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How end-to-end visibility and machine learning can safeguard the vaccine supply chain

Photo by Spencer Davis on Unsplash

For any vaccine, some degree of waste is expected. The problem is inspiring supply-chain companies to explore new technologies that can address a longstanding struggle.

“Before COVID-19, we often saw waste of about 8–10%,” said Ranjeet Banerjee, CEO of Cold Chain Technologies, which provides insulated packaging for drugs and biologics.

A 2019 World Health Organization report citing 2002 data concluded that between 5% and 50% of routine vaccines are wasted.

In some cases, entire pallets or freezers of vaccines are tossed out due to storage unit malfunctions that may have impacted only some vaccine vials.

In general, the biopharma industry loses roughly $35 billion each year as a result of cold-chain, according to a 2019 IQVIA report.

COVID-19 vaccines up the stakes. “COVID vaccine has ten times the complexity,” Banjree said. Not only are a variety of vaccines availabl…

FDA just made pooled COVID testing easier

(Image from Mayo Clinic)

COVID-19 molecular tests have already been authorized for individual use will have an easier time getting an FDA nod for pooled testing.

The FDA said today it will add tests by manufacturers who validated their nasal specimen test for pooling to its list of tests available for use with pooled nasal specimens. This could expand the number of tests that schools and employers can use to routinely screen asymptomatic individuals for SARS-CoV-2, the virus that causes COVID-19.

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

Benefits of J&J COVID-19 vaccine outweigh risks, EU regulator says

The European Medicines Agency confirmed that the benefits of the COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ) outweigh risks of blood clots.

At a meeting today, EMA’s safety committee (PRAC) concluded that there is a link between unusual blood clots with low blood platelets with the COVID-19 vaccine made by J&J’s Janssen Pharmaceuticals unit. PRAC determined that a warning for this potential issue should be added to the vaccine’s product information and the events should be listed as a very rare side effect of the vaccine, according to a news release.

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

Benefits of J&J COVID-19 vaccine outweigh risks, EU regulator says

The European Medicines Agency confirmed that the benefits of the COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ) outweigh risks of blood clots.

At a meeting today, EMA’s safety committee (PRAC) concluded that there is a link between unusual blood clots with low blood platelets with the COVID-19 vaccine made by J&J’s Janssen Pharmaceuticals unit. PRAC determined that a warning for this potential issue should be added to the vaccine’s product information and the events should be listed as a very rare side effect of the vaccine, according to a news release.

The committee considered all available evidence of the events, which came to the fore after six reports of blood clots and one death in the U.S., which led to the country pausing use of J&J’s vaccine. EMA cited eight reports from the U.S. regarding blood clots among more than 7 million people who had received the J&J vaccine.

Blood clots occurred mostly at unusu…

Abbott stock down on mixed bag Q1

Abbott (NYSE:ABT) shares are down today on first-quarter results that were mixed compared to the consensus forecast.

The Abbott Park, Ill.–based company posted profits of $1.8 billion, or $1 per share, on sales of $10.5 billion for the three months ended March 31, 2021, more than doubling its bottom-line on sales growth of 35.3%.

Adjusted to exclude one-time items, earnings per share were $1.32, 5¢ ahead of Wall Street, where analysts were looking for sales of $10.7 billion.

Abbott’s revenues and profits were boosted by $2.2 billion in sales for its COVID-19 testing-related products, although its sales still increased by 7.6% excluding those numbers.

Other factors in the company’s performance included CMS’s expanded reimbursement ruling for Abbott’s MitraClip and the launch of its NeuroSphere virtual clinic for remote care services.

“We’re off to a very strong start to the year, with all four of our major…

Fauci: J&J vaccination could resume shortly

The third vaccine to win emergency use authorization in the U.S. could reappear after a 10-day pause, according to Dr. Anthony Fauci, the nation’s top disease expert.

FDA and CDC had recommended temporarily suspending the use of the Johnson & Johnson (NYSE:JNJ) vaccine after six women developed serious blood clots within weeks of vaccination.

Fauci stressed that he was uncertain how CDC and FDA might proceed with the vaccine but believed that it was unlikely the pause would become permanent.

The vaccine will likely be accompanied by a warning mentioning a small risk of blood clotting problems, including cerebral venous sinus thrombosis presenting with low platelet count.

“I do think that there will likely be some sort of warning or restriction or risk assessment. I don’t think it’s just going to go back and say, ‘OK, everything’s fine,’ and go right back,” Fauci said in an interview with NBC’s “Meet the Press.”

A CDC advisory panel is s…

EU secures additional 100 million Pfizer-BioNTech vaccine doses

The European Union has decided to exercise an option to purchase additional doses of the Comirnaty COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

The two companies will deliver 600 million doses of the vaccine to the EU in 2021.

The Continent’s mass-vaccination efforts have sputtered for much of early 2021, given supply constraints related to the AstraZeneca vaccine and, later, safety concerns related to rare blood clotting problems potentially linked to that vaccine.

In related news, Sweden and several other EU nations are negotiating with Russia to procure that country’s Sputnik V vaccine. The idea behind those talks is to prepare for when the European Medicines Agency authorizes that vaccine.

The EU nations Hungary and Slovakia had already obtained a substantial number of doses of the vaccine, but Russia had asked Slovakia to return hundreds of millions of doses earlier this month, citing contract violations, Reuters repo…

FDA nixes EUA for Lilly’s bamlanivimab

On April 16, Lilly announced that it was requesting FDA to revoke the emergency use authorization (EUA) for the monoclonal antibody bamlanivimab (LY-CoV555) when used alone.

Hours after, the agency agreed to rescind the EUA on the grounds that bamlanivimab is potentially ineffective against some SARS-CoV-2 variants.

Bamlanivimab, however, won’t be disappearing as a COVID-19 treatment but will be paired with another monoclonal antibody known as etesevimab.

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

This wearable could signal cytokine storms

[Image by Kai-Chun Lin]

Researchers at the University of Texas at Dallas have developed a sweat sensor that could detect cytokine storms in patients suspected of having COVID-19 and other illnesses.

Early on in the pandemic, doctors found that patients who developed a surge of pro-inflammatory immune proteins, called “cytokine storms,” were more often the sickest and at the highest risk of dying from COVID-19. According to the researchers, cytokine storms can occur in other illnesses as well, like influenza. Scientists on the study developed a sweat sensor that could act as an early warning system for an impending cytokine storm to help doctors more effectively treat patients.

“Especially now in the context of COVID-19, if you could monitor pro-inflammatory cytokines and see them trending upwards, you could treat patients early, even before they develop symptoms,” Shalini Prasad, …

J&J reportedly asked COVID-19 vaccine developers to study blood clot risks

[Image courtesy of Wikipedia]

Johnson & Johnson (NYSE:JNJ) privately contacted other COVID-19 vaccine makers last week to gauge their interest in studying blood clot risks, according to a Wall Street Journal report. Specifically, the company asked whether its rivals — AstraZeneca, Moderna and Pfizer— had new information about blood clots following vaccination and if they were interested in forming an external panel to examine the issue, according to the article citing anonymous sources.

None of the four companies have confirmed nor denied the report.

J&J researchers did state in NEJM that there is insufficient evidence to link six cases of cerebral venous sinus thrombosis (CVST) paired with low platelet counts to the company’s COVID-19 vaccine. Approximately seven million people in the U.S. have received the vaccine.

AstraZeneca (LON:AZN) is said to have been interested in allying wit…

A quick history of the tech behind J&J, AstraZeneca’s COVID-19 vaccines

Adenovirus image from Wikipedia

Regulatory authorities in the U.S. and Europe have either paused or constrained the use of COVID-19 vaccines from AstraZeneca (LON:AZN) and Johnson & Johnson (NYSE:JNJ), causing some to wonder why the adenoviral-vector vaccines have been potentially linked to similar blood clotting events.

Researchers have observed blood clotting events associated with adenoviral vectors since the late-1990s in early experiments with the platform. But the safety of the platform has improved as genetic engineering has advanced.

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

A quick history of the tech behind J&J, AstraZeneca’s COVID-19 vaccines

Transmission electron micrograph of two Adenovirus particles. Image courtesy of Wikipedia.

After regulatory authorities in the U.S. and Europe have either paused or constrained the use of COVID-19 vaccines from AstraZeneca (LON:AZN) and Johnson & Johnson (NYSE:JNJ), some regulatory authorities wonder why the adenoviral-vector vaccines have been potentially linked to similar blood clotting events.

Researchers have observed blood clotting events associated with adenoviral vectors since the late-1990s in early experiments with the platform. But the safety of the platform has improved as genetic engineering has advanced.

The history of using viruses as vectors dates back to the mid-1970s when scientists Dr. J. Michael Bishop and Dr. Harold Varmus demonstrated that gamma-retroviruses could acquire cellular genes.

Researchers began creating adenoviral vectors in the 1980s, testing replication-de…