covid-19 Archives - Page 36 of 113 - Medical Design Sourcing

Johnson & Johnson launches research partnerships network

Johnson & Johnson (NYSE:JNJ) announced today that it has launched the J&J Centers for Global Health Discovery, a global network of research partnerships to address the world’s health challenges.

The first J&J Satellite Center for Global Health Discovery is at the London School of Hygiene & Tropical Medicine. The pharma and medtech giant plans to open additional J&J Centers through 2022.

Each Satellite Center will focus on entrenched and emerging health threats that are pressing and have a high unmet need. Think tuberculosis (TB), dengue fever, flavivirus, coronavirus and antimicrobial resistance (AMR).

“COVID-19 has shown us that investments in early-stage research, such as novel vaccine technologies, are critical to accelerate our fight against pandemic threats. The J&J Centers for Global Health Discovery are the latest chapter in our efforts to turn science into solutions for diseases that continue to threaten communities …

Pfizer to ask FDA to authorize booster dose of its COVID-19 vaccine

Pfizer (NYSE:PFE) has said that the efficacy of its vaccine wanes after six months in the presence of contagious variants such as Delta. The company and its German partner plan on using that justification to ask FDA to extend their EUA for their COVID-19 vaccine to cover a booster dose of their mRNA vaccine.

Reuters quoted Pfizer Chief Scientific Officer Mikael Dolsten as saying that a recent uptick in COVID-19 cases in Israel is evidence that the vaccine offers less protection against the Delta variant — especially in those vaccinated six months ago or earlier.

After six months, “there likely is the risk of reinfection as antibodies, as predicted, wane,” Dolsten said.

Israel’s Health Ministry shared data on July 5 that indicated that the Pfizer-BioNTech vaccine remained effective at preventing serious COVID-19 infections, but that it was less effective overall against the Delta variant.

Early Pfizer experiments show that a third dose of BNT…

Several companies could vy for next-gen COVID-19 vaccine market share

[Photo by Daniel Schludi on Unsplash]

A couple of years ago, mRNA vaccines remained at the research stage. Now, they are among the best-selling pharmaceutical products with Pfizer (NYSE:PFE), BioNTech (NSDQ:BNTX) and Moderna (NSDQ:MRNA) dominating the market.

That could change in the long run, however, as a growing number of companies develop next generation mRNA COVID-19 vaccines, which promise to be more effective and less likely to cause side effects than their predecessors.

While mRNA COVID-19 vaccines are among the most effective vaccines against the novel coronavirus, researchers have linked their use to rare side effects such as myocarditis.

Future mRNA may be better tolerated. mRNA itself promotes an immune response future mRNA vaccines could optimize reactogenicity through refining the dose or structure of the single-stranded RNA molecule.

Such next-gen vaccines will also likel…

Abbott laying off hundreds of workers as testing demand drops

Abbott (NYSE:ABT) is reportedly laying off as many as 400 workers in Maine as a result of a drop in demand for its COVID-19 diagnostics.

WMTW-TV reported that about 300 Abbott employees will be laid off in Westbrook, Me., as confirmed by the town’s mayor. Additionally, the station reported that about 100 workers at the company’s Scarborough, Me., location will be laid off.

According to an AP report, Abbott announced in May 2020 that it would expand its workforce into Westbrook with approximately 1,200 workers at a facility producing COVID-19 test kits. The company added several jobs for such purposes due to heightened demand for its COVID-19 tests during the pandemic, including around 2,000 in Illinois last September.

“We’ve recently seen a significant, rapid decline in COVID-19 testing demand and anticipate this trend will continue,” Abbott wrote in a statement to WMTW-TV. “Because of this, we are reducing our workforce tha…

President Biden unveils initiative to boost COVID-19 vaccination numbers

President Joe Biden poses for his official portrait Wednesday, March 3, 2021, in the Library of the White House. (Official White House Photo by Adam Schultz)

With new cases of COVID-19 increasing 14% in the past two weeks, President Biden is aiming to convince unvaccinated Americans to get their first dose of the vaccine.

CDC data show that the highly transmissible Delta variant now dominates the U.S., driving close to 52% of COVID-19 cases in the U.S. from June 19 to July 13, according to CDC. Meanwhile, the Alpha variant that first emerged in the U.K. caused 29% of U.S. COVID-19 infections.

“More than 182 million Americans have received at least one shot, including nearly 90% of seniors and 70% of adults over the age of 27,” Biden said in remarks yesterday about the COVID-19 response and the vaccination program.

The U.S. is on the cusp of having 160 million fully vaccinated Americ…

APC debuts ‘medicine accelerator’ in collaboration with Enterprise Ireland

The Dublin-based pharmaceutical R&D firm APC Ltd has launched a ‘Global Centre of Excellence for Vaccine and Advanced Therapeutic Research and Manufacturing.’

The result of a €25 million investment, the new facility will staff 120 new employees.

The facility will have the capacity to produce hundreds of millions of doses of vaccines (including for COVID-19) and other therapeutic products annually.

The new plant will link to supply chains in the U.S. and Europe. Approximately half of APC’s customers are based in the U.S. APC also owns an office in Boston. The trial involves some 400 patients. The protein-based vaccine uses a synthetic version of the SARS-CoV-2 spike protein.

APC is currently partnering with the Australian company Vaxine (Adelaide), which has a Phase 2 trial underway in Iran for a COVID-19 vaccine. Vaxine is a spin-off of Australia’s National Health Sciences Center.

APC’s ‘Global Centre of Excellence for Advanced Therapeu…

Emergent BioSolutions facing a shareholder lawsuits

The Baltimore-based company Emergent BioSolutions (NYSE:EBS) is the subject of at least four lawsuits asking for refunds and pushing for change in the company’s executive ranks. Some of the lawsuits targeting Emergent accuse the company of securities fraud and insider trading.

Emergent has denied the allegations. “Our executives strictly follow the law and our own internal policies to prevent any improper securities trading,” Emergent spokesperson Matt Hartwig told The New York Times.

In any event, the past year has not been kind to Emergent BioSolutions, the multinational biopharma company focused on vaccines and antibody therapeutics.

After initially scoring the support of Johnson & Johnson (NYSE:JNJ) and AstraZeneca (LON:AZN) to manufacture their respective COVID-19 vaccines, the company saw its stock leap to a peak value of $133.42 on Aug. 14, 2020.

In afternoon trading today, its stock’s value was $61.87.

The drop in valuation resu…

J&J COVID-19 vaccine protects against Delta variant

Johnson & Johnson (NYSE:JNJ) has announced that a single shot of its COVID-19 vaccine offers significant protection against the transmissible Delta variant. The vaccine also provides an immune response lasting at least eight months.

The announcement coincides with the company filing two preprint studies to bioRxiv. The first analyzes blood samples from eight patients in the company’s Phase 3 ENSEMBLE study, which it used to win emergency use authorization in the U.S. That study concluded that a single dose of the vaccine led to a higher neutralizing antibody activity against the Delta variant than the Beta variant (B.1.351) that first emerged in South Africa.

Rival Moderna is developing a vaccine known as mRNA-1273.351 based on the Beta variant.

J&J also announced that its vaccine elicited a robust immune response to other common SARS-CoV-2 variants.

The company also said that its vaccine led to a strong neutralizing antibody response that…

Eurofins launches COVID-19 testing network to facilitate European travel

Eurofins announced today that it opened a network of about 500 COVID-19 testing centers across Europe to help facilitate summer travel.

Luxembourg-based Eurofins’ network covers major traveling hubs to provide testing accessibility in locations ranging from supermarkets to business parks and residential areas, too.

According to a news release, the company’s 500-center network is already developed, with plans to establish around 1,000 testing centers this month. The company also operates mobile testing centers to further increase availability and access, with those centers available to municipal authorities to reduce pressure on existing centers with added sampling capacity.

Each mobile collection center can process up to 200 PCR tests per day. Eurofins already launched the mobile service in Belgium, France and Germany.

U.K. preps COVID-19 booster program

Photo by Frank Meriño from Pexels

The U.K. is laying the groundwork for a COVID-19 vaccine booster program starting in the fall, making it one of the first nations to do so.

The interim initiative would prioritize providing boosters to those 70 and older, other high-risk patients and frontline health workers starting in September.

Officials at the Joint Committee on Vaccination and Immunisation (JCVI) also are considering administering COVID-19 vaccines in tandem with flu vaccines. The organization doesn’t anticipate that variant-specific vaccines will be available in time for the launch of the new vaccination drive.

A second phase of the vaccine campaign would provide shots for those 50 and older, adults between the ages of 16 and 49 years who are in an at-risk group and adult household contacts of immunosuppressed individuals.

JCVI officials, however, haven’t made definitive plans yet …

FDA revokes EUAs for certain respirators, decontamination systems after increased N95 access

The FDA issued a briefing confirming the revoking of emergency use authorizations (EUAs) for certain respirators and decontamination systems.

EUAs for all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, including disposable respirators like KN95s, along with decontamination and bioburden reduction systems, were all revoked, having been issued amid the COVID-19 pandemic.

According to an FDA release, the actions were consistent with the updated CDC recommendations for healthcare facilities to not use crisis capacity strategies and promptly return to conventional practices. Manufacturers of decontamination and bioburden reduction systems requested — and the FDA agreed to — the revocation of their EUAs, effective June 30.

Get the full story on our sister site MassDevice.

FDA revokes EUAs for certain respirators, decontamination systems after increased N95 access

The FDA issued a briefing confirming the revoking of emergency use authorizations (EUAs) for certain respirators and decontamination systems.

EUAs for all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, including disposable respirators like KN95s, along with decontamination and bioburden reduction systems, were all revoked, having been issued amid the COVID-19 pandemic.

According to an FDA release, the actions were consistent with the updated CDC recommendations for healthcare facilities to not use crisis capacity strategies and promptly return to conventional practices. Manufacturers of decontamination and bioburden reduction systems requested — and the FDA agreed to — the revocation of their EUAs, effective June 30.

NIOSH approved more than 875 respirator models or configurations since the beginning of the pandemic. The EUA revocations apply to all non-NIOSH approved, disposable facepiece respirator mod…