COVID-19 pandemic Archives - Medical Design Sourcing

Lung-on-chip predicts COVID-19 antiviral response

While vaccines have emerged as a central tool in battling the COVID-19 pandemic, the SARS-CoV-2 virus continues to fuel waves of infections.

COVID-19 antivirals could play a vital role in managing the disease in the future, and a handful are currently in use in the U.S.

One possible way to accelerate the development of additional antivirals for COVID-19 and other respiratory viral infections is the availability of more accurate preclinical models.

The nonprofit engineering innovation company Draper has released a study showing the power of combining human tissue models based on an organ-on-chip platform in a dynamic tissue microenvironment with input from microbiologists and bioengineers.

In essence, the Cambridge, Massachusetts–based company has developed a human lung model known as PREDICT96-ALI that can gauge the efficacy of SARS-CoV-2 drugs, including antivirals.

In the research published on the pre-print server bioRxiv, researcher…

Laying the groundwork for clinical trial diversity

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The COVID-19 pandemic has elevated the importance of clinical trial diversity while also asserting remote clinical trials as a valid approach for a growing number of drug studies, as a recent JAMA study concluded.

At the same time, the pandemic highlighted the need for continued progress, according to Otis Johnson, chief diversity, inclusion and sustainability officer at Clario.

“I think COVID shone too much of a bright light on the lack of diversity in clinical trials for us not to make progress,” Johnson said.

More regulatory clarity

While a growing number of drug developers are prioritizing diversity, “regulatory agencies will need to be more deliberate,” Johnson added. “So far, the guidance has been exactly that — guidance.” Regulatory agencies should mandate best practices supporting diversity in clinical trials, he said.

WHO prequalifies aIL-6R therapy for patients with severe or critical COVID-19

Roche (SWX:ROG) has won World Health Organization (WHO) prequalification for Actemra/RoActemra.

Actemra/RoActemra is an anti-interleukin-6 receptor (aIL-6R) receptor antagonist with tocilizumab as an active substance.

The prequalification will assist in low- and middle-income countries in procuring the therapy for patients on systemic corticosteroids who require supplemental oxygen or mechanical ventilation.

Actemra/RoActemra is the twelfth medicine to win prequalification.

“We’ve partnered with WHO and others throughout the last year to ensure that our COVID-19 medicines and tests can potentially reach more than 100 low- and middle-income countries, and WHO’s prequalification of Actemra/RoActemra is just one of the paths taken together to achieve this,” said Bill Anderson, CEO of Roche Pharmaceuticals, in a news release.

Roche will provide Actemra/RoActemra to WHO and partners at cost.

The company also said it would not assert its p…

Israeli researchers release data on fourth dose of COVID-19 vaccine

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Early data from Israel’s Sheba Medical Center showed that an additional booster of COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) led to a fivefold increase in antibodies one week after receipt of the vaccine.

Pfizer had earlier announced that a third dose of the vaccine increased antibody levels 25-fold compared to a two-dose primary series.

Pfizer and BioNTech, along with their competitor Moderna (NSDQ:MRNA), continue to develop an omicron-specific version of their mRNA vaccine.

The prospect of a fourth dose of the original vaccine for immunocompetent people may be more controversial than a third.

While Israel has begun administering a fourth dose to some individuals, the head of the French vaccination program, Dr. Alain Fischer, said there was insufficient evidence at present to recommend an additional vaccine dose. France could dec…

UK ramps up booster program to confront surge in COVID-19 cases

Boris Johnson

U.K. Prime Minister Boris Johnson has announced that the country will accelerate its coronavirus vaccination booster initiative to fight a “tidal wave” of cases resulting from the infectious Omicron variant.

Johnson acknowledged that two doses of vaccine were unlikely sufficient to fight off the recent surge in infections, which hit the second-highest level in the UK since the pandemic began.

In an interview with Sky News, Johnson reported that at least one individual infected with the Omicron variant had died. In the UK, roughly 10 people with the variant have been hospitalized to date.

To date, the country has confirmed 4,713 cases of the Omicron variant, according to Health Secretary Sajid Javid.

Javid reported that the Omicron variant is now responsible for about one in five cases in the UK.

The country will offer fully vaccinated individuals a third dose by the …

Why global vaccine equity could prolong the COVID-19 pandemic

[Photo by Fusion Medical Animation on Unsplash]

In May, the World Health Assembly set the goal of fully vaccinating 10% of each country’s population by September 30. A number of countries hit the goal, including 15 in Africa, but more than 50 didn’t.

“It’s very concerning,” said Donna Patterson, a fellow at the Wilson Center, in a recent webinar from that organization. Uneven vaccination rates threaten to extend the COVID-19 pandemic’s timelines. Some countries remain far behind the 10% goal. For example, the percentage of fully vaccinated people in Senegal is 5.6%. Burundi’s rate is near 0%. “There are other countries that are higher, mostly in North Africa, including Morocco, but that also varies,” said Patterson, who is also a professor at Delaware State University.

Vaccination rates are also lagging in regions such as the Caribbean, Latin Americ…

UK puts vaccine manufacturing goes up for auction

Image courtesy of VMIC

The U.K. government has put a manufacturing plant up for sale that was instrumental in the country’s plan to battle future pandemics.

According to The Financial Times, the plant, dubbed the Vaccine Manufacturing Innovation Centre (VMIC), had received at least £215 million of public funding since it was launched in 2018.

A handful of companies have placed bids for the 74,000 m2 plant, located in Harwell, approximately 15 miles from Oxford.

The U.K. had planned on using the facility to make vaccines for epidemics, but the COVID-19 pandemic has elevated the role of private industry in vaccine manufacturing.

The country had scheduled to complete work on the Vaccine Manufacturing Innovation Centre in 2023 but moved that date to spring 2022 in an earlier phase of the pandemic.

Created as a nonprofit organization, the Vaccine Manufacturing Innovation Centre (VMIC) …

J&J joins Moderna and Pfizer in researching Omicron variant

Johnson & Johnson (NYSE:JNJ) has announced that it is collaborating with academic institutions internationally to gauge the effectiveness of its COVID-19 vaccine against Omicron and other SARS-CoV-2 variants.

In particular, J&J said it is conducting research on blood serum from clinical trial volunteers who have received single or multiple doses of its COVID-19 vaccine.

The company also vowed to design and develop an Omicron-specific variant vaccine if necessary.

“We remain confident in the robust humoral and cell-mediated immune responses elicited by the Johnson & Johnson COVID-19 vaccine demonstrated by the durability and breadth of protection against variants to date in clinical studies,” said Dr. Mathai Mammen, global head, Janssen Research & Development, in a press release. “Building on our long-term collaboration with scientists on the ground in South Africa and the ongoing real-world effectiveness studies being conducted with the J…

OSHA suspends enforcement of COVID-19 vaccine mandate

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The Biden administration will not proceed with enforcing its vaccine mandate for businesses with at least 100 employees given a recent decision by the U.S. Court of Appeals for the Fifth Circuit.

The administration had planned on putting the Occupational Safety and Health Administration (OSHA) in charge of administering the COVID-19 vaccine mandate. While a statement on the OSHA website proclaims that it “remains confident in its authority to protect workers in emergencies,” the agency agreed it would suspend enforcement of the emergency temporary standard (ETS) that would have required many U.S. employees to be fully vaccinated or face regular testing. However, OSHA could change course in the event of a further court order.

The U.S. Court of Appeals for the Sixth Circuit will hear the challenge to the OSHA-specific vaccine mandate.

For the time being, however, OSHA h…

J&J COVID-19 vaccine to find use in conflict zones

Johnson & Johnson (NYSE:JNJ) has reached an agreement with the U.S. government and the public–private health partnership Gavi to distribute the Ad26.COV2.S vaccine to conflict zones or humanitarian settings.

New Brunswick, NJ–based Johnson & Johnson anticipates deliveries in such areas in the coming days.

“We believe our single-shot COVID-19 vaccine has a critical role to play in conflict zones and other humanitarian settings that can’t be reached by government vaccination campaigns, and we are proud to be part of this effort to protect the world’s most vulnerable people,” said Dr. Paul Stoffels, J&J’s vice chairman of the executive committee and chief scientific officer, in a press release.

To facilitate deliveries to such hard-to-reach areas, Gavi established the concept of a COVAX Humanitarian Buffer earlier this year. Governments and humanitarian agencies can apply for authorization for the distinction from Gavi.

The Inter-Agen…

States sue to block COVID-19 vaccine mandate

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The attorneys general in 26 U.S. states are opposing the Biden administration’s plan to force many employers to require their workers to obtain vaccination against COVID-19.

While the majority of states were Republican-led, Kansas, Louisiana and Kentucky were three Democratic-leaning states that joined the litigation.

White House spokeswoman Karine Jean-Pierre said in a media briefing that the vaccine mandates have a firm legal footing.

The vaccination mandate threatens penalties of almost $14,000 per infraction.

The federal government intends to begin enforcing the rules on January 4.

The rules are more stringent for healthcare facilities receiving funding from Medicare and Medicaid. In such facilities, eligible staff must receive at least one vaccine dose before providing healthcare, treatment or other services by December 5.

Biden’s COVID-19 vaccine mandate goes into effect

President Biden first signaled his intent to require many American workers to obtain full vaccination against COVID-19 in September.

Now, a significant number of employers must ensure their workers are either vaccinated or tested weekly for COVID-19 by January 4 as the rules become official. The requirements will apply to employers with at least 100 employees, translating to approximately 84 million workers.

At present, roughly two-thirds of Americans have received at least one dose of a COVID-19 vaccine, and just over 58% of the U.S. public is fully vaccinated, according to CDC. In addition, about one in ten people have received a booster dose.

Several other countries have substantially higher vaccination rates, including the United Arab Emirates, Portugal, Spain, Israel, Singapore, Japan and Canada.

The federal requirements also enable workers to receive paid time off to obtain vaccine doses and sick time to deal with side effects.

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