jan. 14, results from the trial could be expected in as little as two weeks, although, if approved, immediate production of doses promised to the U.S. government may be hindered by “unanticipated manufacturing delays.”

J&J published interim phase 1/2a data from its vaccine trial in the New England Journal of Medicine last week, with the data demonstrating that the single-dose vaccine candidate provided an immune response that l…

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7 takeaways from Biden’s ‘full-scale, wartime’ plan to combat the COVID-19 pandemic

(Image courtesy of the White House)

President Joe Biden kept to his word to announce plans to “establish clear federal leadership” to tackle the coronavirus pandemic on his first full day in office.

The White House issued a 200-page document on Wednesday, detailing “full-scale, wartime” plans to harness the nation’s manufacturing and distribution capabilities to boost vaccine production, end shortages of medical and personal protective equipment (PPE) and ensure equitable distribution of pandemic supplies.

Get the full story on our sister site, Medical Design & Outsourcing.

And you can read our take on the vaccine portions of the plan on our sister site, Pharmaceutical Processing World.

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Amazon offers to help Biden administration with vaccine distribution

Amazon (NSDQ:AMZN) issued a letter to recently inaugurated President Joe Biden offering assistance with COVID-19 vaccine distribution.

President Biden, who was sworn into office yesterday, was addressed in the letter from Amazon announcing its availability to help with his intent to distribute 100 million COVID-19 vaccine doses in his first 100 days in office.

Get the full story at our sister site, Pharmaceutical Processing World.

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6 questions about facial swelling and COVID-19 vaccines answered

Vials containing the Moderna COVID-19 vaccine. Image from Wikipedia.

The news that Moderna’s (NSDQ:MRNA) COVID-19 had a small risk of facial swelling for patients with dermal fillers has spooked scores of patients. Dermatologists and plastic surgeons have been inundated with queries from concerned patients. But the risk of problems is miniscule, according to Dr. Wilbur Hah, the president of the American Board of Cosmetic Surgery (ABCS).

In the following interview, Dr. Hah puts the risk into perspective, explains why Botox recipients are unlikely to experience vaccine-induced facial swelling and provides a suggestion for drug developers and the CDC.

1. How would you characterize the reaction from patients concerned about Moderna’s vaccine reactivity to dermal fillers?

Dr. Wilbur Hah

Hah: Though it is a potential risk, I want to emphasi…

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New COVID-19 variants could diminish vaccine efficacy

COVID-19 is mutating. And while early data suggest vaccines will be effective against more infectious COVID-19 variants that emerged in the U.K., South Africa and Brazil, the mutations could have a measurable impact on vaccine efficacy.  

There’s perhaps a 50/50 chance that such new variants could lead to a “numerically meaningful drop” in vaccine efficacy, said Shane Crotty, a virologist at the La Jolla Institute for Immunology, in a UBS briefing call. 

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

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New COVID-19 variants could diminish vaccine efficacy

COVID-19

COVID-19 is mutating. And while early data suggest vaccines will be effective against more infectious COVID-19 variants that emerged in the U.K., South Africa and Brazil, the mutations could have a measurable impact on vaccine efficacy.  

There’s perhaps a 50/50 chance that such new variants could lead to a “numerically meaningful drop” in vaccine efficacy, said Shane Crotty, a virologist at the La Jolla Institute for Immunology, in a UBS briefing call. 

The Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) vaccines promise 95% efficacy at reducing symptomatic disease when it comes to the SARS-CoV-2 strains that were dominant in 2020. But it’s plausible the efficacy number could drop to 85% or beyond. “I am definitely not saying that the vaccines would be non-functional anymore or would drop to less than 50% efficacy,” Crotty said.

While Pfizer recently released data suggesting their vaccine w…

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Facial swelling and COVID-19 vaccines: 4 facts

Image from Nataliya Vaitkevich via Pexels

Patients with dermal fillers have a small potential risk of developing facial swelling after obtaining mRNA vaccines.

To date, the FDA has noted the problem in three clinical trial recipients of the COVID-19 vaccine from Moderna(NSDQ:MRNA). The agency hasn’t observed facial swelling in the Phase 3 clinical trial for the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

We reached out to Dr. Whitney Bowe, a board-certified dermatologist and expert injector, to shed light on the topic.

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

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Norway investigating deaths of 23 individuals who received COVID-19 vaccine

Image from Mark König on Unsplash

In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

To date, it has analyzed data from 13 of those individuals.

The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly and frail patients.

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

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Norway investigating deaths of 23 individuals who received COVID-19 vaccine

Image from Mark König on Unsplash

In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

To date, it has analyzed data from 13 of those individuals.

The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly and frail patients.

The agency said in a statement that it had expected deaths close to the time of vaccination, given its plan to vaccinate elderly patients, many of whom have “serious underlying diseases.” Some 400 people in Norway die each week in nursing homes and long-term care facilities.

While it is clear that elderly individuals have a higher risk of mortality from all causes, it will take time to determine what role a vaccine might play, said Updesh Dosanjh, practice le…

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