coronavirus Archives - Page 67 of 99 - Medical Design Sourcing

8 hurdles related to COVID-19 vaccine distribution

Pfizer-BioNTech vaccine image courtesy of Wikipedia

While vaccines remain the most powerful tool in achieving herd immunity for COVID-19, mass-vaccination has thus far proven more challenging than anticipated in many parts of the world. There are expected challenges, such as dealing with the subarctic storage requirements (–112º to –76º F) of the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). But the vaccine rollout is posing a series of challenges, many of which have been hard to anticipate.

1. Lack of standardization

One factor slowing COVID-19 vaccine distribution is confusion. “One of our biggest challenges right now is just lack of standardization across the U.S.,” said Marsha Flores Harris, product manager for FDB Prizm, a knowledge base platform from privately-held First Databank.

Not only is there variability in the storage requirements for the vaccines likely to be used in …

What’s next for the FDA and for Stephen Hahn?

FDA Commissioner Dr. Stephen Hahn

Outgoing FDA commissioner Stephen Hahn says he needs some time to reflect on his future after leading the FDA for a little over a year.

It’s hard to blame him.

Hahn’s brief tenure at FA has been rocky, to say the least.

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

What’s behind the severe allergic reactions from COVID-19 vaccines?

(Image by Sam Moqadam on Unsplash)

Reports of severe allergic reactions to COVID-19 vaccines have made consistent headlines in recent weeks. Still, such anaphylactic reactions are rare, occurring in approximately 11 out of every million doses for the vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), according to CDC.

While that is roughly 10 times the flu vaccine rate, COVID-19 vaccines so far have been generally well-tolerated in the vast majority of patients.

“The anaphylaxis rate for COVID-19 vaccines may seem high compared to flu vaccines, but I want to reassure you that this is still a rare outcome,” said Dr. Nancy Messonnier, the director of the CDC’s National Center for Immunization and Respiratory Diseases in a recent call with reporters.

More recent CDC data suggests a lower rate of anaphylactic reactions of 5.5 per 1 million injected vaccine doses.

Anaphylaxis, a severe …

FDA grants EUA for RapCov rapid COVID-19 antibody test

Advaite announced today that it received FDA emergency use authorization for its RapCov point-of-care COVID-19 antibody test.

Malvern, Penn.-based Advaite’s rapid response IgG antibody test uses fingerstick whole blood in point-of-care settings and is touted as capable of providing results in 15 minutes, according to a news release.

All RapCov rapid COVID-19 test kits are manufactured and assembled at FDA-registered facilities in southeastern Pennsylvania, Advaite said.

The company plans on immediately supplying the market with its testing kits on a national scale following the FDA authorization, it said.

“This is a watershed moment in the fight against this pandemic,” Advaite CEO Karthik Musunuri said in the release. “The RapCov rapid COVID-19 test offers unique advantages in containing the virus. Advaite’s test is simple to use, provides accurate results from a drop of fingertip blood and can detect IgG antibodies t…

How Abbott stayed two steps ahead of COVID-19

Developing a fast COVID-19 that resembled a pregnancy test and building two factories to boost productions — those were but two of the quick-thinking actions that Abbott (NYSE:ABT) officials took in the early months of a deadly coronavirus pandemic.

Abbott began tracking the virus in China at the end of 2019 and into early 2020. By February, the company had an internal meeting to discuss its plan of action as the virus began to spread rapidly and was introduced to the U.S. The World Health Organization declared the COVID-19 outbreak a pandemic on March 11, 2020.

“We knew this virus was different. The outcome was spreading across the globe,” Andrea Wainer, executive VP of rapid and molecular diagnostics at Abbott, said during a CES 2021 panel. “Diagnostic players were going to need to play a role.”

Customers started asking Abbott to develop tests in February. At that time, there were only 72,000 cumulative cases worldwide, according to the Johns …

How Abbott stayed two steps ahead of COVID-19

Developing a fast COVID-19 that resembled a pregnancy test and building two factories to boost production — those were but two of the quick-thinking actions that Abbott (NYSE:ABT) officials took in the early months of a deadly coronavirus pandemic.

Abbott began tracking the virus in China at the end of 2019 and into early 2020. By February, the company had an internal meeting to discuss its plan of action as the virus began to spread rapidly and was introduced to the U.S. The World Health Organization declared the COVID-19 outbreak a pandemic on March 11, 2020.

“We knew this virus was different. The outcome was spreading across the globe,” Andrea Wainer, executive VP of rapid and molecular diagnostics at Abbott, said during a CES 2021 panel. “Diagnostic players were going to need to play a role.”

Customers started asking Abbott in February to develop tests. At that time, there were only 72,000 cumulative cases worldwide, according to the Johns Hopkins U…

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.

1. Facial fillers ≠ Botox

Delayed inflammation is possible for patients who receive either hyaluronic acid or non-hyaluronic acid fillers. The former option, comprising brands such as Juvéderm from AbbVie subsidiary Allergan (NYSE:ABBV) and Restylane from Galderma Laboratories, is the most common.

Facial fillers, however, are distinct from Boto…

EY says COVID-19 stunted medtech M&A in 2020, should see improvement in 2021

[Image from Jp Valery on Unsplash]

Ernst & Young today released its 2021 EY M&A Firepower report, revealing a staggering dip in mergers and acquisitions (M&A) activity in medtech.

Life sciences M&A activity totaled $159 billion in 2020, according to the report — a plunge to nearly half of the 2019 total of $306 billion, representing one of the lowest levels EY has observed since 2014.

Only AstraZeneca’s $39 billion acquisition of Alexion Pharmaceuticals qualified as a “megadeal” while it made up about a quarter of the total M&A activity in the space.

EY addressed the obvious difficulties of making deals during the COVID-19 pandemic, both financially and logistically (virtual negotiations, etc.), and also noted that persistently high valuations for biopharma and medtech targets kept would-be buyers away from making purchases that were already made difficult by the pandemic.

Biopharma acquirers refocused on all…

Pfizer-BioNTech COVID-19 vaccine apparently effective against ‘UK strain’

The BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) seems to offer protection against the new, more transmissible variant of the novel coronavirus identified in the U.K., according to a study from Pfizer and the University of Texas Medical Branch.

The study has not been currently peer-reviewed.

In additional testing, the Pfizer-BioNTech vaccine appeared to be effective against 15 other strains of SARS-CoV2.

The so-called “UK variant” of COVID-19, also known as the B.1.1.7 strain, has spooked the world in recent weeks, given its potential to exacerbate the pandemic. While the U.K. and South African strains may be transmitted more readily than others, researchers have not linked them to increased severity of COVID-19 infections.

Some commentators had suspected that the mutations would be unlikely to have a significant impact on COVID-19 vaccine performance.

For one thing, the mutations have not led to substantia…

FDA warns about COVID-19 molecular test false negatives as virus mutates

The FDA is warning that false negatives may occur with molecular tests used to detect SARS-CoV-2 if a mutation has occurred in the virus’s genome.

According to the FDA, the warning comes as public health officials warn about the new B.1.1.7 variant that appears to be more transmissible than the COVID-19 virus from 2020.

Three molecular tests that have received emergency use authorization have been analyzed by the FDA whose performance could be impacted by the new SARS-CoV-2 genetic variant:

Mesa Biotech’s Accula SARS-CoV-2 test performance may be impacted when a SARS-CoV-2 virus patient sample has a genetic variant at position 28881 when tested. The FDA said the impact does not appear to be significant. Thermo Fisher Scientific’s TaqPath COVID-19 Combo Kit (also labeled as the TaqPath COVID-19 Combo Kit advanced) has significantly reduced sensitivity due to certain mutations in the SARS-CoV-2 virus, including one of the mutations int he r…

CES 2021: Medical technologies you need to know

There are fewer mobile health devices and wearables to check out as this year’s CES goes virtual — with a trend toward medtech to slow the spread of COVID-19.

Scheduled for Jan. 11–14, CES 2021 will feature 419 digital health and 219 wearable devices, down from 546 and 635 devices, respectively, presented at CES 2020.

CES 2021 will include portable air purifiers, hands-free body temperature thermometers, EEG brain mapping devices and more.

Here are seven companies exhibiting digital health and wearable products at this year’s show.

Next >>

FDA authorizes fingerstick COVID-19 antibody test

Nirmidas Biotech announced this week that it received FDA emergency use authorization (EUA) for its COVID-19 test in point-of-care settings.

Palo Alto, Calif-based Nirmidas Biotech’s MidaSpot rapid COVID-19 antibody combo detection kit uses fingerstick serology testing to detect IgG/IgM antibodies related to the SARS-CoV-2 virus causing COVID-19, according to a news release.

MidaSpot, touted by Nirmidas as the first point-of-care fingerstick COVID-19 test to receive EUA, can now be administered widely in CLIA-waived settings (such as doctor’s offices, urgent care facilities, ERs, pharmacies and more) with results yielded in 15-20 minutes.

In point-of-care testing, the test detects and differentiates antibody IgG and IgM post-COVID-19 infection. MidaSpot demonstrated 100% sensitivity for IgG after 14 days post-symptom onset and 100% sensitivity for IgM after seven days post-symptom onset in clinical studies.

Nirmidas previously deployed…