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The first line of vaccines was highly effective at restricting COVID-19’s damage

New analysis answers questions about the ongoing effectiveness of COVID vaccines: How well they protect against infection, hospitalization and death months…

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More than 70 per cent of the world’s population has received at least one COVID-19 vaccination. (Shutterstock)

After more than three years of COVID-19, the World Health Organization (WHO) reports that over 763 million infections, and nearly seven million deaths, have been attributed to SARS-CoV-2.

COVID-19 vaccination was deemed crucial to prevent the continued spread of the disease, protect those infected from experiencing severe effects, counter the rise of new variants, and ultimately end the pandemic.

The WHO has lifted the Public Health Emergency of International Concern, but ending the ongoing threat of COVID-19 still depends on vaccination and other protective behaviours. Understanding the effectiveness of vaccines remains crucial.

Primary doses and boosters

Today, more than 5.5 billion people (72.3 per cent of the world’s population) have received at least one dose of a COVID-19 vaccine. A total of 5.09 billion people have completed a primary COVID-19 vaccination series (i.e., two doses of a two-dose vaccine or one dose of a one-dose vaccine).

At the end of 2021, several countries began offering booster doses in response to research indicating that the effectiveness of the vaccines may diminish over time, especially against the Omicron variant, which emerged in late 2021, and has become the dominant circulating variant.

With this in mind, we sought to answer two questions. First, how well does the primary series of COVID-19 vaccines protect people (against infections, hospitalizations and deaths) four months or more after completing vaccination? Second, how well does the first booster dose protect people three months or more after receiving it?

Answering these questions will provide invaluable information for policymakers to make evidence-based decisions, such as the timing of administering COVID-19 vaccine booster doses.

To answer these questions we sought to identify all studies that:

  1. Compared people who were vaccinated (either with the primary series or a booster) to people who were unvaccinated;

  2. Followed people for at least 112 days after a primary series, or 84 days after a booster dose, and;

  3. Looked at who got infected, was hospitalized or died due to COVID-19.

In total, we identified 68 studies that met these criteria, representing 23 countries. We then combined all the data to better understand how the vaccines’ protection changes over time. The results were published in Lancet Respiratory Medicine.

Protection against COVID-19, in general

The WHO has set standards to define whether a vaccine offers adequate protection. Specifically, vaccines should show at least 70 per cent protection against infections and 90 per cent protection against hospitalizations and deaths.

We found that the primary series offered excellent protection against hospitalizations and deaths in the short term, showing over 90 per cent protection against both outcomes within 42 days after vaccination. This protection waned over time, going below the WHO recommendation, but stayed relatively high, at around 80 per cent against hospitalizations at eight months post-vaccination, and around 85 per cent against deaths at six months post-vaccination.

The primary series also offered good protection against infections in the short term (over 80 per cent within the first 42 days), but that protection fell to around 60 per cent after four months, and 50 per cent after nine months.

The initial protection of a booster dose was around 70 per cent against infections and 90 per cent against hospitalizations within the first month after vaccinations. Protection then fell to around 45 per cent against infections and to around 70 per cent against hospitalizations after four months had passed. Too little data was available to track the long-term effects against deaths.

Overall, the vaccines work at preventing infections, hospitalizations and deaths related to COVID-19, but their effectiveness does decline over time, particularly against infections. Boosters restore protection lost, but may need additional boosting over time.

Protection against the Omicron variant

Vaccines were generally less effective against the Omicron variant, which emerged in fall 2021, about a year after COVID-19 vaccines were introduced.

Within 42 days after vaccination with the original COVID-19 vaccine formulations, the primary series only reached around 60 per cent protection against Omicron-based infections, and this dropped to around 30 per cent after five months.

The primary series’ protection against hospitalization for Omicron infections reached around 70 per cent within the first 42 days, but also dropped over time, reaching closer to 50 per cent after six months. None of these reached the levels recommended by the WHO.

The boosters did fare better in protecting against Omicron. Within the first 28 days after the booster, protection hovered close to the 70 per cent threshold against infections and 90 per cent threshold against hospitalizations recommended by the WHO.

For context, if individuals delayed the administration of the booster by six months after completing the primary series, their protection levels would be around 20 per cent against Omicron infections and around 50 per cent against hospitalizations right before receiving the booster.

Yet, booster protection also waned over time, falling to about 40 per cent against Omicron infections and 70 per cent against hospitalizations after four months post-booster. Too little data was available to comment on long-term effects against deaths.

Syringes lined up in front of two vials of vaccine
Pfizer, left, and Moderna bivalent COVID-19 vaccines were introduced in fall 2022. (AP Photo/Steve Helber)

With Omicron, boosters are particularly needed to maintain adequate protection, but this protection also needs additional boosting as it wanes over time.

New formulations of mRNA COVID-19 vaccines that target the Omicron variant were introduced in fall 2022, and are recommended for booster shots by Canada’s National Advisory Commission on Immunization. The Public Health Agency of Canada recommended in March 2023 that people at high risk of severe COVID-19 get an additional booster shot.

In May, the WHO recommended that new formulations of COVID-19 vaccines should target Omicron XBB variants, which are the dominant variants currently circulating.

Behaviour-based prevention measures remain necessary

While vaccines provide reasonable protection against COVID-19 infections, hospitalizations and deaths, their effectiveness is imperfect and wanes over time, particularly against the now-dominant Omicron variant for people vaccinated with the original vaccines.

Notably, waning is especially pronounced against infections. This means that although being vaccinated is likely to protect most people against becoming severely ill, vaccinated people are still at risk of catching the virus and transmitting it to others — some of whom will be at higher risk of severe complications from the disease.

That means measures like wearing a mask, washing one’s hands, and staying at home when sick remain essential complements to vaccination. Contrary to vaccines, these measures do not decline in effectiveness over time and are particularly well suited to protect people against infections.

Eliminating the threat of new COVID-19 infections will continue to rely heavily on a combination of vaccination and behaviours, whereas new vaccine doses will continue to protect those who are infected from severe complications like hospitalizations and deaths.

Nana Wu receives funding from the Canadian Institutes of Health Research (CIHR).

Keven Joyal-Desmarais receives funding from the Fonds de recherche du Québec (FRQ) and the Canadian Institutes of Health Research (CIHR).

Simon Bacon receives funding from Fonds de recherche du Québec (FRQ), Canadian Institutes of Health Research (CIHR), Canadian Foundation for Innovation (CFI), Public Health Agency of Canada (PHAC), Weston Family Foundation, Canadian Cancer Society (CCS), Heart and Stroke Foundation of Canada (HSFC), Quebec Ministère de l’économie et de l’innovation (MEI), Canadian Partnership Against Cancer (CPAC), Canadian Statistical Sciences Institute (CANSSI), The Auger Foundation, Concordia University, CIUSSS-NIM.

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Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

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To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

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Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

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Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


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Another country is getting ready to launch a visa for digital nomads

Early reports are saying Japan will soon have a digital nomad visa for high-earning foreigners.

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Over the last decade, the explosion of remote work that came as a result of improved technology and the pandemic has allowed an increasing number of people to become digital nomads. 

When looked at more broadly as anyone not required to come into a fixed office but instead moves between different locations such as the home and the coffee shop, the latest estimate shows that there were more than 35 million such workers in the world by the end of 2023 while over half of those come from the United States.

Related: There is a new list of cities that are best for digital nomads

While remote work has also allowed many to move to cheaper places and travel around the world while still bringing in income, working outside of one's home country requires either dual citizenship or work authorization — the global shift toward remote work has pushed many countries to launch specific digital nomad visas to boost their economies and bring in new residents.

Japan is a very popular destination for U.S. tourists. 

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This popular vacation destination will soon have a nomad visa

Spain, Portugal, Indonesia, Malaysia, Costa Rica, Brazil, Latvia and Malta are some of the countries currently offering specific visas for foreigners who want to live there while bringing in income from abroad.

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With the exception of a few, Asian countries generally have stricter immigration laws and were much slower to launch these types of visas that some of the countries with weaker economies had as far back as 2015. As first reported by the Japan Times, the country's Immigration Services Agency ended up making the leap toward a visa for those who can earn more than ¥10 million ($68,300 USD) with income from another country.

The Japanese government has not yet worked out the specifics of how long the visa will be valid for or how much it will cost — public comment on the proposal is being accepted throughout next week. 

That said, early reports say the visa will be shorter than the typical digital nomad option that allows foreigners to live in a country for several years. The visa will reportedly be valid for six months or slightly longer but still no more than a year — along with the ability to work, this allows some to stay beyond the 90-day tourist period typically afforded to those from countries with visa-free agreements.

'Not be given a residence card of residence certificate'

While one will be able to reapply for the visa after the time runs out, this can only be done by exiting the country and being away for six months before coming back again — becoming a permanent resident on the pathway to citizenship is an entirely different process with much more strict requirements.

"Those living in Japan with the digital nomad visa will not be given a residence card or a residence certificate, which provide access to certain government benefits," reports the news outlet. "The visa cannot be renewed and must be reapplied for, with this only possible six months after leaving the countr

The visa will reportedly start in March and also allow holders to bring their spouses and families with them. To start using the visa, holders will also need to purchase private health insurance from their home country while taxes on any money one earns will also need to be paid through one's home country.

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