Authorities investigating death of California recipient of COVID-19 vaccine

[Photo by Daniel Schludi on Unsplash]

Last week, Norwegian officials raised eyebrows when they announced that they were investigating the deaths of 23 elderly patients who had recently received COVID-19 vaccine doses. 

Now, California authorities are investigating the death of a Placer County-based patient who received a COVID-19 vaccine dose on Jan. 21. The patient died hours afterward. 

Placer County officials stressed they had not linked the death to the vaccine. 

They are planning on conducting an autopsy. 

Officials in Florida are also investigating the death of a 56-year-old physician who died 16 days after receiving the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

Pfizer had stressed that it doesn’t “believe at this time that there is any direct connection to the vaccine” in the Florida physician’s death. 

Separately, the World Health Organi…

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The U.S. COVID-19 vaccine rollout continues to lag but is accelerating

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Some 20.5 million doses of COVID-19 vaccines have been administered as of Jan. 23 — roughly in line with the CDC’s end-of-2020 goal. 

The pace of vaccination as of the morning of Jan. 21 was roughly 1 million, about four-fifths involving initial doses of the two-dose vaccine. 

For the sake of comparison, COVID-19 tests were 1.9 million on the same day. 

At the current vaccination rate, vaccinating the majority of Americans could occur by January 2022, according to an analysis from The Wall Street Journal.  

It is likely, however, that the pace will continue to quicken as a growing number of organizations become involved in administering shots. Johnson & Johnson’s (NYSE:JNJ) could also file for emergency use authorization for a single-dose vaccine as early as February.

At present, UBS estimates that 4.6% of the U.S. population has received at least…

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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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AdvaMed wants input on Biden pandemic DPA use

AdvaMed reacted to President Joe Biden’s plan to use the Defense Production Act (DPA) to tackle the pandemic with some cautionary words.

In a letter responding to Biden’s 200-page COVID-19 plan, the medtech trade group asked for collaboration and urged the president to consider the industry’s experience with DPA orders issued by former President Trump.

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

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Moderna’s COVID-19 vaccine may not respond as well against South African variant

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) announced today that it will start a Phase 1 study in the U.S. of an emerging variant vaccine booster candidate against a new COVID-19 variant out of South Africa. The company will also test an additional booster of its present vaccine.

The Cambridge, Mass.–based company said it has observed a sixfold reduction in neutralizing antibodies that its COVID-19 vaccine is able to produce against the new South African variant, though it said it still expects the two-dose regimen of its vaccine to be protective against emerging strains detected to date.

The in vitro neutralization studies, which involved sera from individuals vaccinated with Moderna’s vaccine, found no significant reduction in neutralizing antibodies related to the variant that has emerged out of the U.K.

“As we seek to defeat the COVID-19 virus, which has created…

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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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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 minuscule, 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 advice for drug developers and the CDC.

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

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7 core strategies in Biden’s battle against COVID-19

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Included in President Joe Biden’s sprawling strategy document for dealing with the COVID-19 pandemic are an array of plans intended to ramp up vaccination efforts.

Also included are proposals for accelerating the development of therapies such as antiviral compounds effective against SARS-CoV-2 and other coronaviruses with pandemic potential.

The “full-scale, wartime” plans have considerable relevance for the pharmaceutical and medical device industries. (More information is available on the medical-device ramifications of the plan from our sister site, Medical Design & Outsourcing.)

While the plan stands out from the prior administration’s COVID-19 response in its detail and earnestness, several portions effectively represent a continuation of existing policy. The policy, for instance, says it will end the U.S. government’s practice of stockpil…

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Pfizer, BioNTech to provide up to 40M COVID-19 vaccine doses to COVAX

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) will supply up to 40 million doses of their COVID-19 vaccine this year to COVAX, a global initiative to provide vaccine doses to developing countries. 

The companies said today that they expect the first doses to ship out during Q1; the vaccine will go to COVAX at a not-for-profit price. The financial terms of the deal were not disclosed.

“At Pfizer, we believe that every person deserves to be seen, heard and cared for. That’s why from the very beginning of our vaccine development program, Pfizer and BioNTech have been firmly committed to working toward equitable and affordable access of COVID-19 vaccines for people around the world,” Pfizer CEO Albert Bourla said in a news release. “We share the mission of COVAX and are proud to work together so that developing countries have the same access as the rest of the world, which will bring us another step closer to ending this global pandemic and pro…

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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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